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

Catalog Number R5C4484

Device Problems Disconnection (1171); Fitting Problem (2183)

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

Event Date 03/03/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a minicap extd life trans set was broken.This was further described as the dark blue female connector would not secure when attempting to attach to the patient line of the cassette.It kept spinning and would not lock in place.It was further stated, the light blue plastic above the dark blue threading looked uneven.This occurred during use for peritoneal dialysis therapy.As a result, the patient¿s transfer set was changed.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added to h3 and h6.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.The returned photograph was reviewed, and it was noted that the female connector was separated from the main body.The reported condition of the separation between the female connector and mainbody was verified.The cause of the reported condition was determined to be manufacturing related.A nonconformance has been opened to address this issue.The additional reported issue of the connection issue of the female connector could not be evaluated as an actual sample was not returned.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
• MDR Report Key: 11586152
• MDR Text Key: 245903722
• Report Number: 1416980-2021-01683
• Device Sequence Number: 1
• Product Code: KDJ
• UDI-Device Identifier: 00085412050768
• UDI-Public: (01)00085412050768
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

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: R5C4484
• Device Lot Number: H20K04055
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 03/29/2021
• Supplement Dates Manufacturer Received: 04/15/2021
• Supplement Dates FDA Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMIA AUTOMATED PD CYCLER SET