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

Catalog Number T5C4482

Device Problems Improper or Incorrect Procedure or Method (2017); Difficult to Open or Close (2921)

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

Event Date 10/10/2023

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the twist clamp of the minicap transfer set was unable to close; further described as ¿ the clamp was not fully closed due to moving of the clamp was very hard.¿ this was observed during use of the device for peritoneal dialysis 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

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.Torque engagement testing was also performed with no issues noted.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information: a2, b1, b2, b3, b5, b7, d10, h1, h6 and h10.A2: age at time of event: ¿between the age of 10 to 19¿.B5: upon follow up a physician reported that the peritoneal dialysis (pd) patient experienced a breach in aseptic technique which resulted in peritonitis.The breach in aseptic technique was further described as ¿the clamp could not be fixed by the patient's mother and the father fixed it by force¿, the same day the patient experienced peritonitis.The patient was hospitalized and treated with unspecified antimicrobials for the event.Pd therapy was ongoing.At the time of this report, the patient outcome was not reported.It was not reported if the patient or patient¿s caregiver was retrained on the proper aseptic technique.H0: this report is for a breach in aseptic technique which resulted in peritonitis.Per baxter labeling, users are instructed to use aseptic technique when performing peritoneal dialysis therapy.Product labelling of the transfer set warns users that there is risk of contamination if the set is not handled by adhering to aseptic precautions.The instructions for use (ifu) also advises on the correct way to operate the twist clamp.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: 18092853
• MDR Text Key: 327881264
• Report Number: 1416980-2023-05770
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: T5C4482
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• 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: DIANEAL-N PD4 2.5%.; NI.; YUME HOMECHOICE.
• Patient Outcome(s): Required Intervention; Hospitalization