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

Catalog Number 5C4471R

Device Problem Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is in progress.Upon completion of the investigation, or if any additional relevant information is received, a supplemental report will be submitted.

Event Description

It was reported that a homechoice device emitted a sparking noise.This was noted during prime of peritoneal dialysis.The patient stated that they could not see any visible signs of sparking but the deice was making a noise that sounded like a wire sparking.The technical services representative (tsr) arranged a swap and discussed the use of manual supplies to complete therapy until the new device arrives.There was no patient injury or medical intervention reported.No additional information is available.

Manufacturer Narrative

(b)(4).The homechoice device was returned to baxter healthcare for evaluation.A service history review was performed and did not reveal any previous service events that could have caused or contributed to the reported problem.An external and internal visual inspection revealed no issues.The device was tested and passed the return instrument test/evaluation (rite) electrical test and functional test.A simulated therapy was performed.During priming, the device made a loud sparking sound.The reported condition was verified.The cause of the issue was determined to be a noisy compressor.The device was sent to service with instructions to rework the compressor.A capa has been opened to address this 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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5178482
• MDR Text Key: 29291364
• Report Number: 1416980-2015-40088
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C4471R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2015
• 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
• Patient Age: 57 YR