MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-06 for PEDIATRIC VENOUS HARDSHELL VKMO 11000 manufactured by Maquet Cardiopulmonary Ag.
[57273021]
(b)(4). The product was requested to return for manufacturers laboratory investigation but it was scrapped. Also, there was no information about the lot number of the set and no picture related to the failure. Therefore, dhr review could not be performed. The root cause of the problem could not be established as there was insufficient information concerning this complaint. Additional information regarding the case was requested three times. A review for similar complaints has been performed and a similar incident from the same institution was found. Based on this, a confirmation of the failure based on previous complaints is not possible, and there is no systemic issue indicated. This data will be handled through a designated maquet trending process. If a trend occurs, it will be escalated to quality assurance managemement for review and determination if further investigation is necessary. Due to this no further action will be completed at this time.
Patient Sequence No: 1, Text Type: N, H10
[57273022]
According to the customer:"interior segment of reservoir seemed to have positive pressure despite the application of vacuum. A few cc's of blood vented. Concern they reservoir filter may be clogging. It was mentioned this happened 3 times total. This is the 2nd of those 3 complaints. Device was not retained. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2016-00613 |
| MDR Report Key | 6002819 |
| Date Received | 2016-10-06 |
| Date of Report | 2016-09-20 |
| Date Mfgr Received | 2016-09-20 |
| Date Added to Maude | 2016-10-06 |
| 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 | PEDIATRIC VENOUS HARDSHELL |
| Generic Name | FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE |
| Product Code | DTM |
| Date Received | 2016-10-06 |
| Model Number | VKMO 11000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2016-10-06 |