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)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2019

Event Type  malfunction  

Manufacturer Narrative

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 warns the user not to perform dialysis in the same room as pets or animals.It states that ¿contamination of the fluid or fluid pathways can result if a pet or animal bites a solution bag or the disposable set.Contamination of any portion of the fluid or fluid path may result in peritonitis, serious patient injury, or death.¿ a review of the label for the product family will be conducted.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 cassette leaked; further described as ¿fluid leakage from the cassette supply line tubing¿.The patient¿s cat came into the room and clawed at the tubing, and put a hole in the supply bag tubing, which caused the leak.This was identified during dwell one of five of automated peritoneal dialysis therapy.The patient was connected at the time of the event.Renal therapy services (rts) assisted the patient in ending therapy and with cassette removal.There was no patient injury or medical intervention associated with this event.No additional information is available.

• 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: 8444850
• MDR Text Key: 139598831
• Report Number: 1416980-2019-01534
• 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
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• 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
• Date Manufacturer Received: 02/24/2019
• 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
• Treatment: HOMECHOICE DEVICE