PINNACLE® PC1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04046964447198), received between Aug 11, 2021 and May 15, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2023Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  AS REPORTED BY THE USER FACILITY: EVENT 2 CUSTOMER CALLED TO REPORT THAT THEY HAVE HAD 2 INSTANCES WHERE LIPIDS LEAKED INTO THE LINE WHILE ANOTHER INGREDIENT WAS PUMPING. THEY STATED THAT IT HAPPENED ONCE LAST WEEK AND THEN AGAIN TODAY ((B)(6) 2023).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16931020 ↗
• MalfunctionMay 15, 2023Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  AS REPORTED BY THE USER FACILITY: EVENT 1 CUSTOMER CALLED TO REPORT THAT THEY HAVE HAD 2 INSTANCES WHERE LIPIDS LEAKED INTO THE LINE WHILE ANOTHER INGREDIENT WAS PUMPING. THEY STATED THAT IT HAPPENED ONCE LAST WEEK AND THEN AGAIN TODAY ((B)(6) 2023).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16931019 ↗
• MalfunctionSep 16, 2022Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS REPORTED BY THE USER FACILITY: CUSTOMER CALLED TO REPORT HAVING AN ISSUE WITH 35ML OF A SOLUTION BEING MISTAKENLY ADDED TO A FRESHLY HUNG FINAL CONTAINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15442507 ↗
• MalfunctionJun 13, 2022Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS REPORTED BY USER FACILITY: THE PUMP WAS NOT PULLING UP SOLUTION AT THE BEGINNING OF COMPOUNDING. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14679602 ↗
• MalfunctionSep 24, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS REPORTED BY THE USER FACILITY: THE PINNACLE WILL RANDOMLY SKIP LINES WHILE COMPOUNDING AND THE MOST COMMON LINES SKIPPED ARE LINES 1 (LIPID) AND 2 (DEXTROSE) BUT OTHER LINES HAVE SKIPPED AS WELL. NO ERRORS ARE ALARMED. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526865 ↗
• MalfunctionSep 13, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS REPORTED BY THE USER FACILITY: EVENT 1: THERE ARE ISSUES WITH BAGS OVER-DELIVERING ON THE PINNACLE COMPOUNDER. NO INJURIES WERE REPORTED. FINAL CONTAINERS WERE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12459978 ↗
• MalfunctionSep 13, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS REPORTED BY THE USER FACILITY: EVENT 3. THERE ARE ISSUES WITH BAGS OVER-DELIVERING ON THE PINNACLE COMPOUNDER. NO INJURIES WERE REPORTED. FINAL CONTAINERS WERE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12459972 ↗
• MalfunctionSep 13, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS REPORTED BY THE USER FACILITY: EVENT 2. THERE ARE ISSUES WITH BAGS OVER-DELIVERING ON THE PINNACLE COMPOUNDER. NO INJURIES WERE REPORTED. FINAL CONTAINERS WERE SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12459968 ↗
• MalfunctionAug 11, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS REPORTED BY THE USER FACILITY: EVENT 3: PATIENTS REPORTED TO CUSTOMER THAT BAGS ARE RUNNING DRY DURING INFUSION. THE BAGS ARE COMPOUNDED ON THE PINNACLE COMPOUNDER. USER FACILITY HAS TRIED INCREASING OVERFILL AND CALIBRATING THE PUMP AFTER EVERY BAG. THEY REPORT THAT NO PINNACLE ERRORS HAVE OCCURRED DURING THIS TIME. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306368 ↗
• MalfunctionAug 11, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS REPORTED BY THE USER FACILITY: EVENT 2: PATIENTS REPORTED TO CUSTOMER THAT BAGS ARE RUNNING DRY DURING INFUSION. THE BAGS ARE COMPOUNDED ON THE PINNACLE COMPOUNDER. USER FACILITY HAS TRIED INCREASING OVERFILL AND CALIBRATING THE PUMP AFTER EVERY BAG. THEY REPORT THAT NO PINNACLE ERRORS HAVE OCCURRED DURING THIS TIME. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306364 ↗
• MalfunctionAug 11, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  AS REPORTED BY THE USER FACILITY: EVENT 1: PATIENTS REPORTED TO CUSTOMER THAT BAGS ARE RUNNING DRY DURING INFUSION. THE BAGS ARE COMPOUNDED ON THE PINNACLE COMPOUNDER. USER FACILITY HAS TRIED INCREASING OVERFILL AND CALIBRATING THE PUMP AFTER EVERY BAG. THEY REPORT THAT NO PINNACLE ERRORS HAVE OCCURRED DURING THIS TIME. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306363 ↗