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 10/05/2023

Event Type  malfunction  

Event Description

It was reported that there was a separation between the female connector and the main body of a minicap transfer set.The patient line tubing was unable to be disconnected from the transfer set.This occurred after treatment of peritoneal dialysis therapy.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

E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the device was received for evaluation with a patient connector attached to the female connector of the transfer set.A visual inspection with the naked eye identified a separation between the female connector and main body of the twist clamp.Functional tests including leak, clear passage and clamp function tests were performed with no issues noted.A connection and disconnection test was performed between the female connector and the returned patient connector with no issues.The reported condition was verified.The cause of the condition was determined to be manufacturing related issue due to an inadequate solvent bond between the female connector, insert chip, and main body of the twist clamp.A nonconformance has been opened to address this issue.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: 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: 18073048
• MDR Text Key: 327397802
• Report Number: 1416980-2023-05676
• Device Sequence Number: 1
• Product Code: KDJ
• UDI-Device Identifier: 00085412007731
• UDI-Public: (01)00085412007731
• 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
• Report Date: 12/29/2023

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: 5C4482
• Device Lot Number: H23A10083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• 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: CASSETTE; CYCLER