MAUDE Adverse Event Report: EPIC INTERNATIONAL (THAILAND) CO., LTD. SMART EZ PUMP; PUMP, INFUSION, ELASTOMERIC

Device Problems Use of Device Problem (1670); Inadequate User Interface (2958)

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

Event Description

Wrong elastomeric pump selected and using during compounding process potentially resulting in wrong rate errors situation errors (e.G.Wrong rate, wrong duration) can occur when the incorrect elastomeric pump is selected by pharmacy personnel and filled with a drug for a patient on a continuous infusion that is commonly started in the clinic and continued at home.Background elastomeric pumps are typically used in the home infusion space and are specifically calibrated to deliver a medication at a certain rate or over a prespecified duration.For example, one pump model is designed to deliver at a rate of 2 ml per hour whereas another model is designed to deliver at a rate of 10 ml per hour.Pharmacy compounding personnel need to select the correct pump model for that patient to fill with medication.Current workflow technology used (epic's dispense prep) allows for individual medication components to be scanned ensuring the correct medications prior to compounding.While elastomeric pumps do have a barcodes available on it unlike the drug and base solution, is not part of the medication build and thus is not required to be scanned to ensure the correct pump is selected.Assessment: in order for the pump to be part of the medication build, drug database vendors need to include the device and its barcode to the database.The vendor our organization contracts with ((b)(6)) have denied requests to include these elastomeric pump bar codes into the database.Education, clear labeling of bins, and color coding have already been employed.Recommendation: requesting the assistance of ismp by sharing this error in the ismp acute care newsletter, and writing a letter to first databank encouraging the company to include this as part of the database so that scanning technology can be leveraged.Color coding (done) - separation of pumps with clear labeling of bins (done), education (done, low leverage) - use scanning technology (would like to employ but need drug database vendor to assist).Ismp, (b)(4).Submission id: (b)(4).

• Brand Name: SMART EZ PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.
• MDR Report Key: 14830041
• MDR Text Key: 294940490
• Report Number: MW5110520
• Device Sequence Number: 1
• Product Code: MEB
• 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: 05/18/2022

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2022
• Patient Sequence Number: 1