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

Catalog Number R5C4482

Device Problem Failure to Disconnect (2541)

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

Event Date 08/01/2023

Event Type  malfunction  

Event Description

It was reported that a minicap transfer set had a connection issue.The patient was unable to disconnect themselves from the machine at the end of peritoneal dialysis treatment.A nurse disconnected the patient and changed the transfer set at the same time.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The sample was received for evaluation with a patient connector and shield guard attached to the female connector.A visual inspection with the naked eye noted a separation between the female connector and main body.Functional testing including clear passage testing and clamp function testing were performed with no issues noted.Leak testing failed due to a leak from a cut/hole in the silicone tubing.A connection and disconnection between the returned patient connector and the female connector were performed by hand with no issues or leaks noted.The reported issue of unable to disconnect was not duplicated.The cause of the separation was determined to be manufacturing related due to an inadequate solvent bond between the female connector, insert chip, and main body.The cause of the cut in tubing was undetermined; however, the cut most likely occurred during the disconnection attempt.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: 17647597
• MDR Text Key: 322268127
• Report Number: 1416980-2023-04369
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 08/29/2023

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: Health Professional
• Device Catalogue Number: R5C4482
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/29/2023
• 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 MACHINE