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  

Event Description

It was reported that there was a separation between the female connector (navy portion) and the main body of the minicap transfer set; further described as ¿navy portion of transfer set was no longer properly seated within the transfer set¿.The transfer set was unable to be disconnected from the cassette after peritoneal dialysis therapy.The patient line was clamped and cut distal to the clamp.The transfer set had been used for approximately five and a half months and was replaced as a result of the event.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 and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information added to h3, h6, and h10: correction made to b5: the transfer set was unable to be disconnected from the ultrabag (previously submitted as cassette) after peritoneal dialysis therapy.Correction made to d9: device avail.For eval? no (previously submitted as yes) correction made to d10: remove amia cassette correction made to h3: device returned for evaluation? no (previously submitted as yes) h10: the actual device was not available; however, two (2) photographs and a video of the sample were provided for evaluation.The photographs and video were reviewed and a separation between the female connector and main body was observed.The reported condition was verified.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.A batch review was conducted and there were no deviations found related to this reported 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: 19080696
• MDR Text Key: 339839316
• Report Number: 1416980-2024-01626
• 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
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5C4482
• Device Lot Number: H23L07053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2023
• 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 CASSETTE; DIANEAL
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 106 KG