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

Device Problems Component Falling (1105); Contamination (1120); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per baxter labeling, users are instructed to use aseptic technique when performing peritoneal dialysis therapy.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 the patient made a mistake and had a breach in the sterile pathway when they reconnected to the patient line after it had fallen to the floor.The patient explained that they disconnected and the patient line fell to the ground.They called their registered nurse, who advised to clear the patient line off, cap it off, wait a little while and then reconnect and drain.The patient did so and after draining, stopped the last fill with a fill volume of 0ml.The technical service representative assisted the patient with ending the therapy and explained about not reconnecting to a line that has fallen to the floor.There was no patient injury or medical intervention associated with this event.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: 5391384
• MDR Text Key: 37032310
• Report Number: 1416980-2016-01921
• 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: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• 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: 01/16/2016
• 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: 62 YR