MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-28 for VENOUS HARDSHELL CARDIOTOMY RESERVOIR VKMO 78000 701064525 manufactured by Maquet Cardiopulmonary Ag.
[83960067]
(b)(4). A follow-up medwatch will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[83960068]
According to the hospital:"there was leakage from the one-way valve. So the perfusionist exchanged another set. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2017-00278 |
| MDR Report Key | 6824273 |
| Date Received | 2017-08-28 |
| Date of Report | 2017-10-25 |
| Date of Event | 2017-07-03 |
| Date Mfgr Received | 2017-10-18 |
| Device Manufacturer Date | 2016-11-01 |
| Date Added to Maude | 2017-08-28 |
| 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 RESERVOIR |
| Generic Name | FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE |
| Product Code | DTM |
| Date Received | 2017-08-28 |
| Model Number | VKMO 78000 |
| Catalog Number | 701064525 |
| Lot Number | 92217112 |
| Device Expiration Date | 2018-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-08-28 |