MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-11 for MARS TREATMENT KIT TYPE 1116/1 - X-MARS US 800541 manufactured by Baxter Healthcare Corporation.
[178573925]
The mars treatment was setup without issue or difficulty. Upon initiation of the therapy, it was noticed the albumin turned a pink tinge and it was recognized as a blood leak into the albumin circuit. Therapy was immediately stopped, and the mars blood leak alarm sounded. Blood was not returned as it was mixed with albumin dialysate solution. There did not appear to be an issue with either machine as the leak occurred within the filter system. The kit was removed, capped, and kept for examination by gambro. The patient needed to have a blood transfusion because of the inadequate blood return. Manufacturer response for mars therapy kit, (brand not provided) (per site reporter) currently no response from manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9693236 |
| MDR Report Key | 9693236 |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-01-13 |
| Report Date | 2020-02-07 |
| Date Reported to FDA | 2020-02-07 |
| Date Reported to Mfgr | 2020-02-11 |
| Date Added to Maude | 2020-02-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MARS TREATMENT KIT TYPE 1116/1 - X-MARS US |
| Generic Name | APPARATUS, HEMOPERFUSION, SORBENT |
| Product Code | FLD |
| Date Received | 2020-02-11 |
| Returned To Mfg | 2020-01-14 |
| Model Number | 800541 |
| Catalog Number | 800541 |
| Lot Number | 24650 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | 32650 N. WILLSON BLVD WGL-3N ROUND LAKE IL 60073 US 60073 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-11 |