MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ABACUS SOFTWARE; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Device Problems Use of Incorrect Control/Treatment Settings (1126); Human-Device Interface Problem (2949); Application Program Problem: Medication Error (3198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2022

Event Description

Our hospital uses the abacus tpn compounder sold by baxter.There was an error in which the wrong weight was transcribed from the order (actual patient weight instead of order weight) such that the tpn compounder pumped 25% more nutritional components than ordered (weight based entries), this resulted in a warning that the volume of sterile water to complete the volume remaining was insufficient to flush the pump lines (less than 30 ml).Unfortunately pharmacist did not recognized that the source of the error was that the wrong weight was entered and the patients were subsequently ordered suboptimal tpn mixtures that were more diluted than necessary.Internal systems updates being pursued to decrease risk of this error.Reporting through medwatch to encourage review by baxter of additional safeguards that could be added to their systems including updating weight field to "order weight" and warnings/hard stops if the weight for a given patient changes too quickly (delta greater than xx% since previous order, for example).Integration between emrs and tpn compounders will dramatically reduce programming errors as it has with infusion pumps.Fda safety report id # (b)(4).

• Brand Name: ABACUS SOFTWARE
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 14676543
• MDR Text Key: 294032585
• Report Number: MW5110266
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 DA
• Patient Sex: Male
• Patient Weight: 4 KG