inforMED
MalfunctionBRZ

BAXTER IV BLOOD SET Y-TYPE FENWAL HAND PUMP

Received Jun 20, 2024 · Event occurred Jun 3, 2024

Report MW5156452 · MDR key 19585102

Device

Generic name

Set, Blood Transfusion

Catalog number

4C8723

Lot number

R23516048

Patient

64 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE PATIENT WENT TO THE OR (OPERATING ROOM) FOR AN EMERGENT REPAIR OF ASCENDING AORTA WITH GRAFT, CABG (CORONARY ARTERY BYPASS GRAFT) TIMES 1 AND CYSTOSCOPY WITH SUPRAPUBIC CATHETER PLACEMENT. WHEN THE ANESTHESIOLOGIST USED A STANDARD BLOOD INFUSION SET WITH A HAND PUMP, BLOOD LEAKED FROM THE AREA WHERE THE PUMP CONNECTS WITH THE CHAMBER. THE HAND PUMP IS A FLEXIBLE PLASTIC CHAMBER ABOUT 5 OR 6 INCHES LONG AND IS CAPPED AT BOTH ENDS MOUNTED ABOUT HALFWAY IN THE LENGTH OF THE IV TUBING. A SMALL BALL VALVE ALLOWS BLOOD TO ENTER THROUGH THE TOP OF THIS PUMP WHICH IS THEN HAND SQUEEZED THROUGH THE TUBING AT THE BOTTOM OF THE PUMP. DURING MANUFACTURE THE ENDS ARE GLUED TO THE PLASTIC SQUEEZE CHAMBER. IN THIS CASE, THE BLOOD LEAKED THROUGH THE TOP OF THIS PUMP. THE PRESSURE APPLIED TO THE PUMP SPRAYED BLOOD AROUND THAT SIDE OF THE ANESTHESIA / O.R. AREA. THE PUMP WAS USED WITH BOTH DONATED BLOOD AND AUTOLOGOUS BLOOD.