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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00699753270152), received between Feb 10, 2023 and Nov 15, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Disconnection” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2024Leak/Splash; Leak/Splash

  THERE WAS NO DELAY IN BEGINNING OR CONTINUING THE SURGICAL PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20696696 ↗
• InjuryFeb 10, 2023Disconnection; Disconnection

  THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, THE H/S DISCONNECT AT CUVETTE. AS PER THE USER FACILITY, DURING BYPASS, THE CDI MONITORED DISPLAYED AN H/S DISCONNECT AT CUVETTE MESSAGE. THE CUVETTE WAS DISCONNECTED AND RECONNECTED SEVERAL TIMES BUT THE MESSAGE REMAINED. IT DISAPPEARED AT THE END OF THE CASE WHEN THE MONITOR WAS SWITCHED ON AND OFF. THE CASE WAS CONDUCTED WITHOUT THE USE OF THE CUVETTE. ADDITIONALLY, THE LACTATE DID PEAK AT 3.6MMOL/L, THE VENOUS SATURATIONS AND DO2 WAS NOT MEASURED DURING THE MALFUNCTION. AN INTERMITTENT VENOUS BLOOD GASES WERE DONE DURING THE CASE AND THERE WAS ALSO AN ELEVATED LACTATE; SINCE THERE WAS NO CONTINUOUS HB READING, THE PATIENT WAS TRANSFUSED A 2ND UNIT OF RBCS. THE PRODUCT MALFUNCTION DID NOT LEAD TO ANY APPARENT HARM. *PRODUCT WAS NOT CHANGED OUT. *PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16350125 ↗

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