Sharesource Connectivity Platform 5C9400 (UDI 05413765565694)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05413765565694), received between Mar 30, 2026 and Mar 30, 2026 — classified as 1 injury.

8 other recalls cover devices cleared under the same FDA submission (K151525); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO AUTOMATED PERITONEAL DIALYSIS (PD) PATIENTS USING KAGUYA CYCLERS WITH SHARESOURCE WERE HOSPITALIZED DUE TO "FLOODING", FURTHER DESCRIBED AS "OUTFLOW MODE". THE REPORTER FURTHER INFORMED THAT DIFFICULTY WAS ENCOUNTERED WITH SOME OF THE PARAMETERS PROGRAMMED IN SHARESOURCE, INCLUDING THE "DISCONNECT STATE", WHEREBY PATIENTS SEEM TO END THERAPY "STILL FLOODED". THERE WAS NO REPORT OF PATIENT SYMPTOMS. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME AND ACTION TAKEN WITH PD THERAPY WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO PROVIDE DETAILS ABOUT THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24716961 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151525. One submission often covers many models, so check the product and lot details in each record.

• Z-0550-2024 · Nov 15, 2023 · Open, Classified
  Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
• Z-2174-2021 · Jun 30, 2021 · Terminated
  Kaguya Automated Peritoneal Dialysis System
• Z-2173-2021 · Jun 30, 2021 · Terminated
  Sharesource Connectivity Platform for Use with the Amia Automated PD System
• Z-0850-2019 · Dec 11, 2018 · Terminated
  Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients un
• Z-0849-2019 · Dec 11, 2018 · Terminated
  AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients und
• Z-2597-2018 · Jul 12, 2018 · Terminated
  power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only)
• Z-3133-2017 · Sep 1, 2017 · Terminated
  Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
• Z-1565-2016 · Feb 16, 2016 · Terminated
  Automated peritoneal dialysis (APD) cycler