MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-23 for PERFUSION VALVE TERUMO H-130 VALVE manufactured by Terumo H0130.
[5887438]
Perfusion tubing was being prepped for surgery, not yet hooked up to pt. The one way valve, terumo h-130 was found to be faulty during testing. Diagnosis or reason for use: part of perfusion set up during cabg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042356 |
| MDR Report Key | 4737534 |
| Date Received | 2015-04-23 |
| Date of Report | 2015-04-23 |
| Date of Event | 2015-04-20 |
| Date Added to Maude | 2015-04-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERFUSION VALVE TERUMO H-130 VALVE |
| Generic Name | PERFUSION VALVE TERUMO H-130 VALVE |
| Product Code | MJJ |
| Date Received | 2015-04-23 |
| Lot Number | 209173478 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO H0130 |
| Manufacturer Address | ELMHURST IL 60532 US 60532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-04-23 |