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U.S. Department of Health and Human Services

MedSun: Newsletter #53, October 2010

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Newsletter #53, October 2010

Safety Tips

Aesculap AVM Micro Clip - Medical Device Safety Tips

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FDA Medical Device Safety

Medical Device Safety Tips highlight what can go wrong if labeling is overlooked or not followed, and provide advice on how to mitigate risks. Commonly known as Instruction for Use manuals or package inserts, labeling includes any written material from the manufacturer accompanying medical devices. FDA’s goal is to promote awareness of labeling to enhance device safety and prevent patient harm. Precautions healthcare professionals can take when using these devices are discussed.

Additional Information:

FDA Medical Device Safety. Aesculap AVM Micro Clip - Medical Device Safety Tips. September 24, 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm227107.htm

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Resectoscopes for Infants and Babies - Medical Device Safety Tips

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FDA Medical Device Safety

Medical Device Safety Tips highlight what can go wrong if labeling is overlooked or not followed, and provide advice on how to mitigate risks. Commonly known as Instruction for Use manuals or package inserts, labeling includes any written material from the manufacturer accompanying medical devices. FDA’s goal is to promote awareness of labeling to enhance device safety and prevent patient harm. Precautions healthcare professionals can take when using these devices are discussed.

Additional Information:

FDA Medical Device Safety. Resectoscopes for Infants and Babies - Medical Device Safety Tips. September 24, 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm227105.htm

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Articles

Electric Dental Handpieces and Electric Oral Bone-cutting Handpieces: Safety Investigation of Patient Burns

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FDA MedWatch Safety Alert

FDA is again alerting healthcare professionals and dental organizations of a safety issue described in a 2007 Public Health Notification, "Patient Burns from Electric Dental Handpieces". These devices are AC-powered hand-held devices used to prepare dental cavities for restorations, such as fillings, and for cleaning teeth. These burns range from first degree burns to third degree burns requiring reconstructive surgery. Since the notice, the FDA has received numerous additional reports of patients being burned by electric dental handpieces.

Additional Information:

FDA MedWatch Safety Alert. Electric Dental Handpieces and Electric Oral Bone-cutting Handpieces: Safety Investigation of Patient Burns. September 24, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm227208.htm

FDA Public Health Notification: Patient Burns from Electric Dental Handpieces
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062018.htm

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BagEasy Manual Resuscitation Devices by Westmed, Inc.: Class 1 Recall

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FDA MedWatch Safety Alert

Certain units of the BagEasy device have a potential for disconnection at the retention ring of the patient port manifold. Disconnection causes the unit to be inoperable, which potentially could result in treatment delays while another unit is obtained or technician switches to a different method of resuscitation.

Additional Information:

FDA MedWatch Safety Alert. BagEasy Manual Resuscitation Devices by Westmed, Inc.: Class 1 Recall. September 15, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226014.htm

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Gadolinium-based Contrast Agents: Class Labeling Change - Risk of Nephrogenic Systemic Fibrosis

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FDA MedWatch Safety Alert

FDA is requiring changes in the professional labeling for gadolinium-based contrast agents (GBCAs) to minimize the risk of nephrogenic systemic fibrosis (NSF), a rare, but serious, condition associated with the use of GBCAs in certain patients with kidney dysfunction. NSF has not been reported in patients with normal kidney function. Patients at greatest risk for developing NSF after receiving GBCAs are those with impaired elimination of the drug, including patients with acute kidney injury or chronic, severe kidney disease.

Additional Information:

FDA MedWatch Safety Alert. Gadolinium-based Contrast Agents: Class Labeling Change - Risk of Nephrogenic Systemic Fibrosis. September 9, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm225375.htm

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AngioSculpt EX PTCA Scoring Balloon Catheter by AngioScore, Inc.: Recall - Risk of Catheter Separation

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FDA MedWatch Safety Alert

The AngioSculpt EX Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters may become separated during use, and fragments of the catheter may become lodged in coronary arteries. This may result in serious injuries, including death. This recall includes all Part/REF Numbers 2034-XXYY with lot numbers less than F09060003. This product was distributed from January 30, 2009 through December 4, 2009. Customers should inspect their inventory for this recalled product and separate it from their inventory.

Additional Information:

FDA MedWatch Safety Alert. AngioSculpt "EX" PTCA Scoring Balloon Catheter by AngioScore, Inc.: Recall - Risk of Catheter Separation. September 8, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm225186.htm

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Negative Pressure Wound Therapy: Use with care

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FDA Medical Device Safety

New device and dressing features have been added that make Negative Pressure Wound Therapy (NPWT) safer, more efficient, and more user-friendly in care settings other than hospitals, such as in long-term care facilities, rehab centers, and even patients' homes. Although many patients have benefited from NPWT, adverse events – including deaths and serious injuries - have been reported to the FDA. Precautions healthcare professionals can take when using these devices are discussed.

Additional Information:

FDA Medical Device Safety. Negative pressure wound therapy: Use with care. September 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm225038.htm

FDA Patient Safety News (video). Serious Complications with Negative Pressure Wound Therapy. January 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=94#2

FDA MedWatch Safety Alert. Negative Pressure Wound Therapy (NPWT) systems - Preliminary Public Health Notification. November 16, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190704.htm

Advice for Patients: Serious Complications with Negative Pressure Wound Therapy Devices. November 16, 2009.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm190476.htm

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Hemodialysis Administration: Strategies to Ensure Safe Patient Care

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Pennsylvania Patient Safety Authority

While the technology for hemodialysis is well established and the treatment is a routine part of healthcare delivery, risks are ever-present, given that hemodialysis patients undergo three treatments each week, take multiple medications, and often have multiple comorbidities. Risk mitigation strategies to prevent the likelihood of errors involving hemodialysis administration are provided for medication errors, failure to follow hemodialysis protocol, needle disconnection, needle infiltration, falls, equipment failures, and clotting of the dialysis circuit or blood lines.

Additional Information:

Pennsylvania Patient Safety Authority. Hemodialysis Administration: Strategies to Ensure Safe Patient Care. September 2010.
http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2010/Sep7(3)/Pages/87.aspx

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Strategies for Avoiding Problems with the Use of Pneumatic Tourniquets

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Pennsylvania Patient Safety Authority

Pneumatic tourniquets are used primarily to occlude blood flow and obtain a bloodless field during limb surgery. They also facilitate intravenous regional anesthesia, an alternative to general anesthesia for surgery involving the upper or lower limbs. In this application (also known as a Bier block), the tourniquet prevents infused local anesthetic from flowing out of the limb and also provides a bloodless operating field. This article considers tourniquet problems reported to the Authority and reviews use and maintenance issues that can prevent these types of problems.

Additional Information:

Pennsylvania Patient Safety Authority. Strategies for Avoiding Problems with the Use of Pneumatic Tourniquets. September 2010.
http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2010/Sep7(3)/Pages/97.aspx

FDA Safety Tip: Pneumatic Tourniquet Cuffs, With a Tourniquet System. January 2007.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=11#1

FDA Patient Safety News (video). Safe Use of Pneumatic Tourniquet Cuffs. April 2007.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=62#7

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LabNet

Precautions to Take with Peroxide-Forming Materials

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Lab Manager Magazine

Tips on reducing peroxide-forming materials hazards in the lab.

Additional Information:

Lab Manager Magazine. Precautions to Take with Peroxide-Forming Materials. August 2010.
http://www.labmanager.com/stips.asp?ID=133

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How Laboratorians Can Safely Calculate Workload for FDA-Approved Semi-Automated Gynecologic Cytology Screening Devices

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FDA Medical Device Safety

Clarification for laboratories on how workload should be calculated when using currently FDA-approved semi-automated gynecologic cytology screening devices. This communication is intended for cytotechnologists, technical supervisors, and laboratory managers using these systems and addresses how to count fields of view (FOV) and full manual slide reviews (FMR), as well as establishing maximum workload limits. Exceeding the designated maximum workload jeopardizes the ability of device users to detect precancerous and cancerous lesions of the cervix and is a public health risk.

Additional Information:

FDA Medical Device Safety. How Laboratorians Can Safely Calculate Workload for FDA-Approved Semi-Automated Gynecologic Cytology Screening Devices. July 27, 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm220292.htm

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HeartNet

Featured HeartNet Report of Interest

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Your reports of actual adverse events, and more importantly, reports of 'potential for harm', 'near miss', and 'close call' medical device related safety concerns are of special interest to FDA, MedSun and HeartNet. The following event reported by a MedSun facility resulted in manufacturer action:

Type of Device: angiographic syringe
Device Brand Name: Stellant CT Dual Syringe Kit
Device Manufacturer’s Name: MedRad
Date of this report: April 15, 2010
Other device identifiers: SDS-CTP-QFT

Reported Event:
Multiple problems with tubing not adhering to connectors and t-connectors cracking. For example, in one case the connector will separate from the tubing. In another case the connector hub is cracking when used. This has happened multiple times recently, but 4 times within 24 hours where the product has been saved. We have retained 6 defective sets from two lot numbers. MedRad says they are aware of the problem and will provide replacement tubing. MedRad declined to tell me what lot numbers were affected. This is not a new product for the facility. In most cases this occurred while setting up the injection. No harm to patients, but technicians are concerned that a fragment of the connector could fall into the contrast. In one case they were not sure so they discarded the contrast and started over.
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Health professional's impression
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defective product.

Related Recall: Please see the following Class 2 recall for Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPK manufactured by MedRad. The reason for the recall is due to kits containing a T connector that may be susceptible to cracking or breaking or leaking. This could cause product leakage or, less likely, patient injury. To read the FDA recall notice, see link provided below:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=92193

Additional Information:

Class 2 Recall - Stellant CT Dual Syringe Kits. July 9, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=92193

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HomeNet

FDA Offers Tips about Medical Devices in Emergency Situations

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FDA Medical Device Safety

During natural disasters and other emergency situations, medical devices may be exposed to fluctuating power, contaminants, or unusual levels of heat or humidity. This website offers various resources, which provide additional information about using medical devices during and following emergency situations.

Additional Information:

FDA Medical Device Safety. FDA Offers Tips about Medical Devices in Emergency Situations. June 18, 2009.
http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161498.htm

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KidNet

Emergency Department Visits for Medical Device - Associated Adverse Events Among Children

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Journal of Pediatrics

The purposes of this study were to provide national estimates of emergency department (ED) visits for medical device-associated adverse events (MDAEs) in the pediatric population and to characterize these events further. This study provides national estimates of pediatric MDAEs resulting in ED visits and highlights the need to develop interventions to prevent pediatric device-related injuries.

Additional Information:

Pediatrics. Emergency Department Visits for Medical Device – Associated Adverse Events Among Children. August 2010.
http://pediatrics.aappublications.org/cgi/reprint/peds.2010-0528v1

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Infant sleep positioners: Consumer Warning - Risk of Suffocation

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FDA MedWatch Safety Alert

FDA and the Consumer Product Safety Commission (CPSC) issued a warning not to use Infant sleep positioners. In the last 13 years, the federal government has received 12 reports of babies known to have died from suffocation associated with their sleep positioners. Most of the babies suffocated after rolling from the side to the stomach.

Additional Information:

Infant sleep positioners: Consumer Warning - Risk of Suffocation. MedWatch Safety Alert. September 29, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm227733.htm

CPSC and FDA Warn Against Using Infant Sleep Positioners Because of Suffocation Risk: Initial Communication. September 29, 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm227301.htm

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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 2010. 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.

ANESTHESIOLOGY

Device:
Type: Apparatus, Autotransfusion
Manufacturer: Haemonetics
Brand: Orthopat System

Problem:
OrthoPAT machines have had intermittent problems. Recently, it has come to our attention that the issues are that the machine is not fully charging and when the staff uses the equipment, the lack of battery charge causes machine to turn off or not function properly. When biomeds test machine, they cannot always reproduce the problem. We discovered that the machine not only has to be plugged in but also turned off when it is in storage in order to charge fully. This is not intuitive as most staff think plugging in is enough. Also the on/off switch on the back is not clearly marked, so staff has a difficult time determining if the machine is off or not when they put it is storage.
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Health Professional's Impression
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Poor instructions on the need for plugging machine in and turning it off during storage in order to get a full charge.


Device:
Type: Apparatus, Autotransfusion
Manufacturer: Stryker
Brand: Cbcii Constavac Blood Conservation System

Problem:
Patient underwent a right femoral removal of hardware and right knee reconstruction on a previous date. During procedure, patient had a constavac drain put in. Post op [operative] day 3, the resident received orders to remove the drain. Upon trying to remove the drain, the resident met with some resistance and stopped the procedure.

Consulted with surgeon because the resident thought the drain tubing may have been stitched in. The resident was instructed by the surgeon to remove the drain tubing as it had to come out.

Upon 2nd attempt when removing the drain, it appeared a small piece of the tube remained lodged in the patient. The resident ordered x-rays and the results of the x-ray confirmed that there was a residual of the tube. This was discussed with the patient. The surgeon decided the small tubing residual would remain in the patient and they would monitor the patient closely.
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Health Professional's Impression
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It is believed that the tubing may have been sewn in during the OR procedure.


CARDIOVASCULAR

Device:
Type: Cardiopulmonary Resuscitation Aid Kit
Manufacturer: Cardinal Health
Brand: Crash Cart Kit
Cat #: OM5410346B

Problem:
Material Services employees noticed a pre-packaged crash cart kit with a recalled item as one of its contents. The kit was marked with an overlabel, instructing users to "Immediately upon opening this kit remove the recalled component". The recalled component was a Shiley tracheostomy tube (Cat#s 6DCT and 8DCT). Upon further review, it was also noted that the kit contained a packing slip which showed an expiration date of 4/30/2012, while many items within the kit expire well before this date.

Material Services is in the process of removing all such kits from this facility and working with the vendor to ensure this does not occur again.


Device:
Type: Catheter, Ablation, Cardiac, Rf
Manufacturer: Biosense Webster
Brand: Ez Steer Thermocool Nav
Lot #: 14119991
Cat #: BNI75TCDFH

Problem:
Poor packaging design allowed device handle to fall below sterile line and become contaminated. The plastic pieces of packaging become disconnected from one-another. The handle is relatively heavy (compared to the catheter shaft) and the plastic piece that holds it is on the bottom of the connection, so it just falls off. When the catheter fell out of the sterile package (the handle side is where it is opened) it remained in the short plastic tray.
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Health Professional's Impression
======================
Weight-bearing portion of break-away packaging is on the bottom, as packaging open in this case it was not well engaged into the shaft-portion and hung dependent, pulling the catheter out. With nothing to retain it, the catheter fell to the floor. Pictures will be forwarded for clarification.

Please see device images:
Carto Thermoc NAV Packaging 1: Weight-bearing portion of break-away packaging is on the bottom, as packaging open in this case it was not well engaged into the shaft-portion and hung dependent, pulling the catheter out. With nothing to retain it, the catheter fell to the floor.

Carto Thermoc NAV Packaging 2: Weight-bearing portion of break-away packaging is on the bottom, as packaging open in this case it was not well engaged into the shaft-portion and hung dependent, pulling the catheter out. With nothing to retain it, the catheter fell to the floor.

Carto Thermoc NAV Packaging 3: Weight-bearing portion of break-away packaging is on the bottom, as packaging open in this case it was not well engaged into the shaft-portion and hung dependent, pulling the catheter out. With nothing to retain it, the catheter fell to the floor.


Device:
Type: Ecg Management System
Manufacturer: Phillips Medical Systems
Brand: Tracemastervue
Model#: M5100

Problem:
It was discovered that multiple ECGs were reconciled to one order in our Electronic Medical Record (EMR). The ECG request is placed in the Epic EMR, sent to the Philips Trace MasterVue. The ECG is recorded on an electrocardiography cart and then reconciled in the Trace MasterVue to the Epic order number. When more than one ECG is reconciled to a particular order, the latest ECG reconciled to the order will link to that order in the EMR. Specifically, if a patient has an ECG at 8 am (and it is reconciled to Order #1) and then has a second ECG that day at 12 p.m., it should be reconciled to Order #2 (given the clinician entered a second order for the patient.) If the second ECG is reconciled to Order #1, it will link to that order and replace the first ECG. A second issue recognized is that on occasion ECGs from different patients were reconciled to the same order causing patient mismatches. There were 10 cases identified, all were investigated and resulted in no patient harm.
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Health Professional's Impression
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Manufacturer is aware of patient mismatch when order is re-used but do not have a solution.


Device:
Type: Lead, Defibrillation
Manufacturer: St. Jude Medical
Brand: Durata
Model#: 7121Q/58

Problem:
The patient was having a right ventricular lead revision. The cardiologist inserted a stylet provided by the St. Jude rep into right ventricular lead, but was unable to remove the stylet from the lead. The thoracic surgeon was consulted; he came into the EP lab, examined the patient and recommended capping and abandoning the lead in the patient. Another ventricular lead was inserted into patient. The patient was discharged home without further complication.


Device 1:
Type: Monitor, Physiological
Manufacturer: GE Healthcare
Brand: Dash 4000

Device 2:
Type: Monitor, Physiological
Manufacturer: GE Healthcare
Brand: Dash 3000
Model#: Dash 3000

Lollipop Icon

Problem:
Nurses were at two different patient's bedsides on two occasions providing care when they looked up to note that the two different monitor screens were blank. No alarm notification occurred. Biomedical Engineering called and removed the monitors and replaced with another monitor.
Health Professional's Impression: In response to the Dash 3000 monitor, Biomedical Engineering responded on-site and found that the display was blank, but the monitor appeared to have power and a network connection. The device was swapped out and tested. The device performed to manufacturer specifications and the problem could not be duplicated by Biomedical Engineering in a testing environment. The device has been sent to GE for further testing. In response to the Dash 4000 the screen only had a service message in the corner of the screen about an invalid Ethernet connection.

Update two weeks later for the Dash 3000 by GE reported that the error was most likely caused by software issue on a chip on the main circuit board. This was remedied with a reload of the software according to GE service. A request and activity number were issued.
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Manufacturer response the first Monitor, Physiological, Dash 3000
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GE reported that the error was most likely caused by software issue on a chip on the main circuit board. This was remedied with a reload of the software.
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Manufacturer response for the second Monitor, Physiological, Dash 4000
======================
GE reported that the system board had to be replaced.


Device:
Type: Pacemaker, Implantable
Manufacturer: Medtronic, Inc.
Brand: Adapta Dr
Model#: ADDR01

Problem:
Pacemaker checked via trans-telephonic monitoring and found to be demonstrating elective replacement behavior. The last clinic visit from three months ago had battery with estimated longevity of 7.5 years. The clinic visit today confirmed elective replacement behavior. The company was contacted for troubleshooting. Technical support indicated this is known issue that is remedied by a "special lab programmer". The condition is in the hardware for measurements. The device locks up and returns a battery voltage of zero and measurements are affected, after 12 hours, the device goes to ERI. The software fix will only unlock the hardware issue; however there is no indication thus far whether the issue will resurface. They have unlocked 12 devices so far and of those none have had a re-occurrence. If patient develops pacemaker syndrome, Medtronic recommends device change out. The programmer is being shipped to the local representative within the month. The patient was evaluated and found to be asymptomatic and verbalized understanding of symptoms that require immediate attention. The patient was discharged to home.
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Health Professional's Impression
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No adverse event as yet.


Device:
Type: Physiological Monitor, Mri
Manufacturer: Medrad Inc.
Brand: Veris
Model#: 8600

Problem:
Ongoing issues with artifact on the MRI images that appear to correspond with use of MedRad Veris MRI monitoring system. A "line" or "grainy" appearance has been noted on the MRI images when the monitors are in use in the room only. Concerns for patient safety due to additional scanning causing delays in patient care and decreased image quality.
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Health Professional's Impression
======================
Multiple tests have been done per clinical engineering that seem to point to monitor interference. There is no artifact in either MRI rooms unless the MedRad monitor is in use in the room.


Device:
Type: Transducer, Blood-pressure, Extravascular
Manufacturer: Edwards Lifesciences
Brand: Pressure Monitoring Kit
Lot #: 58857993
Cat #: PXVK225

Problem:
Anesthesia technician reports upon opening a Pressure Monitoring Kit the device was found to have come apart within the packaging. No injury to patient as defect was found prior to use. New kit obtained and used with no further concerns. This kit is a custom kit made for our facility.

It is my understanding a new custom kit was created for our facility as this was not the first incident of this defect, although it was the first reported to our office.


EAR, NOSE, & THROAT (ENT)

Device:
Type: Acoustic Head Phones
Manufacturer: Philips
Brand: Philips Slimline Head Phones
Model#: 104885

Problem:
As technician was in the process of putting the acoustic headphones on the patient, the headphones snapped in two pieces right in the patient's face. One of the broken pieces touched the area just to the left of her left eye. The skin was not broken but the patient was visibly upset.
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Health Professional's Impression
======================
The technician stated that this happens frequently and is probably due to cheap plastic.


Device:
Type: Handswitch
Manufacturer: Stryker Instruments
Brand: Core Universal Handswitch
Model#: 5100-009-700

Lollipop Icon

Problem:
Stryker-Core hand piece safety switch is very loose causing the saw to shut off or come on depending on motion of device or positioning of device. This had previously been reported to company rep and old hand piece switch was replaced; however new switch is just as loose and could cause same problem.


Device:
Type: Sinus Balloon Catheter
Manufacturer: Acclarent, Inc.
Brand: Acclarent Relieva Solo Pro
Model#: BC0716SP
Lot #: 100202F-CM
Other information: Only 1 package saved...it is felt both devices came from same lot and were the same model #.

Problem:
The patient was taken to surgery for sinus septoplasty and submucous resection. The ENT MD attempted to place the Acclarent Sinus Balloon Catheter and inflate it when he noticed it had burst. MD removed device, replaced it with a second device which also ruptured. Two balloons of same make/model both failed. A third balloon catheter was obtained and worked appropriately. The two ruptured devices were retained and it is unknown why they failed. There is a question whether they were defective or if it is possible the patients bone could have lacerated the balloons causing the failure. No injury to patient with these events. Surgeon was able to complete the procedure and patient was taken to PACU for recovery.


GASTROENTEROLOGY & UROLOGY

Device:
Type: Light Source
Manufacturer: Stryker
Brand: Stryker
Model#: X7000

Problem:
During a laparoscopic procedure the light source on a Stryker tower inadvertently shut off during the surgery. After a few moments of confusion the device was turned back on and the case continued until completion with no reported patient harm. After the case the unit was sent to Biomed for evaluation with a note saying a nurse had bumped the unit while controlling another device, but it should not have been hard enough to shut off unit. The light source was tested extensively in Biomed and no problem was found.
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Health Professional's Impression
======================
After further investigation in conjunction with the surgical department it was found that our towers were originally set up in two differing formations, one for laparoscopy and one for arthroscopy, which could have caused confusion as to which device was being controlled in the low light environment of the OR suite. Biomed in conjunction with the surgical department has now standardized the tower layout.
======================
Manufacturer response for Light source, Stryker
======================
Manufacturer representative also noted varied arrangement of towers and suggested standard arrangement.


GENERAL & PLASTIC SURGERY

Device:
Type: Stapler, Surgical
Manufacturer: Covidien LP
Brand: Endo Gia Universal
Lot #: N0C0593
Cat #: 030449

Problem:
Covidien Endo GIA Universal Autosuture stapler #030449 was inserted into chest and placed over lung tissue to be excised. Upon firing, the device snapped, did not form staples properly and cut tissue resulting in tear of lung. The Lung tissue was too thick. Device sent to Biomed for examination. Biomed will return to Covidien for analysis.


Device:
Type: Table, Operating
Manufacturer: MIZUHO Orthopedic Systems Inc
Brand: Jackson Table
Model#: JST2000
Other #: ORTSYS / JST2000

Problem:
A patient was supine and asleep on a Jackson Spinal Table. The Physician was operating on the patient's cervical spine. Suddenly, the Jackson Table jerked hard and made and up and down motion with a loud noise.
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Health Professional's Impression
======================
There was not adverse event but, the potential for one if the table was not stable during the procedure. They suspected some type of mechanical defect in the lift system.
======================
Manufacturer response for Jackson style OR table, ORTSYS / JST2000
======================
Manufacturer could not duplicate the issue of table moving / dropping on its own.


GENERAL HOSPITAL

Device:
Type: Catheter, Umbilical Artery
Manufacturer: Utah Medical
Lot #: 1091919

Lollipop Icon

Problem:
UAC (umbilical artery catheter) was placed in the infant. Bleeding continued from around UAC of unknown origin. There was no air seen in UAC, and placement was a little high. When the RN was pulling back line, line snapped in half. The nurse had control of both ends of the line at all times, and the line was removed from baby. The umbilical artery was clamped.


Device:
Type: Pump, Infusion, Implanted, Programmable
Manufacturer: Medtronic Neuromodulation
Brand: Synchromed Ii
Model#: 8637-40

Problem:
Pt has had intrathecal pump to treat back pain for 4 years. He had a "rotor stalled" and failure of the pump this week. Fentanyl had been turned up in response to the pump and not getting pain relief before they realized that the pump was not working. The plan is to replace the pump and start at a lower dose of Fentanyl.

Comment from FDA: Please see information published by MedTronic about SynchroMed® EL & SynchroMed II Pump Corrosion from Nonindicated Drug Formulations Resulting in Permanent Pump Stalls online available at: http://professional.medtronic.com/wcm/groups/mdtcom_sg/@mdt/@neuro/documents/documents/pump-corrosion.pdf


NEUROLOGY

Device:
Type: Shunt, Central Nervous System And Components
Manufacturer: MEDTRONIC NEUROSURGERY
Brand: Becker
Model#: Becker EDMS II
Lot #: 10763695
Cat #: 46128
Other #: BECKER EXTERNAL DRAINAGE/MON SYS

Lollipop Icon

Problem:
The External Drainage Monitoring System (EDMS) tubing was unclamped for routine emptying of cerebral spinal fluid (CSF) from the drainage chamber into the drainage bag. The tubing below the drain chamber became disconnected. This connection is supposed to be permanent and should not come apart. The disconnection caused 7 ml of CSF to pour onto the floor. There was no harm to the patient.


RADIOLOGY

Device:
Type: Ultrasound Machine, Diagnostic
Manufacturer: Philips Ultrasound, Inc.
Model#: iE 33
Other #: Feller USA (power cord)

Problem:
Ultrasound testing was being performed on a patient in the ED. The ultrasound machine has its own power cord which was plugged into the wall socket. While performing the test, the technician heard a pop, and plumes of smoke and sparks came out of the outlet/plug (plugged into the wall).

BioMed inspected and took pictures of the plug that was burned. The Ground Pin was bent. BioMed inspected the ultrasound machine which functioned properly following an electrical cord change. BioMed opines that the plugs overheat because the blade to wire connection fractured due to abuse. When the connections fracture, excess heat is generated.

This is a highly used device in many areas of the hospital, so it is connected to power outlets several times a day.
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Manufacturer response, according to reporter, for Ultrasound machine, diagnostic -
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They requested that the cord be returned to them for further testing.

Please see device images:

Burned Feller Power Cord: close up view

Burned Feller Power Cord compared to non-burned power cord


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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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Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events With Arthroscopy Pumps

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Arthroscopic pumps are devices that irrigate and inflate joint spaces by delivering fluid at an appropriate pressure and flow rate, during diagnostic and operative arthroscopic procedures.

During arthroscopic surgery, the joint is continuously irrigated with saline fluid which is pressurized to create joint distension. Saline fluid flow removes disturbances in the arthroscopic view which may include excess bleeding, air bubbles or synovial fluid. Improving visibility of the joint capsule is essential to performing arthroscopic procedures safely and efficiently (p. 590, 2008, Tuijthof).

Over the past 2 years, MedSun has received 13 adverse event reports associated with arthroscopy pumps manufactured by Arthrex Inc, Stryker Endoscopy Inc, and CONMED Linvatec (ConMed Corporation), The reports were submitted by 10 hospitals between July 2008 and May 2010.

The reported device problems were:
• Over-irrigation of operative space (9)
• Continuous high pressure alarm condition (1)
• Sensor malfunction (1)
• Device-system disassembly (1)
• System cable malfunction (1)

None of the reported incidents involved a patient death. The patient problems listed below were reported in 11 of the 13 reports.
• Fluid extravasation /edema (7)
• Compromised circulation (4)

Of the reports that listed patient age, 1 had a patient age listed as less than 21 years and 9 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 7 reports involved female patients and a total of 4 reports involved male patients.


The following table lists the MedSun reports that are described in the device problem summary above.

[Note: The reports have been edited for clarity]

Adverse Event Table
Device IdentifiersCatalog/Model/Lot Number Event Description
ARTHREX, INC. CONTINUOUS WAVE III AR-6475 DURING A KNEE ARTHROSCOPY, A MALFUNCTION OF THE EQUIPMENT RESULTED IN THE INFUSION OF THE INCORRECT AMOUNT OF FLUID INTO THE KNEE AND SURROUNDING TISSUE.
STRYKER ENDOSCOPY THE NURSE REPORTED DURING THE SURGEON'S FIRST CASE OF THE DAY, A SHOULDER ARTHROSCOPY, IT WAS NOTED THE PUMP WAS USING AN EXCESSIVE AMOUNT OF ARTHROSCOPY FLUID (34 BAGS TOTAL). THE PUMP WAS RECALIBRATED PARTWAY THROUGH THE CASE AND SEEMED TO WORK BETTER. FOR THE SURGEON'S SECOND CASE OF THE DAY, A DIFFERENT PUMP (BUT SAME MAKE/MODEL) WAS USED AND THE SAME PROBLEMS BEGAN TO OCCUR. THE DOCTOR MADE THE DECISION TO CONTINUE OPERATION WITH GRAVITY FLUID RATHER THAN CONTINUE USING THE PUMPS DUE TO SAFETY CONCERNS. THE FIRST PATIENT HAD A MODERATE AMOUNT OF FLUID EXTRAVASATION TO RIGHT SHOULDER AND BREAST, YET NOT UNUSUAL FOR THIS TYPE OF SURGERY. IT APPEARED THERE WAS NO SIGNIFICANT OR UNEXPECTED INJURY TO THE PATIENTS. HOWEVER, IT DOES APPEAR THE PUMPS MAY HAVE ISSUES WITH MAINTAINING THEIR CALIBRATIONS. OF NOTE, A PREVIOUS REPORT, WITH THE SAME ISSUE/EQUIPMENT WAS FILLED, WHICH REQUIRED EXTENDED HOSPITAL STAY.
ARTHREX, INC. AR-6400 PATIENT UNDERWENT RT. ANKLE ARTHROSCOPY AND CALCANEAL NONUNION EXCISION. IMMEDIATELY POSTOPERATIVELY IT WAS FOUND THAT THE PATIENT HAD RT. LOWER EXTREMITY COMPARTMENTS WITH NO PULSE OF DORSALIS PEDIS ARTERY. ARTERIAL DOPPLER CONFIRMED. IMMEDIATE FASCIOTOMY OF RT. LOWER EXTREMITY RELEASED 4 COMPARTMENTS OF THE LEG AND PULSES IMMEDIATELY RETURNED. PT TRANSFERRED TO MAIN HOSPITAL AND ADMITTED. TWO DAYS LATER, PATIENT UNDERWENT IRRIGATION AND DEBRIDEMENT AND CLOSURE OF RT. LOWER EXTREMITY WOUND. DISCHARGED IN GOOD CONDITION.
ARTHREX, INC. CONTINUOUS WAVE III AR-6475 DURING THE PROCEDURE (9 MINUTES INTO THE TOURNIQUET TIME), THE THIGH WAS NOTED TO BE EXTREMEMLY HARD AND THE PHYSICIAN NOTED SWELLING IN THE LEFT THIGH. THE TOURNIQUET WAS DEFLATED IMMEDIATELY. THE SWELLING DID SUBSIDE AFTER WRAPPING THE THIGH AS FLUID WAS RELEASED. THE MANUFACTURER'S REPRESENTATIVE DID EVALUATE THE DEVICE AND NOTED A LEVER THAT WAS FROZEN AND WOULD NOT MOVE BUT THIS WAS NOT FELT TO HAVE EFFECTED THE PROPER FUNCTIONING OF THE PUMP. THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION WITH NO SIGNS OF COMPARTMENT SYNDROME.
ARTHREX, INC. CONTINUOUS WAVE III PUMP SENSOR NOT SENSING THE PRESSURE IN THE PATIENT'S SHOULDER LIKE IT SHOULD HAVE RESULTING IN EXTRAVASATION OF FLUID INTO THE SHOULDER JOINT.
STRYKER ENDOSCOPY, StrykeFlow II *,*,09133FG2 THE TIP ATTACHED TO THE IRRIGATION PUMP FROM THE SOLUTION SLIPPED OFF & THE SALINE SPILLED & THE TIP FELL ON THE FLOOR. THE PUMP ALSO FELL ON THE FLOOR.
ConMed Linvatec 87k DURING A KNEE ARTHROSCOPY PROCEDURE, THE PUMP PRESSURE WAS SET W/ DISTENTION PRESSURE OF 30. SURGICAL TEAM NOTED THE PT'S LEG WAS FIRM. WHEN PUMP SETTINGS CHECKED, THE PUMP INDICATED A PRESSURE SETTING OF 30 BUT ACTUAL PRESSURE MEASURED WAS 130. THE MD IMMEDIATELY BROUGHT SETTING DOWN TO 23, AT WHICH TIME THE PUMP SEEMED TO REGULATE ITSELF. A THREE LITER IRRIGATION BAG WHICH HAD JUST BEEN HUNG WAS FOUND EMPTY. THE PT HAD NOTICEABLE EDEMA FROM KNEE LEVEL TO LEFT LOWER QUADRANT DOWN INTO PERINEUM. PT DID NOT HAVE COMPROMISED CIRCULATION IN LEG/FOOT. A SIGNIFICANT AMOUNT OF THE SWELLING RESOLVED PRIOR TO THE PATIENT'S DISCHARGE.
THE PUMP WAS ISOLATED AND TESTED INTERNALLY, AND FOUND TO BE FUNCTIONING AS EXPECTED. THE DISPOSABLE TUBING/CASSETTE WERE NOT SAVED AND IS NOT AVAILABLE FOR TESTING.
THE HANDPIECE/CABLE USED DURING THIS CASE WERE NOT ISOLATED. THE HOSPITAL HAS 9 HANDPIECES/CABLES, SO ALL 9 WERE TESTED. TWO WERE FOUND TO HAVE CABLES THAT DID NOT FUNCTION AS EXPECTED. (ONE WAS UNRESPONSIVE TO THE BUTTONS, ONE DID NOT SENSE ANYTHING). THESE HAVE BEEN REPLACED. ONE HAND SWITCH WAS FOUND TO NOT FUNCTION PROPERLY. IT WAS FOUND TO HAVE BUILD UP UNDER THE BUTTONS. IT WAS CLEANED, AND HAS NOT YET BEEN RE-TESTED FOR FUNCTION.

IT WAS UNABLE TO BE DETERMINED BY THE HOSPITAL IF EITHER OF THE CABLES OR THE HAND SWITCH WERE INVOLVED IN THE REPORTED INCIDENT.
STRYKER ENDOSCOPY, Flosteady 350-800-001 STRYKER ENDOSCOPIC FLOSTEADY IRRIGATION MACHINE SEEMED TO BE MALFUNCTIONING. MACHINE CATALOG NUMBER 350-800-001. THE MACHINE PRESSURE SPIKED AND CAUSED INCREASED FLUID IN THE RIGHT KNEE OF THE PATIENT. SMALL AMOUNT OF FLUID ACCUMULATED IN THE KNEE TISSUE. NO SEVERE OR PERMANENT INJURY WAS CAUSED, ONLY SOME SLIGHT TISSUE EDEMA.

MANUFACTURER RESPONSE (AS PER REPORTER) FOR IRRIGATION/DISTENTION SYSTEMS, ARTHROSCOPIC, (BRAND NOT PROVIDED)

A STRYKER REP POINTED OUT THAT THERE COULD BE SOME LAG TIME FROM PUSHING THE "SURGE' BUTTON ON THE REMOTE TO THE UNIT. NOT MUCH TIME TO AFFECT IT, BUT THERE IS A NEW SOFTWARE UPDATE THAT HE IS LOOKING IN TO GETTING. HE ALSO STATED THAT WHEN THIS WAS AVAILABLE STRYKER WILL UP GRADE ALL OF THESE UNITS IN THE HOSPITAL
ARTHREX, INC. AR-6410 DURING SHOULDER ARTHROSCOPIC PROCEDURE, THE ARTHREX ARTHROSCOPY PUMP WAS UTILIZED. IT WAS SET UP PER MANUFACTURER RECOMMENDATIONS. APPROXIMATELY 10 MINUTES INTO THE PROCEDURE, THE PRESSURE ALARM SOUNDED. (PRESSURE WAS SET AT 35 MMHG WITH AS HIGH AS 50MMHG RECOMMENDED). SURGEON NOTED OPERATIVE SHOULDER APPEARED TO BE ABSORBING FLUID IN LOCALIZED AREA AND INTO AXILLA. TUBING WAS CHECKED AND PUMP RESTARTED SEVERAL TIMES FOR ONLY BRIEF MOMENTS BEFORE MACHINE WOULD CYCLE OFF. TUBING WAS TOTALLY SWITCHED OVER FOR NEW TUBING PER MANUFACTURER RECOMMENDATIONS. NEW TUBING APPEARED TO RESOLVE PROBLEM. ARTHROSCOPIC PROCEDURE WAS FINALLY ABORTED AFTER ABOUT 10 MINUTES BECAUSE OF FLUID EXTRAVASATION,(CONSENT WAS FOR ARTHROSCOPIC AND OPEN SHOULDER). PROCEDURE THEN WAS COMPLETED WITHOUT FURTHER INCIDENT. MD EXAMINED PT POST OP AND NOTED THAT RETAINED FLUID WAS RESOLVING. PT TO PACU IN STABLE CONDITION.
ConMed Linvatec 87k THE PATIENT IS AN ADULT WHO UNDERWENT ARTHROSCOPY OF THE LEFT KNEE. IT WAS DISCOVERED THE PATIENT HAD A MARKEDLY SWOLLEN LEFT THIGH FOLLOWING THE ARTHROSCOPIC PROCEDURE AND ABSENT PULSES IN THE LEFT FOOT. EXAMINATION REVEALED SEVERE LEFT THIGH SWELLING IN A DIFFUSE FASHION. THERE WERE NO PALPABLE OR DOPPLERABLE ANKLE OR FOOT PULSES. INFILTRATION OF LACTATED RINGERS OR POSSIBLE AN ARTERIAL INJURY COULD NOT BE ABSOLUTELY RULED OUT. THE PATIENT WAS PREPARED FOR LEFT LOWER EXTREMITY ARTERIOGRAPHY AND POSSIBLE FASCIOTOMY OF THE THIGH. THE VASCULAR SURGEON TOOK PATIENT TO MAIN OR FOR ARTERIOGRAM, ELEVATION MAINTAINED FOR TRANSPORT, COLOR RETURNING TO LEFT FOOT PRIOR TO TRANSPORT, TRANSPORTED WITH CRNA, ANESTHESIOLOGISTS, AND 2 RN'S, PUMP RUNNING THROUGHOUT PROCEDURE WITHOUT DIFFICULTY OR ALARMS AT PRESSURE OF 50 AND FLOW OF MEDIUM, APPROX 5.5 BAGS OF 5 LITER LR RUN THROUGH CASE. SHE WAS TAKEN FROM THE OUTPATIENT SURGICAL CENTER TO THE MAIN OPERATING ROOM AND UNDERWENT ARTERIOGRAPHY VIA RIGHT FEMORAL GROIN APPROACH. FORTUNATELY, THIS STUDY WAS UNREMARKABLE FOR INJURY PER SE TO THE VASCULAR TREE. THE PATIENT'S LEFT LOWER EXTREMITY WAS MAINTAINED AT MAXIMUM ELEVATION, AND HER SOFT TISSUE DISTENTION GRADUALLY ABATED WITH RETURN OF NORMAL FOR VASCULAR FLOW. IT WAS FELT THAT THIS PATIENT SHOULD BE HOSPITALIZED OVERNIGHT FOR CLOSE OBSERVATION AND MONITORING PURPOSES AND WAS DISCHARGED THE FOLLOWING DAY.
ARTHREX, INC. CONTINUOUS WAVE III AR-6457 THE CASE BEGAN IN USUAL MANNER. THE FIELD TURNED BLOOD TINGED. THE SURGEON INSTRUCTED THE SCRUB TO HOLD THE FLUSH BUTTON UNTIL INSTRUCTED TO RELEASE. THE FLUSH BUTTON WAS HELD INTERMITTENTLY FOR SEVERAL MINUTES AT A TIME THROUGHOUT THE PROCEDURE. THE CASE WAS COMPLETED WITH A TOTAL OF 47,250 ML OF SALINE USED. DRESSINGS WERE APPLIED AND DRAPES WERE REMOVED. UPON DRAPE REMOVAL, EDEMA WAS NOTED TO LEFT SHOULDER, LEFT BREAST, LEFT AXILLA, ANTERIOR/POSTERIOR NECK, FACE, SCALP, AND LEFT EAR. SKIN WAS INTACT BUT VERY HARD/TAUNT. THE SURGEON WAS NOTIFIED AND INSTRUCTED TO POSITION PATIENT IN FOWLER'S POSITION. THE ANESTHESIOLOGIST INSTRUCTED THE CRNA TO KEEP THE ENDOTRACHEAL TUBE IN PLACE. PATIENT WAS REPOSITIONED INTO FOWLERS POSITION ON THE STRETCHER AND TRANSFERRED TO PACU.
ConMed Linvatec 87k PATIENT ADMITTED FOR ELECTIVE DIAGNOSTIC SURGICAL ARTHROSCOPY OF THE LEFT KNEE DUE TO HISTORY OF INTERNAL DERANGEMENT OF THE LEFT KNEE. THIS WAS COMPLICATED BY THE DISCOVERY, AT THE TIME OF DRESSING APPLICATION, OF SIGNIFICANT ISCHEMIA OF THE LEFT LOWER EXTREMITY BROUGHT ON BY RINGER'S LACTATE EXTRAVASATION INTO THE LEFT THIGH, COMPRESSING THE FEMORAL ARTERY. THE PATIENT WAS SEEN IN IMMEDIATE CONSULTATION BY VASCULAR SERVICE. SHE WAS TAKEN FROM THE OUTPATIENT SURGICAL CENTER TO THE MAIN OPERATING ROOM AND UNDERWENT ARTERIOGRAPHY VIA RIGHT FEMORAL GROIN APPROACH. FORTUNATELY, THIS STUDY WAS UNREMARKABLE FOR INJURY PER SE TO THE VASCULAR TREE. THE PATIENT'S LEFT LOWER EXTREMITY WAS MAINTAINED AT MAXIMUM ELEVATION, AND HER SOFT TISSUE DISTENTION GRADUALLY ABATED WITH RETURN OF NORMAL FOR VASCULAR FLOW. IT WAS FELT THAT THIS PATIENT SHOULD BE HOSPITALIZED OVERNIGHT FOR CLOSE OBSERVATION AND MONITORING PURPOSES. ON THE PATIENT'S FIRST POSTOPERATIVE DAY, THE WOUNDS ARE CLEAN, DRY AND HEALING ABOUT THE LEFT KNEE AREA. SHE HAS NO EVIDENCE FOR VASCULAR IMPAIRMENT TO THE LEFT LOWER EXTREMITY. HER THIGH IS SOFT. SHE HAS NO NOTABLE PROBLEMS IN THE RIGHT GROIN. THE PATIENT HAS BEEN UP OUT OF BED AND AMBULATORY TO THE BATHROOM WITH CRUTCH ASSIST. SHE IS REASONABLY COMFORTABLE. SHE WILL BE DISCHARGED TO HOME, TO BE SEEN IN ORTHOPEDIC FOLLOWUP IN 12 TO 14 DAYS' TIME.

ON DAY OF ORTHO FOLLOW UP: ON EXAMINATION TODAY THE PATIENT IS ABLE TO AMBULATE WITH ONLY SLIGHT ANTALGIA ON THE LEFT. HER THIGH APPEARS TO BE EQUAL IN SIZE TO HER RIGHT AND THERE DOES NOT APPEAR TO BE ANY ECCHYMOSIS IN THE LEFT THIGH AREA. HER WOUND INCISION SITES REMAIN CLEAN AND DRY AND HER SUTURES ARE REMOVED TODAY UNDER STERILE TECHNIQUE AND STERI-STRIPS ARE PLACED ACROSS THE WOUND SITE OVER BENZOIN. STATED BEFORE SHE DID HAVE SOME NUMBNESS IN THE THIGH FROM THE GROIN TO THE KNEE BUT THIS APPEARS TO BE RESOLVING AND VERY LITTLE PAIN REMAINING WITHIN THE LEFT KNEE ITSELF. ISOMETRIC EXERCISES RECO
STRYKER ENDOSCOPY 350-357-000/AO2 THE CASE WAS STARTED AT 10:23. EDEMA AND INCREASE IN PEAK PRESSURE NOTED AT 1120. SURGEON INFORMED AND PROCEEDED TO WORK. ARTHROSCOPY PUMP RAN AT 80 AND 1.0 FOR MAJORITY OF CASE. TOTAL SALINE USED WAS 55,750ML. SALINE RETURN EQUALED 42,250ML WITH A LARGE AMOUNT OF SALINE ON THE FLOOR UNCOLLECTABLE. SALINE DEFICIT NOTED AT 14,500ML. UPON DRAPE REMOVAL, EDEMA WAS NOTED TO BILATERAL BREAST, AROUND NECK, LEFT EAR, AND BACK OF SCALP. PATIENT WAS MOVED TO STRETCHER AND PLACED IN SITTING POSITION. PATIENT REMAINED INTUBATED AND TRANSPORTED TO PACU AT 1208. AS OF DAY AFTER THE CASE, PATIENT REMAINED INTUBATED IN THE ICU.


Additional Information:

Tuijthof, G.J.M., Boomen, H. Van Den, Heerwarden, R. J. van Heerwaarden, & Dijk, C.N. van. (2008). Comparison of two arthroscopic pump systems based on image quality. Knee Surg Sports Traumatol Arthrosc, 16, 590-594.

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Updated October 1, 2010

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