PlasmaFlow PF0001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850998008003), received between Oct 11, 2023 and Jul 12, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Cycle” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2024Lack of Effect; Lack of Effect

  THE PATIENT SENT A WRITTEN NOTE TO HIS PROVIDER INDICATING THAT HE WAS DIAGNOSED WITH DVT DESPITE USING THE PRODUCT. THE MESSAGE WAS PASSED ON TO MANAMED VIA EMAIL ON 02/14/2024.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19729950 ↗
• MalfunctionJun 21, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  ON MAY 21, 2024, MANAMED RECEIVED REPORT MW5155059 FROM FDA'S MEDWATCH PROGRAM. THE REPORT ALLEGES THAT THE PLASMAFLOW DEVICE FAILED TO ISSUE AN ERROR CODE FOR LOW PRESSURE AND DID NOT TURN OFF OR ALARM WHEN THE CUFF SLIPPED TOWARDS THE ANKLE. ADDITIONALLY, THE REPORT STATES THAT, IN COMPARISON TO AN OLDER MODEL USED 6.5 YEARS AGO, THE SUSPECT DEVICE LACKS THE SEQUENTIAL COMPRESSION VALVE. INSTEAD OF PROVIDING DISTAL-TO-PROXIMAL PROGRESSIVE COMPRESSION, THE CURRENT MODEL INFLATES ALL CUFFS SIMULTANEOUSLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19589802 ↗
• MalfunctionOct 11, 2023No Apparent Adverse Event; No Apparent Adverse Event

  ON 14-SEP-2023, MANAMED RECEIVED NOTIFICATION OF REPORT MW5145189 VIA MEDWATCH. THE FOLLOWING PROBLEM DESCRIPTION WAS PROVIDED IN THAT REPORT: "USING THE PLASMA FLOW DVT PREVENTION DEVICE AND NOTICED IT INFLATED TO BECOME LIKE A TOURNIQUET AND WAS COMPRESSING MY LEG CAUSING ME TO TURN IT OFF. I REFERRED TO THE INSTRUCTIONS PROVIDED THAT SAID IT HAD AN AUDIBLE ALARM WHICH DID NOT WORK. I INFLATED THE DEVICE AGAIN AND IT FAILED TO ALARM A SECOND TIME." NO HEALTH EFFECT WAS REPORTED. THE PROBLEM DESCRIPTION STATES THE DEVICE "INFLATED TO BECOME LIKE A TOURNIQUET", BUT DOES NOT PROVIDE ANY FURTHER DETAIL TO EXPLAIN WHAT THIS MEANS. THE DEVICE IS DESIGNED TO INFLATE AND APPLY 55MMHG PRESSURE TO THE PATIENT'S LIMB. THE PROBLEM DESCRIPTION ALSO STATES THAT THE AUDIBLE ALARM DID NOT WORK. THE ALARM IS DESIGNED TO GO OFF ONLY IF THE BATTERY IS LOW OR IF THE DEVICE FAILS TO INFLATE. NEITHER OF THESE CONDITIONS APPEAR TO HAVE BEEN PRESENT IN THIS SITUATION SO THE ALARM SHOULD NOT HAVE GONE OFF. BECAUSE THE REPORTER CHOSE TO REMAIN ANONYMOUS, WE ARE UNABLE TO INTERVIEW THEM OR GET THE DEVICE BACK FOR ANALYSIS. WE ARE THEREFORE UNABLE TO CONFIRM THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17914658 ↗
• MalfunctionOct 11, 2023Failure to Cycle; Failure to Cycle

  ON 24-AUG-2023, MANAMED RECEIVED NOTIFICATION OF REPORT MW5120348 VIA MEDWATCH. THE FOLLOWING PROBLEM DESCRIPTION WAS PROVIDED IN THAT REPORT: "PLASMAFLOW SCD, (SEQUENTIAL DEVICE) ON PATIENTS LEFT LOWER EXTREMITY FAILED TO DEFLATE FOR THE ENTIRE SIX HOUR 50 MINUTE PROCEDURE. THIS WAS DISCOVERED IN POST OP AFTER PATIENT AWOKE AND MENTIONED LEFT CALF PAIN. SCD WAS TURNED OFF BUT REMAINED INFLATED. SCD WAS REMOVED AND PATIENT WAS ASSESSED BY ANESTHESIA MD AND NURSING TEAM. OUT OF ABUNDANCE OF CAUTION PATIENT WAS TRANSFERRED TO ACUTE CARE HOSPITAL EMERGENCY DEPARTMENT TO RULE OUT COMPARTMENT SYNDROME. REFER TO ADDITIONAL DOCUMENTS IN I2K." THE ORIGINAL REPORT CLAIMED A SERIOUS INJURY AND CITED THE HEALTH EFFECT AS 1994: PAIN. DESPITE REPEATED REQUESTS, THE ORIGINAL REPORTING PARTY HAS REFUSED TO RETURN THE DEVICE, ALLOW ANALYSIS OF THE DEVICE, OR ALLOW US TO INTERVIEW WITNESSES TO THE EVENT. WE ARE THEREFORE UNABLE TO CONFIRM OR REPRODUCE THE REPORTED ERROR, OR TO PERFORM ANY MEANINGFUL INVESTIGATION INTO ITS CAUSE. ALTHOUGH WE DO NOT HAVE ADDITIONAL INFORMATION AT THIS TIME, WE ARE SUBMITTING THIS REPORT AS REQUIRED BY 21 CFR PART 803.

  Patient problems: Pain

  MAUDE report 17914549 ↗