MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ABACUS V3.3 ME; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number 83003393

Device Problem Filling Problem (1233)

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

Event Date 01/31/2022

Event Type  malfunction  

Event Description

It was reported that an overinfusion occurred after using the abacus calculation software.The parenteral nutrition (tpn) was set to a continuous rate in infusion mode; however, appeared as a cyclic rate on the printed tpn bag label instruction.This error resulted in the patient receiving the whole tpn at a much more rapid rate than expected (over a 12-hrs period instead of the intended 24-hrs duration).There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Initial reporter address - (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Corrected information: h6 and h10.Correction to h6: added the investigation codes (omitted on initial).Correction h10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed (omitted on initial).Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ABACUS V3.3 ME
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ECM - ENGLEWOOD; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 13640149
• MDR Text Key: 286432338
• Report Number: 1416980-2022-00827
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 83003393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 03/01/2022
• Supplement Dates Manufacturer Received: 07/13/2022
• Supplement Dates FDA Received: 07/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male