MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-11-17 for MCKAY DEE HSP OGDEN UT 1 N/A 044011800 manufactured by Sorin Group Usa.
[31789882]
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
[31789883]
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
[32663480]
This incident occured during priming and so "no patient involvement" was indicated on the initial report, however patient information has been provided by the facility: pt age: (b)(6) years. Dob not provided. Pt gender. Female. Pt weight. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[35115347]
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 4600040000-2015-8006. This medwatch report is being filed as a result of this action. Two pre-bypass filters were returned to sorin group usa for further analysis. An additional pre-bypass filter from a different lot (lot 1513300043) was pulled from inventory to be used as a control. A visual inspection was conducted on all three devices and no defects were found. A priming test was also conducted using saline solution and both returned devices and the control unit worked as expected and did not occlude flow. An additional priming test was conducted without correctly letting all of the air out of the filter to attempt to simulate the reported occlusion, but this test also was unable to confirm the issue. Without the ability to reproduce the issue, a root cause could not be determined. No trend has been identified for this type of issue. Sorin group will continue to monitor the market for trends relating to this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718850-2015-00453 |
| MDR Report Key | 5231867 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-11-17 |
| Date of Report | 2015-10-05 |
| Date of Event | 2015-05-12 |
| Date Mfgr Received | 2015-11-24 |
| 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, INC. |
| 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 | 3 |
| 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 Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 |