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

Catalog Number ASKU

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.However, it was reported that the transfer set was not opened prior to pressing go, which is a user error that will result in the reported air in the patient 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 make sure the transfer set is open before pressing go.A review of the label for the product family will be conducted.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced air in the patient line of a homechoice cassette without an alarm.This occurred during initial drain of peritoneal dialysis therapy.The patient was connected at the time of the event.The caregiver stated that they had not opened the transfer set before pressing go.Renal therapy services (rts) assisted in disconnecting and advised the caregiver to set up with new supplies.Rts reviewed proper procedures with the caregiver per user manual.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: 7514212
• MDR Text Key: 108253198
• Report Number: 1416980-2018-02868
• 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: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• 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
• Date Manufacturer Received: 04/15/2018
• 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 Age: 67 YR