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 06/09/2023

Event Type  malfunction  

Event Description

It was reported that there was a separation between the female connector (dark blue part) and the main body of a minicap transfer set.The event was further described as ¿the dark blue part of the transfer set looked like it was pulling away from the finger grip." this occurred after treatment of peritoneal dialysis therapy.It was further reported that the transfer set would not disconnect from the patient line of the homechoice cassette.The transfer set was replaced.There was no patient injury or medical intervention associated with this event, however the patient was given prophylactic antibiotics as precautionary measure.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

D4: catalogue #: (remove 5c4449 as previously reported) and update to 5c4482.H10: one actual sample was received for evaluation with a patient connector/ tubing connected to the female connector.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.The patient connector was removed and connected by hand using the returned female connector with no issues.The female connector was connected and disconnected using an in lab minicap with no connection issues noted on the female connector.Therefore, the reported condition of separation between the female connector and main body of the twist clamp was verified.The cause of the condition was due to an inadequate solvent bond between the female connector, insert chip, and main body during the manufacturing process.However, the reported condition of connection issue to female connector was not verified.Should additional relevant information become available, a supplemental report will be submitted.Mitted.

• 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: 17343436
• MDR Text Key: 319936652
• Report Number: 1416980-2023-03638
• Device Sequence Number: 1
• Product Code: KDJ
• 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
• Report Date: 08/23/2023

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: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/18/2023
• Supplement Dates Manufacturer Received: 08/21/2023
• Supplement Dates FDA Received: 08/23/2023
• 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.