MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 101025

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that approximately 2 hours into dialysis treatment with a gambro cartridge set, an external blood leak was observed from the venous dialyzer line.When attempting to administer a bolus injection of heparin via the venous injection port, the venous dialyzer line became disconnected from the venous dialyzer connector, which is connected to the dialyzer.Blood is seen to have sprayed on the lower part of the machine and the floor.The volume of the blood loss was reported to be approximately 50ml.The extracorporeal blood volume was not returned to the patient.The treatment was disconnected and restated with the replacement of the blood lines.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, a photograph of the sample was provided for evaluation.The visual inspection revealed the blue dialyzer connector was detached from the transport tube causing the reported blood leak.The reported condition was verified.The cause could be associated to an operational deviation in which the operator omitted to apply enough solvent during the assembly of the involved component.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: CARTRIDGE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10032439
• MDR Text Key: 190166502
• Report Number: 8030638-2020-00003
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 07332414007836
• UDI-Public: (01)07332414007836
• Combination Product (y/n): N
• PMA/PMN Number: K070414
• 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: 06/11/2020

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: 09/15/2022
• Device Catalogue Number: 101025
• Device Lot Number: 1000237024
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/14/2020
• Initial Date FDA Received: 05/07/2020
• Supplement Dates Manufacturer Received: 06/11/2020
• Supplement Dates FDA Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR