MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MARS; MARS KIT GAMBRO, TYPE 1116/1

Catalog Number 800541

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 01/13/2020

Event Type  Injury  

Manufacturer Narrative

This report was received from medwatch report: (b)(4).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, a pink tinge was observed in the albumin.The pink tinge was a result of a blood leak into the albumin circuit.A blood leak alarm was triggered.The therapy was immediately stopped, however, the blood was not returned to the patient.The patient was transfused with 2 units of packed red blood cells, due to a drop in hemoglobin "below critical care standards" and the loss of blood in the mars set.The patient outcome was not reported.No additional information is available.

Manufacturer Narrative

H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; however, two pictures were received and evaluated.On inspection, blood was observed on the tubing line (unit 1) in the albumin circuit.The reported problem was confirmed.The cause could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: MARS
• Type of Device: MARS KIT GAMBRO, TYPE 1116/1
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9845123
• MDR Text Key: 183874230
• Report Number: 3006552611-2020-00003
• Device Sequence Number: 1
• Product Code: FLD
• Combination Product (y/n): N
• PMA/PMN Number: K133807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/17/2020,04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 800541
• Device Lot Number: 0000024650
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2020
• Distributor Facility Aware Date: 02/18/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2020
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 04/14/2020
• Supplement Dates FDA Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR