MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number 5C4482

Device Problems Failure to Disconnect (2541); Detachment of Device or Device Component (2907)

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

Event Date 11/13/2023

Event Type  malfunction  

Event Description

It was reported that there was difficulty ("hard time") disconnecting a minicap transfer set from the patient line of a homechoice cassette resulting in a separation of the female connector from the mainbody of the transfer set.The event was further described as ¿dark blue piece came extended out¿.This occurred during disconnection from peritoneal dialysis therapy.The patient used a minicap to hold and capture the blue part (female connector) and carefully put it back in their extension tube.The transfer set was replaced.There was no report of 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

Additional information was added to h6 and h10.H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the actual device was returned for evaluation.A visual inspection using the naked eye observed a separation between the dark blue female connector and the light blue main body of the twist clamp on the transfer set.Functional tests were performed which included leak, clear passage, and clamp function tests with no issues noted.An in-lab connector was connected and disconnected to the returned sample with no issues.Therefore, the reported connection issue was not verified; however, the reported condition of ¿the female connector separated from the main body¿ was verified.The cause was determined to be manufacturing related due to an inadequate solvent bond between the female connector, insert chip, and main body.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: MINICAP TRANSFER SET
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18326530
• MDR Text Key: 330498226
• Report Number: 1416980-2023-06528
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K152675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2024

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: Lay User/Patient
• Device Catalogue Number: 5C4482
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 01/16/2024; 04/03/2024
• Supplement Dates FDA Received: 01/16/2024; 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: HOMECHOICE CASSETTE