PEDIMAG BLOOD PUMP 201-90052Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 07640135140634), received between Dec 10, 2021 and May 20, 2025 — classified as 11 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (7 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2025Electrical /Electronic Property Problem; Infusion or Flow Problem; Electrical /Electronic Property Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS A VIDEO OF A "LESS SEVERE EVENT" WHERE THE INFLOW CANNULA BOUNCED AND IT LOW FLOWED. IT LOOKED LIKE A SUCTION EVENT AND REVERSAL FLOW WAS NOT SEEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054878 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE OXYGENATOR FAILED AND WAS EXCHANGED. THERE WAS PATIENT DESATURATION STARTING AT THE TIME OF THE COMPONENT CHANGE. THIS OCCURRED AFTER APPROXIMATELY 20 HOURS OF SUPPORT. IT WAS NOTED TO HAVE RED COLORED FLUID FROM THE GAS EXHAUST PORT OF THE OXYGENATOR, INCREASING WITH SIGH OF LUNG. THE PARAMETERS AT THE TIME WERE 0.28 LPM AT 2600 RPM BLOOD FLOW. THE SWEEP WAS 0.5 LPM AT 1.0 FIO2. THE VENOUS PRESSURE 3/ ARTERIAL PRESSURE 81. THE GAS ANALYSIS WAS PATIENT ARTERIAL 7.36/39.7/54, PUMP VENOUS 7.4/33.7/111 AND PUMP ARTERIAL 7.47/28.7/379.

  Patient problems: Low Oxygen Saturation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004028 ↗
• MalfunctionMay 2, 2025Device Difficult to Setup or Prepare; Noise, Audible; Device Difficult to Setup or Prepare; Noise, Audible

  IT WAS LATER REPORTED THAT NO CIRCUIT INTERVENTION WAS TAKEN, BUT TAPE WAS APPLIED TO MAINTAIN PRESSURE TO KEEP THE HEAD SEATED PROPERLY. NO PRODUCTS WERE EXCHANGED SO NO PRODUCTS WOULD BE RETURNED. THE NOISE WAS CONFIRMED TO HAVE BEEN COMING FROM THE BLOOD PUMP. THERE WAS NO ADVERSE PATIENT IMPACT IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21954301 ↗
• MalfunctionFeb 13, 2025Contamination /Decontamination Problem; Noise, Audible; Contamination /Decontamination Problem; Noise, Audible

  THE CENTRIMAG CONSOLE WAS NOT EXCHANGED. THE WHITE DOT DISAPPEARED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21380386 ↗
• MalfunctionJan 28, 2025Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT'S NURSE HAD NOTICED A RATTLING NOISE TWICE WITH THE CENTRIMAG MOTOR. IT OCCURRED ONCE WHEN THE PATIENT WAS AGITATED AND ONCE DURING A BATH. THE CENTRIMAG MOTOR AND CONSOLE WERE EXCHANGED TO THE BACKUPS. THE RATTLING NOISE RESOLVED. THE UNITS WERE RED TAGGED AND REMOVED FROM CLINICAL USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21256731 ↗
• InjuryJan 22, 2025Device Difficult to Setup or Prepare; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Device Difficult to Setup or Prepare; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  IT WAS REPORTED THAT L06648-0021 MOTOR WAS CAUSING A NOTABLE NOISE FOR 2 DAYS WITH UPTRENDING HEMOLYSIS LABS SO THE MOTOR WAS CHANGED OUT AND THE LABS ARE NORMALIZING WITHOUT NOISE. L06642-0007 WAS THE ORIGINAL MOTOR THE SITE TRIED TO CHANGE TO AND IT DID NOT MAGNETIZE CORRECTLY. THE PUMP WOULD NOT SIT AND THEREFORE THE SCREW COULD NOT BE PLACED INTO THE GROOVE. UPON HOLDING THE PUMP TIGHTER, IT WILL MAGNETIZE AND TURN INTO POSITION BUT NOT NATURALLY.

  Patient problems: Hemolysis

  MAUDE report 21211065 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  IT WAS REPORTED THAT DURING PHYSICAL THERAPY/OCCUPATIONAL THERAPY, THE PATIENTS NURSE NOTICED A RATTLING NOISE FROM THE PEDIMAG MOTOR. CODE WAS ACTIVATED. MULTIPLE ATTEMPTS WERE MADE TO ADJUST THE PUMP IN THE MOTOR HOUSING. THIS WAS UNSUCCESSFUL. THE PUMP WAS SWITCHED TO THE BACKUP MOTOR AND CONSOLE. THE MOTOR AND CONSOLE WERE REMOVED FROM SERVICE AND SENT TO THE BIOMEDICAL ENGINEER.

  Patient problems: Hemolysis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20666093 ↗
• InjuryJul 16, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PEDIMAG PUMP WAS RETURNED TO ABBOTT.

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

  MAUDE report 19751041 ↗
• MalfunctionJun 13, 2024Device Difficult to Setup or Prepare; Premature Separation; Device Difficult to Setup or Prepare; Premature Separation

  IT WAS REPORTED THAT THE TEAM WET PRIMED THE CIRCUITS PRIOR TO USE. WHEN INSERTING THE PEDIMAG PUMP INTO THE MOTOR, THE PUMP HEAD REMAINED LOOSE AND MOVEABLE DESPITE THE MOTOR LOCKING SCREW INSERTED CORRECTLY. THE TEAM ATTEMPTED THE SAME PROCESS ON THE BACKUP MOTOR AND HAD THE SAME RESULT. THE TEAM DID NOT TRUST USING THE MOTOR AND WANTED A REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19531882 ↗
• MalfunctionMay 21, 2024Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PUMP WAS MAKING A RATTLING SOUND. BASED ON THE VIDEO THAT WAS SENT IT APPEARED THAT THE NOTCH ON THE PUMP WAS TOO BIG FOR THE SCREW. THE CLINICIAN ATTEMPTED TO RESEAT THE PUMP, VERIFIED IT WAS SEATED CORRECTLY, CHANGED THE MOTOR AND EVENTUALLY DID AN ENTIRE CIRCUIT CHANGE AS THE SOUND DID NOT RESOLVE. CHANGING THE ENTIRE CIRCUIT RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19360013 ↗
• MalfunctionMay 2, 2024Malposition of Device; Noise, Audible; Malposition of Device; Noise, Audible

  IT WAS REPORTED THAT THERE WAS INCREASED MOBILITY OF THE PUMP WHEN THE TUBING WAS MOVED. THERE WAS A LOUD VIBRATING NOISE FROM THE ROTATION OF THE PUMP. THE SYSTEM'S SETTING AT THE TIME WAS 3200 RPM WITH 1.7 LPM OF FLOW. THE MOTOR WAS REPOSITIONED WITH THE PUMP FACING UPRIGHT AND TAPE WAS ADDED TO REINFORCE THE PUMP POSITION. INTERMITTENT NOISE COMING FROM THE MOTOR REMAINED SO THE TEAM PERFORMED A CONSOLE AND MOTOR EXCHANGE. THE PATIENT TOLERATED THE EXCHANGE EXTREMELY WELL AND WAS HEMODYNAMICALLY STABLE THROUGHOUT. HOWEVER, A DECOUPLING NOISE WAS HEARD AFTER FITTING THE PUMP INSIDE THE NEW MOTOR WHICH RESOLVED QUICKLY AFTER. THE PUMP FUNCTIONED WELL. THERE WERE NO CLINICAL OR LABORATORY SIGNS OF HEMOLYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19233625 ↗
• MalfunctionMar 15, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT, WHO WAS ON A PEDIMAG, HAD SUCTION EVENTS ON THE EVENING ON (B)(6) 2023. NO ALARMS WERE TRIGGERED. LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED A LOW FLOW EVENT SHOWING A DROP TO 0 LITERS PER MINUTE (LPM), ASSOCIATED WITH A LOSS OF FLOW SIGNAL. THE EVENT WAS MUTED OR CLEARED WITHIN 5 SECONDS. THE FLOW DROPPED TO APPROXIMATELY 1.0 LPM (LOWEST VALUE RECORDED WAS 0.9 LPM.) THIS DID NOT RESULT IN AN ALARM BECAUSE THE ALARM THRESHOLD WAS SET TO 0.5 LPM AT THE TIME. THERE WAS ANOTHER LOW FLOW SHOWING 0 LPM, AGAIN ASSOCIATED WITH A LOSS OF FLOW SIGNAL. THIS ALARM WAS ALSO MUTED/CLEARED. AGAIN, THERE WAS ANOTHER LOW FLOW SHOWING 0 LPM, AGAIN ASSOCIATED WITH A LOSS OF FLOW SIGNAL, WHICH WAS ALSO MUTED/CLEARED. RELATED MANUFACTURER REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18915479 ↗
• MalfunctionFeb 6, 2024Device Difficult to Setup or Prepare; Product Quality Problem; Device Difficult to Setup or Prepare; Product Quality Problem

  IT WAS REPORTED THAT A CENTRIMAG PUMP WAS MORE LOOSE THAN OTHER PUMPS. THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR REACHED OUT TO INQUIRE IF THERE HAD BEEN ANY MANUFACTURING CHANGES SINCE THE NURSES HAD THOUGHT THE PEDIMAG PUMPS LOOKED TO HAVE HAD A WIDER MOVEMENT WHERE THE LOCKING SCREW AND THE PLASTIC CRESCENT INDENTION SPACE WAS. THEY WOULD TURN BACK AND FORTH MORE; HOWEVER, ALL THE SCREWS ARE TIGHT AND IN THE GROOVE. NO ISSUES TO THE PUMP, HARDWARE, AND PATIENT WERE REPORTED. THE EXACT EVENT DATE WAS UNKNOWN AND COULD NOT BE PROVIDED. RELATED MANUFACTURER REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18652780 ↗
• InjuryJan 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A BLOOD PUMP EXCHANGE WITH OXYGENATOR REMOVAL ON (B)(6) 2023. ON AN UNIDENTIFIED DATE THE PATIENT WAS ON SUPPORT AND HAD A BRIEF PUMP STOP WHERE THE SPEED AND FLOW BOTH WENT TO 0 SIMULTANEOUSLY FOR A COUPLE OF SECONDS AND THEN RETURNED TO BASELINE WITHOUT INTERVENTION. ONCE IT OCCURRED TWICE ON THE PATIENT, THE MOTOR, CONSOLE, AND FLOW PROBE WERE EXCHANGED AND SENT FOR EVALUATION BUT CAME BACK GOOD. THE SAME THING HAPPENED AGAIN ON (B)(6) 2023. THE PATIENT'S SPEED AND FLOW WENT TO 0 FOR REPORTEDLY 6 SECONDS AND THEN BACK TO BASELINE. THE NURSE REPORTED THAT THE PUMP RUNNING SOUND DISAPPEARED AS IF IT TRULY STOPPED DURING THAT TIME. NO HEMODYNAMIC CHANGES WERE NOTED. FLOW WENT BACK UP TO BASELINE WITHOUT ANY INTERVENTION FROM THE NURSING STAFF. THE CUSTOMER REPORTED THAT THE ONLY CONSTANT THROUGH MULTIPLE EVENTS WAS THE PATIENT'S PUMP. THE CUSTOMER ALSO NOTED THAT THE PUMP WAS MORE "LOOSE" THAN PREVIOUS PUMPS. NO ADVERSE CONSEQUENCES WERE REPORTED AND THE PATIENT REMAINED STABLE ON THE SAME PEDIMAG. RELATED MANUFACTURER REFERENCE NUMBER FOR THE EXCHANGED MOTOR: 3003306248-2024-00027. RELATED MANUFACTURER REFERENCE NUMBER FOR THE EXCHANGED CONSOLE

  Patient problems: Insufficient Information

  MAUDE report 18584069 ↗
• MalfunctionJan 13, 2024Device Difficult to Setup or Prepare; Product Quality Problem; Device Difficult to Setup or Prepare; Product Quality Problem

  IT WAS REPORTED THAT THE NURSES NOTICED THAT THE PUMP WAS MORE ¿LOOSE¿ THAN OTHER PUMPS. RELATED MANUFACTURER REFERENCE NUMBER: 3003306248-2024-00016.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509499 ↗
• MalfunctionJan 8, 2024Device Difficult to Setup or Prepare; Increased Pump Speed; Pumping Stopped; Device Difficult to Setup or Prepare; Increased Pump Speed; Pumping Stopped

  IT WAS REPORTED THAT A WHILE BACK, THE PATIENT WAS ON SUPPORT AND HAD A BRIEF PUMP STOP WHERE THE SPEED AND FLOW BOTH WENT TO 0 SIMULTANEOUSLY FOR A COUPLE OF SECONDS AND THEN RETURNED TO BASELINE WITHOUT INTERVENTION. AFTER IT OCCURRED A SECOND TIME, THE MOTOR, CONSOLE, AND FLOW PROBE WERE EXCHANGED AND SENT FOR EVALUATION WHICH THE CUSTOMER STATED CAME BACK GOOD. ON (B)(6) 2023 IT WAS REPORTED THAT THE SAME THING HAD HAPPENED AGAIN OVER THE WEEKEND. THE PATIENT'S SPEED AND FLOW WENT TO 0 FOR REPORTEDLY 6 SECONDS AND THEN BACK TO BASELINE. THE NURSES DID NOT NOTICE ANY OUT OF THE ORDINARY ALARMS, EXCEPT FOR THE NO FLOW ON THE FLOW GRAPH THAT WAS ABOUT 6 SECONDS. THE FLOW WENT BACK TO BASELINE WITHOUT ANY INTERVENTION BY NURSING. THE NURSE REPORTED THAT THE PUMP RUNNING SOUND DISAPPEARED AS IF IT TRULY STOPPED DURING THAT TIME. ADDITIONALLY, IT WAS REPORTED THE PATIENT HAD RECEIVED A NEW PEDIMAG PUMP ON (B)(6) 2023, AND THE ACCOUNT NOTED THAT THE NEW PUMP FELT MORE ¿LOOSE¿ THAN PREVIOUS PUMPS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE PATIENT REMAINED STABLE ON THE SAME PEDIMAG PUMP AS OF (B)(6) 2024. THIS REPORT CAPTURES THE REPORT OF THE NEW PUMP FEELING LOOSE ON (B)(6) 202

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18465034 ↗
• InjuryAug 14, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A ONE-MONTH-OLD PATIENT WITH PEDIMAG (LOT 8132-LB5) WAS BELIEVED TO HAVE STROKE OCCURRED ON OR BEFORE (B)(6) 2023 WITH NEW ONSET SUB CLINICAL SEIZURES NOTED ON VIDEO ELECTROENCEPHALOGRAM (VEEG) ON (B)(6) 2023. COMPUTED TOMOGRAPHY (CT) SCAN DONE ON (B)(6) 2023 AND CONFIRMED ACUTE EMBOLIC STROKE. THE PATIENT HAD PEDIMAG TUBING/CONNECTORS WITH INCREASED FIBRIN/CLOT BURDEN ON (B)(6) 2023. PUMP AND TUBING WERE CHANGED OUT DONE ON (B)(6) 2023 (NEW LOT 8868806). CLOT BURDEN WAS IN TUBING AT THE CONNECTORS NEAR THE PUMP. THE PATIENT WAS TREATED WITH MEDICATION STARTED INCLUDING KEPPRA, MIDAZOLAM, PHENOBARB AND PHOSPHENYTOIN TO CONTROL SEIZURES, WHICH STOPPED EARLY MORNING ON (B)(6) 2023. THE PATIENT HAS SINCE BEEN CONVERTED TO SINGLE VENTRICLE PHYSIOLOGY AND HAS BEEN WEANED FROM THE DEVICE. THE PATIENT CONTINUED TO MAKE SLOW PROGRESS BUT REMAINS INTUBATED AND ON LOW DOSE INOTROPE THERAPY. THE PEDIMAG WAS NOT FLOWING DUE TO A CLOT IN THE PEDIMAG. PER INTENSIVIST, TYPICALLY FLOWS 0.2-0.4 RPMS. HEARTCARE PROVIDE NOTIFIED ABBOTT BECAUSE FLOWS WERE DOWN TO 0-0.15 LPM AND FLOWS HAD BEEN LOW FOR DAYS. THE LOW FLOW ALARMS HAD BEEN TURNED OFF AS WELL. THE PATIENT HAD HAD COMPUT

  Patient problems: Convulsion/Seizure; Embolism/Embolus; Ischemia Stroke; Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 17543644 ↗
• InjuryJul 24, 2023Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PEDIMAG WAS NOT FLOWING DUE TO A CLOT IN THE DEVICE. PER INTENSIVIST, THE PATIENT WAS 1 MONTH OLD ON PEDIMAG AND TYPICALLY FLOWS 0.2-0.4 RPMS. HEARTCARE PROVIDER NOTIFIED ABBOTT BECAUSE FLOWS WERE DOWN TO 0-0.15 LPM AND FLOWS HAD BEEN LOW FOR DAYS. THE LOW FLOW ALARMS HAD BEEN TURNED OFF AS WELL. THE PATIENT HAD A COMPUTED TOMOGRAPHY (CT) SCAN AND ECHOCARDIOGRAM (ECHO) WHICH SHOWED THAT PATIENT'S HEART WAS FUNCTIONING APPROPRIATELY AND STRONGER. SURGICAL TEAM WAS AWARE BUT DID NOT WANT TO INTERVENE. THE HEALTHCARE PROVIDER REPORTED THERE WAS CLOTTING ALL OVER THE CANNULAS AND TUBING, BUT WERE UNABLE TO SEE IF THERE WAS A THROMBUS IN THE IMPELLER. PATIENT WAS ANTICOAGULATED ON BIVALIRUDIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 17385163 ↗
• MalfunctionJul 10, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT PATIENT HAD FIBRIN FORMATION ON CONNECTORS OF PEDIMAG. THE PATIENT WAS HAVING FLOW 0.4-0.5 L/MIN BEFORE SWITCHING OUT PEDIMAG ON (B)(6) 2023. AFTER PEDIMAG WAS SWITCHED OUT, PATIENT WAS ONLY FLOWING 0.2-0.25 L/MIN ON PEDIMAG. THIS WAS REPORTED TO CLINICAL ON (B)(6) 2023. THE PATIENT RECEIVED FLUID AND CHEST TUBES WITHOUT ANY IMPROVEMENT IN FLOWS. PEDIMAG HAD FIBRIN FORMATION ON CONNECTOR IS REPORTED UNDER MFR# 2916596-2023-04356.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17290918 ↗
• InjuryJul 10, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PATIENT HAD FIBRIN FORMATION ON CONNECTORS OF PEDIMAG. THE PATIENT WAS HAVING FLOW 0.4-0.5 L/MIN BEFORE SWITCHING OUT PEDIMAG ON (B)(6) 2023. AFTER PEDIMAG WAS SWITCHED OUT, PATIENT WAS ONLY FLOWING 0.2-0.25 L/MIN ON PEDIMAG. THIS WAS REPORTED TO CLINICAL ON (B)(6) 2023. THE PATIENT RECEIVED FLUID AND CHEST TUBES WITHOUT ANY IMPROVEMENT IN FLOWS. SECOND PEDIMAG WITH FLOW ISSUE IS REPORTED UNDER MFR# 3003306248-2023-01954.

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

  MAUDE report 17290874 ↗
• MalfunctionJan 31, 2023Device Difficult to Setup or Prepare; Pumping Stopped; Device Difficult to Setup or Prepare; Pumping Stopped

  ADDITIONAL INFORMATION: THE PATIENT HAD BEEN ON PEDIMAG SUPPORT SINCE (B)(6) 2022.THE PUMP STOP HAD BEEN OBSERVED BY A NURSE IN THE ROOM, AND THEY HAD ALSO HEARD THE PUMP STOP ALARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272846 ↗
• MalfunctionJun 14, 2022Product Quality Problem; No Apparent Adverse Event; Product Quality Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE HARD CASE THAT WAS SUPPOSED TO CONTAIN A PEDIMAG WAS EMPTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14687259 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INITIALLY PLACED ON (B)(6) 2022 FOR SUSTAINED VENTRICULAR TACHYCARDIA AND UNSTABLE BLOOD PRESSURE. THE 6 FRENCH ARTERY RETURN CANNULA CLOTTED (B)(6) 2022 AND THE LINE WAS CLAMPED AND REPLACED WITH AN 8 FRENCH, WHICH CLOTTED AGAIN. PARTIAL THROMBOPLASTIN TIME WAS WITHIN NORMAL RANGE ON BIVALIRUDIN/HEPARIN AT INITIATION. THE PATIENT HAD A DOUBLE BRIDGE CONFIGURATION WITH CONTINUOUS RENAL REPLACEMENT THERAPY/SHUNT. THE FLOW WAS BETWEEN 230-300ML. THE PEDIMAG SUPPORT WAS DISCONTINUED ON (B)(6) 2022 AND THE PATIENT REMAINED STABLE OFF SUPPORT.

  Patient problems: Arrhythmia; Thromboembolism

  MAUDE report 13934549 ↗
• InjuryFeb 8, 2022Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2021 AND WAS PLACED ON PEDIMAG SUPPORT ON (B)(6) 2021. THE HOSPITAL TEAM WAS ABLE TO VISUALIZE FIBRIN STRANDS AND THROMBUS IN THE PEDIMAG CIRCUIT AND A DEVELOPMENT OF UROSEPSIS AND INFLAMMATION ON (B)(6) 2021 LEAD TO INCREASED FIBRIN DEPOSITION. BASED ON FREQUENCY OF TRANSFUSIONS AND LABORATORY EVIDENCE OF HEMOLYSIS, THE PATIENT REQUIRED FREQUENT BLOOD TRANSFUSIONS. THE PATIENT¿S HEMATOCRIT (HCT) 30.9 % DOWN FROM 36 AND REQUIRED PACKED RED BLOOD CELLS (PRBCS), LACTATE DEHYDROGENASE (LDH) 1249 U/L, PLASMA FREE HEMOGLOBIN (HGB) 43.5 G/DL. THE TEAM DECIDED TO SEND THE PATIENT TO THE OPERATING ROOM (OR) AND HAVE THE PEDIMAG PUMP AND CIRCUIT EXCHANGED. THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT¿S NEURO STATUS WAS STABLE AND PATIENT WAS ON 8L HIGH-FLOW NASAL CANNULA AND TOLERATED A SLOW INCREASE IN NASOJEJUNAL TUBE FEEDS. THE TEAM WAS NOT CONCERNED WITH ANY INFECTION AND LISTED THE PATIENT FOR HEART TRANSPLANT.

  Patient problems: Hemolysis; Inflammation; Obstruction/Occlusion; Sepsis; Thrombosis/Thrombus

  MAUDE report 13481017 ↗
• InjuryDec 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD LEAKAGE WAS VISUALIZED ON THE BLOOD PUMP. THE PUMP WAS EXCHANGED, AND THE PATIENT TOLERATED WELL WITH NO ADVERSE EVENTS NOTED. THE LEAK WAS ON THE OUTFLOW PUMP HEAD. THERE HAD BEEN ONE PUMP EXCHANGE PREVIOUSLY AFTER APPROXIMATELY 3 WEEKS OF SUPPORT OF THE RIGHT VENTRICULAR ASSIST DEVICE (RVAD) PUMP.

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

  MAUDE report 12980377 ↗