i.v.STATIONRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 08056477790007), received between Apr 26, 2019 and Aug 12, 2021 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (20 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  IT WAS REPORTED THAT 3 EPHEDRINE SYRINGES FROM A DIFFERENT LOT WERE COMPLETED [20210317-EPH25MG-NEX (ID (B)(6))] WITH INCORRECT QUANTITIES THAT ALSO SUCCESSFULLY PASSED TO ROBOT. TWO SYRINGES HAD 4 MLS AND ONE SYRINGE HAD AROUND 3 MLS, WHEN THE REQUESTED AMOUNT WAS 5 MLS. THE PINCER PRESSURE REGULATOR HAS BEEN INSTALLED. THE SYRINGE WAS VALIDATED BY THE PHARMACIST AND PUT INTO QUARANTINE SINCE IT IS AN EBUD PRODUCT. THE ISSUE WAS FOUND MONTHS LATER WHEN IT WAS BEING PULLED OUT OF STORAGE BY THEIR BUYER. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12312070 ↗
• MalfunctionJul 5, 2021Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE DEVICE PRINTED AN INCORRECT BEYOND USE DATE (BUD) ON THE LABEL DURING PREPARATION. THE CUSTOMER PREPARED SUCCINYLCHOLINE 200 MG/10 ML SYRINGE THAT WAS LABELED WITH LABEL WITH AN EXPIRATION DATE OF 8/14; HOWEVER BUT THE VIAL USED IN CREATING THE PREP EXPIRES 8/1. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12116461 ↗
• MalfunctionJul 5, 2021Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE DEVICE PRINTED AN INCORRECT BEYOND USE DATE (BUD) ON THE LABEL DURING PREPARATION. THE CUSTOMER PREPARED SUCCINYLCHOLINE 200 MG/10 ML SYRINGE THAT WAS LABELED WITH LABEL WITH AN EXPIRATION DATE OF 8/14; HOWEVER BUT THE VIAL USED IN CREATING THE PREP EXPIRES 8/1. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12116458 ↗
• MalfunctionJul 5, 2021Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE DEVICE PRINTED AN INCORRECT BEYOND USE DATE (BUD) ON THE LABEL DURING PREPARATION. THE CUSTOMER PREPARED SUCCINYLCHOLINE 200 MG/10 ML SYRINGE THAT WAS LABELED WITH LABEL WITH AN EXPIRATION DATE OF 8/14; HOWEVER BUT THE VIAL USED IN CREATING THE PREP EXPIRES 8/1. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12116456 ↗
• MalfunctionAug 25, 2020Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  ON (B)(6) 2020, A PREPARATION THAT WAS COMPOUNDED BY AN I.V. STATION DEVICE HAD A LABEL AFFIXED THAT CONTAINED INCORRECT CONTENT. THE BEYOND USE DATE (BUD) PRINTED ON THE LABEL EXCEEDED THE EXPIRATION DATE PROVIDED BY THE VIAL MANUFACTURER. SPECIFICALLY, SYRINGE DRUG PREPARATIONS WERE LABELED WITH A BUD OF (B)(6) 2020 WHILE THE SUCCINYLCHOLINE DRUG VIAL USED IN THE PREPARATION INDICATED AN EXPIRATION DATE OF OCTOBER 1, 2020. THE SOFTWARE, WHICH SHOULD CONSIDER VIAL EXPIRATION DATES WHEN CALCULATING THE BUD, DID NOT PERFORM AS INTENDED AND APPLIED A DATE BEYOND ALLOWABLE USE. THE MISLABELED PREPARATIONS WERE IDENTIFIED AND THERE ARE NO KNOWN ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10448169 ↗
• MalfunctionAug 25, 2020Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  ON (B)(6) 2020 A PREPARATION THAT WAS COMPOUNDED BY AN I.V. STATION DEVICE HAD A LABEL AFFIXED THAT CONTAINED INCORRECT CONTENT. THE BEYOND USE DATE (BUD) PRINTED ON THE LABEL EXCEEDED THE EXPIRATION DATE PROVIDED BY THE VIAL MANUFACTURER. SPECIFICALLY, SYRINGE DRUG PREPARATIONS WERE LABELED WITH A BUD OF (B)(6) 2020 WHILE THE SUCCINYLCHOLINE DRUG VIAL USED IN THE PREPARATION INDICATED AN EXPIRATION DATE OF OCTOBER 1, 2020. THE SOFTWARE, WHICH SHOULD CONSIDER VIAL EXPIRATION DATES WHEN CALCULATING THE BUD, DID NOT PERFORM AS INTENDED AND APPLIED A DATE BEYOND ALLOWABLE USE. THE MISLABELED PREPARATIONS WERE IDENTIFIED AND THERE ARE NO KNOWN ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10448166 ↗
• MalfunctionAug 11, 2020Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  ON (B)(6) 2020 AN I.V. STATION DEVICE PASSED AN UNDERDOSED SYRINGE PREPARATION. THE SYRINGE CONTAINED APPROXIMATELY 3 ML OF EPHEDRINE DRUG SOLUTION WHEN IT SHOULD HAVE CONTAINED 5 ML. THE DEVICE WAS MONITORED AND THE INCORRECT VOLUME ISSUE WAS NOT REPRODUCED. ROOT CAUSE HAS NOT BEEN ABLE TO BE DETERMINED AND NO REMEDIAL ACTION HAS BEEN TAKEN. INVESTIGATION IS ONGOING. THE PREPARATION WAS VISUALLY IDENTIFIED AND THERE ARE NO KNOWN ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10394402 ↗
• MalfunctionJul 28, 2020Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  ON (B)(6) 2020 AN I.V. STATION DEVICE PASSED THREE UNDERDOSED SYRINGE PREPARATIONS. THE SYRINGES CONTAINED APPROXIMATELY 4ML OF NEOSTIGMINE DRUG SOLUTION WHEN THEY SHOULD HAVE CONTAINED 5ML. NO ERRORS WERE GENERATED AND THE INCORRECT VOLUME ISSUE WAS NOT ABLE TO BE REPRODUCED. A SYSTEM MODIFICATION WAS MADE TO ENABLE THE ROBOT PINCER PRESSURE REGULATOR IN ORDER TO ENSURE THAT THE SYRINGE IS NOT HANDLED WITH EXCESSIVE PRESSURE CAUSING POTENTIAL DRUG LOSS AFTER THE PREPARATION HAS BEEN WEIGHED AND MARKED ACCEPTABLE. THE PREPARATIONS WERE VISUALLY IDENTIFIED AND REJECTED AND THERE ARE NO KNOWN ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10332184 ↗
• MalfunctionJun 1, 2020Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  ON (B)(6) 2020 A PREPARATION THAT WAS COMPOUNDED BY AN I.V. STATION DEVICE HAD A LABEL AFFIXED THAT CONTAINED INCORRECT CONTENT. THE BEYOND USE DATE (BUD) PRINTED ON THE LABEL EXCEEDED THE EXPIRATION DATE PROVIDED BY THE VIAL MANUFACTURER. SPECIFICALLY, HYDROMORPHONE DRUG PREPARATIONS WERE LABELED WITH A BUD OF (B)(6) 2020 WHILE THE DRUG VIAL INDICATED AN EXPIRATION DATE OF (B)(6) 2020. THE SOFTWARE, WHICH IS INTENDED TO CONSIDER VIAL EXPIRATION DATES WHEN CALCULATING THE BUD, DID NOT PERFORM AS INTENDED AND APPLIED A DATE BEYOND ALLOWABLE USE. THE MISLABELED PREPARATIONS WERE IDENTIFIED AND THERE ARE NO KNOWN ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10104918 ↗
• MalfunctionMar 4, 2020Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  ON (B)(6) 2020 AN I.V. STATION DEVICE PASSED AN UNDERDOSED SYRINGE PREPARATION. THE SYRINGE WAS MISHANDLED AFTER IT WAS WEIGHED AND MARKED ACCEPTABLE BY THE DEVICE DUE TO IMPROPER FUNCTIONALITY OF THE NEEDLE REMOVER AND ROBOT PINCERS. THE NEEDLE REMOVER SENSOR AND NEEDLE GRIPPER PINCERS WERE REPLACED AND CALIBRATED TO PREVENT RECURRENCE OF THIS ISSUE. THE UNDERFILLED PREPARATION WAS IDENTIFIED AND THERE ARE NO KNOWN ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9787295 ↗
• MalfunctionDec 5, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  ON (B)(6) 2019 AN I.V. STATION PRODUCED DRUG PREPARATIONS WITH LABELS THAT CONTAINED INCORRECT CONTENT. TWO LABELS WERE PRODUCED FOR EACH PREPARATION. ONE LABEL CONTAINED THE CORRECT CONTENT AND INDICATED SUCCINYLCHOLINE DRUG; A SECOND LABEL CONTAINED INCORRECT CONTENT MISLABELING THE PREPARATION AS ROCURONIUM. THE INCORRECT BARCODE WAS DUE TO AN ERROR IN THE LABEL CONFIGURATION, WHICH WAS FIXED. THE MISLABELED PREPARATIONS WERE IDENTIFIED AND AS SUCH THERE IS NO KNOWN ADVERSE PATIENT EFFECT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9415981 ↗
• MalfunctionOct 23, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  ON (B)(6) 2019 AN I.V. STATION PRODUCED A DRUG PREPARATION WITH A LABEL THAT CONTAINED INCORRECT CONTENT. TWO LABELS WERE PRODUCED FOR THE PREPARATION. ONE LABEL CONTAINED THE CORRECT CONTENT AND INDICATED ROCURONIUM DRUG; A SECOND LABEL CONTAINED INCORRECT CONTENT MISLABELING THE PREPARATION AS EPHEDRINE. THE MISLABELED PREPARATION WAS IDENTIFIED AND AS SUCH THERE IS NO ADVERSE PATIENT EFFECT. HOWEVER, IF THE IMPROPERLY CONFIGURED LABEL WERE NOT IDENTIFIED, IT COULD RESULT IN THE INCORRECT PREPARATION BEING USED AND SUBSEQUENT PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9226640 ↗
• MalfunctionOct 23, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  ON (B)(6) 2019 AN I.V. STATION DEVICE PASSED AN UNDERDOSED SYRINGE PREPARATION. THE DEVICE REMOVED THE NEEDLE BUT FAILED TO CAP THE SYRINGE AND AS A RESULT SOME DRUG WAS EJECTED FROM THE SYRINGE CAUSING THE FINAL VOLUME TO BE OUTSIDE OF THE ALLOWED PERCENTAGE OF ERROR. THE UNDERFILLED PREPARATION WAS IDENTIFIED AND THERE ARE NO KNOWN ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9226637 ↗
• MalfunctionOct 7, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  ON (B)(6) 2019 AN I.V. STATION DEVICE PASSED AN UNDERDOSED SYRINGE PREPARATION. THE DEVICE FAILED TO REMOVE THE NEEDLE AND CAP THE SYRINGE AND AS A RESULT SOME DRUG WAS EJECTED FROM THE SYRINGE CAUSING THE FINAL VOLUME TO BE OUTSIDE OF THE ALLOWED PERCENTAGE OF ERROR. THE UNDERFILLED PREPARATION WAS IDENTIFIED AND THERE ARE NO KNOWN ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9162113 ↗
• MalfunctionSep 17, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  ON (B)(6) 2019 AN IV BAG THAT WAS PREPARED BY AN I.V. STATION DEVICE HAD A LABEL AFFIXED THAT CONTAINED INCORRECT CONTENT. THE LABEL FOR OXYTOCIN INCORRECTLY INCLUDED INFORMATION FROM 2 DIFFERENT PREPARATIONS DUE TO AN OVERPRINT. THE MISLABELED PREPARATION WAS IDENTIFIED AND THERE ARE NO KNOWN ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9077597 ↗
• MalfunctionSep 17, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  ON (B)(6) 2019 AN I.V. STATION DEVICE PASSED AN UNDERDOSED SYRINGE PREPARATION. THE DEVICE FAILED TO REMOVE THE NEEDLE AND CAP THE SYRINGE AND AS A RESULT SOME DRUG WAS EJECTED FROM THE SYRINGE CAUSING THE FINAL VOLUME TO BE OUTSIDE OF THE ALLOWED PERCENTAGE OF ERROR. THE UNDERFILLED PREPARATION WAS IDENTIFIED AND THERE ARE NO KNOWN ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9077584 ↗
• MalfunctionSep 5, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  ON (B)(6) 2019 AN IV BAG THAT WAS PREPARED BY AN I.V. STATION DEVICE HAD A LABEL AFFIXED THAT CONTAINED INCORRECT CONTENT. THE LABEL FOR A SODIUM PHOSPHATE PREPARATION INCORRECTLY INCLUDED A BAR CODE FOR VANCOMYCIN. THE MISLABELED PREPARATION WAS IDENTIFIED AND THERE ARE NO KNOWN ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8964981 ↗
• MalfunctionAug 16, 2019Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  ON JULY 18, 2019 AN I.V. STATION DEVICE PASSED MULTIPLE UNDERDOSED AND INADEQUATELY RECONSTITUTED VIALS USED FOR FINAL DRUG PREPARATION. SANDOZ VIALS USED FOR CEFAZOLIN PREPARATIONS WERE NOT EFFECTIVELY WEIGHED DURING PREPARATION, CAUSING VIALS TO BE UNDERFILLED WITH DILUENT, NOT FULLY RECONSTITUTED AFTER SHAKING AND OUTSIDE OF THE ALLOWED PERCENTAGE OF ERROR FOR VIAL PREPARATION. ALL VIALS WERE IDENTIFIED AND THERE ARE NO KNOWN ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8901874 ↗
• MalfunctionMay 30, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  ON (B)(6) 2019 A PREPARATION THAT WAS COMPOUNDED BY AN I.V. STATION DEVICE HAD A LABEL AFFIXED THAT CONTAINED INCORRECT CONTENT. THE BEYOND USE DATE (BUD) PRINTED ON THE LABEL EXCEEDED THE EXPIRATION DATE PROVIDED BY THE VIAL MANUFACTURER. SPECIFICALLY, THE DRUG VIAL INDICATED AN EXPIRATION DATE OF JUNE 30, 2019, WHILE THE BUD DATE PRINTED ON THE COMPOUNDED STERILE PREPARATION WAS AUGUST 18, 2019. THE MISLABELED PREPARATION WAS IDENTIFIED AND THERE ARE NO KNOWN ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8653753 ↗
• MalfunctionMay 30, 2019Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  ON (B)(6) 2019 AN I.V. STATION DEVICE PASSED AN UNDERDOSED SYRINGE PREPARATION. THE SYRINGE CONTAINED ONLY 4ML OF NEOSTIGMINE DRUG SOLUTION WHEN IT SHOULD HAVE CONTAINED 5ML. THE PREPARATION WAS VISUALLY IDENTIFIED AND THERE ARE NO KNOWN ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8653750 ↗
• MalfunctionMay 16, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  ON (B)(6) 2019 AN IV BAG THAT WAS PREPARED BY AN I.V. STATION DEVICE HAD A LABEL AFFIXED THAT CONTAINED INCORRECT CONTENT. THE LABEL FOR A VANCOMYCIN PREPARATION INCLUDED A BAR CODE FOR OXYTOCIN. THE MISLABELED PREPARATION WAS IDENTIFIED AND THERE ARE NO KNOWN ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8615497 ↗
• MalfunctionMay 16, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  ON (B)(6) 2019 AN IV BAG THAT WAS PREPARED BY AN I.V. STATION DEVICE HAD A LABEL AFFIXED THAT CONTAINED INCORRECT CONTENT. THE LABEL FOR A PHENYLEPHRINE PREPARATION INCLUDED A BAR CODE FOR OXYTOCIN. THE MISLABELED PREPARATION WAS IDENTIFIED AND THERE ARE NO KNOWN ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8615492 ↗
• MalfunctionMay 10, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  ON (B)(6) 2019 AN I.V. STATION PRODUCED A DRUG PREPARATION WITH A LABEL THAT CONTAINED INCORRECT CONTENT. THE LABEL FOR A VANCOMYCIN PREPARATION INCLUDED A BARCODE FOR OXYTOCIN. THE MISLABELED PREPARATION WAS IDENTIFIED AND WAS NOT ADMINISTERED AND AS SUCH THERE IS NO ADVERSE PATIENT EFFECT. HOWEVER, IF THE IMPROPERLY CONFIGURED LABEL WERE NOT IDENTIFIED, IT COULD RESULT IN THE INCORRECT PREPARATION BEING USED AND SUBSEQUENT PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8601202 ↗
• MalfunctionApr 26, 2019Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  ON (B)(6) 2019 AN I.V. STATION DEVICE MISLABELED A BAG PREPARATION. THE LABEL INTENDED FOR A HEPARIN PREPARATION CONTAINED THE CORRENT HEPARIN INFORMATION, BUT ALSO CONTAINED SOME INFORMATION FOR A SEPARATE VANCOMYCIN PREPARATION. THE LABEL CONTAINING DUPLICATIVE AND INCORRECT CONTENT WAS IDENTIFIED AND DISCARDED, AND AS SUCH THERE IS NO ADVERSE PATIENT EFFECT. HOWEVER, IF THE MALFUNCTION CAUSING INCORRECT CONTENT TO PRINT ON A LABEL WERE TO RECUR, THERE ARE POTENTIAL CIRCUMSTANCES THAT WOULD RESULT IN THE INCORRECT PREPARATION BEING USED, POTENTIALLY CAUSING SERIOUS INJURY AND/OR DEATH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8555708 ↗