inforMED
InjuryJOW

ARJO HUNTLEIGH FLOWTRON ACS 900 DVT PUMP SEQUENTIAL COMPRESSION DEVICE

Received Mar 10, 2023 · Event occurred Jan 17, 2023

Report MW5115706 · MDR key 16530894

Device

Generic name

Sleeve, Limb, Compressible

Model number

526000-01

Product problems

  • No Audible Alarm
  • Calibration Problem
  • Therapeutic or Diagnostic Output Failure

Patient

86 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

HOSPITAL CAMPUS UNDERWENT A CONVERSION OF ITS SCD (SEQUENTIAL COMPRESSION DEVICE) PUMPS. SINCE THAT TIME THERE HAVE BEEN MULTIPLE PUMP/DEVICE FAILURES REPORTED. THE PURPOSE OF THE SCD IS TO PROVIDE DVT PROPHYLAXIS. WE ARE NOT AWARE OF ANY PATIENT HARM EVENTS RELATED TO SCD FAILURES. DEVICE: ASC 900 SERIES ARJO INITIAL PUMP CONVERSION OCCURRED IN (B)(6) 2022. IN SEPTEMBER THE ARJO REP WAS ONSITE FOR 3 DAYS ROUNDING ON NURSING UNITS; A TRAINING VIDEO, AND 1 PAGE QRG WERE PROVIDED. IT WAS STATED THAT THERE SHOULD BE NO MAJOR PROCESS CHANGES WITH THE NEW PUMP CONVERSION. BEGINNING IN (B)(6) 2022, UNITS ACROSS THE HOSPITAL BEGAN HAVING DIFFICULTY WITH THE PUMPS (INABILITY TO PROVIDE THERAPY AND NO ALARMS ALERTING STAFF TO PROBLEMS); A TROUBLESHOOTING GUIDE WAS DISTRIBUTED HOUSE WIDE AT THAT TIME. IN (B)(6) 2023, CONCERNS WERE RAISED AS MULTIPLE UNITS ACROSS THE MINISTRY WERE EXPERIENCING FUNCTIONAL PROBLEMS. THE MINISTRY RESOURCE GROUP REACHED OUT TO ARJO REP TO REPORT THE ISSUES EXPERIENCED, AND THE REP INDICATED THAT THERE WERE OTHER FACILITIES EXPERIENCING SIMILAR PROBLEMS WITH FAULTY UNITS. ARJO ACS 900 REPS DID COME ON-SITE. THEY BROUGHT IN AN ENGINEER AND SOME OTHERS TO DO EDUCATION. THE ENGINEER CHECKED MANY UNITS AND CONCLUDED ABOUT HALF OF THE PROBLEMS ARE DUE TO CALIBRATION AND THE OTHERS ARE DUE TO COMPLIANCE ISSUES. THE COMPLIANCE ISSUE IS WHEN THE SLEEVE IS PUT ON A PATIENT AND IS NOT TIGHT, THE INDICATOR SHOWS THE MACHINE IS MALFUNCTIONING WHEN ALL THAT IS NEEDED IS THE SLEEVE TO BE SNUG ON THE PATIENT. THEREFORE, THE CALIBRATION ISSUES (MULTIPLE) ARE THE REASON FOR THIS VOLUNTARY REPORT. NO PLACE TO PUT THE MULTIPLE SERIAL NUMBERS IN THIS REPORT SO THEY ARE: (B)(4). PATIENT WAS A PRIME CANDIDATE TO RECEIVE THE SCD PUMP. TO OUR KNOWLEDGE, NO PATIENTS WERE HARMED BY THIS CAMPUS WIDE ISSUE. REFERENCE REPORT #MW5115703, #MW5115704 AND #MW5115705.