MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MARS; MARS KIT GAMBRO TYPE 1112/1

Catalog Number 800473

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that upon initiation of therapy with a mars kit, an external blood leak was observed at the top of the filter.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

D4: expiration date added.H10: the actual device was not available; however, two photos of the sample was provided for evaluation.The photos did not reveal the exact location of the leak.The reported condition was not verified due to the lack of actual sample, further investigation was not possible.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: MARS KIT GAMBRO TYPE 1112/1
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10071347
• MDR Text Key: 221296058
• Report Number: 3007697864-2020-00001
• Device Sequence Number: 1
• Product Code: FLD
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

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 Expiration Date: 01/31/2022
• Device Catalogue Number: 800473
• Device Lot Number: 0000024589
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 05/19/2020
• Supplement Dates Manufacturer Received: 06/17/2020
• Supplement Dates FDA Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1