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

Catalog Number 5C8310R

Device Problems Crack (1135); Degraded (1153); Volume Accuracy Problem (1675)

Patient Problem No Patient Involvement (2645)

Event Date 12/23/2014

Event Type  malfunction  

Event Description

During evaluation of a returned homechoice device, a baxter technician determined the device failed fluid volume accuracy testing.No additional information is available.

Manufacturer Narrative

(b)(4).The homechoice device was returned and evaluated by the product analysis lab (pal).A device history record review revealed no issues that could have caused or contributed to the reported issue.An internal/external inspection was performed and did not identify anything related to this return instrument test/evaluation (rite) failure.Electrical testing was performed and the device passed.The fluid volumetric accuracy test that was performed, had failed with the original piston foam.However, when a test article, piston foam, was installed, the device passed the accuracy confirmation testing.The original piston foam was removed and inspection revealed that the piston foam was deteriorated and there was a door piston crack at the rib of the right disposable.The evaluation concluded that the cause of the failed fluid volume accuracy testing was the deteriorated piston foam and door piston.The piston foam and door piston were to be scrapped and the device was sent for servicing.A capa has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE PRO
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4427116
• MDR Text Key: 5370154
• Report Number: 1416980-2015-02292
• 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: 12/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5C8310R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/21/2015
• Initial Date FDA Received: 01/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/19/2015
• 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