CBCII ConstaVac 0225426000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540867698), received between Oct 23, 2018 and Jul 26, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

• MalfunctionJul 26, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT WHEN A NURSE INSERTED A FILTER SPIKE INTO THE BLOOD BAG, THE TIP OF SPIKE PENETRATED THE BLOOD BAG. 500- 600 ML OF BLOOD WAS LOST FROM THE BAG. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL BLOOD. THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8833712 ↗
• MalfunctionDec 10, 2018Inadequate Filtration Process; Inadequate Filtration Process

  THE USER FACILITY REPORTED THAT AN IMPROPER BLOOD INFUSION FILTER WAS USED WITH THE DEVICE FOUND AFTER A TRANSFUSION PROCEDURE. THERE WAS NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8148996 ↗
• MalfunctionDec 5, 2018Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT THE DEVICE STOPPED WORKING AFTER BLOOD WAS COLLECTED FROM THE PATIENT DURING A PROCEDURE. IT IS UNKNOWN HOW MUCH BLOOD WAS COLLECTED BUT THE PATIENT DID NOT REQUIRE ANY ADDITIONAL BLOOD. THERE WAS NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8135673 ↗
• MalfunctionOct 23, 2018Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT DURING A RE-TRANSFUSION PROCEDURE, WHEN A NURSE INSERTED A SPIKE OF THE BLOOD INFUSION FILTER, THE TIP OF SPIKE PENETRATED THE BLOOD BAG FROM THE INSIDE. IT IS UNKNOWN HOW MUCH BLOOD WAS LEAKED FROM THE BAG BUT IT WAS A SMALL AMOUNT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL BLOOD OR BAGGED BLOOD. THERE WAS NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7997268 ↗