MAUDE Adverse Event Report: BAXTER CORPORATION ABACUS TPN CALCULATIONS SOFTWARE

Model Number SOFTWARE V.3.2

Device Problems Fail-Safe Design Failure (1222); Inadequate or Insufficient Training (1643); Application Program Problem: Medication Error (3198)

Patient Problem Multiple Organ Failure (3261)

Event Date 02/20/2017

Event Type  Death  

Event Description

An order was placed for albumin 5% 250ml/normal saline 750ml irrigation solution.In preparing a request for the solution using the abacus automated compounder software v.3.2, the perioperative pharmacy selected the "new solution" pathway instead of the "repeat selected" pathway to access the saved formula.This resulted in generation of a label which, though named "ns 750ml for operating room (liver transplant)," contained bar coding that, when scanned into an automated compounder in the iv room pharmacy, resulted in its preparation of a default diluent fluid of sterile water instead of normal saline as ordered.The discrepancy between the label and the fluid ingredient list was not subsequently recognized in a review of a "mix check" report.The bag containing sterile ater was sent to the perioperative pharmacy where albumin 5% 250ml was added and the product was dispensed.The solution was used to flush a cadaver liver in a basin prior to transplant.The bag was discarded.A pt received the liver on (b)(6)2017.The pt experienced problems with primary non-function of the transplanted liver and subsequent deterioration of his clinical condition.The pt was emergently re-listed for transplant but expired on (b)(6)2017.A subsequent pharmacist check of another ns 750ml bag made by the automated compounder on (b)(6)2017 revealed that the contents contained sterile water instead of normal saline as ordered.A thorough lookback eval was conducted and it was discovered that the incorrect formula dispensed on (b)(6)2017 using the method described above had been used to irrigate the liver of the deceased pt.

• Brand Name: ABACUS TPN CALCULATIONS SOFTWARE
• Type of Device: ABACUS
• Manufacturer (Section D): BAXTER CORPORATION ; englewood CO
• MDR Report Key: 6643157
• MDR Text Key: 77737013
• Report Number: 6643157
• Device Sequence Number: 0
• Product Code: NEP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SOFTWARE V.3.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/23/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 68 YR
• Patient Weight: 87