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

Catalog Number 5C6M10

Device Problem Volume Accuracy Problem (1675)

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

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a homechoice claria presented a slow infusion.This issue occurred during use with patient involvement.The device did not display any alarms and it "was not passed the therapy steps".There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received by baxter.A visual inspection was performed with the naked eye.A service history review revealed that the device has not been serviced in the past.The evaluation included functional testing of the device.The device passed functional testing.A short-simulated therapy was successfully performed.The returned instrument test evaluation (rite) testing and the software testing were performed without problems.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE CLARIA
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; singapore
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; singapore 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7375310
• MDR Text Key: 103658978
• Report Number: 1416980-2018-01674
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00085412522883
• UDI-Public: (01)00085412522883
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5C6M10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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