MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,06 report with the FDA on 2015-02-13 for VKMO 78000 #QUADROX-I HMO 70000+VHK7000 70106.4525 manufactured by Maquet Cardiopulmonary Ag.
[5513574]
It was reported that during use, leakage was noted at the de-airing membrane of the device. The device was replaced. No reported patient effect. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12808853]
The manufacturer is aware of similar complaints for this device. Previous investigations show leakage was observed from the de-airing port. The port as evaluated under an optical microscope and wide pores were observed to be localized in the membrane body. An internal process ((b)(4)) to investigate the root-cause and implement the appropriate corrective action for the observed deficiency has been initiated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2015-00061 |
| MDR Report Key | 4530804 |
| Report Source | 00,01,06 |
| Date Received | 2015-02-13 |
| Date of Report | 2015-01-20 |
| Date of Event | 2015-01-20 |
| Date Mfgr Received | 2015-01-20 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2015-02-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL CAMPBELL |
| Manufacturer Street | KEHLER STRABE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76437 |
| Manufacturer Phone | 2229321132 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VKMO 78000 #QUADROX-I HMO 70000+VHK7000 |
| Generic Name | MICROPOROUS MEMBRANE OXYGENATOR |
| Product Code | DTN |
| Date Received | 2015-02-13 |
| Model Number | 70106.4525 |
| Lot Number | 92143456 |
| Device Expiration Date | 2016-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY AG |
| Manufacturer Address | RASTATT GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-13 |