MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-17 for QUART ARTERIAL FILTER, MODEL HBF 140 HBF 140-J 70103.1617 manufactured by Maquet Cardiopulmonary Ag.
[130786544]
(b)(4). A follow-up medwatch will be submitted when additional information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[130786565]
As stated by the customer: "during the leak test, the leakage was detected. No adverse effect to the patient. Incident occurred before patient use. " no patient involvement. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2018-00332 |
| MDR Report Key | 8170311 |
| Date Received | 2018-12-17 |
| Date of Report | 2018-12-17 |
| Date of Event | 2018-12-03 |
| Date Mfgr Received | 2018-12-10 |
| Device Manufacturer Date | 2018-01-01 |
| Date Added to Maude | 2018-12-17 |
| 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 |
| 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 | QUART ARTERIAL FILTER, MODEL HBF 140 |
| Generic Name | FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE |
| Product Code | DTM |
| Date Received | 2018-12-17 |
| Returned To Mfg | 2019-03-26 |
| Model Number | HBF 140-J |
| Catalog Number | 70103.1617 |
| Lot Number | 70122711 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-12-17 |