MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number ASKU

Device Problems Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a homechoice (hc) device experienced a system error 2240 (air in line/set) alarm.The home patient (hp) was connected at the time of the alarm.This occurred near the end of peritoneal dialysis therapy.During troubleshooting, it was reported that there was a leak between the supply line and the supply bag, and that the they did not properly tighten the connection which caused the leak.The hp stated that they cleared se 2240 and then pressed go until the hc progressed to priming.Renal therapy services (rts) reviewed the alarm log and discovered se 2240.Rts advised the care giver (cg) correct procedures.The cg stated that the solution bag connected to supply line was wet.The cg advised that they were okay to set up the hc with new supplies on their own.Rts reviewed proper procedures per the user manual with the hp.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Upon further review of the information received, it was determined that the cause of this event was due to a use error.As reported by the home patient (hp) the source of the leak was between the supply line and the supply bag, and the hp did not properly tighten the connection which caused the leak and led to the alarm.Therefore, the disposable peritoneal dialysis cassette is no longer considered suspect product in this event.Use errors and proper user instructions are addressed in ¿the homechoice and homechoice pro systems patient at-home guide¿, which is shipped with every homechoice device.The guide instructs the user to check all disposable set connections for a secure fit before beginning therapy.Also, it instructs the user to check lines for disconnected solution bags.It provides step-by-step instructions for connecting the solution bags.It warns the user that if a bag becomes disconnected during therapy, the user should follow the end therapy early procedure.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: NI
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - MOUNTAIN HOME; mountain home AR
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8066220
• MDR Text Key: 127068457
• Report Number: 1416980-2018-07220
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2018
• Initial Date FDA Received: 11/13/2018
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR