MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06,foreign,health pr report with the FDA on 2015-05-18 for VENOUS HARDSHELL CARDIOTOMY RESERVOIR VKMO 71000 70106.4582 manufactured by Maquet Cardiopulmonary Ag.
[5814817]
According to the customer: "when the customer started rewarming during extracorporeal circulation, he/she detected clotting in the veinous reservoir (vkh71000). No adverse effects on the patient. Occurred during patient use. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13395769]
A supplemental medwatch will be submitted after receiving new information.
Patient Sequence No: 1, Text Type: N, H10
[96165709]
We have received a 70106. 4582 bo-vkmo 70000-j set. The reservoir has been cleaned and disinfected. A visual control has been done. Thus clotting could be confirmed. Clotting is a known phenomenon to maquet cardiopulmonary and has been thoroughly investigated in a previous complaint. A review of the reservoir device history records was performed by a designated maquet member, no abnormalities were found. The cause of this failure was determined to not be attributed to a device related malfunction. This complaint #(b)(4) will be closed and the failure will be handled through a designated maquet cardiopulmonary track and trending process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2015-00470 |
| MDR Report Key | 4787280 |
| Report Source | 00,01,05,06,FOREIGN,HEALTH PR |
| Date Received | 2015-05-18 |
| Date of Report | 2015-05-08 |
| Date of Event | 2015-04-30 |
| Date Mfgr Received | 2015-05-11 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2015-06-17 |
| 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 STRASE 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 | VENOUS HARDSHELL CARDIOTOMY RESERVOIR |
| Product Code | DTN |
| Date Received | 2015-05-18 |
| Returned To Mfg | 2015-06-15 |
| Model Number | VKMO 71000 |
| Catalog Number | 70106.4582 |
| Lot Number | 92147079 |
| Device Expiration Date | 2016-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY AG |
| Manufacturer Address | RASTATT GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-18 |