MAUDE Adverse Event Report: BD BD PREFILLED HEPARIN LOCK FLUSH 2500 UNITS/ML; SALINE VASCULAR ACCESS FLUSH

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  No Answer Provided  

Event Description

A pediatric pt at our hosp unintentionally received multiple 5ml doses of antibiotic locks (gentamicin 1mg/ml and heparin 2500 units/ml).These were intended to be used as locks for cvc lines, where the priming volume for the lines would be instilled, dwell for a few hours, and then be withdrawn prior to the next lock administration.The order did not specify a dwell volume for the cvc lines.The above concentration for gentamicin lock with heparin was used based on idsa guidelines.Pt experienced bleeding episodes from several locations and it was later identified that the gentamicin-heparin locks were the likely cause for bleeding.Symptoms were resolved after the gentamicin-heparin locks were discontinued.Perception of antibiotic lock terminology by pharmacy and nursing was found to be different.The nursing team aspirated 5ml from the line before each antibiotic lock administration, and then flushed the new lock through the line after the specified dwell time.There was no pre-built order on epic for this specific lock, and hence it was entered using unlisted pathway which has limitations on specifying the actual drug dose, in this case priming volume for the cvc line.Although administration instructions stated to instill and withdraw after the dwell time, having no dose (priming volume) specified on the order/label led to the administration of the whole contents of the syringe, 5ml.Our improvement actions included house-wide education on antibiotic locks, development of an order set for antibiotic locks, where the priming volume is a hard stop for the providers, development of a policy and also customizing all unlisted iv medications with a hard stop that requires the provider to consult with both the pharmacist and nurse to release the order.Bd prefilled heparin flushes - the name "heparin lock flush" contributed to some confusion on terminology of "lock" vs "flush".Pt counseling provided: unk.(b)(4).

• Brand Name: BD PREFILLED HEPARIN LOCK FLUSH 2500 UNITS/ML
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD
• MDR Report Key: 8744495
• MDR Text Key: 149925261
• Report Number: MW5087695
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• 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: 06/28/2019
• Patient Sequence Number: 1