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U.S. Department of Health and Human Services

MedSun: Newsletter #46, March 2010

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Newsletter #46, March 2010

Articles

Ear Candles: Risk of Serious Injuries

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FDA MedWatch Safety Alert

FDA is notifying consumers and healthcare providers of its warning not to use ear candles - a hollow cone about 10 inches long made from a fabric tube soaked in beeswax, paraffin or a mixture of the two - because they can cause serious injuries, even when used according to the manufacturer’s directions. According to advertised claims, a burning ear candle draws ear wax and “impurities” or “toxins” out of the ear canal. Other claims for ear candles include relief from sinus and ear infections, headache and earache, as well as improved hearing, “blood purification,” improvements in brain function, and cure cancer. FDA has found no valid scientific evidence to support the safety or effectiveness of these devices for any medical claims or benefits.

Additional Information:

FDA MedWatch Safety Alert. Ear Candles: Risk of Serious Injuries. February 20, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm201108.htm

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Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical - Class I Recall

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FDA MedWatch Safety Alert

FDA and Thomas Medical Products Inc. notified healthcare professionals of a Class I Recall of certain lots of the product, tube-like devices placed into blood vessels to insert pacing or defibrillator wires and catheters into blood vessels. The sheath tip may break off and separate while the sheath is inside a blood vessel. If this occurs, the sheath tip could move through the blood vessel into organs such as the lungs and heart or, less commonly, into arteries.

Additional Information:

FDA MedWatch Safety Alert. Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical. February 4, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199927.htm

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Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall

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FDA MedWatch Safety Alert

Cardiac Science Corporation and FDA notified healthcare professionals and consumers of a recall because the automated external defibrillator (AED) may not be able to deliver therapy during a cardiac resuscitation attempt, which may lead to serious adverse events or death. These AEDs were manufactured in a way that makes them potentially susceptible to failure under certain conditions.

Additional Information:

FDA MedWatch Safety Alert. Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall. February 9, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm200138.htm

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BD Q-Syte Luer Access Devices: Recall

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FDA MedWatch Safety Alert

BD, Acacia Inc. (known as MPS Acacia), and FDA notified healthcare professionals of the recall of certain lots of these devices. The BD Q-Syte Luer Access Device is a needleless valve manufactured by BD, intended for use with other infusion therapy products in the administration of fluids into the intravenous system. Use of the recalled devices may cause an air embolism or leakage of blood or therapeutic product which may result in serious injury or death.

Additional Information:

FDA MedWatch Safety Alert. BD Q-Syte Luer Access Devices: Recall. February 9, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm200137.htm

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Steris System 1 Processor: Extension of Recommended Time Period for Healthcare Facilities to Transition to Legally-Marketed Alternatives

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FDA Medical Device Safety website

FDA is extending to 18 months from the date of this notice the total recommended time period for transitioning from Steris Corporation's modified System 1 processor (SS1) to legally-marketed alternative devices. As FDA announced in its December 3, 2009, notice, the Agency has not approved or cleared the SS1 for its labeled claims. Steris Corporation has chosen not to seek FDA clearance of this device and, therefore, its use should be discontinued as soon as practicable.

Additional Information:

Medical Device Safety website. Information About STERIS System 1. Februrary 23, 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm194411.htm

FDA Medical Device Safety website. Steris System 1 Processor: Extension of Recommended Time Period for Healthcare Facilities to Transition to Legally-Marketed Alternatives. February 2, 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm199567.htm

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Launch of Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

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FDA Press Release

The FDA announced an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy. These procedures are the greatest contributors to total radiation exposure within the U.S. population and use much higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography.

Additional Information:

FDA Press Release. Launch of Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging. February 9, 2010.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM200085

FDA Radiation Emitting Products website. Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging. February 23, 2010.
http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/ucm199904.htm

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LabNet

Lyme Disease: Finding the Balance of Diagnostic Testing and Clinical Disease Features

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AACC Clinical Laboratory News

Recent legal and public inquiries brought about as a result of a highly publicized lawsuit between the Infectious Disease Society of America (IDSA) and the state of Connecticut has thrust Lyme disease into the forefront for clinicians and clinical laboratories. The disease's etiology and clinical manifestations are described in this paper, as well as the proper use and interpretations of tests for Lyme disease.

Additional Information:

AACC Clinical Laboratory News. Lyme Disease: Finding the Balance of Diagnostic Testing and Clinical Disease Features. January 2010.
http://www.aacc.org/publications/cln/2010/January/Pages/SeriesJan10.aspx

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Lab Medicine Outlook: What Will the Coming Decade Bring?

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AACC Clinical Laboratory News

The first decade of the 21st Century by any measure has been transformative for lab medicine. Pharmacogenetics (PGx), point-of-care testing (POCT), lab automation, and LEAN went beyond buzzwords to become mainstream realities. Evidence mounted about certain biomarkers and pushed them into the limelight, while others fell out of favor. Still others that showed great promise have yet to make their mark on clinical practice. The field of lab medicine also sharpened its focus on standardizing and improving the analytical performance of assays, and on the methods used to report lab-related research.

Additional Information:

AACC Clinical Laboratory News. Lab Medicine Outlook: What Will the Coming Decade Bring? January 2010.
http://www.aacc.org/publications/cln/2010/January/Pages/CoverStory1Jan10.aspx

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HomeNet

The use of technology at home: what patient manuals say and sell vs. what patients face and fear

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PubMed Abstract

Over the past 15 years, the use of specialised medical equipment by patients at home has increased in most industrialised countries. Adopting a conceptual framework that brings together two research perspectives, i.e. the sociology of technology and the sociology of illness, this paper empirically examines why and how patients use health technology at home and in the broader social world. Our study compares and contrasts the use of four interventions: antibiotic intravenous therapy, parenteral nutrition, peritoneal dialysis and oxygen therapy. We conducted interviews with patients (n = 16) and caregivers (n = 6), and made direct observations of home visits by nurses (n = 16). The content and structure of patient manuals distributed by major manufacturers and hospitals were analysed (n = 26). The aim of our study was to determine how technology was supposed to be used versus how it was actually used. This study shows that patients are deeply ambivalent about the benefits and drawbacks of technology, and that these advantages and disadvantages are shaped by the various places in which the technology is used. While technology can be pivotal in making patients autonomous and able to participate in the social world, it also imposes heavy restrictions that are intimately interwoven with the nature of the particular disease and with the patient's personal life trajectory.

Additional Information:

PubMed Abstract. The use of technology at home: what patient manuals say and sell vs. what patients face and fear. July 2004.
http://www.ncbi.nlm.nih.gov/pubmed/15283780

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Highlighted MedSun Reports

Highlighted Reports

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This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period December 1 through December 31 2009. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.


CARDIOVASCULAR

Device:

Type: Monitor, Central Station
Manufacturer: Philips Medical Systems
Brand: Intellivue Information Center
Model #: M3155
Other #: Software K.00.27


Problem:

A non Philips keyboard was installed. The substitute keyboard had a mute function on it and the Philips keyboard does not. The mute button was pushed by accident on the substitute keyboard and as a result the alarms were heard from bedside monitor and not at the central station.

Biomedical was called and corrected problem by replacing the keyboard with a Philips keyboard.


Device:

Type: System, Thermal Regulating
Manufacturer: Arizant Inc.
Brand: Bair Hugger
Other #: 83125

Problem:

Soon after turning on Bair Hugger, an explosion and flame occurred from unit. Bair hugger immediately removed. Patient assessed. No harm to patient. Problem was found to be the power cord/plug; wires had become dislodged.

Comment from FDA: Recall online available on manufacturer’s website: http://www.arizant.com/pdf/us/603194.pdf


Device:

Type: Fibrillator, Ac
Manufacturer: Peter Schiff Enterprise
Brand: Cardiac Fibrillator
Model #: 310C

Problem:

The Fibrillator pad was placed directly on the patient's heart by the MD. The pad was properly connected to the Fibrillator device by the RN, and then turned to full power at the MD's request. No power was delivered to the pad, although, the output test light came on. We changed out the pad and tried the device again, but there was still no power delivered to the pad. The connections were checked with no response to the change. We were not able to fibrillate the patient using the Fibrillator. We had to cool to fibrillate. Biomed verified the problem with the Fibrillator.


Device:

Type: Monitor, Central, Telemetry
Manufacturer: Phillips Medical Systems
Brand: Intellivue
Model #: M3150B

Problem:

A patient with multiple medical problems had a tracheotomy tube and had a telemetry pulse oximeter monitor which was connected to the central monitor in the nursing station. The patient was found unresponsive with the trach out. Investigation revealed that the staff does not recall hearing the central monitor desaturation alarm. The alarm has settings of 1-10 and was found to be set at "1". Engineering staff can set a minimal alarm level that staff can't go below. As a result, the central monitor minimum alarm volume setting was increased for the involved unit. In addition the central monitor minimum alarm volume setting for each unit in the hospital was assessed and confirmed to be at an appropriate level based on each unit's configuration.


Device:

Type: Electrode, Defibrillator, Medi-trace
Manufacturer: Covidien Kendall
Brand: Medi-trace Cadence Rts
Model #: 22770R
Lot #: 926114

Problem:

Zoll patches were labeled the same, i.e. both pads in the package were identified as being left side pads. This was discovered before the patient was prepped and draped. This was an out-of-the-box failure. There was no harm to the patient.


CLINICAL CHEMISTRY

Device:

Type: Test Strips
Manufacturer: Lifescan Inc.
Brand: Surestep Pro
Lot #: 2947225009
Other #: CTL Code: 0311POUNK

Problem:

Nurse used chemstrips to ascertain infant's sugar level. The RN thought the reading was low and not what had been infant's previously recorded levels. She noticed on the back side of the chemstrip that what should have been a consistent blue was "blotchy" and an "uneven" color. Did a second chemstrip with same result and again there was an uneven blotchy color. Secured chemstrip from different lot and result was more consistent with previous readings.


ANESTHESIOLOGY

Device 1:

Type: Ventilator
Manufacturer: Maquet, Inc.
Brand: Servo IVentilator
Model #: Servo i

Device 2:

Type: Ventilator
Manufacturer: Maquet, Inc.
Brand: Servo IVentilator
Model #: Servo i

Problem:

Transported a low weight infant to radiology for MRI. Ventilators in MRI room did not work. An error message kept occurring.

Tech Error 27 message was generated after ventilator was taken over for use in MRI. Ped's
Servo-i had generated this error code as well. Both vents were in the MRI environment when turned on and error code generated. Both vents were outside of the Safety Zone. Unable to duplicate this error code when the vent was moved to prep area. Tech support was contacted and notified of this error code and service order generated.

This is 3rd time this error code has generated on this vent. Board 1772 was replaced due to this alarm. MRI management is not comfortable with this vent going back into use until representation from mfr is met with and this concern is fixed. Maquet rep notified to setup meeting with MRI management group.


RADIOLOGY

Device:

Type: Ultrasound Probe Cover, Surgical/intraoperative
Manufacturer: Microtek Medical, Inc
Brand: Ultracover
Model #: PC4515
Lot #: D90631
Other #: Large T-shaped latex free probe cover w/gel

Problem:

Ultrasound was being used for intraoperative guidance for an open liver resection which required sterile draping of a clean ultrasound probe which was then placed inside the body cavity on two separate occasions during the operation. Between each insertion of the probe, it remained sterile and on the sterile field. When the surgeon was finished with ultrasound guidance the radiologist undraped the probe and noticed blood mixed with the gel inside the probe cover which indicated a defect in the probe cover, as no material should pass through the cover itself to maintain sterile technique. The probe cover was checked for a tear - it had a gap between the rubber and plastic portions of the probe cover that should normally be sealed closed to prevent material from crossing the barrier of the probe cover to maintain a sterile field. Other probe covers were also determined to not seal effectively enough to prevent them from detaching/allowing contamination.

We have asked that the stock be replaced, as all probe covers seem ineffective.


Device:

Type: Workstation, Angiographic Imaging
Manufacturer: Siemens Medical Solutions USA, Inc.
Brand: Leonardo
Other #: Rotational angiography with 3 D image

Problem:

When processing 3-D reconstructions of left atrium for electrophysiology studies and ablation on the Leonardo Workstation the resolution has been unacceptable to our clinicians. Siemens has recently informed us that the software on this 10 month old workstation is an earlier, lower resolution, version, which captures images every 1.5 degrees. A newer version of the Workstation software apparently offers the higher resolution, which captures images every 0.8 degrees, which would be required to process these images adequately on our system. The issue was discussed with staff at the Siemens training center in North Carolina. According to them, seven months after the install, the low resolution software is no longer available on small detectors like ours because it does not allow for adequate image quality.

As this is an adjunctive imaging tool it is not essential to performing the case. Atrial Fibrillation ablations are usually done without this technology in many centers that have not purchased the system. The goal is to superimpose a three-dimensional shell onto the x-ray screen for better catheter navigation and to guide transeptal puncture, with the hopes of reducing fluoroscopy time and improving patient safety. Atrial Fib ablations can continue to be safely performed without this technology; we are just not getting the added safety benefit that was the intention of the purchase. Instead, by trying to use the technology as intended we are exposing the patient to risk with pulmonary artery catheterization, contrast injection, additional anesthesia time and additional radiation exposure we would not otherwise do in an AF ablation, with often unusable results. In these instances there is no benefit to offset this accumulation of small risks.


NEUROLOGY

Device 1:

Type: Motor, Drill, Pneumatic
Manufacturer: Medtronic
Brand: Midas Rex

Device 2:

Type: Drills, Burrs, Trephines &Accessories (Simple, Powered)
Manufacturer: Medtronic
Brand: Midas Rex Legend
Model #: F2-B1
Lot #: 0001122106
Cat #: F2/8TA23

Problem:

The MD was using the dissecting router when the drill bit drove straight through the foot plate and into the dura. It is unknown which part of the Midas Rex device malfunctioned. There is the motor, the drill bit, and the nose cone attachment with foot plate.

Comment from FDA: See recall online available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=87002


GENERAL HOSPITAL

Device:

Type: Iv Insertion
Manufacturer: BD Medical
Brand: Insyte Autoguard Shielded Iv Catheter
Lot #: 8276402
Cat #: 381444

Problem:

Nurse used a BD Medical Insyte Autoguard Shielded IV Catheter to start an IV. Device entered blood vessel smoothly according to procedure. Nurse pressed release button to retract the needle and expected the catheter to remain in the patient with the Luer adapter (hub) on the skin surface. However, when she pressed the button, the Luer adapter fell to the bed and then the floor. Not seeing where the catheter and metal retainer went, she assumed it entered the patient's blood stream, applied pressure to prevent its movement and requested assistance. Another nurse and two doctors came to assist. A portable C-arm was used to fluoro the hand and forearm, but revealed no catheter. One of the doctors examined the Autoguard device and noticed that the catheter and metal retainer had retracted with the needle into the handle of the Autoguard device. The patient was not at risk, but did require intervention. The patient was not charged extra for the intervention.

Manufacturer response (as per reporter) for IV insertion, Insyte Autoguard Shielded IV Catheter

Very helpful, cooperative and sincerely concerned. Complaint Analyst / Regulatory Compliance, took information via phone and e-mail; also arranged for the return of the device for analysis. She stated that since interventions were used, they would also be filing a report with the FDA.


Device:

Type: Tubing, Iv
Manufacturer: B. Braun Medical, Inc.
Model #: US3130
Cat #: US3130

Problem:

Nurse tried to place tubing into the pump chamber. The tubing between the cassette and the key pin or clamp contained slack (too long), and should have been tight in the chamber. The additional tubing length would not allow the front cover to close or the pump to operate.

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Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events With Infusion Tubing used with Power Injectors

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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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Updated March 1, 2010

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