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

Catalog Number 5C8310

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Patient Involvement (2645)

Event Date 01/06/2015

Event Type  malfunction  

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 the device passed, along with all of the electrical testing.During the evaluation, the fluid was transferred outside of the returned instrument testing evaluation (rite) specified limits and the volumetric accuracy test that followed, showed that the device had failed.Pal performed a more detailed inspection of the door assembly.The inspection showed that the piston foam was deteriorated.The results of the evaluation revealed the cause of the failure to be the deteriorated piston foam.The piston foam was 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.

Event Description

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

Manufacturer Narrative

(b)(4).The device was received and is currently awaiting evaluation.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: 4460888
• MDR Text Key: 20250906
• Report Number: 1416980-2015-03529
• 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: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5C8310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/04/2015
• 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