MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-01-03 for MARS 800540 manufactured by Baxter Healthcare - Rostock.
[96488754]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[96488755]
This is a report of an issue with a mars kit. An alarm pout was triggered by the mars monitor and at the same time a leak on the lower connector of the mars flux (albumin side) was noticed. The treatment was continued using the same set, after reconnecting the lines. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[115699827]
Mdr: 3007697864-12/12/2017-001-r. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The actual device was not available; however, a photograph of the sample was provided for evaluation. Visual inspection of the provided picture showed that the line was detached from the hansen connector in unit 4. The reported condition was verified. The cause of the condition was determined to be an insufficient gluing of the hansen connector to the corresponding line in unit 4 during the manufacturing of the set. 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
| Report Number | 3007697864-2017-00072 |
| MDR Report Key | 7162426 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-01-03 |
| Date of Report | 2018-01-31 |
| Date of Event | 2017-12-15 |
| Date Mfgr Received | 2018-01-23 |
| Date Added to Maude | 2018-01-03 |
| 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 |
| 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 | 2018-01-03 |
| Model Number | NA |
| Catalog Number | 800540 |
| Lot Number | 0000022760 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - ROSTOCK |
| Manufacturer Address | ROSTOCK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-03 |