MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-05 for SARNS 8000 CARDIOPLEGIA MONITOR 16414 manufactured by Terumo Cardiovascular Systems Corp..
[30709635]
(b)(4). The ccp stated that they used a manometer as a backup. The field service representative (fsr) could not duplicate the reported issue. The fsr checked the cpg monitor operation and the cpg pressure monitor worked properly. The unit operated to manufacturer specifications and was returned to clinical use.
Patient Sequence No: 1, Text Type: N, H10
[30709636]
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, one of the pressure channels on the cardioplegia (cpg) monitor was not reading. As a result, an alternate device was employed. The perfusionist (ccp) used a manometer. 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
[34306205]
(b)(4). 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 | 1828100-2015-00948 |
| MDR Report Key | 5204650 |
| Date Received | 2015-11-05 |
| Date of Report | 2015-12-23 |
| Date of Event | 2015-10-13 |
| Date Mfgr Received | 2015-12-23 |
| Date Added to Maude | 2015-11-05 |
| 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. JAN WINDER |
| 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 CARDIOPLEGIA MONITOR |
| Generic Name | ALARM, BLOOD-PRESSURE-SARNS 8000 CARDIOPLEGIA MONITOR |
| Product Code | DSJ |
| Date Received | 2015-11-05 |
| Model Number | 16414 |
| Catalog Number | 16414 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-11-05 |