MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-10-15 for TERUMO PERFUSION SYSTEM 8000 5773 manufactured by Terumo Cardiovascular Systems Corp..
[20936840]
During preparation for use of the device for a cardiopulmonary bypass procedure, the user reported, the air bubble detector would not reset. The device was used for the procedure. The user reported, the surgical procedure was completed successfully, and there was no adverse consequence to the patient as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[21221964]
Evaluation in progress, but not yet concluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1828100-2009-00511 |
| MDR Report Key | 1512484 |
| Report Source | 05,06 |
| Date Received | 2009-10-15 |
| Date of Report | 2009-10-15 |
| Date of Event | 2009-09-17 |
| Date Mfgr Received | 2009-09-18 |
| Date Added to Maude | 2010-01-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVEN ARICK |
| Manufacturer Street | 6200 JACKSON RD. |
| Manufacturer City | ANN ARBOR MI 48103 |
| Manufacturer Country | US |
| Manufacturer Postal | 48103 |
| Manufacturer Phone | 7347416238 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TERUMO PERFUSION SYSTEM 8000 |
| Generic Name | AIR BUBBLE DETECTOR |
| Product Code | KRL |
| Date Received | 2009-10-15 |
| Model Number | 5773 |
| Catalog Number | 5773 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| Manufacturer Address | ANN ARBOR MI 48103 US 48103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-10-15 |