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U.S. Department of Health and Human Services

MedSun: Newsletter #77, October 2012

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Newsletter #77, October 2012

Articles

Don't Get Burned - It is National Fire Prevention Week October 7-13th

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FDA Safe Use Initiative

The Preventing Surgical Fires Initiative's 1 year anniversary is during National Fire Prevention Week. Surgical fires are preventable. Learn what you can do to prevent them! Please make use of the many resources available to you on the FDA Preventing Surgical Fires website to increase awareness of the factors that contribute to surgical fires in addition to various surgical fire prevention tools.

Additional Information:

Preventing Surgical Fires - Collaborating to Reduce Preventable Harm. FDA Safe Use Initiative.
http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/PreventingSurgicalFires/default.htm

Webinar: Practical Advice for Preventing Surgical Fires: Safety Strategies from the Front Lines. FDA Safe Use Initiative.
http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/PreventingSurgicalFires/ucm301411.htm

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National Medical Device Postmarket Surveillance Plan

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The FDA is making available for public comment a preliminary report entitled "Strengthening Our National System for Medical Device Postmarket Surveillance." This report, in addition to providing an overview of FDA's medical device postmarket authorities and the current U.S. medical device postmarket surveillance system, proposes four specific actions, using existing resources and under current authorities, to strengthen the medical device postmarket surveillance system in the United States.

Additional Information:

National Medical Device Postmarket Surveillance Plan. September 6, 2012.
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm301912.htm

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Mom, Can I Get Contact Lenses, Please?

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FDA Consumer Update

Contact lenses can provide benefits beyond improving vision. A three-year study conducted at the Ohio State University College of Optometry (October, 2007) on children between the ages of 8 and 11 showed a definite improvement in a child's self perception when wearing contact lenses as opposed to glasses, especially for girls. This article provides information and safety tips for parents of children who wear or are thinking about wearing contact lenses.

Additional Information:

FDA Consumer Update. Mom, Can I Get Contact Lenses, Please? September 5, 2012.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm318020.htm

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Discussions with Healthcare Providers

Embolization Particles: MedSun Small Sample Survey Summary

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Survey Topic: Embolization Particles - Summary of Responses
Year Conducted: 2012


Background:
Embolization Particles are devices used to obstruct or reduce blood flow to hypervascularized tumors or arteriovenous malformations. They are designed for use under fluoroscopic guidance through compatible delivery microcatheters and are classified by the FDA as Class II medical devices.

FDA wants to learn more about experience with clinical use of these devices. This survey effort addresses the current use of embolization particles and will provide FDA with a better understanding of the clinical use of embolization particles and related issues.

Survey respondents are nine Interventional Radiologists (IRs) from hospitals and group practices on the west coast, east coast, mid-west, south, and southeast. The information that follows is a summary of their responses.

Summary:
The approximate number of embolization procedures performed by the nine Interventional Radiologists (IR) ranges from 50-1000 procedures per year; an average of 150 to 3,000 procedures over the last three years. All nine respondents perform multiple types of embolization procedures at the time of this survey, including procedures to treat uterine fibroids, hepatic neoplasms, abnormal arteriovenous connections, aneurysms, bronchial arteries, and gonadal veins, and also procedures for trauma-related hemorrhage involving the gastrointestinal system- liver, kidney, and spleen. All nine respondents select a manufacturer brand or embolic agent based on the site they intend to embolize. The respondents also use one or more of the following devices for embolization: microspheres, beads, coils, liquid embolic agents, and vascular plugs.

All respondents have discontinued use of one or more of the embolization particles. Six report discontinuing use of a microsphere as a result of performance issues; four discontinued use of a specific microsphere/embolic because they state that good data is unavailable to show that it works; and four stopped using a microsphere because of poor patient outcomes.

Only one respondent states not having any problems or concerns with embolization particles. All others verbalized concerns or problems with embolization. Four of the nine report that some microspheres do not work well with catheters. More specifically, these particles frequently clump and are not calibrated well. Seven respondents indicate that many complications are associated with the skill of the IR; the inappropriate selection of an agent for a particular vascular bed and injecting too much or too little embolic at an inappropriate rate. Several respondents emphasize the importance of training and good imaging equipment for management and placement of microcatheters. In addition, experience using microspheres plays a large role in patient outcomes. Another respondent reports that the material in one microsphere has caused a reaction in some people who are allergic to eggs.

When discussing patient complications associated with multiple types of embolic devices, respondents did not report a difference among currently marketed microspheres. Finally, one respondent believes that embolization works and works well, and complications such as reflux may be largely dependent on the particle size.

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Special Studies and Surveys are two of many tools the Agency is using to evaluate the public health impact of the potential problems associated with the use of medical devices. Additionally, FDA continues to receive adverse event reports from its Medical Device Reporting program. FDA will also continue to make use of the literature and other published information. FDA scientific, medical, nursing and engineering staff are made aware of the survey results as needed. If FDA believes there is a significant risk of adverse events as noted from the survey, it will combine those results with data gained from the other sources. FDA will work with the manufacturers and health care professional organizations to make important information known to the clinical community. Additionally, FDA continues to work with manufacturers to ensure the development, testing and promulgation of methods for reducing the risk associated with these devices and to minimize the complications from adverse events that may occur in the course of normal usage. If the results of any survey raise serious concerns about the safety of these devices, FDA may convene an Ad Hoc group of clinical and manufacturing representatives to discuss further actions.

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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 July 1 through July 31, 2012. 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: Catheter, Intra-aortic Balloon
Manufacturer: Arrow International, Inc.
Brand: Fiberoptix
Other #: 30 cc, 8.0 French

Problem:
The patient was transferred to the hospital in cardiogenic shock and STEMI (ST segment elevation myocardial infarction). Direct admit from ED to Cath Lab. The patient was intubated, required CPR and had an insertion of intra-aortic balloon catheter in the left femoral artery. No note in MD progress notes that IAB catheter was difficult to insert at the time. Inserted in Cath Lab. In the evening of same day, the IAB catheter suddenly had blood in delivery line. Pump turned off immediately. MD inserted a new IAB catheter at the bedside without difficulty to right femoral artery. Discontinued the catheter from the left femoral artery. No harm to the patient.

Device:
Type: Monitor, Physiological
Manufacturer: GE Healthcare
Brand: Solar
Model#: Solar 8000i

Problem:
Staff description: Patient developed ST depressions on the monitor leads II & V1. Called resident and while obtaining a 12-lead EKG, when V2-V6 leads connected the EKG tracing disappeared off the screen and unable to obtain a 12-lead STAT. Changed EKG trunk cable, primary 5 lead connection, V2-V6 connection cable changed, and patient EKG patches (electrodes) changed x2 and re-prepped twice before 12-lead obtained. It took 10 minutes between the start of EKG changes and when 12-lead EKG obtained.

Cardiology contacted for consult by primary team and cardiac ECHO done to R/O MI/ ischemia.

Clinical Engineering analysis: There seems to be several factors involved with this problem, including electrode impedance and the monitor's response to high impedance / noisy signals. Staff report indicates they prepped the skin prior to placing electrodes and the 5 lead monitoring was working OK before attempting the 12-lead. This problem has been ongoing sporadically since we started using the Solar 8000i monitors 4 years ago. The device serial numbers are from the same batch. The problem is not isolated to a particular monitor and has been observed on several different monitors.
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Manufacturer response for Monitor, Physiological, Solar (per site reporter)
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Investigation ongoing. GE suggests problem is due to excessive artifact/noise in EKG signal.


Device:
Type: Monitor, Physiological
Manufacturer: Draeger Medical Systems, Inc.
Brand: Kappa XLT
Model#: Kappa XLT

Problem:
Draeger Kappa XLT monitor failed in use during surgery. The failure was the device switching off during a case. It emitted several loud "bong" sounds and then turned itself off. The battery had been tested for a 10 minute run within the last 10 days and when I inspected the device, the AC power functioned properly (the device had been swapped out before I inspected it). This is one of several similar incidents we have had. We have been working with the vendor to replace the product. This particular device consists of 3 separate parts, a power supply containing the backup battery and AC power supply, a vital signs engine which receives and processes the patient data and the monitor, which is essentially an all-in-one computer running Windows XP. As you are probably aware the life of a desktop computer is 3 to 5 years, these devices are 4 years old. The new product Draeger (Omega) product has put a display on the vital signs engine (unit is called Delta) and sells pretty much the same all-in-one computer to provide touch screen and connect ability functions. This provides a back-up if/when the computer fails.

We have been told there are issues with interconnect cabling on the Kappa product and our experience proves that to be true. The cables, in my opinion, are poorly designed and tend to drop data and cause screen flashes. They are checked for tightness on a regular basis. The monitor restarted without any issues and was subsequently replaced by Draeger. In our experience the vital signs engine and power supplies are stable and all of our issues have been the all-in-one computers and the cabling.
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Manufacturer response for Monitor, Physiological, Kappa XLT (brand not provided) (per site reporter)
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Manufacturer representative repaired/replaced monitor. This issue is a repetitive issue; the manufacturer has agreed to place two spare monitors in-house for immediate replacement.


Device 1:
Type: Monitor, Physiological, 12 Lead Trunk Cable
Manufacturer: GE Healthcare
Brand: Multi-link
Model#: 2017006-001 REV F
Cat #: 2017006-001 REV F

Device 2:
Type: Monitor, Physiological
Manufacturer: GE Healthcare
Model#: Solar 8000i

Problem:
Per bedside RN: "I had an order for a 12 lead EKG. I used the cables in the room. And when I plugged in the 12 lead EKG, the screen went blank. I switched out the 12 lead cables, the regular EKG cables and the cord from the monitor to the cables and the screen still went blank. I finally had to use the portable 12 lead EKG machine and I was able to obtain a 12 lead."

Clinical Engineering analysis: This has been a recurring problem. When using the Solar 8000 in the 12 lead EKG mode, if the signal is poor due to electrode impedance or movement artifact, the EKG sector on the display goes blank and the error messages (if there are any) do not guide the user to the problem. This results in a considerable amount of time wasted trying to troubleshoot the system during which time the patient goes essentially unmonitored for EKG. Frequently the reason for doing the 12-lead EKG in the first place is due to some deterioration in the patient's condition, so this is a critical time to maintain monitoring. This problem has been ongoing sporadically since we started using the Solar 8000i monitors 4 years. The device serial numbers are from the same batch. The problem is not isolated to a particular monitor and has been observed on several different monitors.
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Manufacturer response for Bedside patient monitor, GE (per site reporter)
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Investigation is ongoing. GE suggests the issue is caused by poor skin prep and/or patient movement.


GENERAL & PLASTIC SURGERY

Device:
Type: Bipolar Hf Connecting Cable
Manufacturer: Richard Wolf Medical Instruments Corporation
Brand: Hf Bipolar Connecting Cable
Cat #: 8108.232

Problem:
Taken from an internal report by staff members: "During an ablation using the ERBE machine with a 3000 ml bag of NaCl there was a problem with the hand piece burning at times and not burning at others. It required moving the setting from 5 to 7 and then surgeon asking to lower back to 5 in both bipolar settings. When the ERBE was working, the element was glowing red hot, and we discussed that we had not seen it that color in previous surgeries. Suddenly a loud pop was heard in the room and saline was tossed over the patient's groin. Surgeon quickly removed the element and scope from patient in a very quick manner, and commented on having seen a blast of light at the time of the pop. After the outside skin of the patient was assessed, the surgeon went inside the uterus again, this time with the diagnostic scope, to see if any damage had occurred. Nothing was noticed and patient seemed fine inside the uterus and no other burning or bleeding was present at the time. Patient vitals remain stable without any changes from the time of the pop noise. Surgeon and whole staff in room is aware of what happened. Pieces of equipment were sent to Biomed for further check-up in what happened as well as the ERBE machine."

Taken from a Biomed narrative on testing of the equipment: "Investigation in Progress. Wolf Handpiece and disposable tip had no signs of damage, with some darkness on the cutting tip, but did not appear excessive. Noticeable damage was apparent on the cable at the point before it bifurcates, and on the outflow tubing where the two items may have been touching. The Interconnect cable had burnt and no longer had electrical conductivity. Tested same setup with a new cable and it operated normally. When the cable finally failed completely, there would have been a sizeable spark (as heard by staff) and probably caused the charring on the outflow tubing which was distal from the operation site. Generator operated normally during testing and was returned to service. Non-disposable Wolf Handpiece also worked normally and was returned to service. The cable and disposable cutting tip were placed in a bag for storage. The disposable cutting tip did eventually quit working after extensive testing on the 7 setting and will show more wear than at the time of the operation."

See device images:

Close up of the Bipolar Connecting Cable where a burnt area is apparent on the cable at the point before it bifurcates, and on the outflow tubing where the two items may have been touching.

Zoomed out image of Bipolar Connecting Cable and equipment laying on an orange drape.


Device:
Type: Clip Applier
Manufacturer: Covidien
Model#: 134053
Lot #: P2A0364X

Problem:
During a left femoral endarterectomy and upon deployment of automatic stapling device, doctor stated it "cut into vessel" and refused to use it saying it was "dangerous".
======================
Manufacturer response for PREMIUM SURGICLIP II AUTO SUTURE/CLIP APPLIER, (brand not provided) (per site reporter)
======================
Covidien company rep was informed of malfunctioning device, model number, serial number, expiration date as well as a brief description of malfunction.


Device:
Type: Clip Applier
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Ligaclip
Lot #: J4A18E (same for both cases)
Cat #: MCM20

Problem:
Two reports on this: one which stated the clipper didn't fire each time used. The most recent report states doctor tried to use the clipper on an artery and no clip came out, and "almost" cut the artery. This in turn took more time during the surgery since he had to fix it while I had to run to get another clipper. Feedback from the doctor was that the clipper was handed to him during a critical portion of the case without a clip loaded. I am uncertain if this is an issue with the clipper or with the technician not insuring a clip was loaded. All I can say is the artery was "severed" secondary to this event. The manager followed up and this is her response. I spoke to the RNFA who was assisting the doctor with this procedure. This was a new clip applier, not a reprocessed one. I will speak to the other vascular surgeons to see if they have experienced similar issues. This is an Ethicon product.
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Manufacturer response for LigaClip Multiclipper Medium, LigaClip (per site reporter)
======================
At this time, manufacturer has emailed back to purchasing some follow up questions for their review.


Device 1:
Type: System, Robotic Surgical
Manufacturer: Intuitive Surgical, Inc.
Brand: Da Vinci
Model#: VS 3000
Other #: controller MPN 380614-08 SN 270794, Ins controller MPN 380610-13 SN 265178, Ins cont SN 272019

Device 2:
Type: Electrosurgical Unit
Manufacturer: Covidien, Formerly Valleylab, A Division of Tyco Healthcare
Brand: Force Fx C
Model#: Force FX C

Device 3:
Type: Instrument, Robotic Surgical
Manufacturer: Intuitive Surgical, Inc.
Brand: Endowrist, Fenestrated
Cat #: 420205

Device 4:
Type: Cord, Bipolar, Electrosurgical
Manufacturer: Codman & Shurtleff, Inc.
Cat #: 30-1536

Problem:
During robotic hysterectomy, no one was present at console to activate power source to activate pedal. However, upon advancing instruments, there was smoke and a burn spot on the bipolar cautery instrument. The active ESU cord had been plugged into the ESU monopolar output instead of the bipolar output. There was also a burn on the patient's uterus. The robotic unit had instigated the electrical without anyone telling the panel to. The patient was having a hysterectomy so she was not harmed.
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Manufacturer response for robotic surgical system, (per site reporter)
======================
Error is probable when using singular banana plug receptacles. There is a disposable part that is configured to eliminate the possibility. The part number is E0512. Cord may have been plugged into monopolar port when it should have been in bipolar port.

Note: Human Factors event.

See device image:

Image of Electrosurgical Unit where you can see the close proximity of the monopolar output and bipolar output.  Monopolar output is in the middle; bipolar output is on the left.



Device:
Type: Instrument, Surgical
Manufacturer: Arthrex, Inc.
Brand: Multifire Scorpion Needle
Lot #: 956168N1/04
Cat #: Ref Num: AR-13995N

Problem:
While surgeon performed an open rotator cuff repair, the tip (approximately 3 mm) of the scorpion needle broke off on the 13th horizontal stitch that passed through tissue. A needle search, which lasted 1 1/2 hours, was carried out including suctioning and x-ray. MD finished the procedure and used a new scorpion needle for last stitch, and the wound was closed. The needle tip was found in fluid canister.


GENERAL HOSPITAL

Device:
Type: Catheter, Iv
Manufacturer: BD Medical
Brand: Bd Insyte Autoguard Shielded Iv Catheter
Model#: 381434
Lot #: 2072308, 2096756

Problem:
Nurses in pre-op increasingly report difficulty with catheter since new materials and packing changes implemented.

First there is no flash back of blood, so staff is guessing if the catheter is in the vein. Second they are unable to draw blood from the same due to lack of suction and end up poking the patient second time for blood draw. Third, they have problems advancing the catheter in the vein.


Device:
Type: Catheter, Iv
Manufacturer: B. Braun
Brand: Introcan Safety Iv Catheter
Lot #: 2B14258239
Cat #: 425235-02
Other #: 15327268/0509

Problem:
The IV catheter is difficult to use and difficult to insert into the patient. Also, when removing the IV, blood sprays, leaks all over drapes, staff, and patient.


OBSTETRICS/GYNECOLOGY

Device:
Type: Breastmilk Initiation System
Manufacturer: Medela
Brand: Medela Breastmilk Initiation System
Model#: 67340A

Lollipop Icon

Problem:
Tubing used on Symphony or Lactina breast pumps. Milk backs up in tubing and creates black fungus. The device issues are with the connectors, and have been occurring since November 2011. Problems occur as soon as the milk is plentiful.

The manufacturer has acknowledged the problem, and has asked that we continue to use the equipment, and replace it as necessary.


RADIOLOGY

Device:
Type: X-ray Imaging System, Surgical
Manufacturer: Medtronic Navigation (Littleton)
Brand: O-arm

Problem:
Procedure: Revision decompression right L4-5, fusion L4-5 with segmental pedicle screw instrumentation. During the procedure there was an attempt at optical tracking. The optical tracking pin was placed into the iliac crest. O-arm spins were then made and then an attempt to transfer the images to the Stealth system through the optical tracking failed. Several attempts of this were made and they all failed, so the optical tracking was terminated and the case and placing of pedicle screws was performed by C-arm guidance. There were no complications other than the failure of the O-arm to send signals to the Stealth system.

Follow up action: Per hospital's biomedical engineer: There are user calibrations that need to be done including a motion test. The users were not aware of the need to perform the motion test. It was decided that the Biomed Dept. will be responsible for conducting the calibrations every 30 days and this testing will include performing the motion test.


Device:
Type: X-ray Imaging System, Surgical
Manufacturer: Medtronic Navigation, Inc. (Littleton)
Brand: O-arm

Problem:
When attempting to set up the O-Arm for a surgical multilevel posterior lumbar decompression and instrumented fusion, an error message displayed. "Error initializing collimators" appeared on the first line of the O-Arm. The technician shut down the O-Arm, unplugged it, disconnected the machine before reversing that, and turned it back on. The same message was displayed. Tech support from the company was contacted and the monitor was booted up and diagnostic tests were run after rebooting. The O-Arm still had the same message displayed. An additional phone call to a Medtronic field engineer was made and the error was recognized as being a hardware issue. The O-Arm was removed and the procedure was performed using the C-Arm. The case was delayed by one hour.

This facility has met with representatives from Medtronic to discuss O-Arm problems. Medtronic is working with this facility to resolve any issues.


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Lollipop Icon

Special Note: The lollipop icon distinguishes highlighted reports that describe medical device events involving neonatal or pediatric patients, or those events involving a medical device that is indicated for use in neonatal and pediatric patient populations. FDA defines pediatric patients as less than 21 years of age.

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Updated October 1, 2012

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