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

Catalog Number 5C4471R

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received and is in the process of being evaluated.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.This event occurred in the therapy initiated on (b)(6) 2015 at 21:10:14.During night drain cycle eight, the patient's ultrafiltration reading was 84ml, indicating the patient drained 84ml more than their maximum programmed fill volume of 140ml.No additional information is available.

Manufacturer Narrative

(b)(4).The device was received and the evaluation is complete.This is an ancillary service event.The increased intra-peritoneal volume (iipv) event was identified through an event history log review.The homechoice device received a returned instrument testing evaluation.This evaluation included functional and electrical testing of the device.The device was determined to meet functional performance specification requirements per rite testing.A service history review showed no failures/problems that were the same as, or similar to, the reported issue.In addition, there was no indication that the parts replaced during servicing caused or contributed to the reported issue.Upon conclusion of the investigation, the cause was one or more cycles were advanced to 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
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer (Section G): BAXTER HEALTHCARE - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5339295
• MDR Text Key: 34882640
• Report Number: 1416980-2015-46065
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2016

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: No Information
• Device Catalogue Number: 5C4471R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2016
• 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