Highlighted Reports
MedSun: Newsletter #58, March 2011

This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period December 1 through December 31 2010. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.


ANESTHESIOLOGY

Device 1:
Type: Fiber Optic Blade
Manufacturer: Flexicare Medical Limited
Brand: Briteblade Pro
Model#: Macintosh Size 3
Lot #: 0120

Device 2:
Type: Laryngoscope Handle
Manufacturer: Flexicare Medical Limited
Brand: Venticaire
Lot #: CHT

Problem:
During an attempt to place an intubation tube during a code, the user retrieved a laryngoscope handle and MAC #3 laryngoscope blade to assemble for ET tube placement. When the two sections were snapped together and mated, no light was emitted. Several attempts were made to get the lamp to start, including battery position and re-insertion. The code team had to scramble for another adult intubation tray to get another laryngoscope set. The second set worked and the code team was able to position the ET tube. At the end of code, the respiratory therapist tested the known bad MAC3 blade with another handle and the blade lit. The therapist also tested a different blade onto the known failed handle and the blade lit; we cannot get either the blade or handle to fail when matched with different mates. Sterile processing has been instructed to test the light on the handle by pressing the light housing down unit lit. The blades are usually packaged sterile and are unable to be tested with each handle. These were purchased by the medical center to avoid this very scenario. Distributer of device contacted for manufacturer information. This is a reoccurring issue according to the therapists.
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Health Professional's Impression
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Device failed to work during a code event and a STAT replacement process had to occur. It has been reported that more than one event has occurred with this new disposable system.
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Manufacturer response for Laryngoscope, Bright Blade Pro
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To hand off instrument to distributor.
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Manufacturer response for Laryngoscope Handle, Venticaire
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Return to distributor for evaluation. This is to be returned as a SET along with the blade.


Device:
Type: Prone Position Head Cushion
Manufacturer: Vital Signs, Inc.
Brand: Disposa-view
Lot #: 201005
Cat #: 8000HDP

Problem:
Patient was in a prone position for a surgical procedure for more than 4 hours that resulted in a reddened area across the forehead when the patient was returned to the supine position. A few months later patient has presented with a 3 cm non-healing lesion to his forehead that is requiring additional intervention by Plastics/Dermatology.

No other problems noted with this product in the past.
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Health Professional's Impression
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Decreased circulation to the area (forehead)for a period of time.
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Manufacturer response for Prone Position Pillow, Disposa-View Disposable Prone Position Head Cushion
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There has been no change in the product (i.e. density of the foam or change in product design).


Device:
Type: Regulator
Manufacturer: Controls Corporation of America
Brand: Carbon Dioxide Regulator
Model#: 3042001-01-0XB

Problem:
We were using a CO2 tank prior to procedure. We connected the valve and proceeded to push the button on the side to let the CO2 flow out of the tank. The button pushed down quite hard and then there was a big "bang" sound, much like a gun going off. Turns out the pressure must have built up and the regulator wasn't working. The valve exploded and broke. Couldn't hear well immediately afterwards. Now there is pain in both ears. Mostly in the right ear, and it is much like the start of an ear infection.


CARDIOVASCULAR

Device:
Type: Aortic Bioprothesis Valve
Manufacturer: Edwards Lifesciences
Brand: Carpentier-edwards Perimount Magna Ease Pericardial Bioprothesis-aortic
Model#: 3300TFX

Problem:
Aortic valve placed on the sterile field. As scrub nurse was rinsing the valve, she noticed unusual markings on the inner leaflets of the valve. Surgeon notified. Valve removed from the field and will be returned to the tissue supplier.


Device:
Type: Arrowgard Blue Triple Lumen Central Line Catheter
Manufacturer: Arrow International
Brand: Arrow Bluegard
Lot #/ Cat #: RF8123993

Problem:
Patient washed with chlorhexidine wash evening before and experienced itching with a rash. Self-treated with Benadryl and presented to preop the following morning. Reaction to the wash was explained to the nurse and an "allergy" was recorded. The usual oral rinse with chlorhexidine gluconate 0.12% was completed. Forty-five minutes later a central line was inserted in preparation for the Coronary artery bypass graft (CABG) procedure. Shortly thereafter the patient experienced shortness of breath, and demonstrated "seizure-like" movement. He was intubated to protect his airway and surgery was cancelled. In addition to the central line and oral rinse, staff utilized chlorhexidine hand gel throughout their contact with the patient while prepping him for surgery.


Device:
Type: Arterial Line
Manufacturer: Arrow International
Brand: Arrow Arterial Line Cath Kit
Model#: UM-04018
Lot #: RF0090664
Other #: 18GA. 16cm. 025in. dia.

Problem:
The physician assistant was attempting to place an right femoral arterial line. The spring wire guide was unable to retract or advance once inside the needle. Device was removed and another femoral arterial line set had to be used.


Device:
Type: Catheter, Introducer
Manufacturer: Abbott Vascular
Brand: Viking Guiding Catheter
Model#: 1001966-07
Lot #: 0060791
Other #: 7fr Mpa 2 guiding catheter

Problem:
Catheter tip was misshapen prior to removal from packing. A second catheter had the same issue. The tip seemed to be misshapen. It seemed to be a packaging issue because the tip seemed to get squished against the package holder.


Device:
Type: Clamp, Vascular
Manufacturer: St. Jude
Brand: Femostop Gold
Model#: 11165

Problem:
An elderly patient with femostop compression device applied to thigh. Red tab removed from device. Nurse noted that the number on the monitor registered 100mm/hg. Nurse pumped the device to achieve pressure for hemostasis/groin management of hematoma. The patient then experienced a drop in BP. RN released pressure on FemoStop from 125 to 86. Patient was fluid resuscitated and blood pressure increased. When the nurse attempted to remove the device she opened the white clip on the device and turned the knob on the bulb completely to the left to deflate. The dome of the device would not deflate. The device was removed from the patient and the nurse attempted to remove the air from the dome. Dome would still not deflate. New device applied. The RN placed the device in an office and two days later pressure still read 18 mm/hg.
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Health Professional's Impression
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The device would not deflate.
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Manufacturer response for Femostop Gold, FemoStop Gold
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Manufacturer sent representative from Sweden to review


Device:
Type: Coronary Drug-eluting Stent
Manufacturer: Boston Scientific
Brand: Promus
Lot #: 0061141

Problem:
Stent found to be bent onto the packaging stylette. This was not observed initially by the physician nor the scrub tech. It was later found that the stent was not on the delivery device at the time of insertion. The balloon was inflated over the lesion. It was then discovered that the stent was still located under the yellow wrapping tool on the stylette.
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Health Professional's Impression
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No adverse event. The stent was apparently damaged during the manufacturing process.


Device:
Type: Introducer Catheter
Manufacturer: Arrow International, Inc
Brand: Arrow Select Kits
Model#: UW-09801-SP
Lot #: RF 0091803

Problem:
The introducer catheter leaked while in place in the patient. This has happened with several of these catheters where either blood or IV fluids leaked out of the top of the introducer and have had air in the side port. It appears that the valve in the introducer catheter does not work properly. No patient has been harmed.
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Health Professional's Impression
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possible faulty valve in introducer catheter
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Manufacturer response for Central line introducer catheter, Arrow Select Kits
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Manufacturer has requested that device be returned for analysis


EAR, NOSE & THROAT

Device:
Type: Tube, Tympanic
Manufacturer: Gyrus ACMI, Inc.
Brand: Micron Titanium Bobbin Ventilation Tube
Model#: 14-5272
Lot #: 0625683013
Cat #: 14-5272

Problem:
Patient had previous ossicular reconstructive surgery. After about two months, patient unable to hear. Physician brought patient to OR to do another ossicular reconstruction and noted during surgery the prosthesis from the initial surgery was broken. Prosthesis removed and a new one implanted.
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Health Professional's Impression
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Unknown


GENERAL & PLASTIC SURGERY

Device:
Type: Applier, Clip
Manufacturer: Ethicon Endo Surgery
Brand: Ligamax 5
Model#: EL5ML
Cat #: EL5ML
Lot #: G4TU6E

Problem:
Surgeon was performing a laparoscopic cholecystectomy with intraoperative cholangiogram. When surgeon applied the first clip to the patient's artery, the Ligamax 5 mm Endoscopic Multiple Clip Applier would not release after firing. The clip applier was jammed and the device would not revert back to the open position. The concern was that the artery could have been damaged. The only other option would have been to open the abdomen and try to free the device. However, the surgeon was able to safely remove the clip off the artery with the clip applier still in the closed position. No injury was done to the patient, but this put the patient at risk and the surgeon had to make a decision to try to work the device off or open the patient up to try to remove it. This posed a significant issue during the procedure. Another clipper was used from the same lot number without a problem.
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Health Professional's Impression
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Device would not release after clipping artery.


Device:
Type: Endo Clip
Manufacturer: Covidien/US Surgical
Brand: Autosuture Endo Clip
Model#: REF 176630
Lot #: N0H0411

Lollipop Icon

Problem:
Child admitted with lesion in his left lower chest. Child underwent a video assisted thorascopic surgery. During the procedure, after two clips had been placed on an artery, the clip applier jammed during the placement of the third clip. The surgeon replaced clip applier with another to place the third clip and then performed a partial transection of the artery. The first two clips; however had not closed the artery and the bleeding necessitated conversion of the thorascopic procedure to an open chest procedure.


Device:
Type: Instrument, Surgical
Manufacturer: Spineology Inc
Brand: Spineology EShaper Blade
Model#: 315-0014

Problem:
During a lumbar laminectomy and fusion L4-5, L5-S1 the tip of the Spineology Shaver blade broke off in the L5 disc space.


Device:
Type: Suction Coagulator
Manufacturer: A & E Medical
Brand: Suction Coagulator
Pack lot # 987873
Cat #: 139926
Other #: A & E Medical packaged inside a PHS [Professional Hospital Supply] special made Tonsil/Adenoid Pack.

Problem:
On the wand of the device there is unknown dark gold colored dust.


GENERAL HOSPITAL

Device:
Type: Catheter, Picc
Manufacturer: Medical Components, Inc
Brand: Vascu-picc
Lot #: MBBK 950
Other #: Ref # MRVSP41003

Problem:
Leaking noted at the PICC catheter site. Small tear noted above hub on the clear part of the tubing. PICC removed.


Device 1:
Type: Infusion Pump, Patient Controlled Analgesic
Manufacturer: Smiths Medical ASD Inc.
Brand: Cadd Solis
Model#: Cadd solis 2100

Device 2:
Type: Infusion Pump, Patient Controlled Analgesic
Manufacturer: Smiths Medical ASD Inc.
Brand: Cadd Solis
Model#: Cadd solis 2100

Problem:
We have had multiple reports of the PCA button not working appropriately with our new CADD Solis pumps. In all the reported incidents nurses indicated that the patient was pushing the PCA button in an attempt to receive pain medication but the pump was not registering the button presses. Pump registered that the attempts were 0. Switching out to a different cord solved the problem in one case; in others the nurse simply replaced the pump. Clinical engineering was able to validate that there was a problem with the cords, but they were not able to pinpoint the point of failure.

These pumps and associated cords are only 4 months old. We have seen failures in 4 of our 28 pumps.
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Health Professional's Impression
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The failure of the PCA pump cords caused a delay of medication, and inadequate pain control.


Device:
Type: Pump, Infusion, Elastomeric
Manufacturer: I-FLOW CORPORATION
Brand: On-q
Model#: CB6004
Lot #: 082294

Problem:
The pain service RN called the patient at home to follow up pain control with an I-Flow ON-Q pain pump. Patient stated it leaked so badly that after he'd gone through 7 shirts, he stopped using the pump. Patient returned pump to hospital, and we will return to I-Flow Corporation to investigate. This was a 600mL pump, Lot #082294, Model #CB6004. It was filled to 700mL, which the manufacturer says is okay.


Device:
Type: Pump, Infusion, Pca
Manufacturer: CareFusion 303, INC.
Brand: Alaris Pca Module
Model#: 8120

Problem:
A patient bent a metal fork into a specific shape that allowed him to disengage the plunger mechanism on an Alaris 8120 PCA Module. Once the plunger head was raised above the syringe the patient pressed down on the syringe plunger and self-administered 13mg of Dilaudid. Patient was found unconscious and in respiratory arrest with an O2 sat level of 40%. A reversing agent was administered. After the patient recovered he admitted what he had done, produced the fork and demonstrated how he was able to manipulate the PCA Module. A Clinical Engineering technician was able to duplicate the event. The PCA Module and the fork have been sequestered for further investigation.
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Health Professional's Impression
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The design of the syringe cover allows the introduction of very thin objects into the compartment containing the PCA syringe. There is a very small crack between the two cover halves (1 to 2 mm) when the cover is locked. A tool can be used to turn the release knob and disengage the plunger head if the tool is bent in a very specific pattern.

See device images:
Image of bent fork in the Alaris 8120 PCA Module

Image of bent fork which allowed patient to purposefully manipulate the PCA Module


Device:
Type: Warmer, Infant Radiant
Manufacturer: Draeger
Brand: Babytherm 8004

Lollipop Icon

Problem:
Nursing reported the following.

Temperature probe connected to patient and bed and temp settings set to 36.5. Open warmer showed patient's temp at 37.3, but still within normal limits. Heart rate was high so temperature was checked rectally which showed a temp of 39.0. Patient's temperature should have been regulated correctly with open warmer being connected to patient through temperature probe. The infant was removed and placed in another warmer; monitored vital signs closely.

It was determined that this overheating was caused by a known problem referred to as the Stem Effect. (Technical information available here http://bit.ly/eb6nZI)

Our current policy is to coil the temperature probe to avoid the effects of the Stem effect. Our policy is as follows:

Thermoregulation for all patients admitted into radiant warmers and incubators:
1. Warm bed prior to admission. See CPG table Neutral thermal environment for temperature range to select. (This requires weight and age of patient)

2. Select proper skin temp probe.

3. For low-birthweight patients and those with fragile skin, place a barrier of duoderm between the temp probe cover and patient skin.
a) Cut the duoderm into a circle. Cut out the center portion. Place this against the skin.
b) Place the temp probe into the center of the duoderm against the skin.
c) Make a few coils of the temp probe wiring under the temp probe cover, and place this cover over the duoderm.

4. For patients without specialized skin care needs, place the temperature probe and coils of wiring on the sticky surface of the temperature probe cover and place this on the patient's body.

5. Ensure the incubator/ radiant warmer is set to skin control or servo control, rather than air temperature or manual.

6. Adjust control temperature to maintain baby within normal range. Measure axillary temperatures with cares.


Coiling prevents inadvertent cooling of the temperature probe tip, and helps to maintain a consistent temperature. Improper technique in placing skin probe can cause inadvertent over heating of the patient. We originally found out about the stem effect in 1993. Manufacturer was involved at that time.


PHYSICAL MEDICINE

Device:
Type: Heel Warmer, Infant
Manufacturer: DeRoyal
Cat #: HNICU-100

Lollipop Icon

Problem:
Heel warmer was activated by phlebotomist. The device is hard to activate and requires a significant amount of pressure to do so.

The warmer ruptured, splashing the phlebotomist in the face and forearm. She experienced a burning sensation. She immediately flushed the affected areas with water and then went to the Emergency Room for care. The employee was noted to have erythema to her left cheek and minimal erythema to her forearm. She was sent home by the Emergency Department (ED) physician to shower with unscented soap and instructed to treat the areas with Aloe Vera or antibiotic ointment.


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


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