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
Manufacturer
Baxter Healthcare CorporationCatalog 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.