MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-17 for MCKAY DEE HSP OGDEN UT 1 N/A 044011800 manufactured by Sorin Group Usa.
[31968511]
There was no patient involvement. Sorin group received a report that during priming, the pre-bypass filter of the custom perfusion pack failed to prime and the priming fluid was unable to pass through the filter. There was no patient involvement. A user report was filed for this event under report number (b)(4). This medwatch report is being filed as a result of this action. The investigation is ongoing. A follow-up report will be sent when the investigation is complete. Evaluation is not completed.
Patient Sequence No: 1, Text Type: N, H10
[31968512]
Sorin group received a report that during priming, the pre-bypass filter of the custom perfusion pack failed to prime and the priming fluid was unable to pass through the filter. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718850-2015-00454 |
| MDR Report Key | 5231871 |
| Date Received | 2015-11-17 |
| Date of Report | 2015-10-05 |
| Date of Event | 2015-05-27 |
| Date Mfgr Received | 2015-10-05 |
| Device Manufacturer Date | 2015-01-26 |
| Date Added to Maude | 2015-11-17 |
| 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 | CARRIE WOOD |
| Manufacturer Street | 14401 W. 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal | 80004 |
| Manufacturer Phone | 3034676461 |
| Manufacturer G1 | SORIN GROUP USA |
| Manufacturer Street | 14401 W. 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MCKAY DEE HSP OGDEN UT 1 |
| Generic Name | CUSTOM PERFUSION PACK |
| Product Code | KRJ |
| Date Received | 2015-11-17 |
| Returned To Mfg | 2015-10-09 |
| Model Number | N/A |
| Catalog Number | 044011800 |
| Lot Number | 1502600038 |
| Device Expiration Date | 2017-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP USA |
| Manufacturer Address | 14401 W. 65TH WAY ARVADA CO 80004 US 80004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-17 |