Quantum QSOR (REF 51-000074-00)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05060434421944), received between Dec 9, 2024 and Feb 12, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Unintended Movement

  THE CUSTOMER REPORTED A SUDDEN LOCKING OF THE VENOUS OCCLUDER; AND THAT OPENING THE OCCLUDER WAS NOT POSSIBLE. THE CUSTOMER HAD TO OPEN THE OCCLUDE IN A MANUAL WAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320428 ↗
• MalfunctionJan 29, 2025Activation Failure; Activation Failure

  LOANER OCCLUDER THAT WAS SENT IN RESPONSE TO FON #(B)(6) STOPPED RESPONDING TO OPEN/CLOSE COMMANDS FROM THE QWS. REPORTEES ARE UNSURE IF THERE WAS A "NO OCCLUDER LOCATION" MESSAGE AT THE TIME OF THIS EVENT. THE OCCLUDER WAS ALSO REPORTED TO "EVENTUALLY START WORKING" AGAIN. ISSUE OCCURED APPROX. 1000 PRIOR TO A CASE. RECOMMENDATION WAS GIVEN TO TRY A NEW CABLE AND THEN A NEW PORT ON THE FRAME IF THE CABLE WAS DAMAGED FROM THE FRAME. NO FURTHER INFORMATION. SAME REP CONTACTED AGAIN AROUND 1700 STATING AS BIOMED ATTEMPTED TO DOWNLOAD LOGS FOR THE ISSUE ABOVE, ONLY THE QWS WOULD BOOT UP AND NOT THE REST OF THE SUBMODULES. REST OF THE PUMP WAS TURNED ON VIA THE SOLARIS POWER BUTTON BUT PUMP MANAGER WAS NOT PRESENT. SAP CABLE WAS UNPLUGGED FROM THE QWS AND REPLUGGED IN BUT PUMP MANAGER WAS STILL NOT PRESENT. QWS WAS THEN TURNED OFF WITH A LONG PRESS, THEN SAP CABLE UNPLUGGED AGAIN AND REPLUGGED IN. UPON BOOT UP PUMP MANAGER CAME BACK. MEDTRONIC REP WAS ON FACETIME WITH BIOMED AND VERIFIES THAT SOLARIS WAS PLUGGED INTO THE WALL DURING THIS TIME. HE ALSO SENT A PICTURE OF A QWS WITH A GREEN POWER LED IN THE BOTTOM RIGHT INSTEAD OF BLINKING BLUE, SUGGESTING THAT THE HLM WAS PLUGGED INTO TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264089 ↗
• MalfunctionDec 9, 2024Obstruction of Flow; Obstruction of Flow

  VENOUS OCCLUDER ENGAGED DURING A CASE WITH A PATIENT WHEN NOT ACTIVATED. PERFUSIONIST MANUALLY RELEASED THE CLAMP. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878470 ↗