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 2015-10-23 for SARNS 8000 PERFUSION SYSTEM 5773 manufactured by Terumo Cardiovascular Systems Corp..
[29086115]
(b)(4). The field service representative (fsr) confirmed the broken draw latch. He replaced the draw latch assembly and tested operation satisfactory. 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 supplemental report will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10
[29086116]
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the draw latch on ultrasonic air sensor (uas) broke. The 8k was being set-up for a case the next day. They have a spare uas and swapped it for the one with the broken draw latch. 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 | 1828100-2015-00907 |
| MDR Report Key | 5171591 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-10-23 |
| Date of Report | 2015-10-22 |
| Date of Event | 2015-09-30 |
| Date Mfgr Received | 2015-09-30 |
| Device Manufacturer Date | 2007-10-24 |
| Date Added to Maude | 2015-10-23 |
| 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 | 3 |
| Brand Name | SARNS 8000 PERFUSION SYSTEM |
| Generic Name | DETECTOR, BUBBLE, CARDIOPULMONARY BYPASS-SARNS 8000 |
| Product Code | KRL |
| Date Received | 2015-10-23 |
| Returned To Mfg | 2015-10-13 |
| Model Number | 5773 |
| Catalog Number | 5773 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2015-10-23 |