FDA Adverse Event Injury Summary report: N

CLEARLINK SYSTEM NON-DEHP SECONDARY MEDICATION SET WITH DUO-VENT SPIKE (37 INCH

MDR report key: 4728342 · Received April 20, 2015

Report

Report Number
MW5042259
Event Type
Injury
Date Received
April 20, 2015
Date of Event
April 14, 2015
Report Date
April 20, 2015
Manufacturer
BAXTER HEALTHCARE CORP
Product Code
FPA
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CT, US
Reporter Occupation
PHARMACIST

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
259678 CLEARLINK SYSTEM NON-DEHP SECONDARY MEDICATION SET WITH DUO-VENT SPIKE (37 INCH SECONDARY TUBING FPA BAXTER HEALTHCARE CORP 2H7462 UNK

Patients

Seq Age Sex Outcome Treatment
1 16 YR Required Intervention