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

Catalog Number 103401

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2020

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 at the beginning of a dialysis treatment with a gambro cartridge set, an external blood leak was observed from the end of the heparin line.The volume of the blood loss was not reported.The extracorporeal blood volume was 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

Additional information: h6 and h10.Corrected information added to h4: device was manufactured on 12/05/2019 instead of 12/15/2019 as previously reported.H10: the actual device was not available; however, three photographs were provided for evaluation.The inspection of the photographs observed a maceration in the union of the tube with female luer pivot.The breakage can be associated to pvc maceration caused by excessive amount of cyclohexanone applied when gluing the output of the heparin line to the cartridge.The cause was manufacturing related.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: 10056025
• MDR Text Key: 221561969
• Report Number: 8030638-2020-00004
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 07332414007867
• UDI-Public: (01)07332414007867
• 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: 11/15/2022
• Device Catalogue Number: 103401
• Device Lot Number: 1000245087
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 05/14/2020
• Supplement Dates Manufacturer Received: 05/22/2020
• Supplement Dates FDA Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.