MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-09 for SARNS 8000 PERFUSION SYSTEM 5773 manufactured by Terumo Cardiovascular Systems Corp..
[40211889]
(b)(4). This complaint is related to emdr #182810-2016-00164. The fsr replaced the latch assembly and preventive maintenance/inspection was completed successfully. The unit operated to manufacturer specifications and was returned to clinical use. The suspect part was returned to the manufacturer. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a follow-up emdr will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10
[40211890]
The field service representative (fsr) reported that during preventive maintenance (pm) of the device (refer to emdr #1828100-2016-00164), he found the ultrasonic air sensor (uas) latch assembly was broken. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1828100-2016-00165 |
| MDR Report Key | 5489201 |
| Date Received | 2016-03-09 |
| Date of Report | 2016-03-09 |
| Date Mfgr Received | 2016-02-17 |
| Device Manufacturer Date | 2007-10-16 |
| Date Added to Maude | 2016-03-09 |
| 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 | 0 |
| Brand Name | SARNS 8000 PERFUSION SYSTEM |
| Generic Name | DETECTOR, BUBBLE, CARDIOPULMONARY BYPASS-SARNS 8000 |
| Product Code | KRL |
| Date Received | 2016-03-09 |
| Returned To Mfg | 2016-02-24 |
| Model Number | 5773 |
| Catalog Number | 5773 |
| Device Availability | R |
| 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 | 2016-03-09 |