HAEMONETICS ORTHOPAT SYSTEM 1150H-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10812747017145), received between Jul 18, 2018 and Jul 18, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2018Component Missing; Component Missing

  ON (B)(4) 2018 HAEMONETICS RECEIVED A REPORT OF AN INCIDENT IN WHICH THE CUSTOMER WAS UNABLE TO RETURN BLOOD TO A PATIENT AFTER COLLECTING SALVAGED BLOOD IN THE ORTHOPAT RESERVOIR. BASED ON INFORMATION PROVIDED BY THE HOSPITAL, THE PATIENT WAS UNDERGOING SURGERY TO CORRECT A BROKEN FEMUR. BASED UPON PHOTOGRAPHS PROVIDED, IT IS ESTIMATED THAT APPROXIMATELY 600ML OF SALVAGED BLOOD WAS WITHIN THE RESERVOIR. UPON INSPECTION, THE CUSTOMER IDENTIFIED THAT THERE WAS A MISSING CANNULA COMPONENT WITHIN THE RESERVOIR. THE MISSING CANNULA WAS PREVENTING THE COLLECTED BLOOD FROM BEING DRAWN OUT OF THE RESERVOIR TO BE WASHED AND TRANSFUSED BACK TO THE PATIENT. FOLLOW UP WITH THE HOSPITAL INDICATED THAT THE PATIENT DID NOT REQUIRE AN ALLOGENIC BLOOD TRANSFUSION, HOSPITAL STAFF ESTIMATED THE TOTAL BLOOD LOSS TO BE APPROXIMATELY 450ML.

  Patient problems: Blood Loss

  MAUDE report 7699540 ↗