MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-12-18 for MARS 800541 manufactured by Baxter Healthcare - Rostock.
[95805506]
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The actual sample was not returned for evaluation; however, sample pictures were provided. Based on the pictures, the disconnection between the hansen connector and corresponding line was clearly visible and was caused by insufficient gluing. The hansen connector is used in unit 1 and in unit 4 of the tube set for the connection of the lines to the marsflux dialyzer. The investigation of the available photos confirms the failure description provided by the customer. The cause of the condition was determined to be a manufacturing issue. A nonconformance has been opened to address this issue. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[95805507]
During a training session for xmars treatment, unit #4 of an xmars kit was noticed to be disconnected from its end. This was noticed during set up. In order to continue the training session the staff used glue to reconnect the device. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007697864-2017-00071 |
| MDR Report Key | 7125661 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-12-18 |
| Date of Report | 2017-12-18 |
| Date of Event | 2017-09-19 |
| Date Facility Aware | 2017-11-20 |
| Report Date | 2017-12-18 |
| Date Reported to FDA | 2017-12-18 |
| Date Reported to Mfgr | 2017-12-18 |
| Date Mfgr Received | 2017-11-20 |
| Date Added to Maude | 2017-12-18 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE - ROSTOCK |
| Manufacturer Street | FRIEDRICH-BARNEWITZ-STRASSE 4 |
| Manufacturer City | ROSTOCK 18119 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 18119 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MARS |
| Generic Name | APPARATUS, HEMOPERFUSION, SORBENT |
| Product Code | FLD |
| Date Received | 2017-12-18 |
| Returned To Mfg | 2017-09-20 |
| Model Number | NA |
| Catalog Number | 800541 |
| Lot Number | 0000022648 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - ROSTOCK |
| Manufacturer Address | ROSTOCK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-18 |