MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-10 for VALVE, O.P.S (STERILE) LH130 N/A manufactured by Terumo Cardiovascular Systems Corporation.
[188530264]
Terumo has received the device for evaluation; however, the investigation has yet to be completed. Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188530265]
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the overpressure safety valve leaked. The valve was being used in an aortic root vent line and leaked during cardioplegia delivery. They were on regular integrate flow with the vent on and were told to turn off the vent. When the vent was turned it off, that's when the valve was noted to be leaking and it was like a steady stream coming out from the bottom of the valve. They took the 1st valve out and replaced it with a 2nd valve, which also leaked. The leaking stopped on the 3rd valve replacement. Cardioplegia flows were able to be run at 250-300ml/min and were seeing pressures between 200-250mmhg. There was an approximate blood loss of 250cc. There was a delay of 15 minutes. Product was changed out. Procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1124841-2020-00060 |
| MDR Report Key | 9813736 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CATHLEEN HARGREAVES |
| Manufacturer Street | 125 BLUE BALL ROAD |
| Manufacturer City | ELKTON MD 21921 |
| Manufacturer Country | US |
| Manufacturer Postal | 21921 |
| Manufacturer Phone | 8002837866 |
| Manufacturer G1 | SAME |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VALVE, O.P.S (STERILE) |
| Generic Name | OVERPRESSURE SAFETY VALVE |
| Product Code | DTL |
| Date Received | 2020-03-10 |
| Returned To Mfg | 2020-02-19 |
| Model Number | LH130 |
| Catalog Number | N/A |
| Lot Number | WA15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
| Manufacturer Address | 125 BLUE BALL ROAD ELKTON MD 21921 US 21921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-10 |