MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-05 for SARNS 8000 PERFUSION SYSTEM 16404 manufactured by Terumo Cardiovascular Systems Corp..
[74659539]
(b)(4). Evaluation is in progress, but not yet concluded.
Patient Sequence No: 1, Text Type: N, H10
[74659540]
It was reported that during priming of the device for a cardiopulmonary bypass (cpb) procedure, the perfusionist heard air bubble detector alarming without any air in a circuit. There was a bad connection on back of safety monitor. The air detector was changed out. There was a two minute delay in starting the procedure. The surgery was completed successfully, no adverse event was reported. Per clinical review: during priming, prior to cpb, the air bubble detector was enabled from the safety monitor and an alarm occurred. According to the certified clinical perfusionist (ccp), no air was visible but the air detector continued to alarm. The ccp grabbed a spare cable that connects the air sensor to the back of the safety monitor and he changed out this cable. The cable swap allowed air detection to be reset and the system was able to be used for the procedure. During the cable swap, the ccp mentioned that the air detection module seemed to be a little loose in the back of the safety monitor. The air detector was used for the procedure and the case was completed successfully. The troubleshooting did delay the start of the procedure by about 2 minutes. There was no associated blood loss and no harm was observed.
Patient Sequence No: 1, Text Type: D, B5
[83751124]
(b)(4). The complaint was duplicated during laboratory analysis. Per product surveillance technician (pst), the device under test (dut) safety monitor's air bubble detector (abd) could be turned on and would operate properly but when the cable / connection on the back was slightly moved, false air detection alarms occurred (light-emitting diode and audible alarms). After the abd card cover was removed for inspection, several fatigued and fractured solder connections at the abd connector pins were evident. This was the cause of the intermittent behavior. The product will be sent to service to be brought to manufacturer? S specifications before being returned to the customer. 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 | 1828100-2017-00223 |
| MDR Report Key | 6549463 |
| Date Received | 2017-05-05 |
| Date of Report | 2017-06-07 |
| Date of Event | 2017-04-12 |
| Date Mfgr Received | 2017-05-17 |
| Device Manufacturer Date | 2004-09-24 |
| Date Added to Maude | 2017-05-05 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | DETECTOR, BUBBLE, CARDIOPULMONARY BYPASS-SARNS 8000 PERFUSION SYSTEM |
| Product Code | KRL |
| Date Received | 2017-05-05 |
| Returned To Mfg | 2017-04-24 |
| Model Number | 16404 |
| Catalog Number | 16404 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-05-05 |