MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-05 for S5 ROLLER PUMP 10-80-00 NA manufactured by Sorin Group Deutschland.
[5205520]
Sorin group (b)(4) received a report that the touch screen of the s5 roller pump was unresponsive during set up. There was no pt involvement.
Patient Sequence No: 1, Text Type: D, B5
[12615295]
Sorin group (b)(4) manufactures the s5 roller pump. The incident occurred in (b)(6). This medwatch report is filed on behalf of sorin group (b)(4). The investigation is ongoing. A follow up report will be sent when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[74535697]
Livanova (b)(4) manufactures the s5 roller pump. The incident occurred in (b)(6). This medwatch report is being filed on behalf of livanova (b)(4). A livanova field service representative was dispatched to the facility to investigate. The service representative was able to confirm the reported issue and traced the failure to a defective touch screen. The touch screen was replaced to resolve the issue and subsequent testing found the unit to be working according the specifications. The unit was returned to service. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. A corrective action regarding this type of issue was implemented in 2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718850-2014-00448 |
| MDR Report Key | 4340622 |
| Report Source | 05 |
| Date Received | 2014-12-05 |
| Date of Report | 2017-05-02 |
| Date of Event | 2014-10-20 |
| Date Mfgr Received | 2017-03-31 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2014-12-23 |
| 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 | JOAN CEASAR |
| Manufacturer Street | 14401 W. 65TH WAY |
| Manufacturer City | ARVADA CO 80004 |
| Manufacturer Country | US |
| Manufacturer Postal | 80004 |
| Manufacturer Phone | 2812287260 |
| Manufacturer G1 | LIVANOVA DEUTSCHLAND |
| Manufacturer Street | LINDBERGHSTR. 25 |
| Manufacturer City | MUNICH, 80939 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 80939 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S5 ROLLER PUMP |
| Generic Name | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS |
| Product Code | KRI |
| Date Received | 2014-12-05 |
| Model Number | 10-80-00 |
| 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 D 80939 GM D 80939 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-05 |