MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-01-21 for SARNS 8000 PERFUSION SYSTEM 149673 manufactured by Terumo Cardiovascular Systems Corp..
[36543322]
(b)(4). The reported complaint was confirmed. The user facility? S biomedical engineer (biomed) stated that the broken latch was discarded, therefore no part will be returned. 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
[36543323]
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the red ultrasonic air sensor (uas) latch was broken. The device was not changed out, as they temporarily used adhesive tape to secure the unit. Using this method of securing, the unit has been successful and unit was functioning properly. 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
| Report Number | 1828100-2016-00026 |
| MDR Report Key | 5382868 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-01-21 |
| Date of Report | 2016-01-21 |
| Date of Event | 2015-12-29 |
| Date Mfgr Received | 2016-01-04 |
| Date Added to Maude | 2016-01-21 |
| 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 | 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 |
| Product Code | KRL |
| Date Received | 2016-01-21 |
| Model Number | 149673 |
| Catalog Number | 149673 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2016-01-21 |