MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MINI-BAG PLUS (MBP); EQUIPMENT LOBORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICA

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Type  No Answer Provided  

Event Description

To ensure medication safety, it is important that medications be scanned properly prior to administration.However, the barcodes on mini-bag plus (mbp) and add-vantage ivpbs have caused an issue with this process at (b)(6) hospital.Appropriate barcode scanning by nurses administering these preparations require the scanning of both the drug vial and the ivpb bag.The ivpb bags have a white barcode that makes it difficult for nurses to scan if a pt label is present on the other side.As a result, a medication scan override occurs and the medication ends up not being properly scanned.For example, an analysis was conducted to determine the number of ampicillin 2 g in ns 100 ml mbp bags dispensed over a 24 hour period; 33 bags were dispensed in total; however, 25 bags had at least one component (ampicillin or ns) not scanned.Of the 25 not scanned, 18 were attributed to the ns, 9 of them due to the barcode being unreadable.To fix this issue, the pt label is to be placed sideways on the product or flagged in order for the barcode to be scanned.Although this alteration allows for proper barcode scanning, it is merely a temporary fix.Ultimately, it would be beneficial for the mfr to change the color of the barcode from white to black.This would allow for the pt label to be properly placed on the opposite side while the barcode would now able to be scanned, ensuring the correct medication is going to the right pt.Medication administered to or used by the pt: no.Ismp, (b)(6) access number: (b)(4).

• Brand Name: MINI-BAG PLUS (MBP)
• Type of Device: EQUIPMENT LOBORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICA
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 8128826
• MDR Text Key: 129435315
• Report Number: MW5081788
• Device Sequence Number: 1
• Product Code: LXG
• 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: 10/24/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1