MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-16 for SARNS 8000 CARDIOPLEGIA MONITOR 16414 manufactured by Terumo Cardiovascular Systems Corp..
[28910180]
(b)(4). The subsidiary site service engineer (se) found ampro board was broken and caused the reported problem. The se assembled an old model central processing unit (cpu) board, and now the cpg monitor is working correctly. Per the se, they are not going to send the defective printed circuit board assembly (pcba) to the manufacturer for evaluation. He stated there was no damage or obvious component damage to board.
Patient Sequence No: 1, Text Type: N, H10
[28910181]
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the cardioplegia (cpg) monitor is broken. At first, the monitor housing was very hot after running for some time. Sometimes the numbers on the display of the monitor were frozen. When the user presses the buttons, there's no affect. Now the monitor does not boot-up and always has black screen. As a result, an alternate device was employed. 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
[35321655]
The reported complaint was confirmed via subsidiary evaluation. 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 | 1828100-2015-00896 |
| MDR Report Key | 5156684 |
| Date Received | 2015-10-16 |
| Date of Report | 2016-01-07 |
| Date of Event | 2015-09-01 |
| Date Mfgr Received | 2015-12-22 |
| Device Manufacturer Date | 2009-01-13 |
| Date Added to Maude | 2015-10-16 |
| 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 | 2015-10-16 |
| Model Number | 16414 |
| Catalog Number | 16414 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2015-10-16 |