Blood giving set

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A Blood Giving Set is a sterile, single-use intravenous administration set specifically designed for transfusing whole blood and blood components—including packed red blood cells, platelets, fresh frozen plasma, and cryoprecipitate—to patients with bleeding, anemia, or coagulation disorders. Featuring an integral microaggregate filter (170-260 microns) that removes clots and particulate matter, large-bore tubing for optimal flow rates, and a precision roller clamp for controlled infusion, the blood giving set ensures safe, filtered delivery of life-saving blood products. Compatible with blood warming devices and pressure infusers, the set supports both slow, controlled transfusions for medically fragile patients and rapid, high-volume infusion for those with active hemorrhage. For the clinician, the blood giving set simplifies transfusion set-up, ensures consistent filtration, and enables precise flow control. For the patient receiving blood transfusion due to trauma, surgery, gastrointestinal bleeding, cancer, or bone marrow failure, the blood giving set delivers essential blood components that restore oxygen-carrying capacity, correct coagulation, and support survival.
Description

Blood Giving Set

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Transfusion of Whole Blood and Blood Components
  • Primary Use: Provides a sterile, single-use intravenous administration set specifically designed for transfusing whole blood, packed red blood cells, platelets, fresh frozen plasma, and cryoprecipitate to patients with bleeding, anemia, or coagulation disorders.
  • How it helps: For the nurse, physician, and transfusion specialist, the blood giving set features an integral blood filter that removes clots and microaggregates—ensuring that only safe, filtered blood components reach the patient while preventing infusion of potentially harmful particles. For the patient with acute blood loss from trauma, surgery, or gastrointestinal bleeding, or for those with chronic anemia, cancer, or bone marrow failure, the blood giving set delivers life-saving blood components that restore oxygen-carrying capacity, correct coagulation, and support survival.
2. Integrated Blood Filter for Particle Removal
  • Primary Use: Contains a built-in microaggregate filter (typically 170-260 microns) that removes clots, platelet aggregates, and other particulate matter from blood components during transfusion.
  • How it helps: For the transfusion nurse and clinician, the integrated filter eliminates the need for separate in-line filters—simplifying set-up, reducing manipulation, and ensuring consistent filtration for every transfusion. For the patient, effective filtration prevents infusion of microaggregates that could cause pulmonary complications, febrile reactions, or microvascular obstruction.
3. Controlled Flow Rate for Safe Transfusion
  • Primary Use: Features a precision roller clamp and large-bore tubing that allows controlled flow rates from slow drip to rapid infusion, accommodating different clinical situations and patient tolerances.
  • How it helps: For the clinician managing a patient with active hemorrhage, the blood giving set can deliver blood rapidly (up to 5-10 mL per second) to restore circulating volume; for patients at risk of fluid overload or transfusion-associated circulatory overload (TACO), the roller clamp allows slow, controlled infusion. For the patient, precise flow control matches transfusion speed to their clinical condition—preventing both inadequate resuscitation and life-threatening volume overload.
4. Compatibility with Blood Warming Devices
  • Primary Use: Designed with standard connectors compatible with in-line blood warmers for patients requiring warmed blood transfusions.
  • How it helps: For the anesthesiologist and trauma nurse, the blood giving set connects seamlessly to blood warming devices—preventing hypothermia and cardiac complications during massive or rapid transfusion. For the patient receiving large volumes of cold stored blood, warming prevents hypothermia, coagulopathy, and cardiac arrhythmias that could be fatal.

SECONDARY & SUPPORTIVE USES

1. Massive Transfusion Protocol Activation: Used during massive hemorrhage (trauma, obstetrics, surgery) for rapid infusion of multiple blood units.
2. Exchange Transfusion in Neonates: Used for exchange transfusion in newborns with severe hyperbilirubinemia or polycythemia.
3. Intraoperative Blood Salvage Administration: Used to reinfuse autologous blood collected during surgery.
4. Pre-Operative Blood Preparation: Used to administer blood components to anemic patients before elective surgery.
5. Sickle Cell Crisis Management: Used to administer simple or exchange transfusion in patients with sickle cell disease.
6. Thrombotic Thrombocytopenic Purpura (TTP) Management: Used for plasma exchange and infusion of fresh frozen plasma.
7. Bone Marrow Transplant Support: Used to transfuse irradiated, leukocyte-reduced blood components in transplant patients.
8. Oncology and Chemotherapy Support: Used to transfuse red cells and platelets in patients with chemotherapy-induced cytopenias.
9. Hemophilia and Coagulation Disorder Management: Used to infuse clotting factor concentrates and plasma products.
10. Emergency Department Resuscitation: Used for emergency blood transfusion in trauma, gastrointestinal bleeding, and ruptured aneurysms.
KEY PRODUCT FEATURES

1. BASIC IDENTIFICATION ATTRIBUTES

  • Device Type: A sterile, single-use intravenous administration set specifically designed for transfusing whole blood and blood components, featuring an integral blood filter and large-bore tubing.
  • Designation: Blood Giving Set, Blood Transfusion Set, Blood Administration Set, Blood Infusion Set, Blood Tubing Set, Y-Type Blood Set, Straight Blood Set, Blood Filter Set.
  • Key Components:
o Spike: Integrated piercing spike for blood bag entry.
o Drip Chamber: Large drip chamber with integral blood filter (170-260 micron).
o Tubing: Large-bore, flexible PVC tubing (typically 3.5-4.5mm internal diameter).
o Roller Clamp: Precision flow control clamp.
o Luer Connector: Male Luer or Luer lock connector for IV catheter attachment.
o Injection Port: Latex-free Y-injection port for medication or fluid administration.
o Clamp: Slide or roller clamp for flow control.

2. TECHNICAL & PERFORMANCE PROPERTIES

  • Filter Type: Integral microaggregate filter (typically 170-260 microns).
  • Filter Material: Polyester mesh or nylon screen.
  • Tubing Material: Medical-grade PVC (DEHP or non-DEHP options).
  • Tubing Length: Standard 150-250 cm (60-100 inches).
  • Tubing Inner Diameter: 3.5-4.5 mm for optimal flow rates.
  • Flow Rate: Up to 10-20 mL per second depending on tubing length, patient access, and pressure.
  • Drip Chamber: Flexible or rigid chamber with filter.
  • Spike Type: Piercing spike with protective cover.
  • Connector Type: Male Luer slip or Luer lock.
  • Injection Port: Y-site or pre-injection port for secondary infusions.
  • Sterility: Sterile; ethylene oxide or gamma irradiation sterilized.
  • Latex-Free: Manufactured without natural rubber latex.
  • DEHP-Free: Available in non-DEHP options.
  • Single-Use: Intended for single patient, single use only.

3. PHYSICAL & OPERATIONAL PROPERTIES

  • Construction: Flexible, kink-resistant tubing.
  • Drip Chamber Features: Filter and drip rate observation window.
  • Priming: Standard priming volume (typically 20-30 mL).
  • Packaging: Sterile, individually wrapped peel-pouch.
  • Color: Clear or translucent tubing for visual inspection of blood flow.
  • Port Identification: Color-coded ports for easy identification.

4. SAFETY & COMPLIANCE ATTRIBUTES

  • Regulatory Status: Class II medical device requiring 510(k) clearance.
  • FDA Compliance: Compliant with FDA Quality System Regulations.
  • ISO Standards: Compliant with ISO 1135 (Transfusion equipment for medical use).
  • Filter Standards: Compliant with ISO 1135-4 (Blood transfusion filters).
  • Latex-Free: Standard in all blood giving sets.
  • DEHP-Free: Available for sensitive populations (neonates, pregnant women, oncology patients).
  • Sterility Assurance Level (SAL): 10^-6.

5. STORAGE & HANDLING ATTRIBUTES

  • Storage: Store in a clean, dry location at room temperature; protect from heat, moisture, and direct sunlight.
  • Shelf Life: Typically 2-3 years from date of manufacture; check expiration date before use.
  • Sterility Maintenance: Do not use if package is opened, torn, wet, or damaged.
  • Single-Use Only: Intended for single patient, single use only; do not reuse or resterilize.
  • Inspection: Inspect for damage, kinks, or loose connections before use.

6. LABORATORY & CLINICAL APPLICATIONS

  • Primary Application: Transfusion of whole blood and blood components (red blood cells, platelets, plasma, cryoprecipitate) to patients with bleeding, anemia, coagulopathy, or bone marrow failure.
  • Clinical Role: Essential device in operating rooms, emergency departments, intensive care units, labor and delivery, oncology units, hematology units, medical-surgical wards, and outpatient transfusion centers for safe blood component administration.
SAFETY HANDLING PRECAUTIONS

1. SAFETY PRECAUTIONS

  • Patient Identification: Verify patient identity and blood compatibility with two licensed personnel before initiating transfusion.
  • Filter Use: Do not bypass or remove the integral blood filter; use only blood giving sets with filters for blood products.
  • No Medication Addition: Do not add medications to the blood bag or tubing unless specifically approved; incompatible additives can cause hemolysis.
  • Prime with Normal Saline: Prime the blood giving set with preservative-free normal saline (0.9% sodium chloride); never prime with dextrose solutions (cause hemolysis) or lactated Ringer's (contains calcium, may clot).
  • Do Not Use with Other Fluids: Do not co-infuse medications, dextrose solutions, or lactate Ringer's through the same tubing without blood.
  • Flow Rate Monitoring: Start transfusion slowly (1-2 mL/min) for first 15 minutes; monitor for transfusion reactions before increasing rate.
  • Transfusion Reaction Monitoring: Monitor patient closely for fever, chills, rash, dyspnea, back pain, or hypotension; stop transfusion immediately if reaction is suspected.
  • Time Limit: Complete transfusion of each blood unit within 4 hours of spiking to prevent bacterial growth.
  • Single-Use: Discard set after completing transfusion; do not reuse or flush for later use.
  • Pressure Infusion: Use only pressure infusers designed for blood bags; do not exceed 300 mmHg pressure.

2. FIRST AID MEASURES

  • Suspected Transfusion Reaction: Stop transfusion immediately; disconnect blood giving set from patient; keep IV line open with normal saline; notify physician; return blood bag and set to blood bank for investigation.
  • Air Embolism: If air enters the system, stop infusion, place the patient in the left lateral decubitus (Trendelenburg) position, and seek emergency assistance.
  • Extravasation: If blood infiltrates into surrounding tissue, stop infusion, elevate extremity, apply warm or cold compress as ordered, and notify physician.
  • Hemolysis: If signs of hemolysis (dark urine, back pain, fever, hypotension) occur, stop transfusion immediately and initiate transfusion reaction protocol.

3. FIRE FIGHTING MEASURES

  • Flammability: PVC tubing is combustible; may melt or burn if exposed to flame or high heat.
  • Extinguishing Media: Use water, foam, dry chemical, or CO₂ for fire involving tubing materials.
  • Fire Response: No special fire hazards beyond typical combustible materials.