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

Catalog Number R5C8320

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/21/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is in progress.Should additional relevant 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 which occurred in the therapy initiated on (b)(6) 2014 at 21:35:40.During night drain cycle four, the patient's ultrafiltration reading was 1342ml, indicating the home patient drained 1342ml more than their maximum programmed fill volume of 2000ml.No additional information is available.

Manufacturer Narrative

(b)(4).The device was received and the evaluation is complete.During the event history log review, an increased intra-peritoneal volume (iipv) event was identified.Upon conclusion of the investigation, the cause of this issue was determined to be one or more cycles advances to the next fill when slow or no flow occurred above the minimum drain volume threshold.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE PRO
• 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: 5338777
• MDR Text Key: 34884838
• Report Number: 1416980-2015-46058
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/08/2016

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: R5C8320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2015
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 12/31/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/08/2016
• 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
• Patient Weight: 84