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

Catalog Number 800541

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during treatment with a mars treatment kit, a leakage was observed from the ion exchanger, specified as the top and bottom of the exchanger where it is connected to the middle part of the filter.No visible cracks on the filter were observed.There was no patient injury or medical intervention associated with this event.

Manufacturer Narrative

Additional information: h3, h6 and h10 h10: the actual device was not available; however, four (4) photographs of the sample were provided for evaluation and the reported condition was verified.The cause could not be determined.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
• 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: 12925170
• MDR Text Key: 282195610
• Report Number: 3007697864-2021-00002
• Device Sequence Number: 1
• Product Code: FLD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 800541
• Device Lot Number: 0000025311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 01/05/2022
• Supplement Dates FDA Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: No
• 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