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

Catalog Number ASKU

Device Problems Loose or Intermittent Connection (1371); 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

An alarm indicative of a potential malfunction of the disposable cassette was reported.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.However, it was determined that there was loose connection between the cassette and the empty supply bag which led to this alarm.The cause of the loose connection could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a homechoice device experienced a system error 2240 (air in line/set) alarm.The patient was connected at the time of the alarm.This occurred during dwell three of four of peritoneal dialysis therapy.During troubleshooting, it was determined that there was loose connection between the cassette and the empty supply bag that led to this alarm.Renal therapy services (rts) assisted the patient in disconnecting using aseptic technique and removed the cassette.The patient was advised to notify the peritoneal dialysis registered nurse of the missed therapy.Rts reviewed proper procedures with the patient per the user manual.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information received confirming that the loose connection was due to an use error.The patient did not properly tightened the connection between the solution bag and the cassette line which led to this alarm.No damage was noted on the cassette line.(b)(4).The device is no longer a suspect product.The cause of the loose connection was user error as the patient did not properly tightened the connection between the solution bag and the cassette line.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.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: 8065952
• MDR Text Key: 127067337
• Report Number: 1416980-2018-07217
• 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

• Date FDA Received: 11/13/2018
• 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
• Date Manufacturer Received: 11/14/2018
• 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: 62 YR