CDI™ H/S Cuvette 1/4 x 1/4 - Japan CV-6914Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00699753270138), received between Sep 13, 2019 and May 24, 2023 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 24, 2023Leak/Splash; Leak/Splash

  LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16996667 ↗
• InjuryMay 24, 2023Leak/Splash; Leak/Splash

  LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16995480 ↗
• MalfunctionMay 31, 2022Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, BLOOD BEGAN TO LEAK FROM THE SIDE OF THE CUVETTE. PER FACILITY, WHEN THE CUVETTE WAS NOT CONNECTED TO THE H/S PROBE, THERE WAS NO BLOOD LEAKAGE. THE PROCEDURE WAS CONTINUED WITHOUT CONNECTING THE CUVETTE TO THE H/S PROBE AND SUCCESSFULLY COMPLETED. THE CUVETTE WAS INCORPORATED IN A CARDIOPULMONARY CIRCUIT MANUFACTURED BY TECHNOWOOD. THE PRODUCT WAS NOT CHANGE OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH UNKNOWN AMOUNT OF BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14549782 ↗
• DeathJul 16, 2020Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), BLOOD LEAKAGE FROM THE CUVETTE WAS OBSERVED. ON (B)(6) 2020 AROUND NOON, ECMO WAS STARTED. ON (B)(6) 2020 AT 10:50AM, THE CIRCUIT WAS CHANGED AND THE REPORTED CUVETTE WAS USED. ON (B)(6) 2020 AT 9AM, AIR WAS OBSERVED IN THE UPPER PART OF THE LUNG. AFTER AIR WAS REMOVED, THERE WAS STILL AIR IN THE LUNG. THEN, BLOOD LEAKAGE FROM THE CUVETTE WAS OBSERVED, IT WAS CHANGED OUT AND NO OTHER BLOOD LEAK WAS OBSERVED. THE CUVETTE HAD BEEN USED FOR 22 HOURS ON ECMO PRIOR TO THE UNIT PRESENTING A LEAK. A SOLUTION CALLED INTRALIPOS WAS ADMINISTERED FROM THE LEFT GROIN USING V-VECMO WITH VENOUS LINE FROM THE LEFT INTERNAL CAROTID ARTERY AND ARTERIAL LINE FROM THE RIGHT GROIN. THE PATIENT HAD LEUKEMIA AND DEVELOPED PULMONARY FAILURE. MECHANICAL VENTILATOR AND ECMO WERE INITIATED. IT WAS PLANNED THAT THE PATIENT WOULD BE TRANSFERRED FOR LUNG TRANSPLANTATION. HOWEVER; BEFORE TRANSFER HAPPENED, CEREBRAL EDEMA, CEREBRAL HEMORRHAGE AND BRAIN TUMOR OCCURRED, AND EVENTUALLY THE PATIENT EXPIRED. PRODUCT WAS CHANGED OUT. BLOOD LOSS OF A FEW ML. PROCEDURE WAS COMPLETED SUCCESSFULLY; HOWEVER, THE PATI

  Patient problems: Blood Loss; Death

  MAUDE report 10282279 ↗
• InjurySep 13, 2019Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING USE IN AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT LEAKAGE FROM THE CUVETTE WAS OBSERVED. THE CIRCUIT WAS SUSPENDED IN ORDER TO REPLACE THE CUVETTE WITH A BACKUP CUVETTE TO CONTINUE THE PROCEDURE. HOWEVER, LEAKAGE WAS OBSERVED AGAIN WHEN THE PROBE WAS CONNECTED TO THE CUVETTE. WHEN THE PROBE WAS DETACHED FROM THE CUVETTE, LEAKAGE STOPPED. THE MANUFACTURER WAS PROVIDED WITH THE INFORMATION THAT THE PATIENT WAS AN INFANT, BUT NO DEMOGRAPHICS WERE PROVIDED. THERE WAS LESS THAN 30ML BLOOD LOSS. PRODUCT WAS CHANGED OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Blood Loss

  MAUDE report 9050153 ↗

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-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-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-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