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 1998-04-30 for DP-38 BIO-PROBE DISPOSABLE INSERT 95133 manufactured by Medtronic Bio-medicus, Inc..
[84483]
Hosp reported that 70 hrs into an extracorporeal membrane oxygenation case (ecmo), the dp-38 bio-probe insert broke. The device was removed from the circuit and replaced with another bio-probe insert. Case was continued with no effect to the pt. However, the pt expired the next day due to multi organ failure with severe inflammatory response and general sepsis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124837-1998-00005 |
| MDR Report Key | 166046 |
| Report Source | 01,05,06,07,08 |
| Date Received | 1998-04-30 |
| Date of Report | 1998-04-30 |
| Date of Event | 1998-04-01 |
| Date Facility Aware | 1998-04-22 |
| Report Date | 1998-04-30 |
| Date Reported to Mfgr | 1998-04-22 |
| Date Mfgr Received | 1998-04-22 |
| Date Added to Maude | 1998-05-07 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | RL |
| 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 | 1998-04-30 |
| Returned To Mfg | 1998-04-22 |
| 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 | 161592 |
| 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. Death | 1998-04-30 |