MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-08 for VENOUS HARDSHELL CARDIOTOMY RESERVOIRS BO-VHK 71000-J 701066420 manufactured by Maquet Cardiopulmonary Ag.
[96833134]
(b)(4). A follow-up medwatch will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[96833135]
According to the hospital: "the priming was performed, and was standing-by for the cpb start. Then, water drop was found on the floor under the circuit. They studied the circuit assembly, tightened the each connection, confirmed everything was okay, and then, started the extracorporeal circulation. Before cpb reached to 100%, blood drop was noted on the floor; it was leaking from the one-way valve of the sampling manifold. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2018-00002 |
| MDR Report Key | 7171650 |
| Date Received | 2018-01-08 |
| Date of Report | 2018-07-16 |
| Date of Event | 2017-12-05 |
| Date Mfgr Received | 2018-07-10 |
| Device Manufacturer Date | 2016-10-01 |
| Date Added to Maude | 2018-01-08 |
| 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 Street | MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 |
| Manufacturer City | 76437 RASTATT |
| Manufacturer Country | GM |
| Manufacturer Phone | 4972229321 |
| Manufacturer G1 | BERND RAKOW |
| Manufacturer Street | MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 |
| Manufacturer City | 76437 RASTATT |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VENOUS HARDSHELL CARDIOTOMY RESERVOIRS |
| Generic Name | FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE |
| Product Code | DTM |
| Date Received | 2018-01-08 |
| Returned To Mfg | 2018-01-08 |
| Model Number | BO-VHK 71000-J |
| Catalog Number | 701066420 |
| Lot Number | 92213844 |
| Device Expiration Date | 2018-10-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY AG |
| Manufacturer Address | RASTATT GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-08 |