PINNACLE® 601184Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04046964957437), received between Sep 4, 2016 and Mar 6, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (18 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 6, 2026Application Program Problem: Dose Calculation Error

  THE COMPLAINANT REPORTED OPERATIONAL MALFUNCTIONS INVOLVING A PINNACLE TPN MANAGEMENT SYSTEM. ACCORDING TO THE REPORT, THE UNIT DELIVERED INACCURATE VOLUMES DURING TOTAL PARENTERAL NUTRITION (TPN) COMPOUNDING. IN ONE EXAMPLE, THE SYSTEM WAS PROGRAMMED AND CALCULATED FOR EIGHT (8) TPN BAGS; HOWEVER, THE DEVICE DISPENSED QUANTITIES SUFFICIENT FOR ONLY SEVEN (7) BAGS. THE DISCREPANCY WAS IDENTIFIED DURING THE FACILITY'S DOUBLE-CHECK VERIFICATION PROCESS PRIOR TO PATIENT ADMINISTRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531058 ↗
• MalfunctionMar 6, 2026Application Program Problem: Dose Calculation Error

  THE COMPLAINANT REPORTED OPERATIONAL MALFUNCTIONS INVOLVING A PINNACLE TPN MANAGEMENT SYSTEM. ACCORDING TO THE REPORT, THE UNIT DELIVERED INACCURATE VOLUMES DURING TOTAL PARENTERAL NUTRITION (TPN) COMPOUNDING. IN ONE EXAMPLE, THE SYSTEM WAS PROGRAMMED AND CALCULATED FOR EIGHT (8) TPN BAGS; HOWEVER, THE DEVICE DISPENSED QUANTITIES SUFFICIENT FOR ONLY SEVEN (7) BAGS. THE DISCREPANCY WAS IDENTIFIED DURING THE FACILITY'S DOUBLE-CHECK VERIFICATION PROCESS PRIOR TO PATIENT ADMINISTRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531057 ↗
• MalfunctionNov 14, 2024Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS REPORTED BY THE USER FACILITY: PINNACLE PUMP DISPENSING INCORRECT VOLUMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685902 ↗
• MalfunctionAug 6, 2024Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED DURING A LIVE CALL, THAT ON (B)(6) 2024, AN INFANT IN THE NICU WAS BEING INFUSED PARENTAL NUTRITION (TPN) AND THE INFANT'S GLUCOSE LEVELS DROPPED TO 30. THIS HAPPENED JUST A FEW MINUTES AFTER THE TPN HAD BEEN STATED. IMMEDIATELY THE NURSE PRACTITIONER REMOVED THE TPN AND HUNG A D10% BAG WHICH STABILIZED THE BABY. THE BAG WAS RETURNED TO THE PHARMACY AND SENT TO A LAB FOR TESTING. BABY WAS 1.69 KILOGRAMS IN WEIGHT AND BORN THE SAME DAY (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19919247 ↗
• MalfunctionApr 5, 2024Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  AS REPORTED BY THE USER FACILITY: LIPIDS BACKFLOWING INTO TRANSFER SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19051224 ↗
• MalfunctionAug 4, 2023Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED TPN FINAL CONTAINERS WERE CLOUDY AT THE COMPLETION OF COMPOUNDING, BAGS WERE SCRAPPED AND REPUMPED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17461237 ↗
• MalfunctionJun 28, 2023Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED TPN FINAL CONTAINERS WERE CLOUDY AT THE COMPLETION OF COMPOUNDING, BAGS WERE SCRAPPED AND REPUMPED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17218762 ↗
• MalfunctionMar 29, 2023Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS REPORTED BY THE USER FACILITY: PUMP DISPENSING DEXTROSE WHILE VOLUME SET TO ZERO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16640337 ↗
• MalfunctionApr 14, 2022Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS REPORTED BY THE USER FACILITY: CUSTOMER CALLED TO REPORT AN INTERMITTENT ISSUE WITH THE PUMP DISPENSING LIPIDS INTO ORDERS THAT DO NOT HAVE LIPIDS ORDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14110832 ↗
• MalfunctionMar 14, 2022Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS REPORTED BY THE USER FACILITY: IT WAS OBSERVED THAT COMPOUNDED ORDERS WERE COMING OUT CLOUDY. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13759477 ↗
• MalfunctionOct 11, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS REPORTED BY THE USER FACILITY: EVENT 1: THE PINNACLE OVER-DISPENSED A SIGNIFICANT VOLUME OF AN INGREDIENT AND NO ERRORS OR ALERTS ALARMED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12609419 ↗
• MalfunctionOct 11, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS REPORTED BY THE USER FACILITY: EVENT 2: THE PINNACLE OVER-DISPENSED A SIGNIFICANT VOLUME OF AN INGREDIENT AND NO ERRORS OR ALERTS ALARMED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12609273 ↗
• MalfunctionSep 17, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS REPORTED BY THE USER FACILITY: EVENT 3. BAGS ARE RUNNING DRY DURING ADMINISTRATION. THE BAGS ARE COMPOUNDED ON THE PINNACLE COMPOUNDER. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488838 ↗
• MalfunctionSep 17, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS REPORTED BY THE USER FACILITY: EVENT 1. BAGS ARE RUNNING DRY DURING ADMINISTRATION. THE BAGS ARE COMPOUNDED ON THE PINNACLE COMPOUNDER. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488833 ↗
• MalfunctionSep 17, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS REPORTED BY THE USER FACILITY: EVENT 2. BAGS ARE RUNNING DRY DURING ADMINISTRATION. THE BAGS ARE COMPOUNDED ON THE PINNACLE COMPOUNDER. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488831 ↗
• MalfunctionJun 18, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS PER REPORTED BY THE USER FACILITY: NO FLUIDS WERE PASSING THROUGH THE TUBING ON LINES 5 OR 6 AND NO ERROR MESSAGES WERE RECEIVED. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12024362 ↗
• MalfunctionFeb 22, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS PER REPORTED BY THE USER FACILITY: STATIONS 4 AND 5 ARE OVERFILLING WITHOUT ANY ALARMS AND THE SOURCE POOL CONTAINER RAN DRY TOO EARLY. A VISUAL INSPECTION OF THE FILLED FINAL CONTAINERS SHOWS THERE IS TOO MUCH SOLUTION IN THE FINAL CONTAINER. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11358026 ↗
• MalfunctionFeb 8, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS PER REPORTED BY THE USER FACILITY: DELIVERY ACCURACY WITHOUT ALARMING AS IDENTIFIED BY PATIENTS REPORTING THAT TPN ORDERS ONLY CONTAIN 50CC OF 100CC OVERFILL AMOUNT. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11294182 ↗
• MalfunctionNov 20, 2020Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS PER REPORTED BY THE USER FACILITY: PATIENT FINAL CONTAINERS ARE RUNNING OUT EARLY (1 TO 1.5 HOURS) USING A CURLIN IV PUMP. IT IS REPORTED THAT THE PINNACLE PUMP MODULE IS GOING INTO THE COMPOUNDING COMPLETE SCREEN WITHOUT ALARMING. THIS ISSUE IS ONLY OCCURRING WITH TOTAL PARENTAL NUTRITION (TPN) BAGS WITH LARGE VOLUMES. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10874532 ↗
• MalfunctionSep 21, 2020Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS PER REPORTED BY THE USER FACILITY: THE PUMP IS NOT HOLDING CALIBRATION AND THE FACTORY CALIBRATION KEEPS HAVING TO BE PERFORMED. THIS IS AFFECTING THE POOL BALANCE WITH THE TPN NOT BEING ACCURATE AND THE SOURCE POOL CONTAINER BAG RUN DRY/EMPTY BEFORE THE APPLICABLE PATIENT'S TPN ORDERS WERE COMPLETE. THE AFFECTED FINAL CONTAINERS WERE DISCARDED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10561029 ↗
• MalfunctionSep 9, 2020Inaccurate Delivery; Inaccurate Delivery

  AS PER REPORTED BY THE USER FACILITY: THE LIPID ROTOR 1 IS TURNING WITH NOTHING PROGRAMMED ON STATION 1. AS A RESULT, IT IS PUMPING A SMALL AMOUNT OF LIPIDS IN A NON-LIPID FINAL CONTAINER. THE CUSTOMER DID NOT INDICATE ANY ALARMS WERE SET OFF AND THE FINAL CONTAINER WAS DISCARDED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10506887 ↗
• MalfunctionJul 23, 2020Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED THE SOURCE POOL CONTAINER IS RUNNING DRY DURING COMPOUNDING OF BAG 6 OUT OF 7 BAGS. THE TOTAL VOLUME IN THE SOURCE POOL CONTAINER IS 1019.9ML. THE PROGRAMMED VOLUME OF THE INGREDIENT FOR EACH COMPOUNDED BAG IS 137ML (150.7G). THE VOLUME REQUIRED IN THE SOURCE POOL CONTAINER TO FILL THE ORDERS IS 959ML. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10313587 ↗
• MalfunctionJun 16, 2020Application Program Problem: Parameter Calculation Error; Improper or Incorrect Procedure or Method; Application Program Problem: Parameter Calculation Error; Improper or Incorrect Procedure or Method

  AS PER REPORTED BY THE USER FACILITY: CUSTOMER REPORTED THE 1000 GRAM WEIGHT MEASURED 983 GRAMS DURING CALIBRATION. THEY PLACED ADDITIONAL WEIGHTS ON THE LOAD CELL UNTIL THE CALIBRATION READ THE SCALE AT 1 KILOGRAM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10158502 ↗
• MalfunctionMay 17, 2019Defective Alarm; Defective Alarm

  AS PER REPORTED BY THE USER FACILITY: A TECHNICIAN WAS MIXING TPN ON THE PINNACLE MACHINE AND WHEN CHANGING THE BAGS, THE MACHINE DID NOT PROMPT THE TECHNICIAN TO SCAN THE NEW BAGS. THIS RESULTED IN ATTACHING TWO (2) BAGS TO THE WRONG TUBING. THE MACHINE WAS SET UP TO COMPOUND DEXTROSE, STERILE WATER, TROPHAMINE AND TRAVASOL. THE TECHNICIAN INADVERTENTLY HUNG THE TRAVASOL ON THE DEXTROSE TUBING AND THE DEXTROSE ON THE TRAVASOL TUBING. TWO (2) BAGS OF TPN WERE THEN COMPOUNDED USING THE TRAVASOL INSTEAD OF DEXTROSE - SO THERE WAS STERILE WATER, TROPHAMINE AND TRAVASOL IN THE BAG INSTEAD OF STERILE WATER, DEXTROSE AND TROPHAMINE. THE ISSUE WAS CAUGHT AS THE TPN BAG WAS BEING ADMINISTERED TO A BABY PATIENT. THE BABY PATIENT RECEIVED ABOUT 1.3ML OF THE TPN BAG WHEN THE ISSUE WAS FOUND AND THE INFUSION WAS STOPPED. AT THIS TIME NO KNOWN PATIENT MEDICAL INTERVENTION HAS BEEN REQUIRED. CUSTOMER STATED THAT THE SAFETY PROTOCOL THAT IS TO BE IN PLACE TO FORCE THE USER TO THE SCANNER THE SOURCE CONTAINER AND STATION TUBING BARCODE FLAG DID NOT PREVENT THE USER ERROR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8619352 ↗
• MalfunctionSep 4, 2016Device Displays Incorrect Message; Device Displays Incorrect Message

  PUMP LOCKED-OUT. (B)(4). ON (B)(6) 2016 END CUSTOMER REPORTS HAS 13 PUMPS BEING RETURNED WITH THE SAME ISSUE FROM THE SAME UNIT. ISSUE OCCURRED LAST EVENING IN THE LABOR AND DELIVERY DEPARTMENT. PUMP ALARMED AND FLASHED ERROR AND LOCKED ALL KEYS OUT. REPORTS, 10 PUMPS DID THE SAME THING ON THIS UNIT OVER A 2 HOUR TIME PERIOD, 8 WERE INFUSING SOLUTIONS ON PATIENTS AT THE TIME THE ALARMS OCCURRED, INCLUDING SOME HIGH ALERT MEDS OF MAGNESIUM SULFATE AND PITOCIN. CUSTOMER DID NOT KNOW HOW MANY OF THOSE WERE IN PROGRESS. NO INJURIES REPORTED, UNIT WAS FULL OF PATIENTS AT TIME OF OCCURRENCE. CUSTOMER WILL ONLY BE SENDING IN 5 DEVICES FOR EVALUATION. THIS DEVICE SERIAL NUMBER WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5927359 ↗