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

Catalog Number 800540

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/07/2022

Event Type  malfunction  

Event Description

It was reported that during treatment with a mars treatment kit, a leak was observed from one of the large albumin circuit bubble trap tubing.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

The device was not received for evaluation and the lot number of the device is unknown; therefore, a device analysis could not be completed.Four (4) sample pictures were provided for evaluation confirming that a leakage occurred at the large air trap of mars treatment kit.The air trap was untight at the cover.This led to a too high fluid level in air trap and caused the observed leakage.A potential cause of the condition could have been related to a manufacturing issue.This issue is being further investigated.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

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 60073 ; 2242702068
• MDR Report Key: 15891595
• MDR Text Key: 307687811
• Report Number: 3007697864-2022-00002
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 800540
• Device Lot Number: 0000026000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/02/2022
• 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