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

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A kink in the tubing during prime is a known cause of air in the patient line.As the cassette was not returned and the lot number was unknown, a device analysis could not be completed.The cause of the issue was determined to be due to kinked tubing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that air was observed in the patient line tubing during the initial drain of peritoneal dialysis therapy on the homechoice.The patient was connected at the time the air was observed.During troubleshooting, the patient reported that the patient line was kinked in the cassette door.The technical service representative assisted the patient in ending therapy and reviewed proper procedures with them.There was no patient injury or medical intervention reported.No additional information is available.

• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5692589
• MDR Text Key: 46363489
• Report Number: 1416980-2016-10101
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• 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
• Date Manufacturer Received: 05/19/2016
• 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
• Patient Age: 48 YR