MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MARS DISPOSABLE; APPARATUS, HEMOPERFUSION, SORBENT

Catalog Number 800540

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Anaphylactic Shock (1703)

Event Date 03/22/2022

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

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.

• Brand Name: MARS DISPOSABLE
• Type of Device: APPARATUS, HEMOPERFUSION, SORBENT
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - ROSTOCK; friedrich-barnewitz-strasse 4; rostock 18119 ; GM 18119
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 14166541
• MDR Text Key: 289735164
• Report Number: 3007697864-2022-00001
• Device Sequence Number: 1
• Product Code: FLD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 800540
• Device Lot Number: 0000025782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2022
• Date Device Manufactured: 09/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female