MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-04 for MARS 800540 manufactured by Gambro Rostock.
[69105755]
Patient Sequence No: 1, Text Type: N, H10
[69105756]
During continuous renal replacement therapy, using a molecular adsorbent recirculation system (mars) on a prismaflex machine, clotting of the extracorporeal circuit was observed. This occurred approximately 3 hours after the start of treatment. The treatment was reported to have been performed without the use of an anticoagulant. In order to continue therapy the clotted mars was replaced with a new mars. This resulted in 224 ml of blood that could not be returned to the patient. Clotting occurred within two additional mars throughout the therapy, which resulted in a total blood loss volume of 750 ml. The total amount of patient blood loss required a blood transfusion. At the time of this report, the patient is reported to have left the intensive care unit. No additional information is available. This is report 1 of 3 for the same patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007697864-2017-00001 |
| MDR Report Key | 6378938 |
| Date Received | 2017-03-04 |
| Date of Report | 2017-03-03 |
| Date of Event | 2017-01-28 |
| Date Mfgr Received | 2017-02-06 |
| Date Added to Maude | 2017-03-04 |
| 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 | 2249487578 |
| Manufacturer G1 | GAMBRO ROSTOCK |
| Manufacturer Street | FRIEDRICH-BARNEWITZ-STR. 3 |
| Manufacturer City | ROSTOCK |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MARS |
| Generic Name | APPARATUS, HEMOPERFUSION, SORBENT |
| Product Code | FLD |
| Date Received | 2017-03-04 |
| Model Number | NA |
| Catalog Number | 800540 |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO ROSTOCK |
| Manufacturer Address | FRIEDRICH-BARNEWITZ-STR. 3 ROSTOCK 18119 GM 18119 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-04 |