MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-09 for QUART ARTERIAL FILTER WITH SOFTLINE COATING BO-HBF 140-J 701048784 manufactured by Maquet Cardiopulmonary Ag.
[96852545]
(b)(4). Maquet getinge group is aware of similar complaints from this product. Similar products, showing a similar malfunction, have been tested. We tested the returned filter in our laboratory, following our standard process, on tightness. Therefore, the quart was tested at below water in a water bath and was then pressurized with compressed air (0. 3 bar). Due to the air escaping (visible as air bubbles in water) a leakage in the welding cover has been found. The leakage at the connection between cover and filter body can be confirmed. Most possible root cause could be the bad welding between cover and filter body. Since the reported failure did not contribute to a death or serious injury no corrective action is needed. In addition at this time it cannot be concluded that this is an systemic error. This data will be handled through a designated maquet trending process. If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.
Patient Sequence No: 1, Text Type: N, H10
[96852546]
As stated by the customer: "when leak check(100kpa) at the product inspection, they found the failure and gave the sink test to make sure the leak point. No adverse effect to the patient. Incident occurred before patient use. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2018-00011 |
| MDR Report Key | 7174996 |
| Date Received | 2018-01-09 |
| Date of Report | 2018-10-03 |
| Date of Event | 2017-12-15 |
| Date Mfgr Received | 2017-12-22 |
| Device Manufacturer Date | 2016-10-01 |
| Date Added to Maude | 2018-01-09 |
| 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 | QUART ARTERIAL FILTER WITH SOFTLINE COATING |
| Generic Name | FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE |
| Product Code | DTM |
| Date Received | 2018-01-09 |
| Model Number | BO-HBF 140-J |
| Catalog Number | 701048784 |
| Lot Number | 70114693 |
| Device Expiration Date | 2018-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-01-09 |