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 2007-05-03 for PALL CARDIOPLEGIA PLUS FILTER W/SOLUTION SPIKE CPS02NS NA manufactured by Pall Biomedical, Inc..
[756986]
It was reported that during an inspection of the devices, prior to shipment to another manufacturer, free particulate matter was discovered in the downstream side.
Patient Sequence No: 1, Text Type: D, B5
[7898655]
Device evaluation begun, but not yet completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647898-2007-00008 |
| MDR Report Key | 959850 |
| Report Source | 05,06,07 |
| Date Received | 2007-05-03 |
| Date of Report | 2007-04-04 |
| Date of Event | 2007-04-04 |
| Date Facility Aware | 2007-04-04 |
| Date Reported to Mfgr | 2007-04-04 |
| Date Mfgr Received | 2007-04-04 |
| Device Manufacturer Date | 2006-11-01 |
| Date Added to Maude | 2007-12-07 |
| 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, PHD |
| Manufacturer Street | 25 HARBOR PARK DR |
| Manufacturer City | PORT WASHINGTON NY 11050 |
| Manufacturer Country | US |
| Manufacturer Postal | 11050 |
| Manufacturer Phone | 5168019373 |
| 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 CARDIOPLEGIA PLUS FILTER W/SOLUTION SPIKE |
| Generic Name | JOD: CARDIOPULMONARY BYPASS CARDIOTOMY SUCTION LINE BLOOD FI |
| Product Code | JOD |
| Date Received | 2007-05-03 |
| Returned To Mfg | 2007-04-11 |
| Model Number | CPS02NS |
| Catalog Number | NA |
| Lot Number | 632002 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4.5 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 930113 |
| Manufacturer | PALL BIOMEDICAL, INC. |
| Manufacturer Address | * FAJARDO PR * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-03 |