MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-09 for HEART LUNG MACHINE 701043290 - ROTAFLOW ENGLISH EU-PLUG 701043290 manufactured by Maquet Cardiopulmonary Gmbh.
[182554511]
During patient treatment it was discovered that the power supply board of the rotaflow was defective. The costumer used the emergency drive. During this procedure the patient had a cardiac arrest and died. Complaint number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008355164-2020-00011 |
| MDR Report Key | 9805612 |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-02-20 |
| Date Facility Aware | 2020-03-06 |
| Report Date | 2020-03-09 |
| Date Reported to FDA | 2020-03-09 |
| Date Reported to Mfgr | 2020-03-09 |
| Device Manufacturer Date | 2017-04-12 |
| Date Added to Maude | 2020-03-09 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEART LUNG MACHINE |
| Generic Name | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE |
| Product Code | KFM |
| Date Received | 2020-03-09 |
| Model Number | 701043290 - ROTAFLOW ENGLISH EU-PLUG |
| Catalog Number | 701043290 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 38 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY GMBH |
| Manufacturer Address | NEUE ROTTENBURGER STRASSE 37 HECHINGEN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-09 |