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

Catalog Number R5C4482

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

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

Event Date 02/20/2024

Event Type  malfunction  

Event Description

It was reported that a transfer set failed to disconnect from the tip, but disconnected from the roller instead.This occurred during an unspecified process of peritoneal dialysis therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

E1: additional initial reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the actual device was not available; however, two (2) photographs of the sample was provided for evaluation.The photographs were reviewed and did not show visual evidence of the problem.Due to the nature of the sample, no further evaluation could be performed.The reported condition could was not verified.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The patient performs continuous ambulatory peritoneal dialysis (capd) therapy; no pd cycler or pd cassette was in use during this event.The device was received for evaluation.A visual inspection with the naked eye noted a separation between the female connector and the main body of the twist clamp.Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.Additionally, the female connector of the device was connected and disconnected using an in-lab minicap and a patient connector with no issues or leaks noted.Therefore, the report condition of ¿set failed to disconnect from the tip¿ was not verified, however, the reported condition of a separation issue was verified during the sample evaluation.The cause of the separation issue was determined to be a manufacturing related issue due to an inadequate solvent bond between the female connector, insert chip, and main body of the twist clamp.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: 18902927
• MDR Text Key: 337648580
• Report Number: 1416980-2024-01120
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2024

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: Other
• Device Catalogue Number: R5C4482
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 04/10/2024; 04/17/2024
• Supplement Dates FDA Received: 04/12/2024; 04/18/2024
• 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