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); Nausea (1970)
Date of Event	10/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 shortness of breath and nausea feeling during fill 1.The patient was connected to the homechoice pro device at the time of the events.The patient performed a manual fill of 1000 ml (four hours before starting pd therapy) and did not perform a manual drain.Initial drain volume was 511ml, manually filled 1000ml.Filled 1880mlin fill 1, lfv 1000ml.Renal therapy services advised the patient to follow up with the pd nurse as the patient had already disconnected and started draining manually.The patient reported the symptoms were not present at the time of the call.Further reported the patient connected to the device wet after manual exchange.The device was operational and a swap was not necessary.There was no report of medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE PRO
• Common Device Name: 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 60073 ; 2242702068
• MDR Report Key: 15751818
• Report Number: 1416980-2022-06065
• Device Sequence Number: 6364644
• Product Code: FKX
• UDI-Device Identifier: 00085412079165
• UDI-Public: (01)00085412079165
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 12/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown