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

Catalog Number R5C4479C

Device Problems Component Falling (1105); Loose or Intermittent Connection (1371); Device Displays Incorrect Message (2591)

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

Event Date 06/19/2014

Event Type  malfunction  

Event Description

It was reported that a homechoice device experienced a system error 2240 alarm (air in line/set).This event occurred during dwell cycle one of three of peritoneal dialysis therapy while the patient was connected.During troubleshooting, the patient stated that the supply bag fell off because of a loose connection.The technical service representative advised the patient to make sure that the clamp is closed on the bag when connecting and advised the patient to restart therapy with 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 identified.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).As the device was not returned and the lot number was unknown, a device analysis could not be completed.The cause of the reported alarm was due to a loose connection between a cassette supply line and a supply bag.The cause of the loose connection could not be determined.Should additional relevant information become available, a follow-up report will be submitted.

• 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: 3931932
• MDR Text Key: 4599698
• Report Number: 1416980-2014-22533
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102936
• 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,Followup
• Report Date: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: R5C4479C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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