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

Catalog Number L5C4366

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of all batch record documents was conducted with no issues noted during the manufacturing process.There were no deviations from standard procedure and no exceptions related to the reported condition were noted.The device was not returned for analysis; therefore, no evaluation could be performed.If additional relevant information is obtained, then a follow-up mdr will be submitted.

Event Description

This is a report of a home patient (hp) who experienced a connection issue between a continuous automated peritoneal dialysis (capd) disconnect y-set and an unknown transfer set.This occurred during setup for capd therapy.The hp reported that the y-set continually spun around the transfer set without tightening.The hp tried connecting other y-sets to the same transfer set, but experienced the same result.There was no patient injury or medical intervention reported.No additional information is available.This is report 4 of 9 for the same patient.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a follow-up report will be submitted.

• Brand Name: CAPD DISCONNECT Y SET
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3972780
• MDR Text Key: 12358523
• Report Number: 1416980-2014-24999
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: L5C4366
• Device Lot Number: H12E31141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN TRANSFER SET