MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-05 for HEMOCONCENTRATOR BC 60 PLUS, BC 140 PLUS 70100.2497 manufactured by Maquet Cardiopulmonary Ag.
[141478255]
(b)(4). A follow-up medwatch will be submitted when additional information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[141478256]
During the scheduled surgery, the customer detected the blood leaking at the drainage side. During the extracorporeal circulation, it was observed that the color of the filtrated liquid was turning red as soon as the filtration started. The color of the filtrated liquid was getting darker (redder) and the blood leak was confirmed. A replacement was used to complete the procedure. No adverse effects on the patient. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2019-00061 |
| MDR Report Key | 8389990 |
| Date Received | 2019-03-05 |
| Date of Report | 2019-07-31 |
| Date of Event | 2019-01-29 |
| Date Mfgr Received | 2019-07-02 |
| Date Added to Maude | 2019-03-05 |
| 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 | HEMOCONCENTRATOR BC 60 PLUS, BC 140 PLUS |
| Generic Name | RESTRAINT, WHEELCHAIR, NON-PROTECTIVE |
| Product Code | KID |
| Date Received | 2019-03-05 |
| Model Number | BC 140 PLUS |
| Catalog Number | 70100.2497 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY AG |
| Manufacturer Address | RASTATT GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-05 |