MAUDE Adverse Event Report: BAXTER CORPORATION ENGLEWOOD EXACTAMIX; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Model Number H9382400-DY

Device Problems Calibration Problem (2890); Infusion or Flow Problem (2964); Output Problem (3005); Pumping Problem (3016)

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

Event Date 07/02/2021

Event Type  malfunction  

Event Description

Pharmacy had issues with the total parenteral nutrition (tpn) compounder when the daily setup occurred around 1000.Error messages about connections.Baxter (pump manufacturer) was contacted for troubleshooting sometime before 1200.Baxter had the technicians unplug and re-plug in the load cell (scale) to reset it.Pump started working after this and it ran multiple calibration cycles during the setup.However, staff noted that when they scanned the label barcode, it didn't immediately ask them to pick a bag size.Staff would hit "run" and then it would ask them if they wanted to select a bag size.Staff told the baxter rep about this and he confirmed that was one of the setting options.There was a way to change the order when you selected the bag size, but staff did not want to risk restarting the pump and is having errors again.The baxter rep said this was fine because it was just a preference setting.Pumping of tpns after this time was pretty unremarkable and the weight variances were within range all day.That same night, the pharmacy manager was working overnight and thought those messages about the load cell and bag selection were weird, so she attempted to re-calibrate the pump.Manager had already pumped a few fluid bags without issue.Each time she re-calibrated, it was off by -9%.Manager changed the sterile water and did other things she knew to troubleshoot, and it did not fix the issue, so she escalated to pharmacy is, who then called baxter again.Baxter had her do a re-calibration of the whole pump, but they did not think the load cell alert was concerning.Baxter also had her validate the "oem" (original equipment manufacturer) setting which was set at 0.84.Baxter noted this was "odd." after the manager did the pump reset, the bags were once again within the correct weight range and the oem was updated to 0.98 automatically, which baxter confirmed was "correct." baxter noted that sterile water was likely the issue during pumping, but that staff could not see the oem to know it was wrong.The pharmacy manager decided to go back and weigh the bags she had pumped before this re-calibration and she noticed they were underweight.The charge pharmacist overnight and overnight pharmacy manager called another pharmacy manager to discuss the issue.This pharmacy manager had them weigh some starter tpns that were pumped around 1400 and those were also underweight by 5-8%.Pharmacy staff evaluated mix check reports from pump to determine other fluid bags that may have been affected (6 items): tacrolimus fluid bag, starter tpns, cefepime stock fluids, three patient specific bags.Staff escalated to pharmacy leadership and discussed risk vs.Benefit of continuing to run the tpns.Risks: more concentrated, may run out early, cannot re-pump 36 tpns overnight, unclear how much each tpn was affected, peripheral lines with potentially higher osmolarity benefit: providing critical nutrients, may not be clinically significant.Pharmacy decided to let the medical teams decide how significant it was for each patient since there was a risk to discontinuing therapy.Pharmacy staff also contacted the nicu picu pharmacists to escalate discussion to their medical teams.Pharmacy staff called and spoke with the hospital shift supervisor, who said she would notify charge nurses and providers.Pharmacy staff called the remaining affected medical teams to let them know what the options were (keep running tpn, running equivalent fluid, recommend checking bmp, get tpn order in early for saturday).They also discarded starter tpns and cefepime.Starter tpns weren't used and the cefepime was probably not clinically significant since our antibiotic threshold is usually /- 10%.Pharmacy staff also notified ho pharmacist about potential volume difference with tacrolimus bag that may alter levels.It is likely that all parenteral nutrition from 7/2 was under-pumped by 5-10%.The impacted ingredient was sterile water so tpns may be more concentrated than expected.No patient harm occurred.Patient monitored closely to assure no patient harm.

• Brand Name: EXACTAMIX
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER CORPORATION ENGLEWOOD; one baxter parkway; deerfield IL 60015
• MDR Report Key: 12438402
• MDR Text Key: 270304354
• Report Number: 12438402
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: H9382400-DY
• Device Catalogue Number: 2400DY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 DA