FDA Adverse Event
Malfunction
Summary report: N
PALL CARDIOGPLEGIA PLUS FILTER WITH POSIDYNE MEMBRANE
MDR report key: 858146
·
Received October 5, 2006
Report
- Report Number
- 2647898-2006-00006
- Event Type
- Malfunction
- Date Received
- October 5, 2006
- Date of Event
- September 4, 2006
- Report Date
- September 4, 2006
- Manufacturer
- PALL BIOMEDICAL, INC.
- Product Code
- JOD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION BEGUN, BUT NOT YET COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE PRIMING OF THE EXTRACORPOREAL CIRCUIT (INCLUDING THE FIRM'S DEVICE) IN PREPARATION FOR PERFUSION TO SUPPORT CARDIAC SURGERY, "WHITE WOOLY PARTICLES" WERE DISCOVERED AT THE PRESSURE MONITORING LINE OF THE HEAT EXCHANGER. IT IS PRESUMED THAT THE CIRCUIT INVOLVED WAS REPLACED, PRIMED AND THE PROCEDURE WAS THEN COMPLETE, WITH NO REPORT OF PATIENT SEQUELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALL CARDIOGPLEGIA PLUS FILTER WITH POSIDYNE MEMBRANE | JOD: CARDIOPULMONARY BYPASS CARDIOTOMY SUCTION LINE BLOOD FI | JOD | PALL BIOMEDICAL, INC. | BC1 BULK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |