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 2017-11-10 for MARS 800473 manufactured by Baxter Healthcare - Rostock.
[92630029]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[92630030]
During treatment, the customer noticed an external fluid leak on a mars kit. After treatment start, there was a disconnection of a line. The device was replaced to resolve the issue. There was no patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007697864-2017-00066 |
| MDR Report Key | 7018302 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-10 |
| Date of Report | 2018-01-23 |
| Date of Event | 2017-10-13 |
| Date Mfgr Received | 2018-01-15 |
| Date Added to Maude | 2017-11-10 |
| 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 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 |
| Removal Correction Number | SEE H10 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MARS |
| Generic Name | APPARATUS, HEMOPERFUSION, SORBENT |
| Product Code | FLD |
| Date Received | 2017-11-10 |
| Model Number | NA |
| Catalog Number | 800473 |
| Lot Number | 0000022851 |
| ID Number | NA |
| 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 | 2017-11-10 |