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 2007-03-28 for BIO-MEDICUS FLOW PROBE, PEDIATRIC DP-38P 95134 manufactured by Medtronic Perfusion Systems.
[611575]
Medtronic received info that this sterile flow probe broke after 5 days of ecmo, which resulted in a stoppage of flow. The pt required resuscitation. The flow probe was replaced without reported complication, and ecmo was again initiated. It was reported that sterilium (alcohol based disinfectant) had been used to clean the broken probe prior to use. Add'l info was received that the pt expired 1 week following this incident. It was reported that the broken flow probe was not related to the pt outcome. Pt specific info and listed cause of death have been requested, but have not been made available.
Patient Sequence No: 1, Text Type: D, B5
[7961791]
Analysis: visual inspection of the returned device shows one end of the connector is broken off clean at the probe body. The broken port area of the probe body and the broken port itself appeared cloudy, which was likely due to the alcohol based disinfectant that was used on the product, as reported. The instructions for use for this device state, "do not use alcohol or alcohol based fluids on any surface of this device. " review of the device history record (dhr) for this product showed no abnormalities during the mfg process of this product. The product lot met mfg specifications when released for distribution. Conclusion: reduce performance of the device confirmed through analysis. User inteface contributed to the event. It was reported that the broken flow probe was not related to the pt outcome.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184009-2007-00054 |
| MDR Report Key | 833515 |
| Report Source | 01,05,07 |
| Date Received | 2007-03-28 |
| Date of Report | 2007-02-26 |
| Date of Event | 2007-02-26 |
| Date Facility Aware | 2007-02-26 |
| Report Date | 2007-02-26 |
| Date Reported to Mfgr | 2007-02-26 |
| Date Mfgr Received | 2007-02-26 |
| Device Manufacturer Date | 2004-10-01 |
| Date Added to Maude | 2007-04-04 |
| 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 | CHAD HEDLUND |
| Manufacturer Street | 7611 NORTHLAND DR |
| Manufacturer City | BROOKLYN MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal | 55428 |
| Manufacturer Phone | 7633919558 |
| 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 | 2007-03-28 |
| Returned To Mfg | 2007-03-27 |
| Model Number | DP-38P |
| Catalog Number | 95134 |
| Lot Number | 0410005229 |
| ID Number | NA |
| Device Expiration Date | 2009-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 DAY |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 820836 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR. BROOKLYN PARK 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 | 1. Life Threatening; 2. Required No Informationntervention | 2007-03-28 |