MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99,unknown report with the FDA on 2015-07-13 for VHK31000 RESERVOIR BO-VKMO 31000-J 70106.3849 manufactured by Maquet Cardiopulmonary Ag.
[6029582]
Customer reported that micro-bubbles of 0 to 50um which exist in the reservoir flowed to the oxygenator, and they seemed to be unable to trap. Causual connection between patient death and product nonconformity is unk. The product in question had been disposed at the hospital. The patient died because of serious cerebral infarction after an operation used (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13971952]
A supplemental medwatch will be submitted after receipt of new information.
Patient Sequence No: 1, Text Type: N, H10
[77663591]
Sample was not available for investigation. Clinical evaluation of therapy application manager: however, microbubbles may be entered into the system at any other place / components. It is not even sure if there were micro bubble at all. In the complaint there is no indication of a particular range of microbubbles. When evaluating the currently available information it is not possible to focus what led to this incidence. The cerebral dysfunction could have been triggered by other causes. Thus the failure could not be confirmed. The dhr has been reviewed - no conspicuity could be found. 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
[77663592]
According to the report of customer, the doctor said that consequence of the patient was not death. The patient is still alive with paralysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010762-2015-00803 |
| MDR Report Key | 4914700 |
| Report Source | 99,UNKNOWN |
| Date Received | 2015-07-13 |
| Date of Report | 2015-06-29 |
| Date of Event | 2015-01-03 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2015-07-16 |
| 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 Contact | MICHAEL CAMPBELL |
| Manufacturer Street | KEHLER STRABE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76437 |
| Manufacturer Phone | 2229321132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VHK31000 RESERVOIR |
| Product Code | DTN |
| Date Received | 2015-07-13 |
| Model Number | BO-VKMO 31000-J |
| Catalog Number | 70106.3849 |
| Lot Number | 92118049 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Death; 2. Other | 2015-07-13 |