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 2017-09-25 for MARS 800473 manufactured by Baxter Healthcare - Rostock.
[87660539]
(b)(4). The device has been received and the evaluation is in progress. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[87660540]
This is a report of a patient who is undergoing a treatment with a mars monitor. After treatment it was noticed that there was a leak from the albumin intake line. The issue was due to the albumin intake line of the mars kit being almost completely separated from the system, without any prior manipulation. There was no patient injury or medical intervention associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007697864-2017-00054 |
| MDR Report Key | 6892902 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-09-25 |
| Date of Report | 2017-10-30 |
| Date of Event | 2017-08-30 |
| Date Mfgr Received | 2017-10-23 |
| Date Added to Maude | 2017-09-25 |
| 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 | 2017-09-25 |
| Returned To Mfg | 2017-09-10 |
| Model Number | NA |
| Catalog Number | 800473 |
| Lot Number | 22819 |
| ID Number | NA |
| Device Expiration Date | 2019-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-09-25 |