MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP CLEARLINK SYSTEM NON-DEHP SECONDARY MEDICATION SET WITH DUO-VENT SPIKE (37 INCH; SECONDARY TUBING

Model Number 2H7462

Device Problem Particulates (1451)

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

Event Date 04/14/2015

Event Type  Injury  

Event Description

On (b)(6) 2015 a dose of acyclovir 660 mg prepared on 0.9% nacl 100 ml was administered as a secondary infusion using a clearlink system non-dehp secondary medication set with a duo-vent spike (37 inch tubing) manufactured by baxter healthcare corp (item# 2h7462).(the acyclovir concentration was 6.6 mg/ml, which is within the recommended concentration of <7 mg/ml established by the manufacturer.) the acyclovir infusion was piggybacked into a primary line that was infusing d4w/0.45% nacl.The secondary line as flushed with d5w/0.45% nacl prior to use, which is physically and chemically compatible with acyclovir.Prior to initiation of the acyclovir and d5w/0.45% nacl infusions, all infusions and tubing were free of visible particulate matter.Immediately following initiation of the acyclovir infusion, the fluid contained in the drip chamber of the secondary line in question became cloudy in appearance, reflecting rapid development of particulate matter.The acyclovir infusion was terminated before particulate matter reached the pt via secondary tubing.The secondary line had been in use for approx 90 hours at the time the event occurred.The pt's medication list was assessed for potential incompatible intravenous medications, none of which were administered immediately prior to acyclovir or d5w/0.45% nacl, suggesting that medication or fluid incompatibility did not contribute to precipitate formation.The lot number of the secondary line in question was not documented prior to use.However, lot numbers of secondary tubing present in the pt care area at the time the event occurred included: r15a19134, r14l01099, and r14028098.Given the inability to identify add'l factors that may have contributed to precipitate formation, the possibility of a defect within the tubing is being proposed for investigation.

• Brand Name: CLEARLINK SYSTEM NON-DEHP SECONDARY MEDICATION SET WITH DUO-VENT SPIKE (37 INCH
• Type of Device: SECONDARY TUBING
• Manufacturer (Section D): BAXTER HEALTHCARE CORP; deerfield IL
• MDR Report Key: 4728342
• MDR Text Key: 5669293
• Report Number: MW5042259
• Device Sequence Number: 1
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/20/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 2H7462
• Device Catalogue Number: 2H7462
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR
• Patient Weight: 73