MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CAPD DISCONNECT Y SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number L5C4366

Device Problem Fitting Problem (2183)

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

Event Date 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that an ultra set capd disposable disconnect y-set had a connection issue; described by the reporter as ¿y sets does not connect to drain manually during priming¿.This was identified during set up for peritoneal dialysis therapy.The patient was not connected at the time of the event.The patient contacted the registered nurse regarding missed therapy.There was no patient injury or medical intervention associated with this event.No additional information was available.

Manufacturer Narrative

Additional information in h6, h10.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction: b4/f8: date of this report in follow-up mdr #1 is being corrected from blank to (b)(6) 2021.

• Brand Name: CAPD DISCONNECT Y SET
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12158779
• MDR Text Key: 261260625
• Report Number: 1416980-2021-04258
• Device Sequence Number: 1
• Product Code: KDJ
• UDI-Device Identifier: 00085412090085
• UDI-Public: (01)00085412090085
• Combination Product (y/n): Y
• PMA/PMN Number: K961825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2021

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: L5C4366
• Device Lot Number: H20C04069
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 07/13/2021
• Supplement Dates Manufacturer Received: 08/02/2021; 08/11/2021
• Supplement Dates FDA Received: 08/10/2021; 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.