MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME UV FLASH TRANSFER SETS; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number T5C4326

Device Problem Material Separation (1562)

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

Event Date 03/03/2014

Event Type  malfunction  

Event Description

It was reported that the patient connector of a uv flash transfer set separated from an unknown titanium adapter 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).(b)(6).A request for the return of the device has been made.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device was returned to baxter and an evaluation was performed to investigate the reported event.A visual inspection was performed with discoloration noted.A leak test, clear passage test, and clamp function test were performed with no issues noted.An integrity of seal test was performed and no leaks were detected.The interior diameter of the patient connector was measured and was found to be outside of specification limits.The reported problem was confirmed through evaluation of the sample.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The cause of the reported connection failure was determined to be a manufacturing issue.A capa record currently exists to address the issue.The capa record identified that the molds were not properly measured which allowed for the variance in the transfer set diatemeter.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: UV FLASH TRANSFER SETS
• 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: 3700611
• MDR Text Key: 4266869
• Report Number: 1416980-2014-09895
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: T5C4326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2014
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN TITANIUM ADAPTER