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

Catalog Number L5C4366

Device Problems Device Difficult to Setup or Prepare (1487); Device Slipped (1584)

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

Event Date 07/15/2014

Event Type  malfunction  

Event Description

It was reported the connection of the y-set and transfer set would spin and not lock into place.The event occurred during use.No patient injury or medical intervention was indicated as a result of this event.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Six capd sets (5 opened samples and 1 unused companion sample) were returned for evaluation.No abnormalities were identified during visual inspections of the sets.All devices passed an underwater leak test, a clear passage test, and a clamp functional test.Furthermore, each sample was able to connect to a test transfer set with no issues noted.A batch review of the associated lot number was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported connection issue was unable to be verified during sample analysis.Should additional relevant information become available, a supplemental 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: 3995431
• MDR Text Key: 4774221
• Report Number: 1416980-2014-25878
• 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: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: L5C4366
• Device Lot Number: H14C05106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2014
• 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: TRANSFER SET
• Patient Age: 34 YR
• Patient Weight: 77