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

Catalog Number 5C4482

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907); Difficult to Open or Close (2921)

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

Event Date 08/25/2022

Event Type  malfunction  

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the white twist clamp of a peritoneal dialysis (pd) transfer set was unable to close which resulted in leak.This was observed during use of the device for pd therapy.The patient was given prophylactic antibiotics as precautionary measure.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Medical device problem codes (add code), h6 (update b17 to b01, c20 to c13) and h10.B5: the event was further described as "the twist clamp went all the way off and pulled back".The patient placed a minicap on the transfer set to stop it from leaking.H10: one actual sample was received for evaluation with a minicap attached to the female connector.A visual inspection with the naked eye noted broken occlude feet beneath the twist clamp.Functional leak and clamp function testing was performed which observed a leak through the closed transfer set due to the broken occlude feet; there was no leak at the female connector to cap connection.Clear passage testing was performed with no issues noted.The reported condition was verified.The cause of the broken occlude feet could not be determined; however, the damaged set is consistent with damage caused by exposure to chemical agents such as foreign solvents, dyes, or cleaning agents that damage the transfer set materials.A nonconformance has been opened to address this issue.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 ; 2242702068
• MDR Report Key: 15471668
• MDR Text Key: 305712778
• Report Number: 1416980-2022-05004
• 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: 10/25/2022

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: 08/29/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 10/12/2022
• Supplement Dates FDA Received: 10/25/2022
• 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; HOMECHOICE PRO