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

Catalog Number	5C8310
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Dyspnea (1816); Abdominal Distention (2601)
Date of Event	05/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not received for evaluation; therefore, a device analysis could not be completed.The likely cause of the reported events was associated with use error, bypassed the low drain volume alarm in initial drain phase.The homechoice and homechoice pro apd systems patient at-home guide provides instructions on how to bypass ldv alarm in initial drain.A review of the label for the product family will be conducted.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported an automated peritoneal dialysis patient experienced feeling too full and difficulty breathing during dwell 1 of 4.The patient was connected to the homechoice pro device at the time of the events.Renal therapy services (rts) assisted the patient to manually drain, the drain volume was 2649 ml.The patient reported draining relieved the symptoms.Rts assisted patient in ending the therapy early.The patient stated they performed manual fill prior to the start of therapy of 2000ml and drained 1453ml.The patient had bypassed the low drain volume alarm in initial drain phase to fill 1.The device was operational, and a swap was not necessary.No additional information is available.

• Brand Name: HOMECHOICE PRO
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11898132
• Report Number: 1416980-2021-03199
• Device Sequence Number: 3685354
• Product Code: FKX
• UDI-Device Identifier: 00085412079165
• UDI-Public: (01)00085412079165
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K102936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 5C8310
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other