Cardiovascular Procedure Kit 77368Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00699753513235), received between Jan 13, 2021 and Jan 26, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2021Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED THAT THEY HAD REPLACED THE PACK HEMOCONCENTRATOR WITH A SINGLE STERILE HEMOCONCENTRATOR. DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, A 'RED TINGE' WAS OBSERVED IN THE HEMOCONCENTRATOR EFFLUENT. THE PRODUCT WAS NOT CHANGED OUT AND SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY REPORTED, NO BLOOD LOSS AND NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11228908 ↗
• MalfunctionJan 13, 2021Device Handling Problem; Device Handling Problem

  THE CUSTOMER REPORTED THAT DURING CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE PACK EXHIBITED VARYING LEVELS OF HEMOLYSIS, A 'PINK TINGE' TO THE HEMOCONCENTRATOR EFFLUENT. THE TEAM PRIMED THEIR CPB CIRCUIT AND RECIRCULATED AS PER THEIR NORMAL PROCESS AND ADDED THE PACKED RED BLOOD CELLS (PRBC) TO THE SYSTEM AFTER WHICH, IT WAS NOTED, THERE WAS RED EFFLUENT FROM THE HEMOCONCENTRATOR. THE CIRCUIT WAS UTILIZED IN THE CARDIOPULMONARY BYPASS SURGERY AND ONCE ON BYPASS THEY CUSTOMER COMMENTED THAT THE RED EFFLUENT EVENTUALLY CLEARED UP. THE PRODUCT WAS NOT CHANGED OUT AND SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY REPORTED, NO BLOOD LOSS AND NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Hemolysis; No Known Impact Or Consequence To Patient

  MAUDE report 11159353 ↗
• MalfunctionJan 13, 2021Device Handling Problem; Device Handling Problem

  THE CUSTOMER REPORTED THAT DURING CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE PACK EXHIBITED VARYING LEVELS OF HEMOLYSIS, A 'PINK TINGE' TO THE HEMOCONCENTRATOR EFFLUENT. THE TEAM PRIMED THEIR CPB CIRCUIT AND RECIRCULATED AS PER THEIR NORMAL PROCESS AND ADDED THE PACKED RED BLOOD CELLS (PRBC) TO THE SYSTEM AFTER WHICH, IT WAS NOTED, THERE WAS RED EFFLUENT FROM THE HEMOCONCENTRATOR. THE CIRCUIT WAS UTILIZED IN THE CARDIOPULMONARY BYPASS SURGERY AND ONCE ON BYPASS THEY CUSTOMER COMMENTED THAT THE RED EFFLUENT EVENTUALLY CLEARED UP. THE PRODUCT WAS NOT CHANGED OUT AND SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY REPORTED, NO BLOOD LOSS AND NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Hemolysis; No Known Impact Or Consequence To Patient

  MAUDE report 11159320 ↗
• MalfunctionJan 13, 2021Device Handling Problem; Device Handling Problem

  THE CUSTOMER REPORTED THAT DURING CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE PACKS EXHIBITED VARYING LEVELS OF HEMOLYSIS, A 'PINK TINGE' TO THE HEMOCONCENTRATOR EFFLUENT. THE TEAM PRIMED THEIR CPB CIRCUIT AND RECIRCULATED AS PER THEIR NORMAL PROCESS AND ADDED THE PACKED RED BLOOD CELLS (PRBC) TO THE SYSTEM AFTER WHICH, IT WAS NOTED, THERE WAS RED EFFLUENT FROM THE HEMOCONCENTRATOR. THE CIRCUIT WAS UTILIZED IN THE CARDIOPULMONARY BYPASS SURGERY AND ONCE ON BYPASS THE CUSTOMER COMMENTED THAT THE RED EFFLUENT EVENTUALLY CLEARED UP. THE PRODUCT WAS NOT CHANGED OUT AND SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY REPORTED, NO BLOOD LOSS AND NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Hemolysis; No Known Impact Or Consequence To Patient

  MAUDE report 11159244 ↗