CDI™ H/S Cuvette 3/8 x 3/8 - Japan CV-6913Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00699753270121), received between Mar 2, 2020 and Aug 12, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

4 other recalls cover devices cleared under the same FDA submission (K133658); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2022Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR DURING PRIME, WHEN THE CIRCULATION WAS STOPPED AFTER PRIMING, A LEAKAGE OF PRIMING SOLUTION WAS NOTED AROUND THE CUVETTE. IT IS UNKNOWN IF THERE WAS ANY EFFECT ON THE PATIENT OR RESULTS OF THE SURGERY. DUE TO THE UNKNOWN INFORMATION FOR THIS EVENT, IT IS BEING REPORTED. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY. PRODUCT WAS CHANGED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15220658 ↗
• MalfunctionAug 12, 2022Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR DURING CARDIOPULMONARY BYPASS, THERE WAS A BLOOD LEAKAGE. IT IS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE, WHETHER THE PRODUCT WAS CHANGED OUT, OR THE SURGERY WAS COMPLETED SUCCESSFULLY AND IF THERE WAS ANY EFFECT ON THE PATIENT OR RESULTS OF THE SURGERY. DUE TO THE UNKNOWN INFORMATION FOR THIS EVENT, IT IS BEING REPORTED. TERUMO CONTINUES TO ATTEMPT TO GAIN MORE INFORMATION REGARDING THIS EVENT FROM THE USER FACILITY. ADDITIONALLY, DURING AUXILIARY CIRCULATION, THE CIRCUIT WAS REPLACED ON JULY 10. THE LEAKAGE FROM THE CUVETTE WAS NOTED AT THE CIRCUIT ON JULY 12. THE SURGEON WAS ADVISED TO REPLACE THE CIRCUIT, BUT IT WAS UNKNOWN WHETHER IT WAS REPLACED DURING THE CIRCULATION. THERE WAS AN UNKNOWN AMOUNT OF BLOOD LOSS.

  Patient problems: Insufficient Information

  MAUDE report 15220331 ↗
• InjuryMar 2, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, A BLOOD LEAK WAS NOTED. PER USER FACILITY THE CUVETTE WAS SET TO A CDI PROBE. WHEN ABOUT ONE HOUR PASSED AFTER THE PROCEDURE STARTED, BLOOD LEAKAGE FROM THE CUVETTE WAS OBSERVED. AFTER THE CDI PROBE WAS REMOVED, A TRANSPARENT TAPE WAS USED TO FIX IT. AFTER THAT, NO BLOOD LEAKAGE OR SUCTION OF BUBBLES WAS OBSERVED, AND THE PROCEDURE WAS CONTINUED. PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) WAS USED IN THE CARDIAC CATHETERIZATION LABORATORY. AFTER THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE ICU, AND THEN A CDI500 SYSTEM WAS USED. THE PATIENT EXPIRED AT A LATER DATE, ON (B)(6) 2020.

  Patient problems: Blood Loss; Injury

  MAUDE report 9776695 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133658. One submission often covers many models, so check the product and lot details in each record.

• Z-2751-2018 · Jun 26, 2018 · Terminated
  Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product Usage: The CDI System 500 provide
• Z-2750-2018 · Jun 26, 2018 · Terminated
  CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure o
• Z-1250-2016 · Mar 14, 2016 · Terminated
  CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuous, on-line monitoring of the extrac
• Z-2742-2015 · Aug 7, 2015 · Terminated
  CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen sa