MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2003-05-21 for BIO-PROBE DISPOSABLE INSERT DP38 95133 manufactured by Medtronic Perfusion Systems.
[305579]
Info received indicates the device leaked during the case. The hcp attempted to tighten the connection when the unit broke completely. The device was changed out with no affect other than minimal blood loss to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184009-2003-00029 |
| MDR Report Key | 462480 |
| Report Source | 01,05,07 |
| Date Received | 2003-05-21 |
| Date of Report | 2003-04-30 |
| Date of Event | 2003-04-29 |
| Date Mfgr Received | 2003-04-30 |
| Device Manufacturer Date | 2002-04-01 |
| Date Added to Maude | 2003-05-30 |
| 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 | LISA WEIK |
| Manufacturer Street | 8299 CENTRAL AVENUE, NE |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635146694 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO-PROBE DISPOSABLE INSERT |
| Generic Name | EXTRAVASCULAR BLOOD FLOW PROBE |
| Product Code | DPT |
| Date Received | 2003-05-21 |
| Returned To Mfg | 2003-05-07 |
| Model Number | DP38 |
| Catalog Number | 95133 |
| Lot Number | 0204004152 |
| ID Number | NA |
| Device Expiration Date | 2007-04-28 |
| 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 | 451429 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR. BROOKLYN PARK MN 55428 US |
| Baseline Brand Name | BIO-PROBE DISPOSABLE INSERT |
| Baseline Generic Name | EXTRAVASCULAR BLOOD FLOW PROBE |
| Baseline Model No | DP38 |
| Baseline Catalog No | DP38 |
| Baseline ID | NA |
| 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. Required No Informationntervention | 2003-05-21 |