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

Catalog Number 5C8310

Device Problem Filling Problem (1233)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2022

Event Type  malfunction  

Event Description

It was reported that a homechoice pro underdelivered peritoneal dialysis (pd) solution to the patient.The caregiver (cg) reported that the expected delivery volume is 2500ml; however, patient was filled with 2200ml.This issue was further described as, ¿the cycler is not filling as per the prescription and there is too much solution left over at the end of therapy".This was observed during use of the device for peritoneal dialysis therapy.Renal therapy services (rts) assisted the caregiver (cg) to reset the procard and verified the prescription, check the therapy settings, and explained the issue.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device was received for evaluation.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The returned device passed functional testing and was found to meet specification.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The reported condition was not verified.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 CORPORATION; deerfield IL
• 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 ; 2242702068
• MDR Report Key: 13388750
• MDR Text Key: 284677782
• Report Number: 1416980-2022-00198
• 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: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C8310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2022
• 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: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN PD SOLUTION.