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

Catalog Number ASKU

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2019

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was a disconnection between the heater bag and heater line of a homechoice cassette which resulted in solution leakage and air in the tubing.This occurred during fill four of four of peritoneal dialysis therapy.It was further reported that the caregiver (cg) had not connected the heater line tightly enough to the heater bag which resulted in the disconnection.Renal therapy services (rts) discussed proper procedures 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: 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.

• 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: 8695915
• MDR Text Key: 147896783
• Report Number: 1416980-2019-03245
• 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: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2019
• 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; UNKNOWN PD SOLUTION