MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE HOMECHOICE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 5C4474

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/19/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received and an evaluation was performed to investigate this event.A review of the event history log verified the occurrence of an increased intra-peritoneal volume (iipv) event.Upon conclusion of the investigation, the cause of the issue was determined to be a false empty detect and use error, inappropriate bypass of the low drain volume alarm, not including initial drain.The homechoice and homechoice pro apd systems patient at-home guide gives instructions on how to bypass ldv alarm.Should additional relevant additional information become available, a supplemental report will be submitted.

Event Description

During evaluation of a returned homechoice device, one increased intra-peritoneal volume (iipv) event was identified.This event occurred in the therapy initiated on (b)(6) 2014 23:07:29.During night drain cycle 20, the patient's ultrafiltration reading was 1245ml, indicating the home patient (hp) drained 1245ml more than their maximum programmed fill volume of 1400ml.No additional information is available.

• Brand Name: HOMECHOICE
• 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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5336570
• MDR Text Key: 34742266
• Report Number: 1416980-2015-45915
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5C4474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1