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 2017-03-04 for MARS 800540 manufactured by Gambro Rostock.
[69093969]
Unknown.
Patient Sequence No: 1, Text Type: N, H10
[69093970]
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 4 hours after the start of treatment. A bolus of 2500ui of heparin had been infused for the treatment. In order to continue therapy the clotted mars was replaced with a new mars. This resulted in 279ml 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 750ml. 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 3 of 3 for the same patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007697864-2017-00003 |
| MDR Report Key | 6378998 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-03-04 |
| Date of Report | 2017-03-15 |
| Date of Event | 2017-01-29 |
| Date Mfgr Received | 2017-03-10 |
| 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 | 3 |
| 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 Age | DA |
| 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 |