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 1998-07-08 for ADULT BIO-PROBE FLOW PROBE 3/8" CBDP-38 CB2980 manufactured by Medtronic Cardiopulmonary.
[103568]
The report indicates that leakage was observed from the flow cell during bypass. The device was changed out with no pt injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2022036-1998-00031 |
| MDR Report Key | 176317 |
| Report Source | 01,04,05,07 |
| Date Received | 1998-07-08 |
| Date of Report | 1998-07-08 |
| Date of Event | 1998-06-09 |
| Date Mfgr Received | 1998-06-11 |
| Device Manufacturer Date | 1997-11-01 |
| Date Added to Maude | 1998-07-13 |
| 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 | NA |
| 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 | 1998-07-08 |
| Returned To Mfg | 1998-06-22 |
| Model Number | CBDP-38 |
| Catalog Number | CB2980 |
| Lot Number | 971001231 |
| ID Number | NA |
| Device Expiration Date | 1999-08-31 |
| 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 | 171430 |
| 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 | 1998-07-08 |