MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Device Problems Kinked (1339); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2015

Event Type  malfunction  

Event Description

It was reported that a system error 2240 (air in set/line) alarm occurred during the initial drain of peritoneal dialysis therapy on the homechoice.The patient was connected at the time of the alarm.During troubleshooting, the caregiver reported that the patient line was kinked and had not been properly primed before they had connected.The technical services representative assisted the patient in clearing the alarm and reviewed proper procedures with them.The caregiver planned to complete therapy using new supplies.There was no patient injury or medical intervention reported.No additional information is available.

Manufacturer Narrative

(b)(4).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, a kinked patient line leading to an incompletely primed line is a known cause of this alarm.It was also reported that the patient had connected to an improperly primed 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 provides step-by-step instructions for properly priming the disposable set.It warns the user not to connect to the patient line unless the fluid level is at or near the connector at the end of the disposable set patient line.A review of the label for the product family will be conducted.Should additional relevant information become available, a supplemental report will be submitted.

• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4943214
• MDR Text Key: 6034563
• Report Number: 1416980-2015-30276
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2015
• Initial Date FDA Received: 07/27/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: HOMECHOICE