QinFlow Blood and Fluid Warmer QiF-01 Base Unit (BU)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290016740011), received between May 22, 2018 and Apr 23, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2019Fluid/Blood Leak

  THE USER PROVIDED THE FOLLOWING DESCRIPTION: THEY USED THE UNIT FOR WARMING BLOOD. THE UNIT WORKED WELL FOR ~5 MINUTES. THEN THEY NOTICED BLOOD WAS LEAKING FROM THE CONNECTOR OF THE DISPOSABLE UNIT AND IT FELT TOO HOT. NO ALERT WAS PROVIDED BY THE UNIT. NO SMELL OF SMOKE / BURN. THEY IMMEDIATELY CUT THE WARMING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8540249 ↗
• MalfunctionMay 22, 2018Fail-Safe Design Failure; Device Operational Issue; Fail-Safe Problem; Protective Measures Problem; Fail-Safe Design Failure; Device Operational Issue; Fail-Safe Problem; Protective Measures Problem

  DURING USER VALIDATION TESTING OF THE QIF BLOOD AND FLUID WARMER BASE UNIT AND COMPACT DISPOSABLE UNIT (CDU) BY U.S. AIR FORCE AFMESA, TESTERS RECORDED A HIGH IV FLUID OUTPUT TEMPERATURE OF 75°C (167°F) ON ONE OF THE UNITS. THE OUTPUT TEMPERATURE WAS MEASURED USING A CALIBRATED THERMOCOUPLE. AT THE SAME TIME, THE SUBJECT BASE UNIT DISPLAYED A "MALFUNCTION TOUT 74°C" NOTIFICATION IN ADDITION TO A CONTINUOUS SOUND ALERT. THE TESTERS SUSPECTED THAT THE CDU WAS CAUSING THE HIGH TEMPERATURE PROBLEM AND TESTED IT WITH A DIFFERENT BASE UNIT AND BATTERY USING THE SAME PARAMETERS. THE OUTPUT TEMPERATURE WAS NORMAL AT 38°C. THE SUBJECT BASE UNIT WAS ALSO TESTED WITH A DIFFERENT BATTERY AND CDU. FOR THIS LAST TEST, AS SOON AS THE BASE UNIT WAS TURNED ON TO START THE RUN, THE CDU HOUSING BEGAN TO MELT AND THE TESTERS STOPPED THE TEST.

  Patient problems: No Information

  MAUDE report 7531909 ↗