MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-11 for RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS BO-VKMO 11000 701053444 manufactured by Maquet Cardiopulmonary Ag.
[85938610]
Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4). The device has been requested but not yet received. A follow-up medwatch will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[85938611]
According to the hospital: "we had no trouble priming the circuit (ie. No evidence of high pressure etc. )however with the initiation of bypass, venous return was very limited. A second cannula was placed in the ra with no change in venous return. We had to change the reservoir (and membrane) prior to commencing with bypass. We flushed out the reservoir, no clots are visible. It does seem to fill slower than normal when we try to "re-prime" the reservoir. Dr. (b)(6) it had nothing to do with cannula position. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2017-00290 |
| MDR Report Key | 6856136 |
| Date Received | 2017-09-11 |
| Date of Report | 2018-01-16 |
| Date of Event | 2017-08-29 |
| Date Mfgr Received | 2018-01-15 |
| Device Manufacturer Date | 2017-02-01 |
| Date Added to Maude | 2017-09-11 |
| 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 | RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS |
| Generic Name | FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE |
| Product Code | DTM |
| Date Received | 2017-09-11 |
| Returned To Mfg | 2017-10-09 |
| Model Number | BO-VKMO 11000 |
| Catalog Number | 701053444 |
| Lot Number | 92218708 |
| Device Expiration Date | 2019-02-13 |
| 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 | 2017-09-11 |