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); Fitting Problem (2183)

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

Event Date 01/25/2022

Event Type  malfunction  

Event Description

It was reported that a minicap extended life pd transfer set had a connection issue which resulted in a leak; further described as ¿minicap cannot fit well and iodine leaked out¿.It was further reported that after changing several mini caps the leak issue remained.This was observed prior to use of the device for peritoneal dialysis (pd) therapy.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

Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a minicap extended life pd transfer set had a connection issue which resulted in a leak; further described as ¿minicap cannot fit well and iodine leaked out¿.It was further reported that after changing several mini caps the leak issue remained.This was observed prior to use of the device for peritoneal dialysis (pd) therapy.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

Additional information was added to d9, h3, h6 and h10.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this 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 ; 2242702068
• MDR Report Key: 13586593
• MDR Text Key: 286049420
• Report Number: 1416980-2022-00713
• Device Sequence Number: 1
• Product Code: KDJ
• UDI-Device Identifier: 00085412007731
• UDI-Public: (01)00085412007731
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K152675
• 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,Followup
• Report Date: 03/24/2022

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: Other
• Device Catalogue Number: 5C4482
• Device Lot Number: H21J14089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 03/15/2022
• Supplement Dates FDA Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2021
• 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: MINICAP.