MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-23 for ARTERIELLER FILTER QUART BO-HBF 140-J 701048784 manufactured by Maquet Cardiopulmonary Ag.
[103530160]
(b)(4). A follow-up medwatch will be submitted when additional information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103530161]
According to the hospital: "during priming for a emergency surgery, it was found that the priming solution was leaking from around the bypass valve at the lower part of the device. Replaced the device from the same lot to continue the procedure. " no known consequences to the patient was reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2018-00106 |
| MDR Report Key | 7365435 |
| Date Received | 2018-03-23 |
| Date of Report | 2018-05-08 |
| Date of Event | 2018-03-04 |
| Date Mfgr Received | 2018-05-08 |
| Device Manufacturer Date | 2017-04-01 |
| Date Added to Maude | 2018-03-23 |
| 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 | ARTERIELLER FILTER QUART |
| Generic Name | FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE |
| Product Code | DTM |
| Date Received | 2018-03-23 |
| Model Number | BO-HBF 140-J |
| Catalog Number | 701048784 |
| Device Expiration Date | 2019-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-03-23 |