MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-08-10 for BIO-MEDICUS FLOW PROBE, ADULT DP-38 95245 manufactured by Medtronic Perfusion Systems.
[514305]
Information received indicates flows were not registering as expected, a few minutes after the start of the case. The patient was removed from bypass to investigate the cause of the issue. Intra-operative inspection revealed no device problems were detected. The flow probe component was suspected, but it was not changed-out. The case was completed with no adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
[7799641]
Analysis: evaluation of the returned flow probe component confirms the reason for return, reduced flow rates were seen. Findings from functional tests reveal the product did not perform as expected. Visual inspection of the probe shows excess material from the component molding process is seen covering part of the center pin, in the probe, that exceeds dimensional specifications. Additional event information indicates the reported time off pump was approximately 10 minutes with no patient complication reported. Review of the device history record shows the device met all manufacturing specifications for product released to distribution. Conclusion: no patient consequence. Reduced product performance occurred and was related to the reported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184009-2006-00069 |
| MDR Report Key | 766838 |
| Report Source | 05,07 |
| Date Received | 2006-08-10 |
| Date of Report | 2006-07-12 |
| Date of Event | 2006-07-12 |
| Date Facility Aware | 2006-07-12 |
| Report Date | 2006-07-12 |
| Date Reported to Mfgr | 2006-07-12 |
| Date Mfgr Received | 2006-07-12 |
| Device Manufacturer Date | 2006-03-01 |
| Date Added to Maude | 2006-10-05 |
| 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 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, ADULT |
| Generic Name | FLOW PROBE |
| Product Code | DPT |
| Date Received | 2006-08-10 |
| Returned To Mfg | 2006-07-18 |
| Model Number | DP-38 |
| Catalog Number | 95245 |
| Lot Number | 3710876 |
| ID Number | NA |
| Device Expiration Date | 2008-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNK |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 754729 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR. BROOKLYN PARK MN 55428 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-08-10 |