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

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2015

Event Type  malfunction  

Event Description

It was reported that a patient discovered a leak in a disposable set.This occurred during dwell one of four of peritoneal dialysis therapy.The patient was connected at the time of the event.The patient stated that their patient line was leaking in the middle of the line.The technical service representative advised the patient to start over with new supplies.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Complaint no: (b)(4).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 4809558
• MDR Text Key: 5832542
• Report Number: 1416980-2015-23586
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• 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: 05/17/2015
• 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
• Patient Age: 38 YR