MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-14 for SARNS 8000 PERFUSION SYSTEM 5773 manufactured by Terumo Cardiovascular Systems Corp..
[33951566]
(b)(4). This complaint is related to the following for the same issue (different device) at the same user facility: mdr #1828100-2015-01029, mdr #1828100-2015-01030 and mdr #1828100-2015-01031. The field service representative (fsr) replaced the latch on the uas and the unit operated to manufacturer specifications and was returned to clinical use. There will be no part return. 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
[33951567]
The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the ultrasonic air sensor (uas) latch was missing. The uas was wrapped in velcro. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1828100-2015-01028 |
| MDR Report Key | 5295208 |
| Date Received | 2015-12-14 |
| Date of Report | 2015-12-14 |
| Date Mfgr Received | 2015-11-24 |
| Device Manufacturer Date | 2007-10-16 |
| Date Added to Maude | 2015-12-14 |
| 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 | 2015-12-14 |
| Model Number | 5773 |
| Catalog Number | 5773 |
| Device Availability | Y |
| 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 | 2015-12-14 |