MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-02 for SARNS 8000 PERFUSION SYSTEM 16413 manufactured by Terumo Cardiovascular Systems Corporation.
[76711929]
(b)(4). Evaluation is in progress, but not yet concluded. The fsr troubleshot the problem and determined the temperature/pressure printed circuit board (pcba) was at fault. The fsr replaced the temperature/pressure pcba. The unit operated to manufacturer's specifications. The temperature/pressure pcba was returned to the manufacturer for further evaluation.
Patient Sequence No: 1, Text Type: N, H10
[76711930]
The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the channel a of arterial monitor would not display temperature. It would only display dashes. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[78469381]
(b)(4). The reported complaint was confirmed. During laboratory analysis, product surveillance technician (pst) observed that a damaged input connector caused the channel a input to not display temperature. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1828100-2017-00258 |
| MDR Report Key | 6609442 |
| Date Received | 2017-06-02 |
| Date of Report | 2017-06-26 |
| Date of Event | 2017-05-10 |
| Date Mfgr Received | 2017-06-23 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2017-06-02 |
| 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 | MS. KATIE HOYT |
| Manufacturer Street | 6200 JACKSON ROAD |
| Manufacturer City | ANN ARBOR MI 48103 |
| Manufacturer Country | US |
| Manufacturer Postal | 48103 |
| Manufacturer Phone | 7346634145 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SARNS 8000 PERFUSION SYSTEM |
| Generic Name | MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS-SARNS 8000 |
| Product Code | DTW |
| Date Received | 2017-06-02 |
| Returned To Mfg | 2017-05-31 |
| Model Number | 16413 |
| Catalog Number | 16413 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
| Manufacturer Address | 6200 JACKSON ROAD ANN ARBOR MI 48103 US 48103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-02 |