MAUDE Adverse Event Report: BAXTER HEALTHCARE - LARGO HOMECHOICE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 5C4471R

Device Problems Degraded (1153); Volume Accuracy Problem (1675)

Patient Problem No Patient Involvement (2645)

Event Date 10/13/2014

Event Type  malfunction  

Event Description

During evaluation of a returned homechoice device, a baxter technician determined the homechoice machine failed fluid volume accuracy testing.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).There was nothing found in the event logs that would indicate the rite failure.Review of service history data revealed previous device servicing did not cause or contribute to the reported event.The homechoice (hc) device was returned and evaluated by the product analysis lab (pal).The device failed volumetric accuracy testing.External/internal inspection was performed and passed.A volumetric accuracy test was performed and the device failed.Temperature was within specifications.An inspection of the door assembly revealed the door piston was cracked and the door piston foam deteriorated.The cause for the failed volumetric accuracy test was determined to be the cracked door piston and the deteriorated door piston foam.Pal recommends scrapping the piston and door piston foam.The device was sent to service.If additional relevant information is obtained, a supplemental report will be submitted.

• Brand Name: HOMECHOICE
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer (Section G): BAXTER HEALTHCARE - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 4232880
• MDR Text Key: 4977029
• Report Number: 1416980-2014-39157
• 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
• Report Date: 10/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5C4471R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2014
• Date Manufacturer Received: 10/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1