MAUDE Adverse Event Report: OMNICELL, INC. OMINCELL IVX; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Description

We use omnicell lvx in our sterile compounding suite.We had several recent error reports with cisatracurium syringes where the final concentration on the emr (epic) generated label appears mismatched with the concentration of the source vial product in the omnicell product label.The mismatched concentration on two different labels creates confusion for the nurse.The omnicell product label applied by the technician immediately after compounding contains the barcode whereas the final syringe label (prints after pharmacist check) does not and therefore, it cannot be covered or removed.For example, the 100 mg of cisatracurium source product (2mg/ml) is mixed with 50 ml of d5w to make a final volume of 100 ml.The final concentration of the product label is 1mg/ml in the label.This creates the confusion of whether the concentration of cisatracurium is 2mg/ml or 1ml/ml to the nurse.Omnicell requires software updates to correct the labeling discrepancy and is not available for several more updates.Can ismp help with guidance for iv workflow technology vendors for standardized labeling and encourage vendors to adopt? computer physician order entry poor label design {physical label): label misleading or difficult to read similar labels/packaging communication, poor/lacking (nonspecific) transcription error/misunderstood order.(b)(6).Submission id: (b)(4).

• Brand Name: OMINCELL IVX
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): OMNICELL, INC.
• MDR Report Key: 12813255
• MDR Text Key: 280949673
• Report Number: MW5105292
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Treatment: CISATRACURIUM BESYLATE