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 2020-03-18 for VALVE, O.P.S BULK, N-S LN130B N/A manufactured by Terumo Cardiovascular Systems Corporation.
[188530555]
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
[188530556]
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the valve leaks blood with every heartbeat. Per user facility, the patient had a vent valve issue. From the time the clamp came off until they made the decision to cool and go back was only about 20 minutes. After clamp came off and while the heart was beating. With every heartbeat, a little bit of blood leaks out. During that time the average patient arterial line pressure was 67mmhg. The highest systolic pressure, when they filled to let the heart eject and assess on echo, was 111mmhg (map 86mmhg at that time). The valve had already failed by then and they were switching it out so they could apply the cross clamp again. The vent valve was used in aortic root vent line. There was 3-5cc of blood loss. The product was changed out. The surgery was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1124841-2020-00072 |
| MDR Report Key | 9849519 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-18 |
| 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 BULK, N-S |
| Generic Name | OVERPRESSURE SAFETY VALVE |
| Product Code | DTL |
| Date Received | 2020-03-18 |
| Returned To Mfg | 2020-03-04 |
| Model Number | LN130B |
| Catalog Number | N/A |
| Lot Number | WK06 |
| 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 | 2020-03-18 |