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

Catalog Number 5C4417

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/27/2015

Event Type  malfunction  

Manufacturer Narrative

This is a re-submission of the original initial report that had been previously submitted on 23 dec 2015.The codes in this submission have been updated to align with the current accepted coding.Complaint no: (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) 2015 at 23:45:24.During night drain cycle four, the patient¿s ultrafiltration reading was 1350ml, indicating the home patient drained 1350ml more than their maximum programmed fill volume of 2000ml.No additional information is available.

• Brand Name: HOMECHOICE
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - LARGO; largo FL
• Manufacturer (Section G): BAXTER HEALTHCARE - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 5354621
• MDR Text Key: 288978294
• Report Number: 1416980-2015-45562
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K102936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5C4417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Date Manufacturer Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: No
• 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: 62 KG