MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for OPS VALVE manufactured by Terumo Cardiovascular Systems Corp..
[181721485]
The safety device (one way valve) on the aortic vent over pressurized and malfunctioned. The vent valve was replaced twice and the problem continued to occur. Dr was made aware of the problem. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093333 |
| MDR Report Key | 9763843 |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-02-17 |
| Date Added to Maude | 2020-02-27 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPS VALVE |
| Generic Name | ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS |
| Product Code | DTL |
| Date Received | 2020-02-26 |
| Lot Number | X51916152 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| Manufacturer Address | US |
| Brand Name | OSP VALVE |
| Generic Name | ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS |
| Product Code | DTL |
| Date Received | 2020-02-26 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| Manufacturer Address | US |
| Brand Name | OSP VALVE |
| Generic Name | ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS |
| Product Code | DTL |
| Date Received | 2020-02-26 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-26 |