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U.S. Department of Health and Human Services

MedSun: Newsletter #73, June 2012

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Newsletter #73, June 2012

Articles

FDA, NIOSH and OSHA Joint Safety Communication: Blunt-Tip Surgical Suture Needles Reduce Needlestick Injuries and the Risk of Subsequent Bloodborne Pathogen Transmission to Surgical Personnel

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FDA Medical Device Safety

The Food and Drug Administration (FDA), the Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH), and the Occupational Safety and Health Administration (OSHA) strongly encourage health care professionals to use blunt-tip suture needles as an alternative to standard suture needles when suturing fascia and muscle to decrease the risk of needlestick injury.

Additional Information:

FDA, NIOSH and OSHA Joint Safety Communication: Blunt-Tip Surgical Suture Needles Reduce Needlestick Injuries and the Risk of Subsequent Bloodborne Pathogen Transmission to Surgical Personnel. FDA Medical Device Safety. May 30, 2012.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm305757.htm

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Dialysate Concentrates Used in Hemodialysis: Safety Communication - Alkali Dosing Errors

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FDA MedWatch Safety Alert

Health care providers should review the dialysate acid concentrate labeling for the specific concentrate that they prescribe to determine the components that can contribute to the patient's overall bicarbonate levels. Be aware that metabolic alkalosis (pre-dialysis serum bicarbonate levels > or = to 27 mEq/L) has been associated with a higher risk of death in hemodialysis patients.

Additional Information:

FDA MedWatch Safety Alert. Dialysate Concentrates Used in Hemodialysis: Safety Communication - Alkali Dosing Errors. May 25, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305630.htm

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FDA Safety Communication: Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients

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FDA MedWatch Safety Alert

At this time, the FDA believes there is no reliable evidence from controlled clinical trials that this procedure is effective in treating Multiple Sclerosis (MS). In addition, the criteria used to diagnose Chronic Cerebrospinal Venous Insufficiency (CCSVI) have not been adequately established. Therefore, data to support CCSVI as a clinical entity on its own or its relationship with MS are inconclusive and at times, contradictory.

Additional Information:

FDA MedWatch Safety Alert. FDA Safety Communication: Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients. May 10, 2012.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm303318.htm

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Pediatric X-ray Imaging

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Radiation Emitting Products

The FDA has bolstered its efforts in radiation protection in medical imaging, particularly for pediatric patients. FDA's goals are to encourage manufacturers to address pediatric safety issues in improvements for X-ray imaging devices; and provide health professionals with guidelines enabling them to use the imaging equipment already in use at their facilities safely on pediatric patients.

Additional Information:

Radiation Emitting Products. Pediatric X-ray Imaging. May 14, 2012.
http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/ucm298899.htm

Draft Guidance: Pediatric Information for X-ray Imaging Device Premarket Notifications. Medical Device Guidance Documents. May 10, 2012.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm300850.htm

Public Meeting: Device Improvements for Pediatric X-ray Imaging. Workshops and Conferences. May 18, 2012.
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm

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Discussions with Healthcare Providers

Non-Powered and Powered Patient Lifts: MedSun Small Sample Survey Summary

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Survey Topic: Non-Powered and Powered Patient Lifts - Summary of Responses
Year Conducted: 2011


Background
There are many medical devices designed to lift and transfer patients from one place to another whether it’s from a bed to a chair or stretcher, or in and out of a bathtub. Patient lift devices may be non-powered and manual, or may be powered and operate by batteries and electricity. These devices may be mounted to a ceiling or may be a portable model that can be rolled into a patient care area. Most lifts, unless specified by the manufacturer, are not designed for patient transport.

The purpose of this survey is for FDA to learn about the use of these devices for patient care from the clinical perspective. The information will help FDA better understand the experiences of hospital staff that use patient lifts for daily activities and safe patient transfers.

The survey involves healthcare professionals from nine MedSun facilities. Survey respondents include staff who are nurses, nurse managers, nurse educators, physical therapists, patient safety staff, risk managers, and biomedical engineers. The information that follows is a summary of their responses.

Summary
All respondents use either non-powered or powered patient lifts or a combination of both in their facilities. Although lift manufacturers and models vary among the respondents, all use lifts made by four or five manufacturers. Also the majority of respondents use multiple device types to assist in patient transfers including, but not limited to, ceiling mounted lifts, portable lifts, sit to stand aids, and slider aids. All but one of the nine respondents has a lift that accommodates bariatric patients. Four respondents believe staff is more likely to use the overhead lift because of easy accessibility.

The majority of respondents use slings and accessories from the original lift manufacturer. One respondent reports that occasionally a sling from another manufacturer may be used by mistake because their hospital uses slings and lifts from multiple companies. Two of nine respondents use only disposable slings. The remaining respondents say their slings are reusable or they use a combination of both reusable and disposable slings.

Responses vary to questions about how staff select the correct sling and lift for specific patients. One respondent states their slings are color-coded by size and stored that way for easier selection. Another respondent follows a specific hospital protocol that involves Physical Therapy evaluating patients and recommending the appropriate size sling. Two other respondents report that the sling and lift are kept together in their hospitals for ease of use. Another respondent reports that the manufacturer’s packaging makes it impossible to identify the type of attachment (i.e., loop, button, etc) is on the sling. To address the issue, the facility has materials management staff place stickers on each sling package upon receipt to make it easier for staff to select the correct sling.

Clips are used to attach a sling to a patient lift and the design varies among manufacturers. Some have an open clip design and others a closed design. One person describes an open design with a hook for attaching the sling. This respondent adds that it’s important for staff to verify that the loop on the sling is securely seated down into the hook. Other respondents describe having closed clip designs including some that are spring-loaded and snap in place when weight is applied, and other types that are made of a hard plastic tab that attaches securely onto a metal nub on the lift.

Respondents report no instances of sling detachment with either the open or closed clip design. One respondent comments that appropriate use of the correct sling is important in preventing sling detachments. Also, respondents have no concerns about the durability of slings.
Slings attach to lifts by different types of hanger bars. When discussing hanger bars, most say their staff do not remove them from lifts or interchange one manufacturer’s hanger bar with another. However, according to two respondents, there are situations when they change the hanger bars based on patient status (i.e., mobility, ability to assist, etc.) and the points of attachment on the sling needed for a safe transfer.

All nine respondents use lifts throughout their facilities. Most often, lifts are used to transfer patients who have limited mobility, are elderly, or who require total care, rehabilitation, or physical therapy. Lifts are also used for bariatric patients. Lifts are more frequently used in the intensive care units but are also used on other nursing units. In all facilities lifts are either stored on the units or delivered to the units from a supply area. Frequently during the survey, respondents report that staff will move a patient without a lift instead of waiting for one to be delivered or going to get one. However, staff in facilities with ceiling mounted lifts in patient rooms feel they are used more often because they are readily accessible.

Eight of the nine respondents report that lifts in their facilities are not used to transport patients to other departments. However, one respondent has observed patients being transported in a lift for a short distance in the hospital radiology department.

The majority of respondents have instructions for use attached to the lifts in the form of laminated cards. Whether the staff uses them and finds the instructions helpful is not known. Four of nine respondents feel that using a lift is straightforward and once staff receives training, the instruction card would not be utilized.
Respondents report the average age of lifts in their facilities is between one and seven years old, however, one lift currently in use is 20 years old. One facility will keep lifts until they are obsolete or until obtaining parts for repairs becomes difficult. Another will keep their lifts for 5 to 10 years, depending on use and repairs. Preventive maintenance is only done on an as needed basis in one facility as compared to the others where it is done annually or biannually, and more often if there is a problem.

Almost all of the respondents report that the number one problem with lifts is battery charging and replacement. Most agree that use error is part of the problem with batteries because staff forget to plug in the lift to recharge the batteries when it’s not in use. An issue from one facility involves the frequent breaking of an AC plug that is interchangeable for US/European voltage. The respondent believes that the connection may be weak because it’s an interchangeable plug causing it to break off with continual use. This particular facility is working with the manufacturer to resolve the issue.

Three of nine respondents report a potential tipping problem with lifts. One respondent’s concern is the possibility of the patient’s weight shifting resulting in the lift not raising the patient up evenly. In addition, they say that positioning the lift correctly underneath the bed is critical to prevent the lift from tipping.
Six of nine respondents report some difficulty with lifts fitting under beds or stretchers especially in Radiology Departments. Some radiology equipment has to attach to the floor and positioning a lift close is not always possible. Also, with reference to ceiling mounted lifts, there may be equipment already mounted to the ceilings in radiology rooms, so installing an overhead lift may not be feasible.

When asked about patient or staff injuries, most respondents have no reported incidents. However, one respondent describes a staff injury while using a lift and believes it’s because of improper body alignment and movement by the individual during the process of lifting the patient.

All respondents state their facility provides some type of staff training on the use of lifts. Some have staff complete annual competencies about using lift devices. Others have train-the-trainer programs to establish peer leaders for unit staff. All nine respondents provide training during orientation for new employees on the use of the lifts.

When discussing improvements to lift devices, respondents have many suggestions. They include: 1) a color code for weight limits in large bold print on the lift and sling, and perhaps making the model number coincide with the weight limit, 2) a battery charge indicator on the lift that is easily read, 3) a large digital display of the weight being lifted, 4) a misalignment sensor to remind staff to lift from the patient’s center of gravity and not at an angle, 5) a motor that is strong enough to lift 1000 lbs, 6) more compact lifts for easier storage and accessibility, 7) reduce the cost of lifts, and 8) improve the accessibility underneath bed frames. Additionally, one respondent suggests that a utilization monitor would be good. This feature would inform management about how often lifts are being used. Management could use the information to determine what actions may be needed such as more training, improved accessibility, etc. It would also help with purchasing decisions and deployment of lift devices in the facility.


******
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 March 1 through March 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: Laser, Transmyocardial Revascularization
Manufacturer: Cardiogenesis Corporation
Brand: Sologrip Iii
Model#: 705-37020
Lot #: TA-03797

Problem:
Circulator attempted to open outside packaging to deliver tray with the instrument to the sterile field. In doing so, the peel-away corner of outer wrap either bent back or otherwise made RN think that the inner package had been contaminated. The inner package has semi-rigid tray with a cover (both plastic) that is in turn covered with a peel-back plastic-like covering layer. RN would normally never remove this peel-back covering but would hand tray over using outer paper packaging. Because this product costs $6,000, the RN attempted to peel off the inside cover so she could hand over the tray in open condition. The catheter in the tray flipped out of the packaging and was contaminated. Therefore the product was unusable. Photos can be supplied to demonstrate the conditions.
======================
Manufacturer response for Laser catheter to create new cardiac collateral circulation (TMR), Sologrip III 43% (per site reporter)
======================
"Have never seen this happen before."


Device 1:
Type: Monitor, Physiological
Manufacturer: GE Healthcare
Brand: Solar 8000i
Model#: Solar

Device 2:
Type: Monitor, Physiological, Module
Manufacturer: GE Healthcare
Brand: Patient Data Module (Pdm)
Model#: PDM
Other #: Software Version 1.4

Problem:
During the course of routine general anesthesia, the noninvasive blood pressure monitor (NIBP or NBP) which was set to Auto mode with 2.5 minute interval stopped cycling without warning, notification, or apparent cause.
The monitor was GE Solar 8000i with a PDM (multi-parameter module) with Version 1.14 software. The software version was confirmed with photo of same because software version 2.0 was known to have this problem and was recalled and was removed from use in this hospital. Two physicians observed that there was no blood pressure measured for nine (9) minutes and used the control knobs and touch screen to turn the NIBP back to Auto mode and reset the interval to 2.5 minutes. The location was in an OR. We downgraded our PDM software to version 1.4 and are still seeing the same problem with the PDM's in the OR.
======================
Manufacturer response for Noninvasive blood pressure monitor, Patient Data Module (PDM) software version 1.4 and Solar 8000i (per site reporter)
======================
We have not let the manufacturer aware as of yet; however, we will after this is submitted.

Device:
Type: Pacemaker, Implantable
Manufacturer: Medtronic, Inc.
Brand: Sigma 300 Dr
Model#: SDR303B

Problem:
The patient's pacemaker was implanted 6 years ago. As the pacer was nearing end of life, the patient was transmitting data monthly via telephone. The patient placed a transmission device over the pacer and the pacer stopped working. The patient passed out and awoke as the transmission device fell away. He was brought to an outside hospital. A tech rep met the patient at the outside hospital ED and attempted to interrogate the device. The device malfunctioned and the patient became asystolic for approximately 10 seconds and passed out. The device was moved away from the pacer and it resumed working and the patient awoke. This patient is pacer dependent. The patient was transferred to the hospital for pacer placement. He underwent the procedure and has been discharged home. The pacer and leads (Pace Setter 1388TC were given to the Medtronic rep).
======================
Manufacturer response for Pacemaker, Sigma (per site reporter)
======================
No response yet


EAR, NOSE, & THROAT

Device:
Type: Nasal Packing Foam
Manufacturer: Gyrus ACMI
Brand: Posisep X
Lot #: 1110760A
Cat #: 9210584

Problem:
A trial of a new product that had shellfish ingredients (internal nasal sinus surgery dressing/foam) was applied after the surgery was done as per instructions from the doctor. No one was aware the product had shellfish product until after the surgery was completed. Patient is allergic to shellfish.

The vendor, Gyrus ACMI, notified Dr. after the surgery was done that the trial product has small amounts of shellfish derivative in it. Dr. immediately returned to O.R. to remove the packaging. The patient had no symptoms or signs of allergic reaction during his stay. The patient was monitored and observed per Doctor's orders then discharged home. This packaging comes in a container with five individual packs. The complaint from the staff was they did not know the product contained shellfish derivatives. After conferring with the manufacturer it was discovered the packaging did indicate it had shellfish derivatives, but it is hard to find on the packaging. The suggestion is this caution needs to be more visual.
======================
Manufacturer response for Nasal packing foam, Posisep X (per site reporter)
======================
Reported this issue to the manufacturer through the local sales rep. We were told he will write up the report and email a copy to our facility. Nothing received at present.


GENERAL &PLASTIC SURGERY

Device 1:
Type: Clip Applier
Manufacturer: Covidien
Brand: Autosuture Endoclip Ii
Lot #: NIE0799
Cat #: 176657

Device 2:
Type: Clip Applier
Manufacturer: Covidien
Brand: Autosuture Endoclip Ii
Lot #: J2A0004X
Cat #: 176657

Problem:
During a laparoscopic cholecystectomy, the endoclip applier times two was not operating properly; the clips dropped out. Retrieved clips that did not close and replaced clip applier with one that did function correctly. Instrument involved was reference number 176657 (10 mm medium/large clip), lot# J2A0004x and NLE0799. All clips were retrieved under visualization. There was no harm to the patient.


Device:
Type: Instrument, Robotic Surgical, Tip Cover Accessory
Manufacturer: Intuitive Surgical, Inc.
Brand: Da Vinci
Model#: 400180

Problem:
During robotic assisted total hysterectomy with right salpingo-oophorectomy, the PA reported that an arc was seen coming from the da Vinci monopolar curved scissors tip cover accessory. No flame seen.

Instrument removed and tip cover replaced with a new one. Procedure resumed. No further incidents. QA performed a FDA Maude database search for similar reported problems across the United States. We found many reports regarding tears and holes in the Monopolar Tip cover Insulator accessory part # 400180 used with the Curved Scissors which resulted in some situations arcing or energy being delivered to unintended nearby tissue.

Intuitive Surgical had sent a Customer Safety Notice Letter in October 2011 to customers with Safety Recommendations and Suggestions to prevent this situation from occurring. The main bullet points from the letter to minimize this risk are:

*Avoid Instrument Collisions.
*Carefully Install the Tip Cover.
*Straighten wrist prior to removal.
*Inspect cannula prior to use.
*Do not exceed maximum monopolar cautery settings.
*Only use Validated ESUs.
*Be aware of critical anatomy in contact with the instrument.
*Change Tip Cover in cases with extended cautery use.

Each of bullet items listed above has detailed explanations in the letter. This information has been shared with Surgical Services Management and Administration.


Device:
Type: Instrument, Robotic Surgical, Tip Cover Accessory
Manufacturer: Intuitive Surgical, Inc.
Brand: Da Vinci
Model#: 400180

Problem:
During procedure monopolar curved scissors (hard shears) #420179 was used and electrical arc was observed to uterus by PA and physician.

Scissor and tip were removed. A round hole was seen by scrub technician and circulator in tip cover. We put new tip cover accessory on scissor, no hole was observed and we continued with procedure, without difficulty (slight burn to uterus from arc, but uterus removed in scheduled surgical procedure), so no harm was done to patient.

QA performed a FDA Maude database search for similar reported problems across the United States. We found many reports regarding tears and holes in the Monopolar Tip cover Insulator accessory part # 400180 used with the Curved Scissors which resulted in some situations arcing or energy being delivered to unintended nearby tissue.

Intuitive Surgical had sent a Customer Safety Notice Letter in October 2011 to customers with Safety Recommendations and Suggestions to prevent this situation from occurring. The main bullet points from the letter to minimize this risk are:

*Avoid Instrument Collisions.
*Carefully Install the Tip Cover.
*Straighten wrist prior to removal.
*Inspect cannula prior to use.
*Do not exceed maximum monopolar cautery settings.
*Only use Validated ESUs.
*Be aware of critical anatomy in contact with the instrument.
*Change Tip Cover in cases with extended cautery use.

Each of bullet items listed above have detailed explanations in the letter. This information has been shared with Surgical Services Management and Administration.


Device 1:
Type: Ligature Loop, Endoscopic
Manufacturer: Ethicon Inc.
Brand: Endoloop W/coated Vicryl
Model#: EJ10.01
Lot #: CMS273

Device 2:
Type: Ligature Loop, Endoscopic
Manufacturer: Ethicon Inc.
Brand: Endoloop W/coated Vicryl
Model#: EJ10.01
Lot #: AHX032

Problem:
OR nurse opened two new packages of Endoloop Ligature made with coated Vicryl and discovered the foil packaging had pin prick holes in them. Because the packages had holes this compromised the sterility of the device. The packaging and devices were sequestered. Manufacturer notified. This incident is not new to our facility. We have reported this same incident over a month ago. We have reported at least 5 incidents related to this type of packaging. The other incidents were Endoknot products from the same company; it appears this packaging is not durable enough. Since this is not new to our facility the OR nurses are now checking every single package before they use the device to ensure the sterility of the device. Nurses should not be doing this time consuming process.


Device:
Type: Medline Sterile Drape
Manufacturer: Medline Industries, Inc.
Brand: Medline CSection Sterile (Pack)
Lot #: 11LB2814

Problem:
After start of cesarean section, drape was noted to have large opening at the seam across the patient's chest. Sterile towels were used to cover the area. MD ordered additional antibiotics for the patient post-op.


Device 1:
Type: Renal Vein Retractor
Manufacturer: Omni-Tract Surgical
Brand: Renal Vein Retractor 1" X6"
Cat #: 3101

Device 2:
Type: Splanchnic Retractor
Manufacturer: Omni-Tract Surgical
Brand: Splanchnic Retractor 2" X6"
Cat #: 3099

Problem:
Female patient with severe degenerative disease of the spine underwent an anterior exposure of the spine L4 - L5 - S1 spaces for spinal fusion. Surgery and immediate post-operative recovery were unremarkable. She was re-hospitalized the following week with left ureteral injury which required transfer to tertiary care center for surgical repair of her left ureter.


Device 1:
Type: Stapler, Anvil Assembly
Manufacturer: Coviden, Formerly US Surgical A Division of Tyco Healthcare
Brand: Dst Series Orvil
Model#: EEAORVIL21
Lot #: N1K0120U
Cat #: EEAORVIL21

Device 2:
Type: Stapler, Anvil Assembly
Manufacturer: Coviden, Formerly US Surgical A Division of Tyco Healthcare
Brand: Dst Series Orvil
Model#: EEAORVIL21
Lot #: N1E0393U
Cat #: EEAORVIL21

Device 3:
Type: Stapler, Surgical
Manufacturer: Coviden, Formerly US Surgical A Division of Tyco Healthcare
Brand: Dst Series
Model#: EEAXL21
Cat #: EEAXL21

Device 4:
Type: Stapler, Surgical
Manufacturer: Coviden, Formerly US Surgical A Division of Tyco Healthcare
Brand: Dst Series
Model#: EEAXL21
Cat #: EEAXL21

Problem:
First case; EEAORVIL21 anvil assembly is the product. This OrVil device would not mate to the EEAXL21 stapler. Upon inserting a new OrVil device the two did mate and the case was completed.

Second case; EEAORVIL21 anvil assembly is the product. This OrVil device again would not mate to the EEAXL21 stapler. Upon inserting a new, second OrVil device, there appeared to some mating issues upon the onset of use of the second OrVil, but then they did connect and we were able to fire the stapler. The firing did not result in a complete anastomosis. The surgeon was required to over sew the anastomosis. Over-sewing was done laparoscopically. Upon performing a leak test, there were bubbles which indicated that the anastomosis was still not complete, which resulted in the surgeon deciding to open in order to gain the needed access to the site for repair of the anastomosis.
The OrVil in the first case has been set aside for a return to Covidien. Both OrVil's and the EEA stapler that was utilized in the second case have been set aside to be returned to Covidien. I have filled out Covidien Field Technical Reports for both cases and will provide a FTR number as soon as I receive it. Covidien will send a box to put all the products in for a shipment back to Covidien Quality Assurance Department. Let me know if you need any additional information and I will provide that to you.


GENERAL HOSPITAL

Device:
Type: Catheter, Intraspinal
Manufacturer: Medtronic
Brand: Intrathecal Indura 1p
Lot #: N310091010
Cat #: 8709SC

Problem:
Patient with metastatic breast cancer, and a history of chronic opiate use, is now status post intrathecal pump placement. She was doing well on morphine and bupivacaine, however, recently had a dramatic increase in her pain.
She underwent a side port study under fluoroscopy guidance a few weeks ago, which demonstrated a functioning pump, from which CSF was not able to be aspirated. The catheter lead appeared to have migrated out of the intrathecal space. At that point she was scheduled for an operating room revision of the indwelling intrathecal catheter.


Device:
Type: Catheter, Intravascular, Short
Manufacturer: BD
Lot #: 1339507

Problem:
RN started the IV with a 20 qauge BD Nexiva IV start kit just above the patient's left wrist. Before I hooked it up to the primary bag tubing and the patient, a few drops of blood was noticed on the tubing connected to the hub. There was a tiny hole there which was dripping blood. I removed the IV, and checked the next kit before I started the IV. There was a visible hole in the tubing in that one as well.
I had to use a different type IV that is now connected and infusing well.


Device:
Type: Catheter, Iv
Manufacturer: Smiths Medical
Brand: Jelco
Lot #: ST2139217
Cat #: 3067

Problem:
While placing an IV catheter, the nurse tried to fully retract the introducer needle by sliding back the grip pads. However, they appeared to stick before reaching the full extent of their travel. When the needle guard and hub were removed from the catheter, the introducer needle was still exposed, presenting needle stick hazard.


Device:
Type: Catheter, Picc
Manufacturer: Angiodynamics
Lot #: R43455
Cat #: 12102618

Problem:
This involved a triple lumen PICC. Unable to advance catheter over nitinol wire included in PICC kit. Access maintained, new kit opened and PICC placed without further difficulty. No adverse effects or complaints from patient. Supply sent to Materials Management and Angiodynamic Rep notified of issue. Will meet to identify alternative wires to replace nitinol coated wire in triple lumen PICC kit.


Device:
Type: Catheter, Port, Implanted
Manufacturer: Bard Access Systems, Inc.
Brand: Powerport
Lot #: REVI0840
Cat #: 1808060

Problem:
Port catheter had to be removed due to leaking. Upon removal, a longitudinal fracture halfway between the port and tip was noted.


Device:
Type: Closed Iv Catheter System
Manufacturer: BD Medical
Brand: Bd Nexiva
Model#: 383537
Lot #: 1333507
Cat #: 383537
Other #: N/A

Problem:
When IV inserted into patient, the blood started flowing into tubing and then started running all over the bed. Upon inspection there was a hole in the tubing where the clamp sits. The patient was stuck another time due to defective tubing. Prior to use on two more patients in the same department, the same problem occurred. Additionally, three more problems were found for a total of six problems. The devices were returned to the manufacturer for evaluation. Due to numbers, the entire lot# was pulled from use in the facility. There were more found where the defect could be seen while in the packaging. Not every product in the lot was affected at least visually, but all were pulled as a precaution and replaced by BD. All cuts in tubing are in the same exact location on all samples.

NEUROLOGY

Device:
Type: Rongeur
Manufacturer: Aesculap, Inc.
Brand: Kerrison Rongeur
Model#: AESCULAP FF 661R

Problem:
A lumbar laminectomy tray was opened in the OR suite and it was noted the Kerrison Rongeur had tried bone in the tip of the instrument. This particular model does not come apart. The instrument had been cleaned prior to the procedure per the manufacturer's recommendations. There are no special cleaning tools that are provided with this device. This instrument did not reach the patient.


Device:
Type: Stimulator, Vagus Nerve
Manufacturer: Cyberonics, Inc.
Brand: Vagus Nerve Generator
Model#: 103

Problem:
Upon evaluation of patient, doctor identified that the patient's vagal nerve stimulator was reporting out a very high impedance -specifically greater than 10,000 ohms. This is an unacceptably high impedance from the binary report on the device test. The device did not appear to be at the end of its service life


Device:
Type: System, Eeg Monitoring
Manufacturer: Natus Medical Incorporated
Brand: Stellate
Model#: HSYS-REC-EAMP
Other #: hospital tag 208241

Problem:
Patient was undergoing long term (several days) EEG monitoring on a patient floor. At some point, the patient was leaving to use the restroom within the patient room and the EEG data stopped being captured although the equipment remained in the record mode. The nurse paged the EEG tech and he unplugged and re-seated different connections. Some miscommunication occurred between the nurse and the EEG tech and each felt the problem was resolved but in fact it was not. The following morning the neurologist was attempting to review the study and found no brain activity recorded. This time the 'head box' and 'connections' were re-seated AND the machine was re-booted and the equipment operated fine. The OEM trained biomed investigated and in his opinion, determined that the head box was disconnected upon the patient's trip to the bath room which caused a 'glitch' in the software that did not re-initialize so the PC continued to record zero signal. His alternate theory is that the head box may never have been plugged back in. This incident was not reported to clinical engineering because the EEG and nursing staff felt the problem was simple and was resolved easily. I am reporting this almost a year post incident. I don't know for sure if this was a software glitch or human error. We could not reproduce the problem. The equipment has run for 12 months without further incident.


Device 1:
Type: System, Eeg Monitoring
Manufacturer: Carefusion
Brand: Nicolet One Neeg
Model#: NicoletOne nEEG
Other #: Hospital tag 207642

Device 2:
Type: System, Eeg Monitoring
Manufacturer: Carefusion
Brand: Nicolet One Neeg
Model#: NicoletOne nEEG
Other #: Hospital tag 207667

Device 3:
Type: System, Eeg Monitoring
Manufacturer: Carefusion
Brand: Nicolet One Neeg
Model#: NicoletOne nEEG
Other #: Hospital tag 208040

Problem:
Reported to the Clinical Engineering manager that "Nicolet EEG equipment is frequently bumped off line, several times per day, in the middle of procedures...in the OR during cases... We've been working directly with the OEM under our contract... FYI

"The Clinical Engineering manager promptly visited and asked the staff to complete incident reports every time this occurs and to please notify us to work with both the OEM and the hospital’s Network Teams in order to resolve this."

OPHTHALMIC

Device:
Type: Constellation
Manufacturer: ALCON LABORATORIES INC (SURGICAL DIVISION)
Brand: 25+ Totalplus Vitrectomy Pak
Lot #: 1245923H
Cat #: REF 8065751462

Problem:
OR nurses had set up for a 25 gauge vitrectomy with our new Constellation machine. The machine had been primed and calibrated. The patient was brought into the room, prepped and draped. The surgeon started the case and said that the 25 gauge vitrector was not working correctly. We do not have 25 vitrectors separately, so another set up was obtained. We replaced the vitrector, re-primed etc. The machine noted low cut rate vitrector and the machine still did not work correctly. Additional help for third set-up was called. Help came in and opened yet another 25 gauge set up. This set up was re-primed and it worked.


ORTHOPEDIC

Device:
Type: Application, Fixation, Spinal
Manufacturer: Stryker Corporation
Brand: Reflex Hybrid Revision Driver Draw Rod
Lot #: 109527
Cat #: 48511906B

Problem:
The tip of Stryker Revision Driver Draw Rod broke off in screw during anterior cervical diskectomy. Screw removed with tip of driver in place. No foreign body retained in patient. No patient harm.


Device:
Type: Curette, Vertebroplasty
Manufacturer: Medtronic, Inc.
Brand: Kyphon Express Curette
Model#: A13A
Lot #: unk
Cat #: A13A

Problem:
Patient was undergoing kyphoplasty of thoracic 10 and 12 for vertebral body fracture, osteoporosis and low back pain. A core biopsy of the thoracic 10 vertebral body was taken. The space was drilled and a curette was used to enlarge the space. The curette broke, "would not fire", and had shirring. The surgeon felt the curette was problematic. No patient injury sustained.


RADIOLOGY

Device:
Type: Linear Accelerator
Manufacturer: Varian Medical Systems, Inc.
Brand: Varian Ix-s
Model#: Ix-S
Other #: B300487

Problem:
A patient was scheduled for external beam radiation therapy on a medical linear accelerator (LINAC). As part of the set up for treatment, orthogonal X-ray images of the patient are acquired. The LINAC involved has an on-board imaging (OBI), consisting of an X-ray source and digital X-ray detector, system mounted on the LINAC gantry. The source and detector are mounted on retractable arms which are extended for imaging and retracted for treatment. After taking orthogonal X-ray images, the X-ray tube arm was directly over the patient. Therapists were outside the room at the treatment console. Therapists started to retract the OBI and noticed device errors as well as the device going in the wrong direction. Upon entering the room, the X-ray tube support assembly was observed to have descended to within 6 inches of the patient. There was no harm to the patient. The motion was not expected and was traced to a failed motor assembly in the X-ray tube support arm.


Device:

Type: Media, Coupling, Ultrasound
Manufacturer: Pharmaceutical Innovations, Inc.
Brand: Other-sonic
Model#: NDC 36-1111-25
Other #: 250 mL

Problem:
In late December 2011, the Department of Epidemiology identified an increase in the number of patients undergoing surgery who developed colonization or infection with P. aeruginosa. An immediate investigation was begun. The patients were localized to one unit, among patients undergoing cardiovascular surgery. Colonization/infection was confined to the respiratory tract. No surgical wound infections, device-associated infections, or bloodstream infections were identified.

A total of 16 patients eventually were found to harbor P. aeruginosa. The majority of cases were either asymptomatic (colonized) or had mild tracheobronchitis. Molecular typing of 10 case isolates were similar. Dates of onset were from early December, 2011 through mid-January of 2012. Cases were found to be more likely to have TEE probes in place for longer periods of time than non-cases. Therefore, the TEE probes were inspected and cultured - all culture results were negative. Since TEE probes are inserted with an ultrasound transmission gel, the 250mL dispensers of "bacteriostatic" ultrasound transmission gel were removed from all OR's as a precaution and replaced with single dose sterile ultrasound gel (pending culture results). After this intervention, no further cases developed.

The 250mL dispensers of "bacteriostatic" Other-Sonic ultrasound gel manufactured by Pharmaceutical Innovations, Inc., Newark, NJ (Ref #NDC 36-1111-25) were cultured and found to harbor various organisms including P. aeruginosa matching the case strain by molecular typing. Unopened bottles of Other-Sonic gel were cultured as well to exclude intrinsic contamination. At least 2 of the sealed bottles are growing microorganisms (presumptively, P. aeruginosa) to date.

The hospital has internally recalled the Other-Sonic gel in question in mid-February of 2012.


Device:
Type: Nuclear Gamma Camera
Manufacturer: Philips Medical Systems
Brand: Brightview
Model#: 50084759

Problem:
Patient was on imaging table having nuclear stress test pictures. Patient's arm became wedged in detector. Sensor did not engage and stop camera. Patient was eventually freed from camera but stated she then had left arm pain.

Vendor completed service call. Tested camera under same conditions to ensure that motion would stop when a collision is detected. Pressed on the corner or edges of the collimators at 90 degrees and did not cause collision detection. When the collimator FOV (field of view) was pressed, instead the black outline, all motions stopped. The areas that are not sensitive on the collimator face and edge are due to electronics being housed inside those areas. The electronics are related to auto body contouring. A customer complaint about the collimator design and an incident report about the patient collision have been submitted to the manufacturer.


Device:
Type: Shield, X-ray, Mobile
Manufacturer: Fluke Biomedical (formerly Nuclear Associates)
Brand: Clear-pb Mobile Barriers
Model#: 56-604

Problem:
The patient was undergoing coronary angiography. The attending physician was walking across the procedure room in order to insert some documents into the patient's chart. Since fluoroscopy was ongoing, he was moving the mobile x-ray shield across the room so that he would remain behind it. Just after he let go, the upper portion of the window snapped off just above the vertical mounts on both sides. The cracked edge was smooth but not sharp like glass. The piece that fell to the floor did not shatter nor strike anyone or anything that would have compromised the procedure.

Staff fortunately saved the two parts of the broken window. It's made of plastic, not glass so the part that fell didn't shatter. The device is considered a radiation safety device by the manufacturer. My opinion is that there was a notch near one of the side support channels and that the continued flexing and handling of the unsupported upper portion of the window over a long period of time resulted in a crack growing from the notch until this catastrophic event occurred.


Device:
Type: X-ray System, Cath/angio
Manufacturer: GE Healthcare
Brand: Innova
Model#: 2320045-5

Problem:
Patient on table for Cardiac Cath Lab procedure, but procedure had not started. Table instantly dropped, falling abruptly. No one was near table to accidentally press buttons or levers. Attempted to raise table to proper height again, and the same thing happened. No adverse outcome.

GE Healthcare replaced the table lift assembly to repair the issue.


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Medical Device Problem Summaries

Summary of MedSun Reports Describing Problem with Mattress Covers

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Mattress covers are described in FDA regulations under 21 CFR 880.6190 as, "A mattress cover for medical purposes, intended for medical purposes, used to protect a mattress. The mattress cover may be electrically conductive or contain a germicide" (Food and Drug Administration Product Code Classification, 2012).

Mattress covers may be also be considered part of an alternating pressure air flotation mattress. An alternating pressure air flotation mattress is, “a device intended for medical purposes that consists of a mattress with multiple air cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, and automatic changes in the distribution of body pressure. The device is used to prevent and treat decubitus ulcers (bed sores).” (Food and Drug Administration Product Code Classification, 2012)

Over the past 2 years, MedSun has received 5 adverse event reports with mattress covers manufactured by Encompass Therapeutic Support Systems, Hill-Rom, Stryker Medical, and Tempur-Pedic North America. The reports were submitted by 5 hospitals between January 2009 and May 2012.

The reported device problems were:
• Foul odor permeating from the mattress - 2
• Mattress cover allowed fluids to backflow from the core to the outside of the cover – 2
• Mattress cover was noted to have deteriorated allowing fluid ingress - 2
• Mattress core contained stains - 1
• Compromised zippered mattress overlay allows penetration of blood/body fluids - 1
• Manufacturer’s guidelines or protocols unclear regarding the suggested frequency of laundering mattress overlays and/or proper disinfection between patient uses - 1
• Leaks appearing to have come from the mattress cover seams - 1

None of the reports involved patient death or serious injuries.

The following were potential harms mentioned in the reported events:
• Patient exposed to fluids that seeped up from the mattress core
• Potential to cause patient exposure to communicable diseases

None of the reports listed patient age. A single report listed patient sex, which was a male patient. Two hospitals informed having over 20 mattresses compromised in their facility.

These MedSun reports listed above, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems.

There are no device recalls associated with mattresses since 2009.

The following table lists MedSun reports that are described in the device problem summary above. Please note, the reports have been edited for clarity.

MedSun Reports Describing Problems with Mattress Covers
Device Manufacturer and BrandDevice Identifiers (Catalog Number, Model Number, Lot Number) Event Description
Stryker Medical, XPRT Sleep Surface NA, NA, H50045
A bed found at our facility in a storage area and was noted to have a foul odor. It had recently been used and removed from service due to the odor. Engineering unzipped the mattress cover because of the odor. The mattress inside was found to be covered in red foul-smelling fluid.

The mattress was examined and there were no holes, tears or cuts noted in the cover. The mattress was contained and wrapped by hospital personnel.

It was noted by staff that the bed had been recently worked on by the Stryker staff, and the foul odor was mentioned to the representative.
Stryker Medical, Isoflex NA, 100212000, NA
The Stryker silver top mattress was found to have dark small rounds spots on it which appeared to be possible mold.
Encompass Therapeutic Support Systems, Accumax Quantum Complete NA, AK-169N10-384, NA
Mattresses on low flow beds used in critical care unit revealed compromised zippered mattress overlays, allowing penetration of blood/body fluids into the internal cotton layer, which has the potential to cause patient exposure to communicable diseases when the fluids seep back up. Also, black overlays make this issue more difficult to identify. Marketing materials states routine surface cleaning sufficient and that material prevents leakage but now mfg. Stating overlays should be laundered every 90 days or when saturated.
Hill-Rom, Inc. NA, NA, NA A patient was admitted to a bed. The mattress cover was noted to have "deteriorated" and subsequently allowed fluids stored in the mattress foam to seep upwards through the cover up through the sheets. Upon examination, there were breaks in the mattress liner appearing that fluid had accumulated into the foam and when the patient’s weight compressed the foam, fluids seeped back through the non-intact cover staining the sheets with a fluid substance that was red-tinged.

These mattresses were thought to have a non-permeable cover that protected them from absorbing any fluids into the mattress foam or cushion.

After the first bed was identified, the manufacturer scheduled 2 days to assist in the evaluation of beds at the system's two largest hospitals. The institution realized that these mattresses have a one year warranty and this time frame was exceeded in many instances. The contracted housekeeping service followed our Infection Control Department guidelines for cleaning the mattresses but did not routinely unzip and check the integrity of the liners. Hill-Rom is contracted to do preventive maintenance on the hardware or the mechanics of the beds but not the mattresses. Multiple beds in the facility were identified as being at risk of non-permeable barriers and protection from body fluids.
Tempur-Pedic North America, Inc., Medical Division, Tempur Med Pressure reducing Product
NA, 5767277, NA We have discovered in two (2) different departments in the facility blood & mold stains on the cushions that are within an impermeable cover. The cushion and cover are manufactured by one company but sold by another company as part of their procedure table for the Interventional Radiology Department and Endovascular Lab.


Additional Information:

Product Classification. 21CFR880.6190 Sec. 880.6190. Mattress cover for medical purposes. Retrieved from:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=880.6190.

Product Classification. 21CFR880.5550 Sec. 880.5550 Alternating pressure air flotation mattress. Retrieved from:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=880.5550.

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Updated June 1, 2012

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