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

Catalog Number 5C4474

Device Problem Noise, Audible (3273)

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

Event Type  malfunction  

Event Description

It was reported that when a homechoice is ¿plugged into a 220 ac there is a spark noise from the switch¿ (unspecified).It is unknown if there was any patient (pt) involvement.No further information was provided.Additional information was requested but is not available.

Manufacturer Narrative

(b)(4).The device is expected to be received and evaluated.An event history log review will be performed.Should any relevant information be obtained from this review that is related to the reported event or through other means, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The evaluation of the device was completed.A capa was initiated to investigate the event further.If additional relevant information is obtained, then a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.An event history review did not confirm the reported condition.Functional and electrical testing was performed with no issues noted.Upon powering up the device, the power entry module was found to produce a spark noise, confirming the reported condition.The cause of the condition was determined to be due to a faulty power entry module.The power entry module was replaced to correct the issue.Should additional relevant information become available, 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: 3630716
• MDR Text Key: 3985379
• Report Number: 1416980-2014-05643
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: GR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2014

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: Lay User/Patient
• Device Catalogue Number: 5C4474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/29/2014
• Initial Date FDA Received: 02/17/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/12/2014; 06/23/2014
• 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