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 Type  malfunction  

Manufacturer Narrative

D4: lot #: suspected lots h21f10092 and h23e04038.E1: initial reporter address: (b)(6).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 (navy tip) and the main body of a minicap transfer set.The patient was unable to disconnect from the patient line of the amia cassette after completing peritoneal dialysis therapy.The patient had to cut the patient line to disconnect.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

B5: the alleged transfer set was new as it had been placed on the patient within the past 3 weeks.D4: lot #: suspect lot # h21f10092, expiration date 06/10/2026, manufacturing date 06/10/2021.D4: lot #: suspect lot # h23e04038 expiration date 05/04/2028, manufacturing date 05/04/2023.H10: the actual device was not available; however, seven (7) photographs were provided for evaluation.A visual inspection with the naked eye identified a separation between the female connector and the main body of the twist clamp.The separation between the two components could cause difficulty to disconnect; however, due to a photo only, the connection issue with the female connector of the device was not verified and only the reported condition of separation was verified.The cause of the condition was determined to be manufacturing related due to inadequate solvent to the insert chip.A batch review was conducted on the two suspect lot numbers and there were no deviations found related to this reported condition during the manufacture of these lot numbers.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the device was received for evaluation with a white connector connected to the female connector.A visual inspection with the naked eye noted a dark blue female connector separated form the light blue main body.Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.The white adapter was hand removed from the female connector; therefore reported connection issue with female connector was not verified.The separation between the female connector and main body was verified.The cause of the separation was due to an inadequate solvent bond between the female connector, insert chip, and main body during the manufacturing process.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: 17691996
• MDR Text Key: 322752771
• Report Number: 1416980-2023-04506
• 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,Followup
• Report Date: 11/15/2023

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: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 10/04/2023; 10/26/2023
• Supplement Dates FDA Received: 10/13/2023; 11/15/2023
• 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: AMIA AUTOMATED PD CYCLER SET