MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-12-02 for BIO-PROBE DP38P * manufactured by Medtronic Perfusion Systems.
[21247235]
The pt was transferred to our facility soon after birth with respiratory failure and primary pulmonary hypertension. She was delivered pulseless with the cord prolapsed. She was initially admitted to the nicu but was not responding to ventilatory support or pressors and was hypovolemic and hypotensive. Ecmo (extracorporeal membrane oxygenation) was initiated on the fourth day after admission. There were some clotting issues while on ecmo, but they remained in the tubing and did not reach the patient. The day prior to the incident being reported, the patient was inadvertently decannulated but was easily recannulated and had no adverse effects. On the fifth day on ecmo the nurse noted that the flowprobe had cracks in the hard plastic that worsened as it was observed. The flowprobe was changed with no apparent harm to the patient. Ecmo was discontinued on the following day and the pt was transferred back to the nicu on a ventilator three days later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 656429 |
| MDR Report Key | 656429 |
| Date Received | 2005-12-02 |
| Date of Report | 2005-12-02 |
| Date of Event | 2005-11-25 |
| Report Date | 2005-12-02 |
| Date Reported to FDA | 2005-12-02 |
| Date Added to Maude | 2005-12-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO-PROBE |
| Generic Name | FLOW PROBE |
| Product Code | DPT |
| Date Received | 2005-12-02 |
| Model Number | DP38P |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 645918 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR. MINNEAPOLIS MN 55428 US |
| Baseline Brand Name | BIO-MEDICUS FLOW PROBE, PEDIATRIC |
| Baseline Generic Name | FLOW PROBE |
| Baseline Model No | DP-38P |
| Baseline Device Family | BIO-PROBES |
| 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 | 2005-12-02 |