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 12/12/2014

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 and a service history review revealed no issues that could have caused or contributed to the reported issue.Internal and external inspection was performed and no issues were noted.The homechoice device received a returned instrument testing evaluation (rite).This evaluation included functional and electrical testing of the device.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 and the door piston was cracked.The results of the evaluation revealed the cause of the failure to be the deteriorated piston foam and cracked door piston.The piston foam was scrapped and replaced.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

During evaluation of a returned homechoice device, the product analysis laboratory determined that the homechoice machine failed to meet volumetric test performance specifications.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).The device was received and in the process of evaluation.Should additional 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: 4393994
• MDR Text Key: 12805490
• Report Number: 1416980-2015-00789
• 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: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• 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: 12/12/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2015
• 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