MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-11-01 for BIO-MEDICUS FLOW PROBE, PEDIATRIC CBDP-38P 1133012-501 manufactured by Medtronic Perfusion Systems.
[510250]
Info rec'd indicates that the pt has been on ecmo as a "bridge to transplant. " after 7 weeks, the bio-probe started leaking blood and required emergent change-out. The pt was without ecmo support while the probe was changed out. It was reported that the bio-probe was in contact with alcohol shortly before the leak occurred. The pt ultimately did have transplant surgery but rejected the heart and expired (dates not provided).
Patient Sequence No: 1, Text Type: D, B5
[7803817]
H6: device history review. Device history review found the product met specifications when released for distribution. H3: analysis: a visual inspection of the returned product shows several stress cracks located on the body, the flange area, and at the port/body interface of the device. The cracks in the device were the source of the leakage. The damage observed is consistent with that seen when this product is subjected to alcohol, which was the reported event. Product labeling specifically warns against using alcohol or alcohol-based fluids on any surface of the device. Conclusion: operational context contributed to the event. The reported death was related to heart transplant rejection, and not the reported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184009-2006-00105 |
| MDR Report Key | 779135 |
| Report Source | 05,07 |
| Date Received | 2006-11-01 |
| Date of Report | 2006-10-02 |
| Date of Event | 2006-09-29 |
| Date Facility Aware | 2006-09-29 |
| Report Date | 2006-10-02 |
| Date Reported to Mfgr | 2006-10-02 |
| Date Mfgr Received | 2006-10-02 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2006-11-13 |
| 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 | LAURALIE MILLIKAN |
| Manufacturer Street | 7611 NORTHLAND DR |
| Manufacturer City | BROOKLYN MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal | 55428 |
| Manufacturer Phone | 7633919124 |
| Manufacturer G1 | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Street | 7611 NORTHLAND DRIVE |
| 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 | BIO-MEDICUS FLOW PROBE, PEDIATRIC |
| Generic Name | DPT |
| Product Code | DPT |
| Date Received | 2006-11-01 |
| Returned To Mfg | 2006-10-02 |
| Model Number | CBDP-38P |
| Catalog Number | 1133012-501 |
| Lot Number | 5088671 |
| ID Number | NA |
| Device Expiration Date | 2008-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1.3 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 766902 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR. BROOKLYN PARK MN 55428 US |
| Baseline Brand Name | CARMEDA PEDIATRIC BIO-PROBE |
| Baseline Generic Name | EXTRAVASCULAR BLOOD PLOW PROBE |
| Baseline Model No | CBDP-38P |
| Baseline Device Family | FLOW PROBE |
| 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 | 2006-11-01 |