MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number T5C4500P

Device Problem Misconnection (1399)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The yume set was returned and analyzed.No abnormalities were identified during visual inspection.The yume set was able to connect to a test transfer set properly, and a test clamshell closed successfully over the connection.A dimensional inspection was performed and the spike connection port was within specification limitations.The reported connection issue was unable to be confirmed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a uv flash yume set was not connecting properly with the patient¿s transfer set.The connection collar of the yume set was reported to be unable to fit over the connection between the transfer set and yume set.The issue was noticed after priming but prior to beginning automated peritoneal dialysis (apd) therapy.There was no patient injury or medical intervention indicated at the time of the report.No additional information is available.This is report 1 of 2 for this event.

Manufacturer Narrative

(b)(4).(b)(6).The yume set has been reported to be available for evaluation but has not yet been received.If the sample is received or additional relevant information becomes available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE AUTOMATED PD SET WITH CASSETTE
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3679719
• MDR Text Key: 11739003
• Report Number: 1416980-2014-08622
• Device Sequence Number: 1
• Product Code: FKX
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: T5C4500P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2014
• 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