MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-03-26 for LEUKOGUARD CARDIOPULMONARY BYPASS ARTERIAL LINE FILTER LG-6 manufactured by Pall Biomedical Products, Inc..
[17421]
Arterial line filter installed within cardiopulmonary bypass pump circuit became occluded during bypass.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1008721 |
| MDR Report Key | 31468 |
| Date Received | 1996-03-26 |
| Date of Report | 1996-03-26 |
| Date of Event | 1996-02-16 |
| Date Added to Maude | 1996-03-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEUKOGUARD CARDIOPULMONARY BYPASS ARTERIAL LINE FILTER |
| Generic Name | CARDIOPULMONARY BYPASS ARTERIAL LINE FILTER |
| Product Code | KRI |
| Date Received | 1996-03-26 |
| Returned To Mfg | 1996-03-26 |
| Model Number | LG-6 |
| Lot Number | 427601A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 32612 |
| Manufacturer | PALL BIOMEDICAL PRODUCTS, INC. |
| Manufacturer Address | 2200 NORTHERN BLVD EAST HILLS NY 11548 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 1996-03-26 |