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 09/07/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was a separation between the female connector (blue tip) and the main body of a minicap transfer set.This occurred after treatment of peritoneal dialysis therapy when trying to disconnect from the patient line.The patient had used alcavis to clean the transfer set.The patient closed the transfer set and clamped off the patient line and went into the clinic.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

The device was received for evaluation.A visual inspection with the naked eye noted a separation between the light blue main body and the twist clamp.Clear passage testing was performed and no issues were observed.Leak and clamp function testing failed due to a leak with the twist clamp closed.The device was also connected and disconnected using an in-lab connector with no issues.The reported connection issue with female connector was not verified.The cause of the separation between the light blue main body and the twist clamp was due to broken occluder feet.The cause of the broken occluder is the reported use of alcavis.The product labeling warns users to not allow the following products and/or chemicals to come into contact with the transfer set: hand sanitizer, hydrogen peroxide, alcohol, bleach (sodium hypochlorite), or chlorhexidine gluconate.Do not use solvents intended to remove adhesive on the transfer set.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.

Manufacturer Narrative

Investigation findings: replace c1601 with c13 correction made to investigation conclusions: replace d0301 with d1102 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: 17861400
• MDR Text Key: 324808442
• Report Number: 1416980-2023-04980
• Device Sequence Number: 1
• Product Code: KDJ
• UDI-Device Identifier: 00085412007731
• UDI-Public: (01)00085412007731
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2023

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: Lay User/Patient
• Device Catalogue Number: 5C4482
• Device Lot Number: H23E15026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 10/03/2023
• Supplement Dates Manufacturer Received: 10/19/2023; 10/19/2023
• Supplement Dates FDA Received: 11/01/2023; 11/01/2023
• 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