MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,08 report with the FDA on 1998-07-15 for DP-38 BIO-PROBE DISPOSABLE INSERT 95133 manufactured by Medtronic Bio-medicus, Inc..
[121734]
Hospital reported that during cariopulmonary support, blood leaked from the dp-38 bio-probe disposable insert. The device was removed from the circuit and replaced with another bio-probe insert. Case was completed with no effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124837-1998-00010 |
| MDR Report Key | 178080 |
| Report Source | 01,05,06,07,08 |
| Date Received | 1998-07-15 |
| Date of Report | 1998-07-14 |
| Date of Event | 1998-06-15 |
| Date Facility Aware | 1998-06-17 |
| Report Date | 1998-07-14 |
| Date Mfgr Received | 1998-06-22 |
| Date Added to Maude | 1998-07-22 |
| 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 | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DP-38 BIO-PROBE DISPOSABLE INSERT |
| Generic Name | PROBE, BLOOD FLOW, EXTRACORPOREAL |
| Product Code | DPT |
| Date Received | 1998-07-15 |
| Returned To Mfg | 1998-06-22 |
| Model Number | DP-38 |
| Catalog Number | 95133 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 173162 |
| Manufacturer | MEDTRONIC BIO-MEDICUS, INC. |
| Manufacturer Address | 9600 WEST 76TH ST. EDEN PRAIRIE MN 55344 US |
| Baseline Brand Name | BIO-PROBE DISPOSABLE INSERT |
| Baseline Generic Name | EXTRAVASCULAR BLOOD FLOW PROBE |
| Baseline Model No | DP-38 |
| Baseline Catalog No | 95133 |
| Baseline ID | BIO-PROBE FLOW |
| Baseline Device Family | BIO-PROBE |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K830858 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-07-15 |