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 2000-10-05 for PEDIATRIC BIOPROBE FLOW PROBE DP38-P CB4627 manufactured by Medtronic Perfusion Systems.
[17488528]
The hosp reported a blood leak caused by a crack in flow probe. Flow probe used approximately 65 hours before being changed out. Note: product used off label.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184009-2000-00082 |
| MDR Report Key | 299589 |
| Report Source | 05,06,07 |
| Date Received | 2000-10-05 |
| Date of Report | 2000-10-05 |
| Date of Event | 2000-07-03 |
| Date Mfgr Received | 2000-09-05 |
| Device Manufacturer Date | 1998-11-01 |
| Date Added to Maude | 2000-10-12 |
| 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 | PEDIATRIC BIOPROBE FLOW PROBE |
| Generic Name | FLOW PROBE |
| Product Code | DPT |
| Date Received | 2000-10-05 |
| Returned To Mfg | 2000-09-01 |
| Model Number | DP38-P |
| Catalog Number | CB4627 |
| Lot Number | 9811001399 |
| ID Number | * |
| Device Expiration Date | 2003-11-01 |
| 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 | 289985 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR. BROOKLYN PARK MN 55428 US |
| Baseline Brand Name | PEDIATRIC BIOPROBE FLOW PROBE |
| Baseline Generic Name | FLOW PROBE |
| Baseline Model No | DP38-P |
| Baseline Catalog No | CB4627 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-10-05 |