MARS DISPOSABLE
Received Apr 21, 2022 · Event occurred Mar 22, 2022
Report 3007697864-2022-00001 · MDR key 14166541
Device
Generic name
Apparatus, Hemoperfusion, Sorbent
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
800540
Lot number
0000025782
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
39 YR · Female
- Anaphylactic Shock
- Anaphylactic Shock
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING TREATMENT WITH A MARS TREATMENT KIT, THE PATIENT EXPERIENCED A HEMODYNAMIC COLLAPSE AND BLOOD PRESSURE WAS AS LOW AS 35 MMHG. URTICARIA WAS OBSERVED AND AN ANAPHYLACTIC SHOCK WAS SUSPECTED. THE PATIENT WAS TREATED WITH POLARAMINE (ANTIHISTAMINE) AND 60 MG OF SOLUPRED (CORTICOSTEROID WITH AN ANTI INFLAMMATORY ACTIVITY). TREATMENT WAS INTERRUPTED WITHOUT RETURNING THE EXTRACORPOREAL BLOOD TO THE PATIENT. THE PATIENT RECOVERED AND IS AT PRESENT AWAITING A LIVER TRANSPLANT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
H10: THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. 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.