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

Catalog Number T5C4326

Device Problem Misconnection (1399)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received.Should additional information become available, a supplemental report will be submitted.

Event Description

It was reported it had been difficult to set the transfer set into uv assist device.There was gap between actual sample of transfer set and cap.After changing to new transfer set, there were no issues.There was no patient injury or medical intervention indicated at the time of the report.No additional information is available.

Manufacturer Narrative

(b)(4).The device was received for evaluation.A gross visual inspection and microscopic inspection were performed and identified a damaged patient adaptor and a gap between the transfer set's flow control barrel and the disconnect cap.Functional testing of the device included leak testing, clear passage testing, and clamp function testing; no issues were found that could have caused or contributed to the reported problem.The reported issue was verified; however, the cause could not be determined.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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5339397
• MDR Text Key: 34883278
• Report Number: 1416980-2015-46094
• 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: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: T5C4326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2016
• 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