MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-27 for FILTER, PRE BYPASS PRE-BYPASS PLUS .2 MICRO FILTER 72698 manufactured by Terumo Cardiovascular Systems Corp..
[2403309]
A pre-bypass filter used with the cardiopulmonary bypass (cpb) circuit occluded during set up for an unknown reason. There was no pt exposure. The pre-bypass filter failed to operate correctly. It appears to have come from the factory sealed on the inflow side.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2494521 |
| MDR Report Key | 2494521 |
| Date Received | 2012-02-27 |
| Date of Report | 2012-02-24 |
| Date of Event | 2012-02-10 |
| Report Date | 2012-02-24 |
| Date Reported to FDA | 2012-02-27 |
| Date Added to Maude | 2012-03-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FILTER, PRE BYPASS |
| Generic Name | DISPOSABLE PRODUCT (DESCRIBE BELOW) |
| Product Code | KRJ |
| Date Received | 2012-02-27 |
| Returned To Mfg | 2012-02-27 |
| Model Number | PRE-BYPASS PLUS .2 MICRO FILTER |
| Catalog Number | 72698 |
| Lot Number | NP19 |
| ID Number | * |
| Device Availability | R |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| Manufacturer Address | 125 BLUE BALL RD. ELKTON MD 21921 US 21921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-27 |