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

Catalog Number R5C4482

Device Problems Break (1069); Failure to Disconnect (2541); Detachment of Device or Device Component (2907)

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

Event Date 10/27/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a minicap extended life pd transfer set was unable to disconnect from the patient line of a homechoice cassette which resulted in separation between the female connector and the main body of the transfer set.This occurred after treatment, when the nurse tried to disconnect the transfer set and cassette for peritoneal dialysis (pd) therapy.Specifically, "the miniset line male part in the very dark blue plastic was unscrewing from the light blue plastic when i was holding the light blue plastic in my left hand and trying to undo/unscrew the patient line white female plastic from the cassette".To resolve the issue, the transfer set was replaced.On unscrewing of the patient line from original transfer set, there was a small piece of broken plastic at the connection site.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Correction made to h4: device manufacture date: 04/18/2022 (previously submitted as ni) additional information was added to d9, h3, h6 and h10.H10: the device was received for evaluation.A visual inspection with the naked eye noted the female connector was separated from the main body.Functional testing including clear passage and clamp function testing were performed with no issues observed.The set was leak tested with an in lab minicap attached to the female connector and no leaks were observed.The minicap was removed by hand with no issues, therefore the reported connection issue was not verified.The reported separation issue was verified.The cause of the separation was due to inadequate solvent application to the set during the manufacturing process.A nonconformance has been opened to address this issue.A batch review was conducted and there were no deviations found related to this 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: 15934220
• MDR Text Key: 308009770
• Report Number: 1416980-2022-06699
• Device Sequence Number: 1
• Product Code: KDJ
• UDI-Device Identifier: 00085412008776
• UDI-Public: (01)00085412008776
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 01/06/2023

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: Health Professional
• Device Catalogue Number: R5C4482
• Device Lot Number: H22D18040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 01/04/2023
• Supplement Dates FDA Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2022
• 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