MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,05,07 report with the FDA on 1998-04-29 for ADULT BIO-PROBE FLOW PROBE 3/8" CBDP-38 CB2980 manufactured by Medtronic Cardiopulmonary.
[85166]
The report indicated that following 45 hours of extra corporeal membrane oxygenator support, leakage was observed. The flow probe was changed out. Based upon condition of the returned device co was unable to complete the failure investigation and determine the exact failure mode.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2022036-1998-00018 |
| MDR Report Key | 165308 |
| Report Source | 01,04,05,07 |
| Date Received | 1998-04-29 |
| Date of Report | 1998-04-29 |
| Date of Event | 1998-03-29 |
| Date Mfgr Received | 1998-03-30 |
| Device Manufacturer Date | 1997-06-01 |
| Date Added to Maude | 1998-05-04 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADULT BIO-PROBE FLOW PROBE 3/8" |
| Generic Name | FLOW PROBE |
| Product Code | DPT |
| Date Received | 1998-04-29 |
| Returned To Mfg | 1998-04-16 |
| Model Number | CBDP-38 |
| Catalog Number | CB2980 |
| Lot Number | 9706000872 |
| ID Number | N/A |
| Device Expiration Date | 1999-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 160891 |
| Manufacturer | MEDTRONIC CARDIOPULMONARY |
| Manufacturer Address | 4633 EAST LA PALMA AVE. ANAHEIM CA 92807 US |
| Baseline Brand Name | ADULT BIO-PROBE FLOW PROBE 3/8" |
| Baseline Generic Name | FLOW PROBE |
| Baseline Model No | CBDP-38 |
| Baseline Catalog No | CB2980 |
| Baseline ID | NA |
| Baseline Device Family | FLOW PROBE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K891687 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1998-04-29 |