MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-03 for PEDIATRIC VENOUS HARDSHELL VKMO 11000 manufactured by Maquet Cardiopulmonary Ag.
[59415246]
(b)(4). A follow-up medwatch will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
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According to the customer: "during use, the user indicated that there was positive pressure on the interior area of the reservoir. Supposedly an attached bag slightly inflated. Supposedly additional vacuum deflated the bag there clearly is a question about the pressure relief valve. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2016-00655 |
| MDR Report Key | 6076734 |
| Date Received | 2016-11-03 |
| Date of Report | 2017-09-08 |
| Date Mfgr Received | 2016-10-06 |
| Date Added to Maude | 2016-11-03 |
| 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 | 2016-11-03 |
| Model Number | VKMO 11000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2016-11-03 |