MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2006-10-05 for PALL CARDIOGPLEGIA PLUS FILTER WITH POSIDYNE MEMBRANE BC1 BULK NA manufactured by Pall Biomedical, Inc..
[18917812]
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.
Patient Sequence No: 1, Text Type: D, B5
[19003848]
Device evaluation begun, but not yet completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647898-2006-00006 |
| MDR Report Key | 858146 |
| Report Source | 05,06,07 |
| Date Received | 2006-10-05 |
| Date of Report | 2006-09-04 |
| Date of Event | 2006-09-04 |
| Date Facility Aware | 2006-09-04 |
| Date Reported to Mfgr | 2006-09-04 |
| Date Mfgr Received | 2006-09-08 |
| Date Added to Maude | 2007-06-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LEONARD BERMAN, PH.D. |
| Manufacturer Street | 2200 NORTHERN BLVD. |
| Manufacturer City | EAST HILLS NY 11548 |
| Manufacturer Country | US |
| Manufacturer Postal | 11548 |
| Manufacturer Phone | 5164845400 |
| Manufacturer G1 | PALL BIOMEDICAL, INC. |
| Manufacturer Street | PALL BLVD. 98 |
| Manufacturer City | FAJARDO PR 00738 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00738 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALL CARDIOGPLEGIA PLUS FILTER WITH POSIDYNE MEMBRANE |
| Generic Name | JOD: CARDIOPULMONARY BYPASS CARDIOTOMY SUCTION LINE BLOOD FI |
| Product Code | JOD |
| Date Received | 2006-10-05 |
| Returned To Mfg | 2006-09-07 |
| Model Number | BC1 BULK |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 842010 |
| Manufacturer | PALL BIOMEDICAL, INC. |
| Manufacturer Address | * FAJARDO PR * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-05 |