MAUDE Adverse Event Report: MEDICATION BAG; SET, I.V, FLUID TRANSFER

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2018

Event Type  No Answer Provided  

Event Description

We would like to make ismp aware of a supply error that has occurred in our facility on two occasions now.Our pharmacy routinely orders 20% intralipid solutions [fresenius (b)(4)] through our central supply system and they are delivered to the pharmacy in blue totes.On (b)(6) 2018, our pharmacy received a tote of intralipids that also contained a bag of viper slide lubricant[csi] mixed in with the intralipid bags.Viper slide lubricant is indicated for use with csi orbital atherectomy systems.You can see from the attached pictures that these products look extremely similar both in fluid consistency (white liquid) and packaging.The viper slide lubricant bag was not initially noticed by our pharmacy technician and was stocked, unknowingly, in our iv room along with the other intralipids from that tote.Thankfully, one of our pharmacists noticed the lubricant error when they went to pull it for medication preparation.Then, last week, a pharmacist found another bag of lubricant mixed in with our intralipid order.We have communicated these errors to our central supply group and they are investigating how these lubricant bags are ending up in our intralipid supply.Csi should change their packaging to ensure it cannot be confused with other intralipid solutions.Medication administered to or used by the patient: no; where did the error occur: hospital; level of staff who discovered the error: pharmacist.(b)(6); access number: (b)(4).

• Brand Name: MEDICATION BAG
• Type of Device: SET, I.V, FLUID TRANSFER
• MDR Report Key: 8228384
• MDR Text Key: 132791883
• Report Number: MW5082939
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2018

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
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1