MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-08-19 for WILLIAM HARVEY OVER PRESSURE SAFETY VALVE LN130B manufactured by Terumo Cardiovascular Systems Corp..
[19461201]
On july 23, 2009, it was reported by a user facility ((b) (4)) to terumo cardiovascular that during a cardiopulmonary bypass procedure, an overpressure relief valve may have exhibited a crack during use. As a result of this event, the device was replaced and the surgery was successfully completed without further incident. The user facility reported that the pt did not suffer injury of any type as a result of this event (although it is apparent that there was minimal/insignificant blood loss).
Patient Sequence No: 1, Text Type: D, B5
[19712201]
The user facility reported that the pressure relief valve may have exhibited a crack due to the "spray of blood" that was observed in a vent line during a cardiopulmonary bypass procedure. The user facility did not maintain the device - and immediately discarded it after removing from the circuit. Terumo's investigation (including interviews with the user facility) revealed that the device most likely performed exactly it is intended in that the positive pressure umbrella "activated" when there was a pressure increase in the circuit. Terumo draws this conclusion based upon the "spray" that was described in the complaint. If the device had been defective/cracked, the likely scenario is that fluid would leak from the valve and would not have sprayed from the valve. Terumo does not consider this event to be the result of a defective product, but rather the result of another event that occurred during the operational context of the surgery. The valve appears to have performed as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1124841-2009-00029 |
| MDR Report Key | 1493064 |
| Report Source | 05,06 |
| Date Received | 2009-08-19 |
| Date of Report | 2009-07-23 |
| Date of Event | 2009-07-20 |
| Date Facility Aware | 2009-07-20 |
| Report Date | 2009-07-23 |
| Date Mfgr Received | 2009-07-23 |
| Device Manufacturer Date | 2009-02-01 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | GARRY COURTNEY, MGR |
| Manufacturer Street | 125 BLUE BALL RD. |
| Manufacturer City | ELKTON MD 21921 |
| Manufacturer Country | US |
| Manufacturer Postal | 21921 |
| Manufacturer Phone | 8002837866 |
| Manufacturer G1 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| Manufacturer Street | 125 BLUE BALL RD. |
| Manufacturer City | ELKTON MD 21921 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21921 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WILLIAM HARVEY OVER PRESSURE SAFETY VALVE |
| Generic Name | PRESSURE RELIEF VALVE |
| Product Code | MNJ |
| Date Received | 2009-08-19 |
| Model Number | NA |
| Catalog Number | LN130B |
| Lot Number | LC04 |
| ID Number | NA |
| Device Expiration Date | 2011-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-19 |