MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-23 for BE-HQV 33800#COMPLETE PACK BE-00175 701002503 manufactured by Maquet Cardiopulmonary Ag.
[55794700]
(b)(4). Maquet cardiopulmonary ag is aware of similar complaints from this product. Similar products, showing a similar malfunction, have been tested. The tested products has the same leakage at the same position. This could be determined as bonding failure. Visual inspection, tightness test acc. To lv 203 and tightness test with roller pump have been performed. Results: during tightness test acc. To lv 203 the exact position of the leak in the arterial filter between the cover and the housing could be detected (improper ultrasonic welding). During testing with roller pump leakage at quart could also be detected but the exact position was not found during this kind of test. The existing liquid collected at the lowest point of the filter and drained. Most possible root cause could be the bad bonding between cover and filter body. The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process. Due to this no further investigation initiations will be completed at this time.
Patient Sequence No: 1, Text Type: N, H10
[55794701]
It was reported that prime a leak occurred at by opening the bypass. No known consequences to the patient were reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2016-00588 |
| MDR Report Key | 5972617 |
| Date Received | 2016-09-23 |
| Date of Report | 2016-08-31 |
| Date of Event | 2016-08-16 |
| Date Mfgr Received | 2016-08-31 |
| Device Manufacturer Date | 2016-05-01 |
| Date Added to Maude | 2016-09-23 |
| 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 | BE-HQV 33800#COMPLETE PACK |
| Generic Name | FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE |
| Product Code | DTM |
| Date Received | 2016-09-23 |
| Model Number | BE-00175 |
| Catalog Number | 701002503 |
| Lot Number | 92189712 |
| Device Expiration Date | 2018-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY AG |
| Manufacturer Address | RASTATT GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-23 |