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

Catalog Number 5C8310

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Pain (1994); Vomiting (2144); Abdominal Distention (2601)

Event Date 11/23/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A peritoneal dialysis (pd) patient experienced nausea/vomiting, severe shoulder pain, eye pain, and severe abdominal distention due to a large amount of fluid that was in the patient.The patient drained 4700 ml despite a prescribed fill volume of 2200ml.There was no medical intervention reported.The patient¿s outcome was not reported.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The homechoice device received a returned instrument testing evaluation (rite).This evaluation included functional and electrical testing of the device.The device was determined to meet functional and electrical performance specification requirements per rite testing.Analysis indicated all pressures were correct and stable.A short simulated therapy was successfully performed.The reported problem of high drain volume was identified during the event history log review.The direct cause of the high drain event was the initial drain alarm setting was inappropriately programmed (i.E.False empty detect and use error).The initial drain alarm was set to 0 ml.The sample analysis revealed no device malfunction that could have caused or contributed to the reported problem.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
• 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; ni; largo FL 33773
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6180813
• MDR Text Key: 62596354
• Report Number: 1416980-2016-18424
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/26/2017

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: 12/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2017
• 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
• Treatment: CASSETTE; DIANEAL PD4 1.5%; DIANEAL PD4 2.5%
• Patient Outcome(s): Other
• Patient Age: 91 YR
• Patient Weight: 65