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 2001-11-26 for BIO-SOURCE BATTERY PACK 200 95110 manufactured by Medtronic Perfusion Systems.
[16481125]
The hosp reported that within 5 mins of use, the capacity of the biosource was depleted. The device was changed out. The pt later expired and the cause of death is not known. The physician has indicated that the death was not related to the delay in transportation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184009-2001-00083 |
| MDR Report Key | 364416 |
| Report Source | 05,06,07 |
| Date Received | 2001-11-26 |
| Date of Event | 2001-10-31 |
| Date Mfgr Received | 2001-11-05 |
| Device Manufacturer Date | 1993-05-01 |
| Date Added to Maude | 2001-12-10 |
| 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 |
| Manufacturer Contact | MARIE HOLM |
| Manufacturer Street | 7611 NORTHLAND DR |
| Manufacturer City | BROOKLYN PARK MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal | 55428 |
| Manufacturer Phone | 7633919183 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO-SOURCE BATTERY PACK |
| Generic Name | BATTERY PACK |
| Product Code | MOX |
| Date Received | 2001-11-26 |
| Returned To Mfg | 2001-11-05 |
| Model Number | 200 |
| Catalog Number | 95110 |
| Lot Number | NA |
| ID Number | * |
| 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 | 353522 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR. BROOKLYN PARK MN 55428 US |
| Baseline Brand Name | BIO-SOURCE BATTERY PACK |
| Baseline Generic Name | BATTERY PACK |
| Baseline Model No | 200 |
| Baseline Catalog No | 95110 |
| Baseline ID | NA |
| Baseline Device Family | BIO-SOURCE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K853126 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2001-11-26 |