MPS 3 ND Console 5301000NDRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20634624531004), received between Aug 25, 2021 and Aug 20, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2025Improper Flow or Infusion; Improper Flow or Infusion

  THE REPORT RECEIVED FROM THE CUSTOMER STATES THAT THE DEVICE DELIVERED AN INAPPROPRIATE VOLUME OF SUBSTRATE BASED ON THE INPUT SETTING. THE SETTING WAS 36ML/L. 1400ML OF "MICRONIDO" DEL NIDO CARDIOPLEGIA WAS INTENDED TO BE ADMINISTERED TO THE PATIENT. HOWEVER, ONLY 10.9 ML OF SUBSTRATE WAS GIVEN. PERFUSIONIST PROVIDED NO ERROR CODES AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851834 ↗
• MalfunctionFeb 7, 2025Infusion or Flow Problem; Infusion or Flow Problem

  THE REPORT STATES THAT ADDITIVE WAS WORKING FINE BUT ON THE LAST COUPLE DOSES, IT WAS NOT WORKING ANYMORE AND NO ADDITIVE WAS BEING ADDED. THE ADDITIVE HAD TO BE MANUALLY DELIVERED TO THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS RESULTING FROM THE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21339502 ↗
• InjuryJan 27, 2025Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  A PERFUSIONIST AT (B)(6) IN (B)(6), ONT, REPORTED AN ISSUE WITH AN MPS3 ND CONSOLE TO A QUEST REPRESENTATIVE. IT WAS STATED THAT DURING A CASE, THE ARREST AGENT APPEARED TO DELIVER ITS CONTENTS FASTER THAN EXPECTED. WHEN A REFILL WAS ATTEMPTED; THE PLUNGER UNEXPECTEDLY PUSHED THE ENTIRE CONTENTS OUT AT ONCE. A SUBSEQUENT REFILL TEST USING SALINE YIELDED THE SAME RESULT. IT WAS DISCLOSED THAT DURING THE INITIAL SETUP, THE CARTRIDGE WAS INSTALLED WITHOUT THE PLUNGER ATTACHED, CAUSING APPROXIMATELY 10-20CC OF FLUID TO SPILL ONTO THE UNIT. THIS INCIDENT RESULTED IN AN EXTENDED ON-PUMP TIME AND REQUIRED THE PATIENT TO UNDERGO A BLOOD TRANSFUSION, AS EXCESS POTASSIUM NEEDED TO BE PURGED FROM THE MPS DISPOSABLE. THE CONSOLE HAS BEEN REMOVED FROM SERVICE AND WILL BE RETURNED TO QUEST MEDICAL FOR INVESTIGATION.

  Patient problems: Electrolyte Imbalance

  MAUDE report 21245924 ↗
• MalfunctionJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(6) MEMORIAL OF AN ALLEGED ISSUE WITH MPS 3 ND UNIT. THE UNIT WAS ALLEGED TO HAVE REPEATEDLY ERRORED (EC 103) WHILE TRYING TO DELIVER CARDIOPLEGIA. THE UNIT WAS POWERED DOWN AND RE-STARTED WITH NO SUCCESS. AFTER THE FINAL DOSE WAS GIVEN AND THE CROSS CLAMP WAS REMOVED, A BLOOD GAS LEVEL WAS DRAWN AND NOTED A HIGH SERUM POTASSIUM LEVEL. IT WAS CONFIRMED THAT THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Electrolyte Imbalance

  MAUDE report 17075669 ↗
• MalfunctionJul 29, 2022Therapeutic or Diagnostic Output Failure

  MEDWATCH REPORT # MW5110455 WAS RECEIVED BY QUEST MEDICAL. THE REPORT STATED THAT WHEN ATTEMPTING TO RUN CARDIPLEGIA TO THE FIELD, THE CARDIOPLEGIA PUMP GENERATED AN ALARM. IT WAS CLEARED AND ALLEGEDLY THE UNIT WAS STILL NOT FUNCTIONAL. THE REPORT STATED THAT THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15135910 ↗
• MalfunctionAug 25, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  IT WAS REPORTED TO QUEST THAT DURING A CASE, WHILE DELIVERING CARDIOPLEGIA, THE AMOUNT NOTIFICATION ALERTED THE USER THAT THERE WAS 10ML OF ARREST AGENT LEFT IN THE CARTRIDGE. AFTER THE PERFUSIONIST PRESSED THE REFILL BUTTON AND PUSHED THE DRUG INTO THE CARTRIDGE, THE BUTTON FAILED TO APPEAR ALLOWING THE USER TO CONTINUE THE OPERATION. THE CONSOLE HAD TO BE POWER CYCLED AND RE-PRIMED IN ORDER TO REACTIVATE THE ARREST DRUG PISTON. AFTER POWER CYCLING, THE DEVICE FUNCTIONED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12365296 ↗