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U.S. Department of Health and Human Services

MedSun: Newsletter #28, September 2008

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Newsletter #28, September 2008

LabNet

FDA Approves New Genetic Test for Patients with Breast Cancer

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FDA Press Release

FDA News
FOR IMMEDIATE RELEASE
July 8, 2008

Media Inquiries:
Karen Riley, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Approves New Genetic Test for Patients with Breast Cancer
The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab).

The SPOT-Light HER2 CISH kit is a test that measures the number of copies of the HER2 gene in tumor tissue. This gene regulates the growth of cancer cells.

A healthy breast cell has two copies of the HER2 gene, which sends a signal to cells, telling them when to grow, divide and make repairs. Patients with breast cancer may have more copies of this HER2 gene, prompting them to overproduce HER2 protein so that more signals are sent to breast cells. As a result, the cells grow and divide much too quickly.

“When used with other clinical information and laboratory tests, this test can provide health care professionals with additional insight on treatment decisions for patients with breast cancer,” said Daniel Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health.

The SPOT-Light test counts the number of HER2 genes in a small sample of removed tumor. The removed piece is stained with a chemical that causes any HER2 genes in the sample to change color. This color change can be visualized under a standard microscope, eliminating the need for the more expensive and complex fluorescent microscopes required to read assays already on the market. Unlike existing tests, the SPOT-Light allows labs to store the tissue for future reference.

Patients who over-produce HER2 protein are typically treated with the drug Herceptin, which targets HER2 protein production. This helps to stop the growth of HER2 cancer cells.

The FDA based its approval of the SPOT-Light test on a study using tumor samples from patients with breast cancer in the United States and Finland. These studies confirmed that the test was effective in determining how many HER2 genes were in these patients.

SPOT-Light is manufactured by Invitrogen Corp. of Carlsbad, Calif. Herceptin is manufactured by Genentech, of San Francisco, Calif.

Additional Information:

FDA Approves New Genetic Test for Patients with Breast Cancer. FDA Press Release. July 8, 2008.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116918.htm

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HeartNet

Implantable Cardiac Defibrillator Lead Failure or Mypotential Oversensing? An Approach to the Diagnosis of Noise on Lead Electrogram

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By: Kowalski, M; Ellenbogen, KA; Wood, MA; et al
PubMed

ABSTRACT:
The appearance of noise on electrograms (EGMs) recorded from the lead of an implantable cardioverter-defibrillator (ICD) may be owing to oversensing of myopotentials, insulation breach, conductor coil fracture, loose set screw, or electromagnetic interference from an external source. The extraneous noise may lead to inappropriate shocks or inhibition of pacing. We describe two cases of pectoral myopotentials oversensing in patients with ICD and an approach to distinguish among the various extraneous noises recorded on EGMs. A systematic approach to identify the cause of the noise is important to render an appropriate treatment, which might include simple device re-programming or require re-operation and lead revision or replacement.

Additional Information:

Implantable Cardiac Defibrillator Lead Failure or Mypotential Oversensing? An Approach to the Diagnosis of Noise on Lead Electrogram. By: Kowalski, M; Ellenbogen, KA; Wood, MA; et al. PubMed. August 2008.
http://www.ncbi.nlm.nih.gov/pubmed/18565976?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

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Hypersensitivity Reactions Associated with Endovascular Devices

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By: Honari, G; Ellis, SG; Wilkoff, BL; et al
PubMed

ABSTRACT:
Allergic reactions to endoprostheses are uncommon and reported in association with orthopaedic, dental, endovascular and other implanted devices. Hypersensitivity reactions to the biomaterials used in endovascular prostheses are among the infrequent reactions that may lead to local or systemic complications following cardiovascular therapeutic interventions. This article reviews potential immunotoxic effects of commonly used biomaterials. Reports of putative hypersensitivity reactions to endovascular devices, including coronary stents, perforated foramen occluders, pacemakers and implantable cardioverter defibrillators are also reviewed.

Additional Information:

Hypersensitivity Reactions Associated with Endovascular Devices. By: Honari, G; Ellis, SG; Wilkoff, BL; et al. PubMed. July 2008.
http://www.ncbi.nlm.nih.gov/pubmed/18537993?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

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Recently Recalled Devices

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To view recently recalled devices, please visit the website listed under Additional Information below.

Additional Information:

Recently Recalled Devices
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/medicaldevicesafety/recalls.cfm

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HomeNet

The Joint Commission Announces 2009 National Patient Safety Goals for Home Care Program

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The Joint Commission
The Joint Commission has announced the 2009 National Patient Safety Goals and related requirements for accredited home care organizations. The National Patient Safety Goals promote specific improvements in patient safety by providing health care organizations with proven solutions to persistent patient safety problems. These Goals apply to the more than 15,000 Joint Commission-accredited and -certified health care organizations and programs. Major changes include new requirements related to preventing deadly central line-associated bloodstream infections.

Additional Information:

The Joint Commission Announces 2009 National Patient Safety Goals for Home Care Program. The Joint Commission. June 17, 2008.
http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/09_ome_npsgs.htm

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KidNet

Medical Device Problem Summaries

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Please see this month's Medical Device Problem Summaries describing issues summarized from reports received by MedSun hospitals.



Additional Information:

Summary of MedSun Reports Describing Adverse Events With Electrocardiograph Electrodes in Pediatric Patients and Related Reference
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=28#8

Summary of MedSun Reports Describing Adverse Events With Thermal Regulating Systems in Pediatric Patients and Related Reference
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=28#9

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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 June 1 through June 30. 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.


GASTROENTEROLOGY/UROLOGY

Device: Forceps, Grasper; ReNew Laparoscopic LapClinch Grasper Forcep Tip
Catalog #3251
Manufacturer: Microline Pentax, Inc.

Device: Handle, Laparoscopic;
Catalog #3904
Manufacturer: Microline Pentax, Inc.

Problem: Patient underwent laparoscopic cholecystectomy earlier this year. The patient tolerated the procedure well, but later developed jaundice. An ERCP was performed the following day to evaluate the patient for retained stones and/or bile duct trauma. The pancreatogram was normal; however, there was an incidental finding of a radiodense object that did not correspond to a known post-surgical object. This was disclosed to the patient. Two days after the original surgery a laparoscopic procedure was performed to remove the object, which was found to be a grasper tip from the initial surgery. The patient tolerated the procedure well. The device has two parts - a long handle and a threaded tip that screws on to the handle. The two parts were preassembled in the central processing. The members of this surgical team thought the instrument was only a one piece item; therefore the tip was not correctly included in the surgical count. If the tip is not firmly attached and/or be partially unscrewed during use it may fall off the handle. Now the two piece instrument is packaged unassembled in central processing, both pieces are included in the OR counts.

Device: Robotic Surgical System, da Vinci
Mode l#370761-04
Other Device # camera cable #5
Manufacturer: Intuitive Surgical, Inc.
Problem: In attempting to dock the Intuitive robot for a robotic-assisted laparoscopic prostatectomy, the patient cart would go forward a few inches, and then alarm and the screen would read "Fault." It was determined that the fault was due to either a short in the red cable between the cart and the console or by dust in the cable connections. All connections were cleaned and the robot worked without fault.

Device: Xenon Light Source
Model #X7000
Other #: Ref #220-190-000
Manufacturer: Stryker Endoscopy
Problem: Pt returned from the OR procedure, with a wound to the lateral aspect of the left hand. Reported to the bedside RN to be a burn from the OR equipment. Wound includes brownish/yellow areas to outside aspect of left hand and tips of two fingers. Doctor´s note lists wounds as second degree burns. Initially, we thought this was due to operator error, but subsequently there were 3 more reports of burns involving the same piece of equipment. The device was evaluated using a light meter, and found to be delivering about 12% higher light output than a different light source of the same model using the same lamp cartridge in both units. In addition, the heat output seemed to be much higher than the comparison unit, but we do not have proper test equipment to specifically measure heat output. It is possible the heat filter is not working properly, but no damage was visible. Excessive lamp current may be responsible for the dramatically increased heat output.


GENERAL AND PLASTIC SURGERY

Device: Electrode, ESU, Dispersive; REM Polyhesive II
Lot #136379
Other Device#: Ref#E7507
Manufacturer: Covidien ValleyLab

Device: Generator, Ablation, Cardiac; Stockert RF Generator
Manufacturer: Biosense Webster

Problem: Faint blush noted on patient’s left lateral side where pad was placed. There was a documented 2 inch linear red rash. The patient was then transported to PACU. The physician was notified and he ordered a wound care nurse consult and Silvadene creme. The patient was discharged in an improved condition with no delay in discharge. Discussion with reps from Biosense Webster and Valley Lab and risk manager: The red Valley Lab pads (REM Polyhesive II) are safer than the blue (Polyhesive) pads; however, these are the one causing the burns. It was discussed that quality of adherence or location/placement may be creating the problem. Also, monitoring of the ablation time should be 10 seconds on and 30 seconds off. Next steps: Use red pads and adhere properly and ensure correct location.

Device: ESU; Aquamantys 2.3 Bipolar Sealer
Manufacturer: Salient Surgical Technologies, Inc.

Device: Grounding Pad
Model# E7512
Manufacturer: Covidien (Valleylab)

Problem: Pediatric patient taken to surgery for liver mass. A bipolar electrosurgical device was used during the procedure. A grounding pad was placed on the left shoulder. After the procedure, it was discovered that the patient sustained two burns to the left shoulder area. The first burn was a 1.5cm.x1cm full thickness burn and located on the superior aspect of the left shoulder, slightly posterior. The second burn was also full thickness and measured 2cm x 3cm and was located on the upper back just lateral and inferior to the spine of the scapula.

Device: Cytoscopic Transurethral Injection Needle; Coaptite
Lot #100615
Other #: Ref #890-302
Manufacturer: Boston Scientific Corporation

Device: Cystoscopic Transurethral Injection Needle; Coaptite
Lot #1005143
Other #: Ref #890-302
Manufacturer: Boston Scientific Corporation

Problem: During transurethral Coaptite injection, needle became clogged and would not inject Coaptite. Different needle of same type/brand also was tried but also became clogged and would not inject Coaptite.

======================
Manufacturer response for cytoscopic transurethral injection needle, Rigid Injection Needle
======================
They have developed a new needle that works better.

CARDIOVASCULAR

Device: Catheter, Sheath, Introducer
Catalog #SI-09903-E
Other Device #AO-09000 (obturator)
Manufacturer: Teleflex Medical
Problem: This problem is actually ongoing. Once a cardiac patient no longer needs a pulmonary artery catheter, then it can be removed but the introducer is often left in place as an access site for fluids via the sideport. The access for the catheter, however, must be blocked off using an obturator. Nurses have repeatedly complained that it is more difficult now to put the obturator (aka blue cap) on the introducer's hemostasis valve resulting in patient discomfort and potential for minor injury. Comparison of current vs. earlier version of product with scanner: An older introducer (same product) was obtained from a nurse who specializes in training others about catheters, lines and access devices. The obturator easily goes onto this earlier version. Images of the hemostasis valves and o-rings were scanned and the difference in pixels between the o-rings' diameters translates to 0.005" with the current one being larger. This may be enough of a difference to account for the difficult obturator insertion.
======================
Manufacturer response for Percutaneous Sheath Introducer, Arrow Int'l
======================
The AO-09000 (the obturator) was measured and determined to be within specs by the manufacturer. It's the reporter's belief that the manufacturer did not attempt to fit it on recently manufactured hemostasis valves to see that is has become difficult to insert.

Device: Monitor, Multi-parameter module; CARESCAPE
Manufacturer: GE Medical Systems Information Technologies
Problem: During use in the OR, anesthesiologist observed "SpO2 module malfunction" when using GE PDM with Solar patient monitor. Changed out and re-seated SpO2 cables with no effect. GE responded by sending Engineering on-site to assess, evaluate situation and perform testing. Upon testing, GE worked with Masimo to determine root cause. Latched error message thought to be caused by fluid ingress in the Masimo cable (where contact is made) due to cleaning in the OR between cases. Biomed worked with Masimo to change out LNOP cable to LNCS cable which is less prone to fluid ingress issues. Will keep observing with new cables. GE issued an Internal Complaint in their tracking system to work on disable latching of probe/module malfunction message if a new cable is attached.

Note from FDA: Similar reports have been submitted with the Carescape monitor. To view these reports, visit the MedSun Reports simple search screen and enter Carescape in the 'Search For' text box.

Device: Patient Warming System; Hypo/hyperthermia Unit
Model# M1000
Manufacturer: Kimberly Clark
Problem: During a surgical procedure a patient received a small first degree burn on their back from a warming pad. The case was several hours and the temp was operating at 41 degrees. It was found during a root cause analysis (RCA) that there was a deviation from the standard usage of the warming pad with the use of a rolled towel causing the concentrated heat. The towel was rolled up and placed against the warming pad. The patient's weight, position of the patient (rolled on side to provide access during procedure) and the towel forced the warming pad tighter to the patient's skin causing a burn.

Device: Transmitter, Telemetry, Physiological; PatientNet Ambulatory Transceiver
Model #DT-4500
Other #: FCC ID: BQI01DT-4500
Manufacturer: GE Medical Systems Information Technologies
Problem: Patient was on a telemetry floor and was being monitored by an ambulatory transceiver. Patient heard a sudden loud noise and felt a slight vibration of the ambulatory transceiver. The central monitoring station noted a loss of signal from the transceiver, indicating a battery failure, so a nurse went to the patient to change the battery. While the nurse was changing the battery, (9V Duracell Procell product number 4F21 G305 17) the battery "popped" and the cardboard bottom came off the battery. The internal cylinders started to push out the bottom of the battery. The plastic cap on the end of some of the cylinders also popped off of the cylinder. The transceiver was taken out of service and the event reported to Biomedical Engineering. Engineering will be looking at the transceiver to see if there was a malfunction of the transceiver that caused the battery failure. Engineering believes that this is a battery problem, but felt a report should be completed in case other facilities are reporting this type of problem. The nursing staff found other batteries that popped. These were discarded/used batteries in the disposal bin and would pop in the bin. Duracell Global Marketing was notified of the battery failure and they removed all the batteries with lot #'s 4F15 and 4F21. The failed batteries will be returned to them so that they can look into the battery failure.

Device: Defibrillator, External, Biphasic; M series
Manufacturer: Zoll Medical Corporation
Problem: Failure to rescue a morbidly obese patient.
A morbidly obese patient with non-ST elevation myocardial infarction status post cardiac catheterization, placement of stent x2 when he had a cardiac arrest. Ten defibrillation attempts were made with the Zoll M Series biphasic defibrillator at 200 joules (the max) and hands free pads anterior / posterior placement. Unable to rescue patient. Another manufacturer's BIPHASIC device was obtained and the patient was shocked x1 with 360 joules which resulted in conversion to a perfusing rhythm. The Zoll M Series defibrillator was fully checked after this event and is working to specification. This is the second event we have seen of a failure to rescue a morbidly obese patient with a biphasic device at the maximum capacity 200 joules.


OBSTETRICS/GYNECOLOGY

Device: Vacuum Assist Device with Vacuum Cup, Fetal; Mytyvac, M Style, Mushroom
Catalog# 10007LP
Manufacturer: Cooper Surgical
Problem: After obtaining consent for a vacuum delivery, the mushroom cup Mityvac was placed and position was checked. Over the next two contractions, the physician did attempt to pull with the vacuum and there was one pop-off. The vacuum was not maintaining adequate suction beyond a level of 10-15. The vacuum was removed and a new replacement pump was obtained as well as the vacuum cup and tubing. The new vacuum was placed and again position was checked. Steady progress was made and the vacuum was maintained at approximately 45-50 in the green zone and there were no pop-offs. The cup and tubing was not retained and the lot number was not recorded. Early this year, a recall notice was received from Cooper Surgical regarding a recall of specific lot numbers of the disposable vacuum assisted delivery products. We did pull from inventory 12 items from one affected lot number.

Recall Online Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=34888


ANESTHESIOLOGY

Device: Anesthesia Machine; Aisys Carestation
Serial# ANAL00353
Manufacturer: GE Medical Systems, LLC
Problem: A serious concern has been identified due to the lack of alarm on GE Medical Aisys Carestation anesthesia machine when inhalation agent is turned off by system and not by anesthesiologist. In this particular case, the anesthesiologist moved the machine backwards and inadvertently touched alternate O2 button on the machine. He realized it when he saw the message on the screen. When he turned the alternate O2 system off, the O2 flow came back to 2L, but the agent did not return to the original setting. This was missed until the patient was moved and sevoflurane was turned back on. Since ET sevo was still at 2, the 'agent off' did not draw his attention. GE was informed of the event, and has opened up an Internal Complaint in their tracking system on this particular issue.

Device: Ventilator
Manufacturer: Puritan Bennett
Problem: Physician and Respiratory Therapy were at the bedside making a ventilator setting change. Ventilator went in-operable and was not ventilating patient. The patient was removed from the equipment and staff started bagging the patient. The equipment was removed and replaced. Alarm screen went blank and the backup system did not kick in. There was no harm to the patient.

======================
Manufacturer response for Ventilator, Puritan Bennett 840 Ventilator
======================
Problem was caused by a defective GUI CPU. Vendor replaced GUI CPU. Performed Gas output and port hardware update and installed ferrites. Performed all required calibrations/verifications. Unit passed EST, PVT and electrical safety test.

Device: Analyzer, Arterial Blood Gas; ABL820 Flex
Serial #1902-754R0090N0005
Manufacturer: Radiometer America, Inc.
Problem: The patient was in the Emergency Department for altered mental status. Venous blood gases were run twice on this patient. The device was in the "green light" status. The first sample taken did not have a pH result, so a two point calibration was done and the sample was run again, the results were pH: 6.819, pCO2: 58.1, pO2: 59.2, cHCO3: 6.5, cBase: -26.1. The results were reported to the physician as critical, but per the physician, this was not consistent with the patient's clinical presentation. An hour later, a second sample was obtained and run with device in "green light" status and no pH value was given. A second two point calibration was done, the sample was run again with results of pH: 6.659, pCO2: 47.8, pO2: 41.6, cHCO3: 4.1, cBase: -31.6. These results were reported to the physician as critical, and again this did not match the patient's clinical presentation. Bicarb was considered, but was not given. An ABG was drawn and run on a different machine and the results were within normal limits. There was no patient harm. Coincidentally, the machine's power supply blew and the machine became inoperable. After the power supply was replaced and the machine tested, it was determined that there was a dried blood clot in the analyzer. This was removed and the machine functioned properly. The facility is currently assessing a new syringe that will mix samples better to prevent clotting.

Device: Anesthetic Gas Module; IntelliVue
Model #M1019A
Manufacturer: Philips Healthcare
Problem: This has been an ongoing concern in our OR's and has been affecting multiple machines. 12 Phillips G5 IntelliVue Anesthetic Gas Modules were introduced to our OR's earlier this year. We immediately started having issues with the G5's "locking up." It happens in all stages during the case and even after the case when the patient has been disconnected and out of the room. It has even happened in empty rooms. The G5 LED's will be flashing and the patient monitor is on "standby". Phillips decided to replace the original 12 machines with 12 new ones thinking perhaps we had received a bad batch. The problems have continued - Phillips has even sent techs from Germany and Andover on two separate occasions to troubleshoot the issues, as well as having Radio Frequency (RF) and Power experts to look at possible environmental concerns. All of their testing shows no obvious reason for this to be happening. Our Biomed Tech has described the problem as: The Phillips monitor displays all question marks where the information from the G5 should be displayed. The anesthesiologists don't have any c02, in02, inN20, etN20 readings. They lose the gas identification and all of the other necessary information. The G5 has two LED's on the front (set up and standby). When we experience this problem the standby LED is lit solid and the setup one flashes and is not responsive to anything but a power cycle. From having the Phillips techs onsite we have discovered the G5 loses communication with the monitor and if the data cable is removed from the patient monitor for 10-15 seconds and then plugged back in the data will re-populate again. This is faster than the power cycle so when these problems occur the doctors and anesthesiologist techs have just been removing this cable and reattaching to get the data back. This problem does not affect any other information on the patient monitor such as ECG, SP02, NIBP. It is just the information from the G5 gas analyzer.

Phillips has indicated they feel the issue is environmental but it is so sporadic and intermittent it is difficult to determine what exactly could be causing problems.

Device: Kit, ETCO2; Aquat-knot II Kit
Manufacturer: GE Medical Systems, LLC
Problem: The manufacturer has issued a rolling back order and the product is temporarily out of stock with no safety back up. The product is necessary for ETCO2 monitoring in the ICU and intraoperatively.


NEUROLOGY

Device: Clamp, Surgical, Head Support; Mayfield Skull Clamp
Model #A1059
Manufacturer: Integra LifeSciences Corporation
Problem: Surgeon placed skull clamp on patient's head. Patient then turned prone in preparation for surgery on cervical spine. Clamp was firmly attached to Mayfield base support which is firmly attached to the OR table. While head was being repositioned by surgeon the swivel lock appeared to become unlocked and patient's head fell downward with the bridge of his nose striking the crossbar of the skull clamp. This injury was superficial. The surgeon once again repositioned and re-secured the head but then the head was "spontaneously ejected" from the skull clamp, resulting in a deep 5cm laceration above the right ear. This required closure with skin staples.

======================
Manufacturer response for Skull clamp/head support, Mayfield
======================
The manufacturer acknowledged the device's inherent instability. They supplied us with a loaner clamp while they evaluate ours. They provided me with the instructions for use at my request. The IFU does state that "The direction of the single pin should point directly through the center point created by the centerlines of the patient's head with the pins on the two-pin side of the skull clamp being equidistant to single-pin line of direction to obtain the highest degree of stability."

Recall Online Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=33840

Device: Generator, Lesion; Radionics
Manufacturer: Covidien Valleylab
Problem: Burn to left scapula area discovered after the trigeminal nerve ablation surgery. Burn is size of a dime, full thickness requiring Silvadene cream and follow-up in Burn Clinic.
Impedance all over, changed the cable. Took off the grounding pad and didn't notice anything.
The impedance was found to vary significantly during this lesion (up to 4000 ohms), but it returned to normal (around 300 ohms) following the lesion.


RADIOLOGY

Device: Transformer, Low ImpedancePower Conditioner
Model #4450028-01 50/60 HZ 3 Phase
Manufacturer: TEAL Electronics

Device: Scanner, CT; VISION MX 8000
Model #728201
Manufacturer: Philips Medical Systems

Problem: The isolation transformer caught fire in the Phillips CT scanner, while the scanner was sitting idle. The emergency response alert was initiated and the fire was extinguished. The damage was all contained inside the transformer cabinet. There was some smoke released into the surrounding air, but no harm to staff or patients.

Recall Online Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=64322


ORTHOPEDIC

Device: Plate, Orthopedic; DVR-Distal Volar Radius Plate
Model# DVRA-A STANDARD LEFT PRODUCT; DVRA-L
Manufacturer: Hand Innovations, LLC
Problem: Patient was admitted to the hospital for repair of a fractured left wrist. The operation required the use of a plate with seven (7) screws to stabilize the fracture. Each screw has a guide device used to direct the screw into the bone. After the screw is inserted into the bone, the guide is removed. It was determined that this particular style of orthopedic device was not frequently used by our staff and was designed to have separate fast guides whereas other similar devices were designed with all of the fast guides connected together so that they were removed as a set rather than individually. Consequently, this device requires a separate count for each screw guide while the more frequently used device removes all of the screw guides at once. The OR staff was not aware of this counting requirement with this device. A post-operative X-ray was taken to verify the placement of the plate. The X-ray revealed the presence of one of the screw guides. The patient was return to the OR and the guide was removed without complication.

Note from FDA: Please see recent article describing issues seen in this report, posted in August 2008's Newsletter online available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=27#5


OPTHALMIC

Device: Glaucoma Valve Flexible Plate; Ahmed Glaucoma Valve Flexible Plate
Model #FP7
Lot #B0308
Manufacturer: New World Medical Inc
Problem: Patient returned to OR 8 days after initial surgery due to collapsed anterior chamber of the left eye. The tube on the device was noted to have a laceration upon inspection after removal. Manipulation of the tube on inspection led to splitting of the tube.


GENERAL HOSPITAL

Device: Pump, IV, CPU; Medley
Model #8015
Manufacturer: Alaris Medical Systems, Inc.

Device: Pump, IV, Module; Medley
Model# 8100
Manufacturer: Alaris Medical Systems, Inc.

Device: pump, IV, module; Medley
Model# 8100
Manufacturer: Alaris Medical Systems, Inc.

Problem: Patient receiving TPN at 80 ml/hr. Infusion stopped at 0430 to draw labs. Nurse restarted infusion and thought that rate was set at 80 ml/hr with approximately 2000 ml still in bag. Approximately 2 hours later, pump alarming and TPN bag empty. Pump taken out of service. When event/error log downloaded revealed that rate had been set at 880 ml/hr. Concern that there may be keypad bounce that is not immediately evident to user. Pt developed a-fib and was transferred to ICU had no long term harm.

Device: Pump, PCA/chemo; GemStar
Manufacturer: Hospira Global Medical Affairs
Problem: Patient had received a home infusion pump with 5FU infusing. Two days later the patient arrived as per appointment for discontinuation of medication and pump. Infusion was set to run for 46 hours.

On arrival, patient stated that the infusion pump had alarmed approximately 30 minutes prior to arrival. The patient stated that after the pump alarmed she took out the batteries. Patient stated that the pump screen read "bag empty" before she removed the batteries. She stated that she noticed that the bag was not empty.

Upon assessment of the pump, the screen was blank and pump was off. The batteries were not inside the pump. The patient gave me the batteries. I reinserted the batteries and turned the pump on. I checked the pump history. Screen indicated volume infused: 133ml. Settings were: Volume - 138 ml, Rate: 3ml/hr, as per MD order. Air alarm ON. Contents of IV bag were drawn up, and 55 cc of chemo agent remained in the bag, representing 16 hours of medications that had not infused. Various factors were reviewed and none could explain the remaining volume. Pharmacy loads the bag and has a triple check mechanism in place using three different people to verify the contents, rate and volume. The machine was not yet due for a re-calibration (required every 6 months).

We believe there is a faulty mechanism that does not deliver the intended volume despite remaining fluid in the bag. In this case, the machine was set and verified at 138 ml for total volume to be infused. However, the machine only delivered 83 ml. This may not seem like much - but over the course of 12 chemo treatments - close to 16 hours or more of chemo will not be infused. We are reviewing all chemo patients for the past several months, looking at what the Gemstar delivered versus what was ordered.

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Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events With Electrocardiograph Electrodes in Pediatric Patients and Related Reference

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By Elizabeth Eydelman, Patient Safety Staff, 2008

From June 2007 to May 2008, MedSun has received 10 adverse event reports involving electrocardiograph electrodes associated with three manufacturers: Conmed Corporation (7), Tyco Healthcare Group LP (2), and 3M Company (1). The reports were submitted by 2 hospitals between June 2007 and May 2008. The two most frequently reported device problems are:

• Fluid Leak
• Loose-fitting nature of device

There are no MedSun reports involving a patient death during this time period. There are 6 reports that do not list the type of adverse event, 3 that list injury adverse event type, and 1 report lists malfunction as the type of adverse event. The most frequently reported patient problems are:

• Rash/Blisters/Erythema (7)
• Prolonged/Repeated Surgical Procedure (2)
• Skin Erosion/Drainage (1)
• Necrosis (1)

All of the reports feature pediatric and neonatal intensive care unit patients in each respective hospital. Of the reports that list patient gender, a total of 8 reports involve female patients and 1 report involves a male patient. These reports contribute to FDA’s post-market experience and understanding of problems associated with the use of these devices.

The chapter on Skin and Skin Care in the 5th edition of the Handbook of Neonatal Intensive Care (St. Louis: 2002) provides tips for skin care of preterm and term infants: (1) minimize tape use when possible by using smaller pieces, (2) utilize soft gauze wraps to secure probes and electrodes, and (3) remove adhesives slowly and carefully with warm water and cotton balls.

[Note: The reports have been edited for clarity]



MedSun Electrocardiograph Electrode Adverse Event Reports Received Between June 2007 and May 2008
Device Device Identifiers Event Description
Conmed Corporation/Electrocardiograph Electrode Lot: 0703051 WHEN CHANGING PATIENT'S LEADS, IT WAS NOTED THERE WAS SKIN BREAKDOWN UNDER THE LEAD ON PATIENT'S LEFT LOWER ABDOMEN.
Conmed Corporation/Electrocardiograph Electrode Lot: 0703051 DURING A ROUTINE PATIENT ASSESSMENT AND THE REPLACEMENT OF THE ELECTRODES DUE TO THEIR SLIDING OFF, SMALL BUMPS WERE FOUND ON THE CHEST AND STOMACH, UNDERNEATH THE ELECTRODES. THE CHEST BUMPS WERE NOTED TO BE REDDENED AND ONE WAS BLISTERED. THE STOMACH BUMPS WERE NOTED TO RESEMBLE PIMPLES WITH WHITE HEADS.
Conmed Corporation/Electrocardiograph Electrode Lot: 0703051 WHILE BATHING THE PATIENT, WHICH INCLUDED REMOVAL OF THE ELECTRODE LEADS, SMALL BLISTERS WERE NOTED UNDER ELECTRODE LEAD AREA ON THE CHEST AND ABDOMEN. THE BLISTERS ON THE ABDOMEN APPEARED TO BE OPEN.
Conmed Corporation/Electrocardiograph Electrode Lot: 0703051 THE ECG LEADS CAUSED BLISTERS ON THE UPPER CHEST. THE BLISTERS WERE NOTED TO BE WORSE ON THE RIGHT SIDE OF THE PATIENT.
Conmed Corporation/Electrocardiograph Electrode Lot: 0703051 THE PATIENT WAS NOTED TO HAVE SIGNS OF DRAINAGE AND SKIN EXCORIATION UNDER THE ELECTRODE.
Conmed Corporation/Electrocardiograph Electrode Lot: 0703051 THE PATIENT WAS NOTED TO HAVE A RED RASH UNDER TWO OF THE THREE ELECTRODES. IN ADDITION, YELLOW DRAINAGE WAS NOTED ON THE ELECTRODES THEMSELVES.
3M Company/Electrocardiograph Electrodes Lot: B 2008-09 AB ELECTRODES FAILED TO STICK TO THE SKIN OF A 5 WEEK OLD MALE, STATUS POST-OP FOR TOTAL ANOMALOUS PULMONARY VENOUS REPAIR PERFORMED AT ANOTHER FACILITY (TERTIARY CENTER). PATIENT CODED WHILE AT HOME; CPR WAS COMMENCED AT HOME. PATIENT WAS TRANSPORTED VIA AMBULANCE. DURING CODE, ELECTRODES FAILED TO ADHERE TO PATIENT'S SKIN. NURSE DESCRIBED PATIENT SKIN AS "STRANGE - ALMOST SLIMY". NURSE IMPROVISED BY TAPING ELECTRODE TO SKIN. MANUFACTURER RESPONSE FOR PEDIATRIC MONITORING ELECTRODE, RED DOT ELECTRODE: MANUFACTURER PRODUCT COMPLAINT LINE WAS NOTIFIED. TECHNICAL PERSON WOULD CALL BACK.
Conmed Corporation/Electrocardiograph Electrode Lot: 0710111 IT WAS REPORTED THAT "A CHILD HAD A HOLTER MONITOR ON FOR LESS THAN 48 HOURS. USING 1650-005, AT 4 LOCATIONS, BLISTERS DEVELOPED, NOW THEY APPEAR TO BE SCAR TISSUE. CHILD IS TO BE SEEN BY A DERMATOLOGIST."
Tyco Healthcare Group LP/Electrocardiograph Electrode Device Identifiers Unknown/Not Available FLUID FILLED BLISTERS NOTED ON RIGHT CHEST UNDER EKG ELECTRODE -KENDALL PUPPY DOG 5 LEAD PREWIRED NEONATAL/PEDIATRIC RADIOLUCENT ELECTRODE-. ELECTRODES PLACED ON CHILD IN 2008 FOR OPEN HEART SURGERY. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: CARDIAC MONITORING. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: NO.
Tyco Healthcare Group LP/Electrocardiograph Electrode Device Identifiers Unknown/Not Available DT FOUND TO HAVE DEVELOPED BLISTERS UNDERNEATH 2 OF THE FIVE EKG LEADS -KENDALL PUPPYDOG 5 LEAD PREWIRED NEONATAL/PEDIATRIC RADIOLUCENT ELECTRODES-; RIGHT UPPER CHEST UNDER WHITE LEAD AND LEFT MIDCLAVICULAR LOWER TRUNK UNDER BROWN LEAD. MD NOTIFIED AND AT BEDSIDE TO ASSESS PT WITH CHARGE NURSE. PICTURE TAKEN OF BLISTERS AND DOCUMENTED. LEADS WERE REMOVED AND REPLACED WITH NEOTRODE LEADS. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: CARDIAC MONITORING. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.


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Summary of MedSun Reports Describing Adverse Events With Thermal Regulating Systems in Pediatric Patients and Related Reference

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By Elizabeth Eydelman, Patient Safety Staff, 2008

MedSun has received 9 adverse event reports involving thermal regulating systems associated with 4 manufacturers: Cincinnati Sub-Zero Products, Inc. (7), Arizant Healthcare (1), Augustine Healthcare, Inc. (1), and Maquet Cardiopulmonary (1). The reports were submitted by 3 hospitals between March 2007 and April 2008. The most frequently reported device problem is:
• Leaking (6)

There are no MedSun reports involving a death during this time period. There are 6 reports that list malfunction as the type of adverse event, 2 reports do not list type of adverse event, and 1 report lists “other” as the type of adverse event. Of the reports that list patient problems, the most frequently reported patient problems are:

• Thermal burns/injury (2)
• Decreased body temperature (1)
• Elevated body temperature (1)
• Prolonged surgery (1)

All of the reports featured describe patients in the neonatal intensive care unit (NICU) or pediatric intensive care unit (PICU) of each respective hospital. Of the reports that list patient gender, a total of 7 reports involve female patients and a total of 2 reports involve male patients.

These reports contribute to FDA’s post-market experience and understanding of problems associated with the use of these devices. Skin injury associated with thermal regulating systems may occur due to a cumulative effect of time, temperature, and pressure. Mary Frances D. Pate, author of a chapter 14, Thermal Regulation in Oski's Principles and Practice of Pediatrics (Philadelphia:1999), cautions that when children are cold and have peripheral vasoconstriction, the ability of surface capillaries to dissipate heat is diminished, increasing the risk for bums. Monitoring for patient skin integrity and proper device function are essential for safe and effective use of both water-filled and forced air thermal regulating systems.

[Note: The reports have been edited for clarity]




MedSun Thermal Regulating System Adverse Event Reports received between March 2007 and April 2008
Device Device Identifiers Event Description
CINCINNATI SUB-ZERO PRODUCTS, INC./THERMAL REGULATING SYSTEM Model: 874THE USER FACILITY REPORTED THAT A MAXI THERM LITE BLANKET LEAKED ONTO THE FLOOR. THE BLANKET WAS NOT BEING
USED ON A PT AT THE TIME BUT RATHER WAS SITTING ON TOP OF A PIECE OF EQUIPMENT.
CINCINNATI SUB-ZERO PRODUCTS, INC./THERMAL REGULATING SYSTEM Lot: 7796 THE USER FACILITY REPORTED THAT THE NURSE FOUND THE LINENS AND FLOOR WERE WET. NEW BLANKETS WERE OBTAINED. USER FACILITY REPORTED THAT THE PATIENT'S TEMPERATURE DECREASED APPROXIMATELY 0.1 DEGREE CELSIUS.
CINCINNATI SUB-ZERO PRODUCTS, INC./THERMAL REGULATING SYSTEM Lot: 7796 THE USER FACILITY REPORTED THAT A MAXITHERM LITE BLANKET WAS FOUND LEAKING ONTO THE BEDDING AND FLOOR. THE PATIENT WAS REMOVED AND THE LINENS WERE REPLACED. USER FACILITY ALSO REPORTED THAT THE PATIENT'S TEMPERATURE ROSE SLIGHTLY OUT OF THE PARAMETERS FOR CURRENT WARMING PROTOCOL AND WAS RETURNED TO REQUIRED TEMPERATURE PER PROTOCOL ONCE NEW EQUIPMENT WAS ACQUIRED.
CINCINNATI SUB-ZERO PRODUCTS, INC. and ARIZANT HEALTHCARE, INC. /THERMAL REGULATING SYSTEM Model: 111W/ Model: 505 PATIENT UNDERGOING RESECTION OF LARGE LIVER TUMOR. AFTER SURGERY, PATIENT HAD TWO BURNS ON THE LEFT SHOULDER AND BACK APPROXIMATELY 7 CM IN DIAMETER WHICH REQUIRED SURGICAL DEBRIDEMENT AND FLAP CLOSURE.
Augustine Medical, Inc./ THERMAL REGULATING SYSTEM Model: 500 UPON REMOVING DRAPES, IT WAS NOTED A CIRCULAR WOUND APPROX 3CM IN DIAMETER WITH DEPRESSED AREA IN MIDDLE APPROX 1CM ON LEFT INNER CALF. BAIR HUGGER BLANKET WAS UNDER BODY AND ATTACHMENT HOSE WAS CONNECTED TO BLANKET APPROX 1 FOOT BELOW PATIENTS FEET. DATES OF USE: ONE DAY IN 2007. DIAGNOSIS OR REASON FOR USE: SURGERICAL REPAIR OF CLEFT PALATE.
CINCINNATI SUB-ZERO PRODUCTS, INC./THERMAL REGULATING SYSTEM Lot: 8288 WHILE INFANT WAS ON BODY COOLING, THE BLANKET BEGAN TO LEAK LARGE AMOUNTS OF WATER. THERE WAS AN APPARENT HOLE/LACERATION IN THE BLANKET ITSELF. THE BLANKET IN USE WHEN LEAK OCCURRED WAS MAXI-THERM LITE, CATALOG NUMBER 874 BY CINCINNATI SUB-ZERO. THE BLANKET AND THE BED WERE IMMEDIATELY REPLACED, INFANT TEMPERATURE REMAINED AT RECOMMENDED LEVEL(32.5 C) FOR TREATMENT AFTER CHANGE OUT OF EQUIPMENT OCCURRED.
CINCINNATI SUB-ZERO PRODUCTS, INC /THERMAL REGULATING SYSTEM Lot: 316186 COOLING BLANKET LEAKING.
MAQUET CARDIOPULMONARY/THERMAL REGULATING SYSTEM Model: HCU30 THE HEATER/COOLER FAILED DURING A CARDIOPULMONARY BYPASS PROCEDURE. THE CLINICIANS STARTED TO WARM THE CARDIOPLEGIA SIDE FROM 4 DEGREES CELSIUS. THIS SIDE WARMED UNUSUALLY SLOW. THE TEMPERATURE ONLY REACHED 16 DEGREES CELSIUS AFTER 20 MINUTES. AT THIS POINT THE HEATER/COOLER SOUNDED A CONTINUAL AUDIBLE ALARM, LOCKED OUT THE CONTROLS, AND STOPPED WARMING THE PATIENT. THERE WAS NO VISUAL INDICATION OF THE ALARM. THE UNIT WAS TURNED OFF AND BACK ON AGAIN (RE-BOOTED). THE UNIT WORKED FINE AGAIN, BUT DURING THE BOOT-UP SELF TEST IT CYCLED COLD MOMENTARILY, AND THE PATIENT WAS SUBSEQUENTLY COOLED BY APPROXIMATELY 2 DEGREES CELSIUS. THIS RESULTED IN MORE TIME NEEDED ON CARDIOPULMONARY BYPASS TO CONTINUE WARMING THE PATIENT. THE APPROXIMATE DELAY WAS 10 MINUTES.
CINCINNATI SUB-ZERO PRODUCTS INC/THERMAL REGULATING SYSTEM Model: 874 POST-OPERATIVE INFANT BEING COOLED AND LYING ON MAXI-THERM LITE PEDIATRIC COOLING BLANKET. SUDDENLY BLANKET STARTED TO LEAK AT THE CORNER WHERE TUBING ENTERS BLANKET, SPRAYING WATER OVER PATIENT AND PARENT SITTING AT BEDSIDE.

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Updated September 1, 2008

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