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

Catalog Number 5C8310

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Dyspnea (1816); Abdominal Distention (2601)

Event Date 04/06/2019

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 feelings of fullness, bloated, difficulty breathing and chest pain during dwell 4 of 5.The patient was connected to the homechoice device at the time of the events.The patient bypassed to perform manual drain; however, the device continued filling the patient.It was reported the device did alarm; however no low drain volume alarmed or was associated with the reported event.Renal therapy services (rts) assisted the patient to end therapy and instructed to use manual supplies to drain.The patient reported draining relieved symptoms.The patient drained a total amount of 6300ml (drain bag one- 2800ml and drain bag two 3500 ml).Rts checked the alarm log and found: check lines and bags alarm, refilling the heater, and refill not finished alarm for the same date as the reported event.Rts checked the therapy log and found total fluid volume was 11,680, total drain volume was 10,152, and total uf of 1568.There was no report of medical intervention associated with this event.At the time of this report, the patient outcome was not reported.No additional information is available.

Manufacturer Narrative

Additional information: the device was received for evaluation.External visual inspection did not identify any abnormalities that could have contributed to the reported condition.Internal visual inspection revealed pest infestation.The homechoice device received a returned instrument testing evaluation (rite) which included functional testing of the device.The device was determined to meet functional specification requirements per rite testing.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue of fullness.The logs showed check lines and bags, and refill not finished.The logs revealed the therapy for the date of the reported issue has the initial drain alarm (ida) was set to 0.When the ida is set at 0ml, the therapy will move on to the 1st fill cycle.Difficult to advance was verified due to the numerous check line and bags alarm.The therapy was eventually aborted and the patient retained 1528ml of fluid.The direct cause for excessive drain was determined to be insufficient drain - inappropriate programmed i-drain alarm setting.The homechoice and homechoice pro apd systems patient at-home guide warns that "too low an i-drain alarm volume 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 - SINGAPORE; singapore
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; singapore 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8571287
• MDR Text Key: 143794710
• Report Number: 1416980-2019-02467
• 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: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• 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: 04/23/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2019
• 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