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 2004-04-29 for CARMEDA ADULT BIO-PROBE CBDP-38 CB6110R1 manufactured by Medtronic Perfusion Systems.
[20140626]
Information received indicates the unit leaked six hours after ecmo bypass began. The unit was replaced and the case completed with no consequence reported for the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184009-2004-00044 |
| MDR Report Key | 556942 |
| Report Source | 01,05,07 |
| Date Received | 2004-04-29 |
| Date of Report | 2004-04-12 |
| Date of Event | 2004-04-12 |
| Date Facility Aware | 2004-04-12 |
| Report Date | 2004-04-12 |
| Date Reported to Mfgr | 2004-04-12 |
| Date Mfgr Received | 2004-04-12 |
| Device Manufacturer Date | 2003-07-01 |
| Date Added to Maude | 2004-12-01 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA WEIK |
| Manufacturer Street | 8299 CENTRAL AVE NE |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635146694 |
| Manufacturer G1 | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Street | 7611 NORTHLAND DR |
| Manufacturer City | BROOKLYN PARK MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55428 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARMEDA ADULT BIO-PROBE |
| Generic Name | EXTRAVASCULAR BLOOD FLOW PROBE |
| Product Code | DPT |
| Date Received | 2004-04-29 |
| Returned To Mfg | 2004-04-21 |
| Model Number | CBDP-38 |
| Catalog Number | CB6110R1 |
| Lot Number | 0307005029 |
| ID Number | NA |
| Device Expiration Date | 2005-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 546615 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR. BROOKLYN PARK 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 | 2004-04-29 |