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 2018-07-02 for MARS 800540 manufactured by Baxter Healthcare - Rostock.
[112852651]
(b)(4). The actual device was not available; however, a photograph was evaluated. Visual inspection did not identify any abnormalities that could have contributed to the reported condition. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The reported condition was verified. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[112852652]
It was reported that during treatment with a mars flux, albumin was found to be leaking on the surface of the filter. The treatment was terminated and a new set was primed and therapy restarted. 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
[115700872]
The actual device was not available; however, a photograph of the sample was provided for evaluation. During the visual inspection of the provided photos, albumin was observed on the outer side of the device. No failure was visible on the provided photos. The reported problem was confirmed. The cause of the event could not be determined. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[115700873]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007697864-2018-00005 |
| MDR Report Key | 7654104 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-07-02 |
| Date of Report | 2018-07-23 |
| Date of Event | 2018-06-04 |
| Date Mfgr Received | 2018-06-28 |
| Date Added to Maude | 2018-07-02 |
| 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 | 2018-07-02 |
| Model Number | NA |
| Catalog Number | 800540 |
| Lot Number | 6-7921-H-01 |
| 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 | 2018-07-02 |