MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-02 for H/S CUVETTE 3/8X3/8-JAPAN CV-6913 N/A manufactured by Terumo Cardiovascular Systems Corporation.
[188529534]
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
[188529535]
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, a blood leak was noted. Per user facility the cuvette was set to a cdi probe. When about one hour passed after the procedure started, blood leakage from the cuvette was observed. After the cdi probe was removed, a transparent tape was used to fix it. After that, no blood leakage or suction of bubbles was observed, and the procedure was continued. Percutaneous cardiopulmonary support (pcps) was used in the cardiac catheterization laboratory. After the procedure, the patient was transferred to the icu, and then a cdi500 system was used. The patient expired at a later date, on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1124841-2020-00048 |
| MDR Report Key | 9776695 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2020-03-02 |
| 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 | H/S CUVETTE 3/8X3/8-JAPAN |
| Generic Name | BLOOD GAS MONITOR |
| Product Code | DRY |
| Date Received | 2020-03-02 |
| Returned To Mfg | 2020-02-21 |
| Model Number | CV-6913 |
| Catalog Number | N/A |
| Lot Number | XC11 |
| 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 | 2020-03-02 |