MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-07 for SARNS 8000 MODULE PERFUSION SYSTEM 149673 manufactured by Terumo Cardiovascular Systems.
[59562312]
(b)(4). The field service representative was dispatched to the user facility. He performed functional testing of the air bubble detector (abd) also known as the ultrasonic air sensor (uas). The fsr could not duplicate any problems. The system met manufacturers specifications and was returned to clinical use.
Patient Sequence No: 1, Text Type: N, H10
[59562313]
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the air bubble detector (abd) information would not populate on the monitor of the heart lung machine. The perfusionist could not reset the abd to turn it "on". When she turned it "on" without going through reset button it would stop the arterial pump head. Therefore, the surgery was initiated without utilizing an abd. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient. Additional information obtained: the abd was located between the venous reservoir and the arterial roller pump in an operating room that was very cold (around 58 degrees fahrenheit). The latch on the abd seemed more difficult than normal to close but there were no visual signs of damage. The perfusionist actions to trouble shoot were to disconnect the power cord from the control box and also from the abd. She turned off the control box and allowed it to reboot. She cleaned the abd sensor and red box with alcohol swabs. However, she could never get it to "reset" and therefore be able to turn it on.
Patient Sequence No: 1, Text Type: D, B5
[65366309]
The reported complaint was not confirmed. 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 | 1828100-2016-00715 |
| MDR Report Key | 6081133 |
| Date Received | 2016-11-07 |
| Date of Report | 2017-01-17 |
| Date of Event | 2016-10-13 |
| Date Mfgr Received | 2017-01-12 |
| Device Manufacturer Date | 2008-06-30 |
| Date Added to Maude | 2016-11-07 |
| 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 EILEEN DORSEY |
| Manufacturer Street | 6200 JACKSON ROAD |
| Manufacturer City | ANN ARBOR MI 48103 |
| Manufacturer Country | US |
| Manufacturer Postal | 48103 |
| Manufacturer Phone | 7347416074 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SARNS 8000 MODULE PERFUSION SYSTEM |
| Generic Name | DETECTOR, BUBBLE, CARDIOPULMONARY BYPASS-SARNS 8000 PERFUSION SYSTEM |
| Product Code | KRL |
| Date Received | 2016-11-07 |
| Model Number | 149673 |
| Catalog Number | 149673 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS |
| Manufacturer Address | 6200 JACKSON ROAD ANN ARBOR MI 48103 US 48103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-07 |