Quattro, Japan, Final Packaged Kit (Applause) IC-4593Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00849111050050), received between May 16, 2016 and Jun 7, 2019 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2019Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem

  DURING PATIENT USE, THE USER OBSERVED DECREASING SALINE VOLUME IN THE SALINE BAG. THE USER WAS UNABLE TO IDENTIFY THE LOCATION OF THE LEAK. REPLACED BOTH THE START-UP KIT (SUK) AND THE QUATTRO CATHETER TO CONTINUE THE TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8679454 ↗
• MalfunctionJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 44-YEAR-OLD POST-CARDIAC ARREST SYNDROME (PCAS) FEMALE PATIENT WAS ADMITTED FOR THREE DAYS FOR IVTM THERAPY FROM (B)(6), 2018. ZOLL QUATTRO CATHETER (LOT 81006) WAS PLACED IN PATIENTS LEFT FEMORAL VEIN WITHOUT ISSUE. NO PRIOR ADJUNCT PROCEDURES WERE PERFORMED. FIVE DAYS (B)(6) 2018), AFTER THE IVTM THERAPY WAS COMPLETED; DVT (DEEP-VEIN THROMBOSIS) WAS DETECTED IN INFERIOR VENA CAVA ON AN ABDOMINAL ECHO; HOWEVER, THE PATIENT WAS NOT IN A HIGH-RISK CATEGORY FOR DVT. PER PHYSICIAN, THE PATIENT HAD BEEN MONITORED FOR SIX DAYS WITHOUT DVT TREATMENTS DUE TO THE HEMOPTYSIS (COUGHING UP OF BLOOD) AND HAD A BLEEDING TENDENCY. THE CAUSE OF THE HEMOPTYSIS IS UNKNOWN. THERE WERE NO MEDICATIONS PROVIDED FOR THE HEMOPTYSIS TREATMENT. BASED ON THE CONSENT FROM THE PATIENT'S FAMILY, PHYSICIAN DECIDED TO WAIT BEFORE TAKING ANY ACTION. FOLLOWING THIS, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE PATIENT'S CURRENT STATE. THE QUATTRO CATHETER WAS DISPOSED BY THE CUSTOMER AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Thrombosis

  MAUDE report 8241176 ↗
• MalfunctionMay 22, 2018Leak/Splash; Device Issue; Leak/Splash; Device Issue

  THE PATIENT WAS INSERTED A QUATTRO CATHETER AND RECEIVED IVTM THERAPY. ON DAY 2, THE CLINICAL ENGINEER OBSERVED THAT THE FLUID LEVEL ON THE SALINE BAG WAS LOW. UPON INSPECTION, NO SIGNS OF LEAK ON THE SUK, THERMOGARD CONSOLE AND ON PATIENT BEDSIDE WAS OBSERVED. NO ALARM ON THE CONSOLE WAS OBSERVED. BLOOD ON THE CATHETER TUBING WAS OBSERVED. A CATHETER LEAK IS SUSPECTED. IVTM THERAPY WAS DISCONTINUED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7535467 ↗
• InjuryApr 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) AT 09:36, A (B)(6) MALE LOST CONSCIOUSNESS AND WENT INTO CARDIAC ARREST DURING EXERCISE ACTIVITY. BYSTANDER CPR AND AED WERE ADMINISTERED WHILE WAITING FOR THE EMERGENCY RESPONSE TEAM. DURING TRANSPORT TO HOSPITAL, THE PATIENT'S CIRCULATION RETURNED, BUT PATIENT'S STATE OF CONSCIOUSNESS WAS POOR. THE PATIENT WAS THEN TRANSFERRED TO (B)(6) AND WAS ADMITTED AT 16:28. THE PATIENT'S GCS AT THE TIME OF HOSPITALIZATION WAS 1-1-4 AS AN UNSPECIFIED SEDATIVE AGENT WAS ADMINISTERED AT THE PREVIOUS HOSPITAL. AT 17:25, A ZOLL QUATTRO CATHETER WAS INSERTED IN THE PATIENT AND THE HYPOTHERMIA TREATMENT WAS STARTED. TARGET TEMPERATURE WAS SET AT 34 DEGREE CELSIUS AND REWARMING AT TARGET TEMPERATURE OF 1 DEGREE CELSIUS PER DAY. NO ANTICOAGULATION TREATMENT WAS GIVEN DUE TO PATIENT'S HEMORRHAGIC TENDENCY (APTT AT 53 SECONDS). ON (B)(6), IVTM TREATMENT ENDED AS SCHEDULED. ON (B)(6) AT 12:00, FEVER WAS OBSERVED AND INFECTION WAS SUSPECTED. THE PATIENT'S BLOOD AND THE QUATTRO CATHETER WERE TESTED. RESULTS SHOWED GRAM-POSITIVE (+) COCCI DETECTED. ANTIBIOTICS WERE ADMINISTERED. ON (B)(6), ECHOCARDIOGRAPHIC EXAMINATION WAS PERFORMED. A CASE OF INFERIOR VENA CAVA THROMBOSIS WAS CONFIRMED AND THE

  Patient problems: Bacterial Infection; Thrombosis

  MAUDE report 6490830 ↗
• MalfunctionOct 3, 2016Leak/Splash; Leak/Splash

  THE SITE REPORTED; QUATTRO CATHETER WAS INSERTED IN THE PATIENT FOR THE PURPOSE OF TREATING POST CARDIAC ARREST. IT WAS NOTICED A WHILE LATER THAT THE SALINE LEVEL WAS LOW. THE OPERATION OF A THERMOGARD WAS SUSPENDED AND THE CATHETER WAS REMOVED. A NEW QUATTRO CATHETER WAS INSERTED IN THE PATIENT AND THE THERMOGARD WAS RESTARTED. WITH THE SECOND CATHETER, THE SALINE LEVEL DID NOT DECREASE. TREATMENT WAS CONTINUED. THERE IS NO HEALTH INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5995587 ↗
• MalfunctionMay 16, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PATIENT USE OF THE COOLGARD IVTM SYSTEM AND QUATTRO CATHETER A POSSIBLE CATHETER LEAK WAS OBSERVED. A FEMALE PATIENT, (B)(6), WAS HOSPITALIZED FOR CARDIAC ARREST. HER CLINICAL SYMPTOMS WERE PROBLEMS WITH MAINTAINING BODY TEMPERATURE, PRIOR TO CARDIAC ARREST, THEREFORE THEY HAD PLACED A BAIR HUGGER DEVICE OVER HER. SHE HAD ACUTE LIVER DISEASE, CONTINUOUS RENAL REPLACEMENT THERAPY AND COAGULOPATHIES (INR 3). THE PATIENT ALSO HAD A MEDICAL HISTORY THAT INCLUDED LUPUS AND CHRONIC KIDNEY DISEASE. THE PATIENT WAS TO BE TREATED FOR TEMPERATURE MANAGEMENT USING THE COOLGARD IVTM SYSTEM. THE QUATTRO CATHETER WAS PLACED IN HER LEFT FEMORAL VEIN BY AN EXPERIENCED PHYSICIAN. THE INSERTION WAS SMOOTH AND ONLY ONE ATTEMPT WAS MADE. THE ROOM TEMPERATURE WAS 30 DEGREES CELSIUS. THE IVTM WAS SET TO MAX RATE OF COOLING/WARMING. THE SET TEMPERATURE POINT WAS 37 DEGREES CELSIUS. THE PATIENT'S TEMPERATURE BEFORE STARTING THE TREATMENT WAS 35 DEGREES CELSIUS AND THE DESIRED TEMPERATURE WAS 37 DEGREES CELSIUS. A SEPARATE CATHETER (VAS CATH - VENOUS CATHETER USED FOR DIALYSIS) WAS IN USE, LINE, WHICH WAS PLACED IN THE LIJ (LEFT INTERNAL JUGULAR VEIN. THE NURSE ON DUTY ENTERED T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5658198 ↗