MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-28 for SC MORRISTOWN MORRISTOWN NJ 2 627308301 manufactured by Sorin Group Usa, Inc..
[4659511]
Sorin group received a report of inadequate flow through the heart lung pack circuit during the first several mins after going onto bypass. The pt had not yet been cooled but was on ventilation. A new heart lung machine with a disposables circuit was brought in. The pt was placed back on bypass. The case proceeded and was completed without further incident. There was no report of pt injury.
Patient Sequence No: 1, Text Type: D, B5
[12116677]
The investigation is ongoing. A f/u report will be sent when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718850-2014-00167 |
| MDR Report Key | 3855580 |
| Report Source | 05 |
| Date Received | 2014-05-28 |
| Date of Report | 2014-05-01 |
| Date of Event | 2014-04-23 |
| Date Mfgr Received | 2014-05-01 |
| Device Manufacturer Date | 2014-02-01 |
| Date Added to Maude | 2014-06-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHERI VORHEES, MGR. |
| Manufacturer Street | 14401 WEST 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal | 80004 |
| Manufacturer Phone | 3034676527 |
| Manufacturer G1 | SORIN GROUP USA, INC. |
| Manufacturer Street | 14401 WEST 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80004 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SC MORRISTOWN MORRISTOWN NJ 2 |
| Generic Name | CUSTOM PERFUSION PACK |
| Product Code | KRI |
| Date Received | 2014-05-28 |
| Model Number | NA |
| Catalog Number | 627308301 |
| Lot Number | 1405800047 |
| ID Number | NA |
| Device Expiration Date | 2016-02-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP USA, INC. |
| Manufacturer Address | 14401 WEST 65TH WAY ARVADA CO 80004 US 80004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-28 |