MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2002-05-16 for ADULT BIO PROBE, FLOW PROBE 3/8" CBDP-38 CB2980 manufactured by Medtronic Perfusion Systems.
[248226]
During ecmo, a crack in the device was discovered. Unit was changed out and blood substitutes were given to patient. The patient was not affected by the blood loss.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184009-2002-00016 |
| MDR Report Key | 395844 |
| Report Source | 01,05,06 |
| Date Received | 2002-05-16 |
| Date of Report | 2002-04-17 |
| Date of Event | 2002-04-09 |
| Date Mfgr Received | 2002-04-17 |
| Date Added to Maude | 2002-05-24 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KATHY LYNESS |
| Manufacturer Street | 7611 NORTHLAND DRIVE |
| Manufacturer City | BROOKLYN PARK MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal | 55428 |
| Manufacturer Phone | 7635142860 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADULT BIO PROBE, FLOW PROBE 3/8" |
| Generic Name | FLOW PROBE |
| Product Code | DPT |
| Date Received | 2002-05-16 |
| Returned To Mfg | 2002-05-09 |
| Model Number | CBDP-38 |
| Catalog Number | CB2980 |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 384851 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR. MINNEAPOLIS MN 55428 US |
| Baseline Brand Name | CARMEDA ADULT BIO-PROBE |
| Baseline Generic Name | EXTRAVASCULAR BLOOD FLOW PROBE |
| Baseline Model No | CBDP-38 |
| Baseline Catalog No | CB2980 |
| Baseline ID | NA |
| Baseline Device Family | BIO-PROBES |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K891687 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-05-16 |