Hemocor HPH HPH JuniorRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00677964000867), received between Sep 19, 2018 and Aug 5, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 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.

• MalfunctionAug 5, 2021Leak/Splash; Leak/Splash

  A MEDIVATORS DISTRIBUTOR OF BLOOD FILTERS, REPORTED THAT A FILTER LEAK OCCURRED DURING USE WHICH RESULTED IN APPROXIMATELY 20ML OF PATIENT BLOOD LOSS. AS THE PATIENT WAS PEDIATRIC, AN ERYTHROCYTE TRANSFUSION WAS PERFORMED. NO FURTHER MEDICAL INTERVENTION OR ADVERSE EFFECT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12284836 ↗
• InjurySep 19, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4), DISTRIBUTOR OF HEMOCOR HEMOCONCENTRATORS, REPORTED ON BEHALF OF A USER FACILITY THAT WHILE USING A HPH JUNIOR HEMOCONCENTRATOR DURING A BYPASS PROCEDURE, A PEDIATRIC PATIENT LOST LESS THAN 10 ML OF BLOOD. THE BLOOD LOSS WAS REPORTED TO BE DUE TO A LEAK OUT OF THE HEADER CAP. THERE WERE NO ADVERSE EFFECTS AS A RESULT OF THE REPORTED COMPLAINT.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7891581 ↗