MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-01-31 for STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP 60-02-15 NA manufactured by Sorin Group Deutschland.
[3327439]
Sorin group rec'd a report that the scp displayed an error code during priming. There was no pt involvement as the issue occurred during priming.
Patient Sequence No: 1, Text Type: D, B5
[10585355]
Sorin group (b)(4) manufactures the stockert centrifugal pump system. The incident occurred in (b)(6). This medwatch report is filed on behalf of sorin group (b)(4). A sorin group field svc rep was dispatched to investigate. While at the facility the svc rep replaced the cpu board and subsequent testing confirmed that the issue was resolved. The investigation is ongoing. A follow-up report will be filed when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718850-2013-00004 |
| MDR Report Key | 2957223 |
| Report Source | 05 |
| Date Received | 2013-01-31 |
| Date of Report | 2013-01-04 |
| Date of Event | 2013-01-04 |
| Date Mfgr Received | 2013-01-04 |
| Device Manufacturer Date | 2012-05-01 |
| Date Added to Maude | 2013-02-27 |
| 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 BOORHEES, 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 DEUTSCHLAND |
| Manufacturer Street | LINDBERGHSTR. 25 |
| Manufacturer City | MUNICH D80939 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D80939 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP |
| Generic Name | CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS |
| Product Code | JPZ |
| Date Received | 2013-01-31 |
| Model Number | 60-02-15 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| 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 DEUTSCHLAND |
| Manufacturer Address | LINDBERGHSTR. 25 MUNICH D80939 GM D80939 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-31 |