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

Catalog Number 5C8310

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Dyspnea (1816)

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported an automated peritoneal dialysis patient experienced shortness of breath and "did not pull enough during the initial drain".The patient was connected to the homechoice pro device at the time of the event.The patient reported the last fill volume (lfv) during the initial drain was 1000ml, the drain volume (dv) was 565 ml and went to fill 1.Renal therapy services (rts) reviewed the initial drain volume was set at 0ml.The patient experienced shortness of breath.Rts reviewed the total ultrafiltration, which was set at 0ml.The patient reported the normal ultrafiltration was "around 900".Rts assisted to fill volume 122ml, went to manual drain with dv of 2ml, went to manual drain again with dv of 158ml and went back to fill.The patient reported they did not feel empty and continued having shortness of breath.Rts assisted the patient to end therapy and reviewed program.Rts advised the patient to follow up with the nurse to increase the initial drain volume and target ultrafiltration.Rts advised the patient to go to the emergency room if still having difficulty breathing.The patient reported they were feeling better.Rts initiated a swap of the device and continuous ambulatory peritoneal dialysis was discussed.There was no report of medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: the device was received for evaluation.The event history log review showed that the initial drain volume was set to 0 ml, and the last fill volume was set to 1000 ml.The homechoice device received a returned instrument testing evaluation (rite).This evaluation included functional testing of the device.The device was determined to meet functional performance specification requirements per rite testing.The cycler remote toolbox software was used to diagnose the device¿s pneumatic system and all pressures were correct and stable.Internal and external inspection was performed and no issues were noted.All connections appear correct and secure.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The reported issue was not verified.The cause of the condition was the initial drain alarm setting was inappropriately programmed.The i-drain alarm was set to 0 ml and the previous therapy left the patient with 999 ml.The homechoice and homechoice pro apd systems patient at-home guide warns that ¿setting the i-drain alarm volume too low or off can result in an incomplete initial drain followed by a full fill.This can result in an increased intraperitoneal volume (iipv) situation.¿a review of the label for the product family will be conducted.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 - 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 60073 ; 2242702068
• MDR Report Key: 8598914
• MDR Text Key: 144668424
• Report Number: 1416980-2019-02615
• 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: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C8310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 07/30/2019
• Supplement Dates FDA Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other