MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1997-11-02 for DP-38P BIO-PROBE DISPOSABLE INSERT 95134 manufactured by Medtronic Bio-medicus, Inc..
[112111]
Hospital reported that 39 hours into an extracorporeal membrane oxygenation case (ecmo), blood leakage was noticed at one of the dp-38p bio-probe tubing connectors. The device was removed from the circuit and replaced with a second bio-probe insert. Case was continued with no effect to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124837-1997-00025 |
| MDR Report Key | 131187 |
| Report Source | 05,06,07 |
| Date Received | 1997-11-02 |
| Date of Report | 1997-11-02 |
| Date of Event | 1997-09-26 |
| Date Facility Aware | 1997-10-24 |
| Report Date | 1997-11-02 |
| Date Mfgr Received | 1997-10-28 |
| Date Added to Maude | 1997-11-13 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DP-38P BIO-PROBE DISPOSABLE INSERT |
| Generic Name | PROBE, BLOOD FLOW, EXTRACORPOREAL |
| Product Code | DPT |
| Date Received | 1997-11-02 |
| Returned To Mfg | 1997-10-28 |
| Model Number | DP-38P |
| Catalog Number | 95134 |
| Lot Number | UNK |
| ID Number | * |
| 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 | 128234 |
| 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 | 1997-11-02 |