Summary of MedSun Reports Describing Adverse Events With Infusion Tubing used with Power Injectors
MedSun: Newsletter #46, March 2010

Description of infusion tubing taken from the Code of Federal Regulations:

Infusion tubing is a component of an intravascular administration set. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container [1].

The tubing described above is often used to access the vascular system for physiologic imaging procedures in connection with a power injector. As defined, “Power injectors are devices that are used to enhance diagnostic images by injecting radiopaque contrast media at controlled rates” [2].

Over the past 2 years, MedSun has received 17 adverse event reports associated with ruptured infusion tubing and power injectors. The infusion tubing associated with the reports was manufactured by 7 firms in total: Baxter HealthCare Corporation (4), Cardinal Health 200, Inc. (3), Hospira LTD (6), ICU Medical, Inc. (2), C.R. Bard, Inc. (1), Mallinckodt Inc., Liebel-Flarsheim Business (1), The reports were submitted by 12 hospitals between August, 2007 and August, 2009.

The reported device problems were:
• Material rupture (5)
• Split (5)
• Burst (1)
• Component broke off (1)
• Cracked (1)
• Detachment of device component (1)
• Exploded (1)
• Failure to infuse (1)
• Leak (1)

No patient injuries were listed in these reports. One technician injury occurred when blood sprayed in the technician’s face and eye.

Of the reports that listed patient age, 1 had a patient age listed as less than 21 years and 13 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 11 reports involved female patients and a total of 3 reports involved male patients.

The following is a list of recommendations made by an FDA working group and an independent author made to minimize the risk of ruptured tubing:

1. Check the labeling of each vascular access device for its maximum pressure and flow rate. If none is provided, assume device is NOT intended for power injection and do not use. [3].

2. Know the pressure limit setting for your power injector and how to adjust it. [3]

3. Ensure that the pressure limit set for the power injector does not exceed the maximum labeled pressure for the vascular access device(s) [3].

4. Know the manufacturer's recommendations and your facility's protocols for the injection of contrast media using power injectors. [2].

5. Monitor the patient for adverse reactions [2].


It is important to note that if the recommended pressure for a vascular access device is exceeded, the device may weaken even if no rupture is obvious, and the weakened device could fail to operate properly when it is used again [3].

The following table is a listing of events that have occurred pertaining to tubing rupture in use with a pressure injector over the time line specified above. Note: some descriptions may have changed for clarity.

Event Reports Involving Ruptured Infusion Tubing and Power Injectors
Manufacturer NameBrand Name Model # Lot # Catalog # Event Description
BAXTER HEALTHCARE CORPORATION INTERLINK SOLUTION SET None S08L06047R OR S08K09043R 2C6402S IV ACCESS WAS OBTAINED FOR CT IMAGING. SALINE TUBING WAS CLAMPED, AND THE IV CONTRAST POWER INJECTOR TUBING WAS ATTACHED TO THE PORT CLOSEST TO THE IV SITE. INITIALLY, THERE WERE NO PROBLEMS, AND THE PATIENT HAD NO PAIN. AFTER APPROXIMATELY 25 SECONDS, THE TUBING DISTAL TO THE CLAMP BURST.
LIEBEL-FLARSHEIM CO HIGH PRESSURE EXTENSION TUBE WITH ROTATING MALE LUER ADAPTER 601281 1146129 None VISIPAQUE WAS BEING INJECTED VIA HIGH PRESSURE EXTENSION TUBING AT A RATE OF 1200 PSI. THE TUBING BROKE, CAUSING THE MEDICATION TO SHOOT OUT OF THE TUBING. THE MALE LUER CONNECTOR BROKE OFF WHERE THE MALE LUER LOCK ATTACHES TO THE TUBING. THERE WAS NO PATIENT HARM.
CARDINAL HEALTH 303, INC. ALARIS 2420-0007 None None THE PATIENT WAS SCHEDULED FOR A CT SCAN. THE RN WAS ADMINISTERING IV CONTRAST WHEN THE IV TUBING EXPANDED AND THE TUBING CRACKED. THE TUBING WAS QUICKLY REPLACED. THERE WAS A MINOR DELAY TO REPLACE THE TUBING. THERE WAS NO PATIENT HARM.
C.R. BARD, INC. POWERLOC None ASQLS003 672010 PATIENT ARRIVED WITH POWER PORT IN PLACE. ACCESSED PORT WITH POWER PORT HUBER NEEDLE, EASY ACCESS WITH BLOOD RETURN, FLUSHED PORT WITH 10CC NORMAL SALINE. PATIENT ON CT SCANNER. CT SCAN COMPLETED AND PATIENT MENTIONED TO STAFF THAT SHE FELT WET NEAR HER LEFT AXILLA. STAFF LOOKED AND FOUND NO CAP ON SIDE PORT OF PORTACATH HUBER NEEDLE AND BLOOD BACKING OUT OF SIDE PORT. THE CAP THAT WAS COVERING THE SIDE PORT WAS GONE. CT CONTRAST WAS INJECTED INTO PATIENT AS SEEN ON CT SCAN. PORT WAS FLUSHED AGAIN WITH 10ML NORMAL SALINE AND THEN HEPARIN. NEEDLE REMOVED WITHOUT INCIDENT. POWER INJECTOR WAS USED TO INJECT CONTRAST.
BAXTER HEALTHCARE CORPORATION CONTINU-FLO SOLUTION SET None None 2C8537 THE TECH WAS INJECTING IV CONTRAST INTO THE IV TUBING PORT CLOSEST TO THE CATHETER. THE PATIENT HAD AN 18 GAUGE CATHETER IN THE ANTECUBITAL SPACE. A POWER INJECTOR WAS BEING USED AT THE RATE OF 4ML/SECOND. SUDDENLY, THE IV TUBING EXPLODED, BLOOD BACKED UP FROM THE IV CATHETER AND SPRAYED INTO THE TECHNICIAN'S FACE AND EYES.
BAXTER HEALTHCARE CORPORATION CLEARLINK, CONTINU FLO CLEARLINK, CONTINU FLO None 2C8537 ISSUE INITIALLY ADDRESSED WITH BAXTER EARLIER THIS MONTH ABOUT TWO ONCOLOGY CLINICS ISSUES. ISSUE: "NO FLOW" OCCURRED BETWEEN THE PRIMARY SET INJECTION PORT AND THE SECONDARY MEDICATION SET WHEN ADMINISTERING MEDICATION TO PATIENTS. REPORTING MEMBER PROVIDED BAXTER TWO SETS FROM EACH AFFECTED LOT. THE REPORTED CONDITION OF "NO FLOW" COULD NOT BE CONFIRMED. BAXTER LOOKED AT THE SETS TO CONFIRM THAT THE SLIT IN THE VALVE WAS AS IT SHOULD BE (SO THAT LIQUID WOULD NORMALLY FLOW). BAXTER STATED THAT THE SLITS WERE WITHIN THEIR SPECIFICATIONS. BAXTER ALSO TESTED ALL OF THE LUERS TO SEE THAT THEY WERE WITHIN SPECIFICATION. REPORTING MEMBER STILL HAD THE BAG THAT HAD THE NO FLO SET UP. BAXTER TRIED TO RESTART THE SET AND ALSO GOT "NO FLOW." AFTER REPOSITIONING THE BAGS, RE-HANGING THEM AND THE DOING AN UPSIDE DOWN PRIME ON THE BAGS AND RECONNECTING THE TUBING, BAXTER WAS ABLE TO GET THE LIQUID TO FLOW OUT OF THE PRIMARY AND SECONDARY SETS. REPORTING MEMBER MENTIONED TO BAXTER THAT THOUGH BAXTER (AFTER ABOUT 10 MINUTES) WAS ABLE TO CORRECT THE "NO FLOW" PROBLEM, OUR CLINICIANS DON'T HAVE TEN MINUTES (EVERY TIME THEY GO TO ADMINISTER CHEMO) TO REPRIME AND CHECK ALL TUBING. REPORTING MEMBER MENTIONED THAT WE WOULD BE SENDING THIS REPORT TO FDA. BAXTER IS ALSO DOING SOME ADDITIONAL IN SERVICES AT REPORTING MEMBERS FACILITIES DUE TO THE FACT THAT THE PROCESS/TECHNIQUE TO USE THE CLEARLINK PRODUCTS IS QUITE DIFFERENT THAN OTHER TECHNIQUES. BAXTER ALSO TOOK ADDITIONAL SETS (WITHIN THE SAME PRODUCT CODE) FROM THE FACILITY AS IT DOING ADDITIONAL TESTING AND PROVIDING REPORTING MEMBER A SECOND FOLLOW UP REPORT. MANUFACTURER RESPONSE FOR TUBING, IV, CLEARLINK, CONTINU FLO: REPORTING MEMBER PROVIDED BAXTER TWO SETS FROM EACH AFFECTED LOT. THE REPORTED CONDITION OF "NO FLOW" COULD NOT BE CONFIRMED. BAXTER LOOKED AT THE SETS TO CONFIRM THAT THE SLIT IN THE VALVE WAS AS IT SHOULD BE (SO THAT LIQUID WOULD NORMALLY FLOW). BAXTER STATED THAT THE SLITS WERE WITHIN THEIR SPECIFICATIONS. BAXTER
BAXTER HEALTHCARE CORPORATION BAXTER EXTENSION SET (1C8363) None None 1C8363 "OVER THE SUMMER, THE NICU CNS (CLINICAL NURSE SPECIALIST), REPORTED FOUR INCIDENTS OF LEAKS WHILE USING THE BAXTER 0.22 MICRON DOWNSTREAM HIGH PRESSURE EXTENDED LIFE, POLYETHYLENE LINED TUBING, MALE LUER LOCK ADAPTER (MANUFACTURING # 1C8363). I CONTACTED THE BAXTER REPRESENTATIVE AND SENT FAILED TUBING TO THE BIOMEDICAL DEPARTMENT AS WELL AS BAXTER'S QUALITY TESTING DEPARTMENT. OVER THE PAST WEEK, THREE MORE INCIDENTS OF FAILED TUBING WERE REPORTED. ALL LEAKING FROM TUBING LOCATED AROUND THE LUER LOCK ADAPTER, SIMILAR TO LEAKS REPORTED OVER THE SUMMER. I SPOKE WITH BAXTER QUALITY REGARDING THE FINDINGS FROM THE SUMMER. BAXTER QUALITY INFORMED US BY WRITTEN REPORT THAT THEY DID FIND A DEFECT WITH THE TUBE BONDING AROUND THE LUER LOCK ADAPTER. MANUFACTURER RESPONSE FOR MALE LUER, BAXTER EXTENSION SET (1C8363): ALL SIX SAMPLES WERE VISUALLY INSPECTED FOR CRACKS AT THE MALE LUER THAN COULD CAUSE LEAKS. ALL SIX SAMPLES HAD A CRACK ON THE TUBING PORT OF THE MALE LUER. THE SAMPLES WERE THEN PRESSURE TESTED WITH WATER AT 45 PSI, AND ALL SAMPLES LEAKED AT THE CRACK ON THE LUER; CONFIRMING OUR REPORT. THE CONFIRMED LEAKAGE IS RELATED TO THE SUPPLIED MALE LUER COMPONENT. THE ONE PIECE MALE LUER HAS SINCE BEEN REPLACED WITH AN ALTERNATIVE LUER ON CODES THAT ARE MANUFACTURED FOR THE SAME TUBING. ADDITIONALLY, WE DID COMPLETE A BATCH REVIEW OF THE PROVIDED LOT NUMBER AND FOUND NO DISCREPANCIES IN THE MANUFACTURING PROCESS. THIS CONDITION WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS.
CARDINAL HEALTH 303, INC. None None None 2260-0500 RN HUNG NEW IV LINE FOR PT AT 0330 PER PROTOCOL. WHEN THE INFUSION CHANNEL WAS RESTARTED, THE CHANNEL ALARMED "AIR IN LINE" FOR THE CYCLOSPORINE INFUSION. RN OPENED THE INFUSION CHANNEL TO CHECK THE ALARIS NITRO 2260 TUBING FOR AIR. RN SLIGHTLY STRETCHED AND FLICKED THE TUBING TO REMOVE AN AIR BUBBLE. THE TUBING POPPED NEAR THE TOP OF THE PORTION OF TUBING THAT SITS WITHIN THE ALARIS PUMP CHANNEL. THE RN IMMEDIATELY CLAMPED OFF BOTH ENDS OF THE RUPTURED TUBING, STOPPED THE INFUSION, AND ALERTED THE CHARGE NURSE, FOR ASSISTANCE. SPILL OF CHEMO WAS LIMITED TO A FEW DROPS TO THE RN'S HAND AND SCRUB PANTS.
ICU MEDICAL, INC. None B9286 None None "PATIENT WAS HAVING A CT SCAN PERFORMED AND THE RN CONFIRMED THE FLOW OF THE IV FOR THE CT SCAN. DURING THE ADMINISTRATION OF THE CONTRAST INJECTION; THE TUBING ""BLEW"" WITH A SLICE ABOVE THE HUB AND BELOW THE FIRST PART. PATIENT BECAME VERY ANXIOUS. HOWEVER, NO HARM OR INJURY.
HOSPIRA,INC. LIFESHIELD EXTENSION SET 14929-48 71178 5H 14929-48 "IV TUBING RUPTURED DURING A POWER INJECTION OF IV CONTRAST. THIS IS THE SECOND EVENT OF THIS TYPE AT OUR FACILITY. THE INJECTOR PRESSURE HAD BEEN REDUCED FROM 300 TO 200 PSI MAXIMUM AFTER THE PREVIOUS EVENT. THE PACKAGING ON TUBING STATES: THE SAFETY AND EFFECTIVENESS OF THIS DEVICE FOR USE WITH POWER INJECTION AND HIGH POWER INFUSION SYSTEMS HAVE NOT BEEN ESTABLISHED. UPON FURTHER FOLLOW-UP WITH HOSPIRA AFTER OUR LAST INCIDENT WITH RUPTURED TUBING, HOSPIRA DISCLOSED THAT THEY DO NOT TEST THE TUBING FOR USE WITH POWER INJECTORS. HOWEVER, ACCORDING TO HOSPIRA, SINCE THE TUBING IS RATED UP TO 325 PSI, IT IS ACCEPTABLE FOR USE WITH POWER INJECTIONS IF THE MAXIMUM PRESSURE IS BELOW 325 PSI.
HOSPIRA,INC. SETSOURCE Z1457 NOT AVAILABLE Z1457 SETSOURCE IV CHECK VALVE (IV TUBING LOOP) RUPTURED WHEN INFUSION FOR CT SCAN WAS STARTED.
MEDRAD INC. MEDRAD STELLANT None None INJECTOR TUBING RUPTURED DURING AN INJECTION FOR A CT SCAN. MAXIMUM PRESSURE LISTED ON THE TUBING IS 325 PSI. MAXIMUM PRESSURE SETTING ON THE INJECTOR WAS 300 PSI, AND THE DISPLAYED MAXIMUM PRESSURE WAS 309 PSI. THE OPERATOR MANUALLY ABORTED THE INJECTION AFTER THE RUPTURE.
HOSPIRA,INC. LIFESHIELD LATEX FREE EXTENSION SET, 8 INCH None LOT6614ONS 19197-01 A PATIENT WAS TO UNDERGO A CT CHEST- PE (PULMONARY EMBOLISM) EXAM. THE IV EXTENSION WAS CONNECTED TO AN 18 GAUGE ANGIO. UPON INTRODUCTION OF CONTRAST VIA INJECTOR, THE TUBING SPLIT OPEN FROM INTERNAL PRESSURE. A REPEAT ATTEMPT HAD A SIMILAR RESULT.
ICU MEDICAL, INC. EXT SET W/CLAVE, CLAMP, LEUR LOCK None None C2005 THE CLAVE EXTENSION SET BURST WHILE IV CONTRAST WAS BEING INJECTED. THE TUBING SPLIT IN MIDDLE AND THE AREA HAD AN OUTPOUCHING AT THE SITE.
CARDINAL HEALTH 303, INC. ALARIS C20022 EXTENTION SETTING 20 INCHES None None PATIENT HAD A BARD POWERPORT THAT WAS ACCESSED USING THE BARD POWERLOC INJECTOR NEEDLE SET. AN ALARIS IV EXTENSION TUBING SET WAS ADDED AND ALL FLUSHED SMOOTHLY. TECH ATTACHED CONTRAST INJECTOR TUBING TO THE EXTENSION TUBING AND INJECTION OF CONTRAST WAS GIVEN USING THE CONTRAST INJECTOR. POST INJECTION, UPON ENTERING THE ROOM, WE FOUND THE ALARIS IV EXTENSION TUBING HAD A SPLIT IN IT ABOUT 1/2" LONG AND SOME OF THE IV CONTRAST HAD COME OUT. THE CT WAS FULLY COMPLETED AND THE PORT WAS NOT HARMED.
HOSPIRA,INC. LIFESHIELD MACROBORE IV EXTENSION SET, 7 INCH TUBING 12094-02 None 12094-02 DURING TWO CT ANGIO CHEST STUDIES, THE IV TUBING SPLIT WHEN THE CONTRAST WAS BEING INJECTED. DURING A CAT SCAN OF THE ABDOMEN/ PELVIS, THE IV TUBING BECAME SOFT AND LOOKED LIKE IT WOULD SPLIT SO IT WAS REPLACED.
HOSPIRA,INC. ABBOTT LIFESHIELD CLAVE None 59029NS None THE IV LINE SPLIT APART DURING THE POWER INJECTION BOLUS PART OF A CT EXAM. INJECTING AT A PSI OF 325 WITH A FLOW RATE OF 4.0 ML/SEC. NO HARM TO PATIENT, BUT RE-SCAN WAS REQUIRED. THE RADIOLOGY TECHS REPORT THAT THIS HAS OCCURRED WITH OTHER IV LINES OF THIS PRODUCT.

Additional Information:

[1]. Code of Federal Regulations Title 21. (2008). Intravascular Administration Set. Retrieved August 11, 2009. Website:
http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=880.5440&SearchTerm=tubing

[2]. Eakle, M., Lange, S. (2004). Power injectors put I.V. lines under pressure. Retrieved August, 14, 2009 from Nursing.

[3]. Food and Drug Administration. (2009). Reminders from FDA Regarding Ruptured Vascular Access Devices from Power Injection. Retrieved August 7, 2009. Website:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm070193.htm.


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