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

Catalog Number ASKU

Device Problems Hole In Material (1293); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problem Peritonitis (2252)

Event Date 03/02/2018

Event Type  Injury  

Manufacturer Narrative

The reported product is an unknown baxter cassette.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 to follow aseptic technique taught by the dialysis center when handling lines and solution bags to reduce the possibility of infection.Also, it warns the user that using damaged sets can result in contamination of the fluid or fluid pathways.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

A peritoneal dialysis (pd) patient experienced a use error which resulted in peritonitis.It was reported that a there was a hole in tubing of homechoice cassette which resulted in an alarm.The patient placed tape over the hole and continued to perform pd therapy.It was not reported if the patient was hospitalized for the event.On an unspecified date, the patient was treated with unspecified antibiotics (dose, route, duration and frequency were not reported) for peritonitis.At the time of this report, antibiotic treatment was ongoing and the patient was not recovered from peritonitis.The action taken with pd therapy was not reported.It was not reported if the patient was retrained on the proper technique.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: 7386245
• MDR Text Key: 103980066
• Report Number: 1416980-2018-01752
• 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
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Date Manufacturer Received: 03/05/2018
• 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
• Treatment: HOMECHOICE
• Patient Outcome(s): Required Intervention