ICU Medical 42646-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00840619028053), received between Oct 26, 2016 and Aug 21, 2024 — classified as 1 death, 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2024Break; Break

  AN EVENT INVOLVING A TRANSPAC® IV MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLING PORTS, 84" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT) EXPERIENCED BREAKAGE. IT WAS REPORTED THAT THE CUSTOMER HAD A FAULTY TUBING. THE EVENT WAS NOTED ON 22-JUL-2024. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND UNKNOWN HUMAN HARM. IT WAS REPORTED THAT THE PRODUCT HAD A BROKEN ART LINE KIT. UPDATE: IT WAS NOTED THAT THERE WERE NO VISIBLE DEFECTS SEEN PRIOR TO THE BRAKEAGE. THERE WAS PATIENT INVOLVEMENT, NO HUMAN HARM, AND THERE WAS DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20017343 ↗
• InjuryJun 28, 2024Break; Break

  THE EVENT INVOLVED A TRANSPAC IV MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLING PORTS, 84" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT) WHERE THE CUSTOMER REPORTED THAT THE DEVICE HAD A "BROKEN ART LINE KIT". THE PATIENT WAS FOUND BLEEDING PROFUSELY ON HIS ARM. NO INTERVENTION WAS REPORTED. NO OTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19635429 ↗
• MalfunctionJul 13, 2023Material Separation; Material Separation

  THE EVENT INVOLVED A TRANSPAC® IV MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLING PORTS, 84" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT).IT WAS REPORTED THAT THE TUBING HAS BEEN DISCONNECTED FROM THE SOURCE AND IT WAS DETECTED BY THE NURSE RIGHT AWAY. THE TUBING WAS HOOKED UP TO A CENTRAL LINE FOR CENTRAL VENUS PRESSURE MONITORING AND CAME APART. THE TUBING WAS PROPERLY SECURED WITH A LINE HOLDER ABOUT 10 MINUETS PRIOR, THE PRESSURE TUBING WAS USED FOR A BLOOD DRAW FROM CENTRAL VENUS LINE WITHOUT ANY ISSUE. LAB CAME BACK AND NEEDED ADDITIONAL BLOOD AND THE PATIENT WAS NOT REPOSITIONED AND THE TUBING WAS NOT TOUCHED SINCE THE PAST DRAW AND NEEDED ADDITIONAL BLOOD AND THE PATIENT WAS ALSO NOT REPOSISTIONED. WHEN THE VAMP WAS LIFTED OFF THE BED, A PORTION OF THE TUBING CAME APART WITH VERY LITTLE FORCE. A SMALL PORTION OF THE PRESSURE TUBING WAS LEFT ATTACHED TO THE CVL AND THE TUBING WAS IMMEDIATLEY CLAMPED PROXIMAL TO THE PATIENT. THE TUBING WAS UNHOOKED FROM THE CVL. THE TUBING WAS NOT RIPPED AND THE END DUD NOT HAVE A LUER LOCK OR ANY ATTACHMENT WHERE IT COULD BE INTENTIONALLY DISCONNECTED. THE TUBING SEEMED ABNORMALLY WEAK THERE WAS PATIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17318330 ↗
• MalfunctionApr 1, 2022Material Separation; Material Separation

  THE EVENT INVOLVED A TRANSPAC® IV MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLING PORTS, 84" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT). IT WAS STATED THAT THE A-LINE SEPARATED IN HALF DURING A PROCEDURE. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO HUMAN HARM AND NO DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13980787 ↗
• MalfunctionMar 29, 2022Material Separation; Material Separation

  THE EVENT INVOLVED A TRANSPAC® IV MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLING PORTS, 84" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT) IN WHICH THE CUSTOMER REPORTED THAT THE ARTERIAL SYRINGE BECAME SEPARATED FROM THE RUBBER. THE EVENT HAPPENED DURING PROCEDURE ON A PATIENT. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO HARM WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13941160 ↗
• DeathDec 11, 2020Break; Break

  THE EVENT INVOLVED A TRANSPAC IV MONITORING KIT THAT THE CUSTOMER REPORTED THE TRANSPAC BROKE AT THE CONNECTION OF THE SAFESET AND THE TUBING NEAR THE WHITE ONE WAY STOPCOCK DURING PATIENT USE. SOMEONE BECAME AWARE OF THE ISSUE SINCE THE PATIENT BLED OUT FROM A MAJOR ARTERY. THE CUSTOMER WAS UNABLE TO QUANTIFY THE BLOOD LOSS. THE PATIENT WAS A COVID POSITIVE PATIENT. THE CUSTOMER STATED THE BREAK HAPPENED DURING A CODE. PRESSURE WAS HELD AT THE SITE AND IMMEDIATELY CHANGED OUT TO ANOTHER SET. THE CUSTOMER STATED THERE WERE NO OTHER MEDICAL INTERVENTIONS REQUIRED RELATED TO THE TUBING BREAK. THE CUSTOMER REPORTED THE PATIENT DECEASED ON A UNSPECIFIED DATE. THE CUSTOMER DECLINED TO PROVIDE ADDITIONAL INFORMATION UPON FOLLOW-UP.

  Patient problems: Blood Loss

  MAUDE report 10990734 ↗
• MalfunctionAug 9, 2017Leak/Splash; Leak/Splash

  COMPLAINT RECEIVED REGARDING ONE 42646-06, TRANSPAC IV MONITORING KIT. REPORT STATES: PATIENT HAD L. FEMORAL ARTERIAL LINE THAT BROKE OFF AT 3-WAY STOPCOCK, WHERE THE TUBING FITS INTO THE LUER. PRESSURE BAG BECAME INEFFECTIVE. CLAMPED OFF THE LINE AND REPLACED IT WITH A NEW ARTERIAL LINE WITH NO FURTHER ISSUES. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6778249 ↗
• MalfunctionOct 26, 2016Detachment Of Device Component; Device Inoperable

  ARTERIAL LINE SAFESET SYRINGE PLUNGER CAME APART AND WAS NON-FUNCTIONAL. BLACK ROBBER STOPPER WAS DETACHED FROM SYRINGE. BLOOD WAS BACKED UP IN THE SYRINGE AND UNSURE IF AIR WAS PRESENT. SAFESET CHANGED. NO HARM TO PT. ALSO NOTED IN OTHER SAFESETS THAT THE RUBBER SLEEVE INSIDE THE SYRINGE DETACHED FROM ITS ANCHOR POINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6063184 ↗