CARPEDIEM IB7010250Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08051736003652), received between Sep 30, 2021 and Aug 18, 2025 — classified as 3 deaths, 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Display or Visual Feedback Problem; Smoking; Display or Visual Feedback Problem; Smoking

  ACCORDING TO THE REPORTER, AFTER THE MACHINE WAS TURNED ON, THE MACHINE HAD A DISPLAY FAILURE, AND THE CUSTOMER REPORTED A BURNING SMELL AS WELL. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WERE NO LABELING AND/OR PACKAGING ISSUES. THE SERVICE EVENT WAS NOT AN OUT-OF-BOX FAILURE. THERE WERE NO ALARMS ACTIVATED. THERE WAS NO ALLEGED DEFICIENCIES RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF THE PRODUCT DURING THE SERVICE AND REPAIR CALL OR EVENT. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. AS A REMEDIAL ACTION, THE MACHINE WAS PULLED OUT OF USE, AND REPAIR WAS SCHEDULED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22828096 ↗
• MalfunctionAug 11, 2025Display or Visual Feedback Problem; Smoking; Display or Visual Feedback Problem; Smoking

  ACCORDING TO THE REPORTER, DURING CVVHD (CONTINUOUS VENO-VENOUS HEMOFILTRATION AND DIALYSIS) TREATMENT, THE MACHINE'S DISPLAY WENT B LACK, AND THE CUSTOMER REPORTED A BURNING SMELL. NO ALARMS WERE ACTIVATED. THERE WERE NO LABELING AND PACKAGING ISSUES. THE EVENT WAS NOT CONSIDERED LIFE-THREATENING. THERE WAS NO MEDICAL INTERVENTION REQUIRED TO PREVENT PERMANENT HARM OR DEATH. THE TREATMENT WAS INTERRUPTED DUE TO THE EVENT, AND THE BLOOD WAS SUCCESSFULLY RETURNED TO THE PATIENT. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSIONS PERFORMED. THE EVENT DID NOT RESULT IN ANY IMPACT TO THE PATIENT, AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772158 ↗
• MalfunctionOct 9, 2024Smoking; Smoking

  ACCORDING TO THE REPORTER, WHILE PREPARING FOR USE, DURING INSPECTION, THE MACHINE WAS ALARMING. THE CUSTOMER STATED THAT THE UNIT ALARMED AS SOON AS IT WAS TURNED ON, AND IT SMELLED LIKE BURNT ELECTRONICS. THERE WERE NO LABELING AND/OR PACKAGING ISSUES. IT WAS NOT A SERVICE EVENT AND OUT OF BOX FAILURE. THERE WERE OTHER REPORTED ISSUES. THE EVENT WAS NOT CONSIDERED LIFE-THREATENING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407615 ↗
• MalfunctionJan 30, 2024Display or Visual Feedback Problem; Smoking; Display or Visual Feedback Problem; Smoking

  ACCORDING TO THE REPORTER, DURING THE CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) CVVHD (CONTINUOUS VENO-VENOUS HEMODIALYSIS) TREATMENT, THE DISPLAY WENT BLACK WITH A BURNING SMELL. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. PRIMING WAS DONE WITH A NORMAL RESULT.  THERE WERE NO OTHER DEFECTS OR DAMAGES FOUND ON THE MACHINE. THERE WERE NO ALARMS ACTIVATED. THE PROCEDURE WAS CONTINUED AND COMPLETED AFTER THE DISPLAY WAS REPLACED AS A REMEDIAL ACTION. THE PATIENT WAS NOT TREATED WITH ANY OTHER EQUIPMENT. THE MACHINE WAS PULLED OUT OF USE FOR SERVICING. THERE WAS NO BLOOD LOSS, AND A BLOOD TRANSFUSION WAS NOT PERFORMED. THERE WAS NO MEDICAL TREATMENT PROVIDED TO THE PATIENT DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608021 ↗
• MalfunctionJan 10, 2024Display or Visual Feedback Problem; Smoking; Display or Visual Feedback Problem; Smoking

  ACCORDING TO THE REPORTER, THE NURSE STATED THAT THE MACHINE'S SCREEN WENT BLACK OR DARK AND HAD AN ELECTRICAL BURNING SMELL. IT WAS ALSO STATED THAT IT HAD A BLANK DISPLAY AND THAT THE BACKLIGHT WAS INOPERABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18481796 ↗
• MalfunctionJan 3, 2024Display or Visual Feedback Problem; Smoking; Display or Visual Feedback Problem; Smoking

  ACCORDING TO THE REPORTER, THE MACHINE HAD A DAMAGED SCREEN AND BURNT SMELL. THE CUSTOMER STATED THAT UPON SETUP, THERE WAS A BURNT SMELL AND THE SCREEN STARTED TO FLICKER AND THE DISPLAY WAS BLANK. THERE WERE NO OTHER ISSUES REPORTED (POV VERIFIED). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18440544 ↗
• MalfunctionDec 20, 2023Display or Visual Feedback Problem; Smoking; Display or Visual Feedback Problem; Smoking

  ACCORDING TO THE REPORTER, DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) IN CVVHD (CONTINUOUS VENO-VENOUS HEMODIALYSIS) TREATMENT, THE MACHINE'S DISPLAY SCREEN WENT BLACK, AND THE CLINICIAN OBSERVED A WIRE-BURNING SMELL FROM THE MACHINE. THE TREATMENT WAS NOT COMPLETED. THE TREATMENT WAS INTERRUPTED AT ALL. NO ALARMS WERE ACTIVATED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THE PATIENT WAS DISCONNECTED FROM THE TREATMENT AND THE MACHINE; THE MACHINE WAS PULLED OUT OF SERVICE AND PATIENT USE, AND A SERVICE TICKET WAS OPENED FOR REPAIR AS REMEDIAL ACTIONS PERFORMED TO ADDRESS THE ISSUE. THE DISPLAY COMPONENT WAS REPLACED. THE PATIENT WAS NOT TREATED WITH ANY OTHER EQUIPMENT. NO CLINICAL OUTCOMES WERE REPORTED DUE TO THE EVENT. NO MEDICAL TREATMENT WAS PROVIDED TOTHE PATIENT DUE TO THE EVENT. THERE WAS NO BLOOD LOSS. THERE WERE NO BLOOD TRANSFUSIONS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369575 ↗
• DeathDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) CONTINUOUS VENO-VENOUS HEMODIALYSIS (CVVHD) AT 04:18, THE PATIENT PASSED AWAY. THE PATIENT'S SUSPECTED CAUSE OF DEATH WAS PULMONARY EMBOLISM, BUT THIS HAD NOT BEEN CONFIRMED. THERE WAS NO ALLEGATION OF A DEVICE ISSUE, AND NOTHING UNUSUAL WAS OBSERVED ON THE MACHINE PRIOR TO USE. THE PATIENT HAD NO HISTORY OF THROMBI OR CLOTTING ISSUES. THE ANTICOAGULANT ADMINISTERED WAS 1,000 UNITS OF HEPARIN IN 1,000 MILLILITERS (ML) OF INTRAVENOUS (IV) 0.9% SODIUM CHLORIDE FOR INITIAL PRIME, AND HEPARIN 2 UNITS/KILOGRAMS/HOUR (KG/HR) X 3.82 KG = 7.64 UNITS/HR CONTINUOUS. THE BLOOD FLOW (QB) WAS 35 MILLILITERS/MINUTE (ML/MIN), THE DIALYSATE FLOW (QD) WAS 4 ML/MIN, THE ULTRAFILTRATION (UF) RATE HAD A WEIGHT LOSS OF 0 GRAMS (G), THE VEIN PRESSURE (VP) WAS 40 MILLIMETER MERCURY (MMHG), AND THERE WAS NO TRANSMEMBRANE PRESSURE (TMP) AVAILABLE WITH THIS MACHINE. IT WAS STATED THAT THE CRRT WAS INITIATED ON SEPTEMBER 28, 2023.

  Patient problems: Insufficient Information

  MAUDE report 18319003 ↗
• MalfunctionDec 7, 2023Display or Visual Feedback Problem; Smoking; Display or Visual Feedback Problem; Smoking

  ACCORDING TO THE REPORTER, DURING THE CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) CVVHD (CONTINUOUS VENO-VENOUS HEMODIALYSIS) TREATMENT AT 2300, THE MACHINE'S DISPLAY WENT OUT, HAD A BLANK/BLACK SCREEN, AND HAD A BURNING (SMOKE) SMELL. THE MACHINE WAS PULLED OUT OF USE FOR DISPLAY REPLACEMENT. THERE WERE NO ALARMS ACTIVATED. THERE WAS NOTHING UNUSUAL OBSERVED ON THE MACHINE PRIOR TO USE. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON MACHINE. CITRATE WAS THE ANTICOAGULANT ADMINISTERED. PRIMING WAS DONE WITH NORMAL RESULT. THE TREATMENT WAS INTERRUPTED AND WAS TERMINATED EARLY. THERE WAS NO REMEDIAL ACTION PERFORMED. THE PATIENT WAS NOT TREATED WITH ANY OTHER EQUIPMENT AND THE TREATMENT WAS NOT COMPLETED. THE PATIENT WAS SWAPPED AND TREATED WITH ANOTHER MACHINE THAT THE HOSPITAL HAD, AND THE TREATMENT WAS COMPLETED. THERE WERE COMPONENTS REPLACED ON THE MACHINE. THERE WAS NO BLOOD LOSS, AND NO BLOOD TRANSFUSION WAS PERFORMED. THERE WAS NO MEDICAL TREATMENT PROVIDED TO THE PATIENT DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18288547 ↗
• InjuryJul 24, 2023Loss of Power; Protective Measures Problem; Loss of Power; Protective Measures Problem

  ACCORDING TO THE REPORTER, THE MACHINE REQUIRED DIAGNOSIS. IT WAS STATED THAT DURING THE THERAPY, THE MACHINE SHOWED AN AIR BUBBLE ALARM IN THE VENOUS CHAMBER. THE NURSE STOPPED THE OPERATION OF THE MACHINE WITHOUT MUTING THE MACHINE, WHICH CAUSED FOR SAFETY, AND WHICH KEPT IT IN THAT FUNCTION. THE SOLUTION WAS THE FULLY ASSEMBLED KIT WAS CONNECTED AND AIR WAS EXTRACTED FROM THE VENOUS CHAMBER WITH A SYRINGE UNTIL IT REACHED A PRESSURE OF -40 ACCORDING TO THE RECOMMENDATIONS IN "HELP". IT WAS ALSO STATED THAT THE MACHINE HAD SHUT DOWN BEFORE ENDING THE TREATMENT. THERE WAS DELAY IN TREATMENT SINCE TREATMENT HAD TO BE STOPPED AT 5PM AND MACHINE REPAIRED AT 1:50AM. TREATMENT WAS RESTARTED AT 1 PM SINCE PATIENT HAD TO GO TO OR (OPERATING ROOM) FOR EMERGENCY SURGERY DUE TO BOWEL ISCHEMIA AND RESECTION. PATIENT WAS IN CRITICAL STATUS WITH ACUTE KIDNEY INJURY, ACIDOSIS, SEVERE HYPERKALEMIA AND ANURIA WHO REQUIRED C RRT TO INCREASE THE CHANCE OF SURVIVAL AND WOULD HAVE HAD IMPROVED METABOLIC STATUS IF THE PATIENT HAD BEEN ABLE TO RECEIVE CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY) BUT COULD NOT RESTART TREATMENT SINCE MACHINE COULD NOT BE RESET BY MEDTRONIC TECHNICIAN.

  Patient problems: Insufficient Information; Ischemia

  MAUDE report 17379427 ↗
• DeathDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE INFANT WAS BORN VIA FORCEPS ASSISTED VAGINAL DELIVERY. FORCEPS DELIVERY RESULTED IN SUBGALEAL HEMORRHAGE. AN ULTRASOUND WAS PERFORMED ON (B)(6) 2022 AND RESULTS SHOWED SUBCUTANEOUS HEMORRHAGE. THE SUBJECT WAS TRANSFERRED TO STUDY HOSPITAL ON DAY OF BIRTH WITH DECOMPENSATION RESULTING IN CARDIAC ARREST, ACUTE RESPIRATORY FAILURE, AND MASSIVE TRANSFUSION. THE PATIENT BECAME MASSIVELY FLUID OVERLOADED, ANURIC AND CVVHD (CONTINUOUS VENO-VENOUS HEMODIAFILTRATION) TREATMENT WAS STARTED WITH THE MACHINE ON (B)(6). ON (B)(6) 2022, AN ULTRASOUND WAS PERFORMED ON THE HEAD WITH A DIAGNOSTIC RESULT OF PARENCHYMAL HEMORRHAGE. THE TREATMENT WAS COMPLETED AND THE TREATMENT WITH THE MACHINE WAS STOPPED ON (B)(6) 2022 DUE TO HEMODYNAMIC INSTABILITY. OUTSIDE OF THE TREATMENTS WITH THE MACHINE ON (B)(6), THE SUBJECT WAS TREATED WITH MECHANICAL VENTILATION AND BLOOD PRODUCT ADMINISTRATION. IN ADDITION, THERAPUETIC HYPOTHERMIA WAS USED. THE FAMILY DECIDED TO WITHDRAW CARE ON (B)(6) 2022 AND THE PATIENT PASSED AWAY LATER THAT DAY. IT WAS ALSO STATED THAT THE PRINCIPAL INVESTIGATOR (PI) HAD INDICATED THAT THE MACHINE SYSTEM WAS NOT RELATED TO THE DEATH. THE MACHINE SYSTEM W

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 16052337 ↗
• MalfunctionDec 27, 2021Display or Visual Feedback Problem; Leak/Splash; Protective Measures Problem; Pumping Problem; Display or Visual Feedback Problem; Leak/Splash; Protective Measures Problem; Pumping Problem

  ACCORDING TO THE REPORTER, DURING CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY), THE NURSE RECEIVED AN ALARM 28 WHICH REQUIRED A CALIBRATION SHORTLY AFTER THE NURSE RECEIVED AN ALARM 58 EFFLUENT PUMP FAULT ALARM. IT WAS ALSO STATED THAT THE ISSUE WAS RELATED TO PUMP FAILURE. THE MACHINE ALSO HAD A BLD ALARM AND THE DISPLAY WAS DISCOLORED FROM TOP TO BOTTOM AND SO THE DISPLAY WAS CHANGED OUT. CITRATE WAS THE ANTICOAGULANT USED. TREATMENT WAS TERMINATED AND THE MACHINE WAS REMOVED FROM USE BY THE HOSPITAL. THE PATIENT WAS NOT TREATED WITH ANY OTHER EQUIPMENT. BLOOD TRANSFUSION WAS NOT NEEDED AND NO MEDICAL TREATMENT WAS PROVIDED TO THE PATIENT DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087606 ↗
• DeathSep 30, 2021Product Quality Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD NEUROBLASTOMA CANCER WITH INTERMEDIATE RISK NOTED ON THE (B)(6) 2021 AND ADMITTED TO THE HOSPITAL ON THE (B)(6) 2021 FOR A SCHEDULED ROUND OF CHEMOTHERAPY. ON THE (B)(6) 2021, THE PATIENT WAS TRANSFERRED TO THE PEDIATRIC INTENSIVE CARE UNIT (PICU) REQUIRING INTUBATION AND VASOPRESSOR SUPPORT STARTED ON THE (B)(6) 2021. THE PATIENT COURSE WAS FURTHER COMPLICATED BY TYPHLITIS, ACUTE RENAL FAILURE, AND LIVER DYSFUNCTION WITH RESULTANT COAGULOPATHY. THE PATIENT HAD ACUTE RESPIRATORY FAILURE WITH HYPOXIA AND HYPERCAPNIA NOTED ON THE (B)(6) 2021. ON THE (B)(6) 2021, THE PATIENT CONDITION HAD WORSENED AND ON THE (B)(6) 2021, THE PATIENT BECAME BRADYCARDIC THAT PROGRESSED TO ASYSTOLE. NO CARDIOPULMONARY RESUSCITATION (CPR) WAS ATTEMPTED DUE TO PARENTS DIRECTION AND ON THE (B)(6) 2021, THE PATIENT DIED DESPITE MAXIMAL VENTILATOR SETTINGS AND VASOACTIVE SUPPORT. THE CARPEDIEM MACHINE WAS NOT IN USE FOR CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT AT THE TIME OF DEATH. THE PATIENT DEATH WAS NOT RELATED AND HAD NO CONNECTION TO THE SYSTEM/MACHINE. THE PATIENT DEATH WAS DUE TO MULTI-SYSTEM ORGAN FAILURE IN THE SETTING OF PSEUDOMONAL SEPTIC SHO

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 12555866 ↗