MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-18 for SARNS 8000 PERFUSION SYSTEM 16413 manufactured by Terumo Cardiovascular Systems Corp..
[75610826]
(b)(4). The field service representative was unable to duplicate the reported issue. The unit operated to manufacturer's specifications. 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
[75610827]
It was reported that before use of the device for a cardiopulmonary bypass (cpb) procedure, the display for arterial pressure was not showing any information. The other displays in the monitor were normal. The perfusionist replaced the arterial pressure cable and the arterial pressure transducer and still had the problem. The customer used the cardioplegia monitor channel b in place of the arterial pressure for the case and removed the unit from service. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
[96742487]
Patient Sequence No: 1, Text Type: N, H10
[113938945]
The reported complaint was not confirmed. The field service representative (fsr) replaced power manager board in safety monitor as precaution. This board supplies power to arterial monitor and may have intermittent problem. 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 | 1828100-2017-00242 |
| MDR Report Key | 6575317 |
| Date Received | 2017-05-18 |
| Date of Report | 2017-10-03 |
| Date of Event | 2017-04-25 |
| Date Mfgr Received | 2017-09-21 |
| Device Manufacturer Date | 1994-04-14 |
| Date Added to Maude | 2017-05-18 |
| 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 | 0 |
| Brand Name | SARNS 8000 PERFUSION SYSTEM |
| Generic Name | MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS-SARNS 8000 |
| Product Code | DTW |
| Date Received | 2017-05-18 |
| Returned To Mfg | 2017-06-28 |
| Model Number | 16413 |
| Catalog Number | 16413 |
| ID Number | GTIN (01)00886799000205 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| Manufacturer Address | 6200 JACKSON ROAD ANN ARBOR MI 48103 US 48103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-18 |