MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2004-10-15 for MEDTRONIC OVERPRESSURE/ VACUUM RELIEF VALVE VRV-100 1140333-1 manufactured by Medtronic Perfusion Systems.
[696905]
Information received indicates that restricted flow was noted through the vent line and vrv-100 valve, during the procedure. Product change-out was completed during the case without interruption to bypass, and no patient complication was reported.
Patient Sequence No: 1, Text Type: D, B5
[7879004]
Analysis: visual inspection of the returned product shows no sign of physical damage to the valve body or umbrella components. The unit was cleaned and pressure tested. Product evaluation and functional testing does not confirm the reason for return. The device operated according to specifications and appeared mechanically functional; the valve opened in the flow direction and remained closed per performance specification with no problems noted. Product specific information (e. G. , manufacturing lot number) was not provided by the user; therefore, review of the device history record could not be performed. Conclusion: no patient event. Device evaluated and alleged failure could not be duplicated-an exact cause is unknown for the reported product problem.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184009-2004-00101 |
| MDR Report Key | 910336 |
| Report Source | 05,07 |
| Date Received | 2004-10-15 |
| Date of Report | 2004-10-05 |
| Report Date | 2004-10-05 |
| Date Reported to Mfgr | 2004-10-05 |
| Date Mfgr Received | 2004-10-05 |
| Date Added to Maude | 2007-09-12 |
| 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 AVENUE 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 | MEDTRONIC OVERPRESSURE/ VACUUM RELIEF VALVE |
| Generic Name | VACUUM RELIEF VALVE |
| Product Code | MNJ |
| Date Received | 2004-10-15 |
| Returned To Mfg | 2004-10-07 |
| Model Number | VRV-100 |
| Catalog Number | 1140333-1 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 884115 |
| 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 | 2004-10-15 |