MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number L5C4531

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2014

Event Type  malfunction  

Event Description

It was reported that the home patient (hp) dropped the patient line of their automated peritoneal dialysis (apd) set with cassette, at the point of ¿connect yourself¿ on the homechoice (hc) device.The caregiver (cg) explained that the hp was in the process of connecting for therapy when they dropped the line on the floor with the cap off the line.The cg reported that the patient did connect themselves to the setup after that, but did not open the transfer set.The hp ended up disconnecting after that to ask for assistance from the technical service representative (tsr).The tsr advised the cg to have the hp start over with all new supplies.There was no patient injury or medical intervention indicated at the time of the report.No additional information is available.

Manufacturer Narrative

(b)(4).A break in aseptic technique by the patient was reported.Per baxter labeling, users are instructed to use aseptic technique when performing peritoneal dialysis therapy.A formal review of the label for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.

• Brand Name: HOMECHOICE AUTOMATED PD SET WITH CASSETTE
• 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: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3632095
• MDR Text Key: 4178371
• Report Number: 1416980-2014-05775
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923065
• 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: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: L5C4531
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2014
• 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: 74 YR