Highlighted Reports
MedSun: Newsletter #61, June 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 March 1 through March 31, 2011. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.

ANESTHESIOLOGY

Device:
Type: Emg Endotracheal Tube
Manufacturer: Medtronic Xomed Inc
Brand: Nim Contact
Lot #: 71258000
Cat #: 8229506

Problem:
NIM machine was reading too much feedback for the stim one cord. We could not get feedback fixed. Switched to different NIM Endotracheal tube and feedback went away. The blue wire on the NIM Endotracheal tube didn't give feedback to the NIM Machine. They had to remove the tube and re-trach the patient with a new tube. The new one worked fine.

Device:
Type: Endotracheal Tube
Manufacturer: Covidien Nellcor Mallinckrodt
Brand: Reinforced Tracheal Tube
Model#: Cuffed
Lot #: 2001-03 4934
Cat #: 86553

Problem:
Intubated ICU patient, s/p [status post] craniotomy, was brought to MRI. Significant artifact was noted on MRI exam. It was subsequently noted that the ETT contained a metal reinforcement coil which interfered with the MRI. The product packaging and device do not indicate that the tracheal tube contains metal and is not safe for MRI scanning.

Device:
Type: Laryngeal Mask
Manufacturer: Anesthesia Equipment Supply, Inc
Brand: Aes Ultra Flex Cpv
Lot #: DG12117108
Cat #: 1037225

Problem:
LMA [Laryngeal Mask Airway] was tested prior to use by Anesthesiologist. Cuff on AES Ultra Flex CPV LMA (size 2.5, Lot # DG12117108) would not hold air once inflated. A total of 7 LMAs were tested & failed prior to finding one that worked. All were from same lot as listed above. As a result, remaining LMAs with this lot # were pulled from stock. We have been using these LMAs for approximately 2 years. We have not seen this issue previously.

Device:
Type: One-way Valve
Manufacturer: CareFusion 211
Brand: Airlife
Model#: 001800
Lot #: Y10S0086
Cat #: 001800

Problem:
During a pulmonary function test, albuterol was being administered through a one-way valve. During the inhalation, the soft movable piece of the valve separated from the device and was inhaled by the patient. Patient complained of initial discomfort but an attempt to recover the valve material through bronchoscopy was unsuccessful. Patient regained a feeling of normalcy, possibly having coughed up and swallowed the material.
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Manufacturer response for One-way valve, AirLife
======================
None as yet.

See device image:

 Image of the three components that make up the one-way valve.  One of the three components is the soft movable piece of the valve that separated from the device. <br>


Device:
Type: Oxygen Flowmeter
Manufacturer: Precision Medical Inc.
Brand: Oxygen Flowmeter
Model#: 2MFA1001
Other #: date code 5-95

Problem:
Nurse noticed something was not right with the flow meter and asked the charge nurse to check the flow meter. The patient was on an oxygen face mask connected to the flow meter involved in the incident. As the charge nurse entered the room she noticed that it smelled like something was burning. She observed that the flow tube was black. She had Respiratory Therapy paged to come to the room. She then began to turn down the flow meter, as she was adjusting the flow meter, it exploded and flames began to shoot out of the wall. A code red was initiated via the phone. The patient was immediately evacuated from the room and the door to the room was closed. The nursing supervisor turned off the oxygen to half of the unit. Security extinguished the burning pieces. There was no patient harm, employee injury or damage to the facility. Flowmeter had been in use for almost 4.5 days before this reported event occurred.
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Manufacturer response for Oxygen Flowmeter, Oxygen Flowmeter
======================
I spoke with Precision Medical representative. He took down my information and a summary of what occurred. He made a reference that there was a recall on this device in the late 1990's. He was going to research the previous recall. He mentioned that this was the first incident with this device that he was aware of in his 10 years with the company.

Device:
Type: Ventilator, Continuous, Facility Use
Manufacturer: GE
Brand: Engstrom Carestation
Model#: 1505-9000-000
Cat #: 1505-9000-000

Problem:
Unit shut down during transport of a patient. During biomed testing, the unit was turned on with the power cord plugged in. Ventilator was in stand-by mode. The ventilator was then unplugged from AC power. The LED for power turned off but the unit did not show that it was running on battery power ("On battery" dialog box and green battery symbol on graphic display did not present). Furthermore, the device did not produce the appropriate audible tone signifying disconnection from AC power. After about 2 minutes the ventilator shut down and the alarm did not sound for another 10 seconds.


CARDIOVASCULAR

Device:
Type: Physiological Monitor, Mri, Ecg Module
Manufacturer: MedRad, Inc.
Brand: Veris
Model#: 8600
Cat #: 3010459

Problem:
Thursday evening about 9:00 pm, the device was disconnected from its battery charger and placed at the foot end of the table of the Siemens Espree MRI scanner in preparation for the arrival of an ICU patient. That patient was kept in the hallway outside the room while their IV lines were being switched over to two MR compatible pumps, one of which encountered an unexpected air-in-line condition causing a delay. During that delay, the ECG module started to smolder and quick-thinking staff removed it from the exam room and called a Code Red. There was no harm to the patient or staff. The principle concern, however, is that the device has a short lead set so that when it is connected to the electrodes on a patient's chest, it is then laid on the chest and connected via a fiberoptic cable to the actual display monitor. A tech grabbed the smoldering device by the lead set and took it down a different hallway and placed it on another MR table that is kept there. A little later, he moved it to the floor. The smoke from the device did not set off the smoke detectors. (I found a reference to the company Nexergy on the charger.) The event was clearly the result of some kind of battery failure but we don't know the exact nature.
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Manufacturer response, according to reporter, for Physiological Monitor, MRI, Interface, Veris:
======================
They checked their records and tell us this has not happened anywhere or at anytime before.

See device images:

 Image of ECG module with smoldered area in the middle.  Image also shows lead set to the left of the smoldered ECG module.

 Image of MedRad label.  ECG Patient Module for use with Veris.  Manufactured by Nexergy by Egston.  Medical Charger information provided on label.  Output: 500mA at 7.4V.  Warning: Do not take into magnet room.  Contains Ferromagnetic Material.

Device:
Type: Catheter, Angioplasty, Peripheral, Transluminal
Manufacturer: Abbott Vascular
Brand: Viatrac 14 Plus Peripheral Dilation Catheter
Lot #: 0051151
Cat #: 1008193-20

Problem:
During the procedure the surgeon took the post dilated balloon and dilated it up to 12 atmospheres and the balloon burst, leaving fragments of the balloon on the wire. The surgeon was unable to get the fragments to come into the shuttle sheath. After several attempts the surgeon was able to get the shaft of the balloon out. The surgeon then took out the shuttle sheath and advanced an introducer sheath and was then able to snare all of the remaining balloon fragments and the embolic protection system. The surgeon successfully removed the balloon fragments without complications to the patient.

Device:
Type: Catheter, Flow Directed
Manufacturer: Edwards Lifesciences
Brand: Swan-Ganz, Vip
Model#: 831HF75
Cat #: 831HF75

Problem:
I spoke with the nurse in the ICU who had the Swan-Ganz catheter. She stated, when the patient first arrived and was hooked up to the physiological monitors, the temperature would register normal thermal 98 degrees. After awhile it would slowly creep up until it registered 104 degrees. She said that they took the tympanic temperature, temple, and orally and they were normal thermal. She even checked the patient to make sure they did not feel warm. She said they changed the cables, module and used a different monitor. None of these changes made a difference.
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Manufacturer response for Catheter, Flow Directed, Swan-Ganz, VIP:
======================
Sending box in to return and sending a replacement. Will also send report after examination of product.


Device:
Type: Clamp, Vascular
Manufacturer: St. Jude Medical (Radi)
Brand: Femostop Gold Sheath
Cat #: 11165

Problem:
Two RNs from cath lab at bedside to discontinue femoral sheath. Femostop applied per protocol and sheath was removed without incident. After approximately ten (10) minutes, when pressure was to be reduced by use of the manometer on Femostop, they were unable to do so. Pressure was reduced by loosening Femostop belt. No bleeding at site. Pedal pulses palpable. After 30 minutes Femostop was removed and a wedge dressing was applied as in hand-held protocol. After removal from the patient, the nurses were still unable to deflate the pressure pad on the Femostop. Cath checks were completed without bleeding or hematoma.

Device:
Type: Clamp, Vascular
Manufacturer: Maquet
Brand: Heartstring Iii Proximal Seal System
Model#: HSK-3038
Lot #: 25023772

Problem:
Scrub tech attempted to load the Heartstring III and it would not load properly.

Device 1:
Type: Device, Hemostasis, Vascular
Manufacturer: Abbott Laboratories
Brand: Proglide Suture Mediated System
Lot #: 8500164
Cat #: 12673

Device 2:
Type: Device, Hemostasis, Vascular
Manufacturer: Abbott Laboratories
Brand: Proglide Suture Mediated System
Lot #: 8500164
Cat #: 12673
Problem:
The surgeon attempted to tie down the Perclose sutures but the right side failed to seal. On the left side one suture went down and the other suture pulled out. The surgeon performed bilateral femoral artery cutdowns and proximal distal control was obtained on the common femoral profunda femoris and superficial femoral arteries and the arteriotomy was closed with multiple interrupted 5-0 Prolene sutures.


EAR, NOSE, & THROAT

Device 1:
Type: Nerve Stimulator
Manufacturer: Medtronic
Brand: NIM
Model#: NIM 2.0

Device 2:
Type: Nerve Stimulator
Manufacturer: Medtronic
Brand: NIM

Problem:
After the first surgery, surgeon #2 made a complaint to the OR manager stating that he wanted the NIM's checked out since the probe function was questionable during the procedure. He stated the patient could have nerve damage, but that the patient had promising signs of eye blinking. At that time it could not be identified which of two owned NIM's was used. Both NIM's were sent to our BioMed department who reported "Setup and tested both units per manufacturers checklist. All tests passed...no problems indicated." Neurosurgeon assessment after surgery #1 indicated right facial weakness. Surgeon #2 noted complete eye closure with effort, no nystagmus in primary or lateral gaze. Facial nerve had good prognosis. Since the complaint from surgeon #2 was made, we made a decision to keep both NIM's out of service until we could determine if the patient was affected. Surgeon #2 told us that he "feels" the patient was injured because of this NIM. He said he has problems with the old NIM's of the same model. He said he had just had a problem the day before at a neighboring children's hospital with the same model of the NIM's. He feels all the older NIMs are having issues. He said he reported multiple concerns from three other hospitals to Medtronic Representative. The surgeon said that all the problems were with the "old" equipment models and that other hospitals needed to buy the newer model as the new model is more "sensitive." Per neurosurgeon in discharge summary, the patient's discharge condition was improved. There is no way to definitely determine if the patient was impacted.


GENERAL & PLASTIC SURGERY

Device:
Type: Clip Applier
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Ligaclip
Model#: ER320
Other #: size M/L

Problem:
Operating staff report patient undergoing laparoscopic cholecystectomy. Upon the surgeon using the Ethicon Ligaclip Endoscopic Rotating Multiple Clip Applier the applier deployed too many clips with firing of the device. All clips accounted for but not retained. Surgeon utilized a different clip applier to finish the procedure. No injury or harm to the patient. Patient was sent to PACU for recovery. Original clip applier was removed from the field and sequestered for Risk Management pick up.


Device:
Type: Gauze, Sponge
Manufacturer: Covidien
Brand: Vistec
Model#: 7318
Lot #: 100000071062

Problem:
Debris observed inside sterile package during room set-up. There was no patient impact.

See device image:

 Image of sponge gauze packaging with black speck within gauze.  Image also shows the outer packaging of the sponge gauze.  Outer packaging text is too small to read from image.




Device:
Type: Magnetic Pad
Manufacturer: Medical Action Industries Inc.
Model#: 200-20A
Lot #: 104649

Problem:
Magnets are pulling loose from fabric when pad is being opened. Pad removed from sterile field. Opened second pad and same thing happened again. Went without magnetic drape for this case. This appears to be a problem that is specific to this lot number. All applicable hospitals are pulling this lot number from service.

Device:
Type: Tissue Sealing Device
Manufacturer: Ethicon Endo-Surgery, Inc
Brand: Enseal
Lot #: 54RN53
Cat #: NSEAL545H

Problem:
During the surgery, it was noted that the black coating on the shaft of the EnSeal was peeling away. Product was removed from the surgical field and replaced immediately.


GENERAL HOSPITAL

Device:
Type: Catheter, Picc
Manufacturer: Navilyst Medical
Brand: Xcela Picc With Pasv Valve Technology
Model#: H965457350
Lot #: 4092320
Other #: order # 45-735

Problem:
Per the IV Team Nurse Manager: For the last five weeks we have been trialing the Navilyst PICC. Within the first two weeks of using the product we had concerns. Concerns were addressed with the firm as well as our support representative from the Navilyst company. The support representative worked with us to get us as successful as possible. Unfortunately, I regret to report that my team continues to have concerns for patient safety.

Over numerous occasions my team has encountered:
1. Bleeding at the catheter insertion site, requiring pressure dressings and sometimes removal of PICC.
2. With dressing changes it was found that scrubbing the site (per protocol) actually removed the ink markings on the catheter resulting in not being able to identify position/placement of PICC. (markings are centimeters that assist with the length of the catheter and how much is inside the patient's arm).
3. Two of my nurse's experienced missing ink markings after removal of the PICC line, questioning whether or not they got the PICC completely out.
4. Repeated lab draws due to erroneous values. (it was advised that our closed system technique could be the issue and it was recommended that we go back to syringe drawing)
5. Guide/Stiffening wires were getting kinked, coiled, or stuck in the patient.
Apparently other hospitals have been using the Navilyst PICC for sometime without issues. To my understanding another hospital has started their trial with the Navilyst PICC this week. For us at our hospital we will discontinue our Navilyst trial and return back to using AngioDynamics until we here further on the decision to consolidate with one company.


Device:
Type: Internal Transport Incubator/isolette
Manufacturer: International Biomedical
Brand: Airborne 750
Model#: A750i
Cat #: M1061999/731-0160

Lollipop Icon

Problem:
During transport of a neonate to another care area, the clinician smelled a strong electrical odor coming from the isolette on the side being pushed. The caregiver turned off the power to the isolette and transferred the infant to another isolette. The isolette was sent to biomedical for evaluation.

Device:
Type: Picc, Catheter
Manufacturer: BD Medical Systems
Brand: L-cath
Lot #: 0123897
Cat #: 384539
Other #: 26GA (1.9F) X 30cm

Problem:
While attempting to trim PICC line to correct length during an insertion procedure, the catheter line cutting block did not cut all the way through the catheter. Catheter tube only partially cut. A similar incident occurred the day before with a catheter from the same lot number. The user was attempting to trim the catheter using the supplied trim block tool included in the catheter kit. Catheter exchanged for new and insertion completed with no problem or issues. No patient harm during this sizing task.
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Manufacturer response for Peripherally Inserted Central Catheter [PICC], L-Cath
======================
Will ship back to mfg. in next two days

Device:

Type: Port, Catheter, Implanted
Manufacturer: Navilyst Medical
Brand: Xcela Power Injectable Port
Lot #: 101557000
Other #: REF H965451030

Problem:
RN in ER accessed patient's port with a power loc safety needle because he had a port-a-cath device card that indicated the port was a Xcela Power Injectable Port, suitable for IV contrast injection. RN used this card as identifier, but when patient went to CT, x-ray of chest was done as second identifier and the "CT" symbol that was supposed to be second ID was not on the port. This made the port unusable per our policy and since patient refused to have IV started for contrast, CT had to be done w/o contrast. Product is supposed to have this symbol on their ports suitable for use with IV contrast and with the power loc needle.
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Manufacturer response for Power Injectable Port, Xcela Power Injectable Port
======================
Per the Radiology APN:
The manufacturer was quite concerned that the CT was not visible. They have the lot number and are to be following up on that. They said they take it very seriously.


Device:
Type: Splittable Needle Introducer
Manufacturer: Becton Dickinson
Brand: Bd Splittable Needle Introducer
Lot #: Kit: 0266521; Needle: 0110590
Cat #: Kit Ref # 384516

Lollipop Icon

Problem:
Neonatal Nurse Practitioner (NNP) was placing a peripherally inserted central catheter (PICC). The needle was inserted with good blood return. The catheter placed and the needle withdrawn. This is a break away needle. The NNP attempted to break away the needle and part of the plastic remained at the junction of the needle and the hub resulting in the inability to remove the needle from the PICC. Attempts were made to break away the needle. The end result was that the catheter needed to be removed and another attempt made which was successful. The harm to the infant was a second needle stick for the placement of the PICC. A similar event with same device filed last fall.
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Manufacturer response for Splittable Needle Introducer, BD Splittable Needle Introducer; Kit Name: BD L-Cath PICC
======================
The Manufacturer has made arrangements to pick up the device.


NEUROLOGY

Device 1:
Type: Router Foot Plate
Manufacturer: The Anspach Effort, Inc
Brand: Anspach
Model#: CRANI-A

Device 2:
Type: Spiral Router
Manufacturer: The Anspach Effort, Inc
Brand: Anspach
Model#: 2.15mm x 22 mm fluted spiral router
Lot #: D533043246
Cat #: A-CRN-S

Problem:
During routine craniotomy, the spiral router drill bit broke while turning the cranial flap. 2 separate pieces of drill bit were accounted for. A second bit broke on the same day, different room, different surgeon, same lot number. When the bits break, there is always the possibility of a small fragment being left behind. They normally x-ray the patient to look for pieces, but a very small piece could be missed. There is a high likelihood these patients will need a MRI at some point in the future and the router material is highly magnetic, which could pose a safety problem. At the very least, there is a delay in the case while they look for the pieces.

In-house evaluation of the broken bits shows they both broke at the same location. We have had previous breakage problems with this type of bit. There may be an issue with the hardening process and/or the shape of the flutes that contributes to the breakage problem. Photos available.

Of note, the foot plate involved was checked and it seemed to be in perfect condition. (The foot plate is a re-usable part that protects the dura from the tip of the router bit during use. The foot plate contains a set of bearings that guide the router shaft).

See device images:

 Close up image of broken spiral router drill bit.  2 separated pieces of drill bit are shown in this picture.

 Close up image of broken spiral router drill bit.  Image shows 2 separated pieces of drill bit next to a ruler.  There is approximately 1 centimeter between the 2 separated pieces of drill bit.

 Zoomed out image of broken spiral router drill bit next to ruler.  Image also shows the foot plate used during the craniotomy next to the broken spiral router drill bit.  The foot plate is in perfect condition.


ORTHOPEDIC

Device:
Type: Trocar Drill Guide
Manufacturer: Stryker Instruments
Brand: Trocar Drill Guide
Model#: 62-02000
Cat #: 62-02000

Problem:
After surgery, patient was noted to have a burn on the cheek where it was in contact with the drill guide.

A similar incident occurred on several months ago with the same device.

The device was tested later and was noted to get extremely hot very quickly if the drill is pushed against the stop. There is a shoulder on the drill bit that makes contact with a stop near the tip of the drill guide. Drill console defaults to 40,000 rpm on startup. Manufacturer recommends a maximum speed of 25,000 rpm for this device.

Similar devices from other manufacturers make contact on non-rotating surfaces, so they cannot generate heat. Suspect devices have been removed from service. Device photos available.

See device image:

 Image of trocar drill guide and its components


RADIOLOGY

Device:
Type: Catheter, Brachytherapy, Breast
Manufacturer: Hologic, Inc.
Brand: Cytyc Mammosite
Lot #: 10D23R
Cat #: REF #2456
Other #: Size 4-5

Problem:
Patient was in for surgery for breast lumpectomy, sentinel node dissection/Possible Axillary Node Dissection/Placement of Mammosite Catheter. Pt had to return to surgery a week later for exchange of mammosite catheter due to "defective device". Progress note states "balloon asymmetry preventing PBRJ planning" (this would be radiation therapy planning). The balloon was intact, but deemed asymmetrical, hence needing replacement.


Device 1:
Type: Imaging Coil, Mri, Knee
Manufacturer: Siemens Medical Solutions USA, Inc.

Device 2:
Type: Mri System, 1. 5t
Manufacturer: Siemens Medical Solutions USA, Inc.
Brand: Symphony Tim

Problem:
Patient was pre-screened to make sure he was MRI safe, and that there were no metal implants in his body or on his person. He was brought into the MRI scan room. He was wearing a sweatshirt, shorts and his socks. He was positioned with his left knee in the knee coil and his right leg was wrapped in the cloth RF blanket. During the 4th sequence the technician heard yelling. There was a radio on in the room for the patient, so the tech didn't realize it was the patient until he started flailing his arms. The tech immediately stopped the scan and turned the intercom on to ask if he was ok? The patient felt he was on fire. The tech ran into the scan room, fed the table out, and as she pulled it out, she saw smoke. The tech grabbed the RF blanket, threw it on the floor, noticing that it had a burn hole in it and was still orange around the ring. She got the top of the knee coil off, and after the patient sat up, she took his sock off, which was burned. She grabbed a washcloth with cool water and put it on the burned area on his leg, and wrapped that with Coban to keep it on. The other tech called security, the supervisor and EC, and Siemens (the manufacturer of the MRI). The 1st tech took the patient by wheel chair to the EC. While on the way to the EC patient stated that during the scans he felt warm in the leg area and moved his leg a little and it was ok. But it continued to get warm and then proceeded to get hot until it was unbearable. He knew from previous MRIs, that you can experience warmth. The tech examined his sock to see if there was anything on the sock that may cause it to catch fire, but nothing was visible. The patient had a burn on his leg. The area looked yellow. There was nothing worn or damaged on the whole top part of the knee coil input plug and coil-cord/ tail. The RF Blanket was later analyzed, and it appears that it is lined with a copper material, that frayed or possibly wrapped around itself to create a conductor that heated up during the MRI scan.

Device:
Type: Radiology Room
Manufacturer: Siemen's Medical Solutions USA, Inc.
Brand: Axiom Luminos
Model#: 2000132

Problem:
Pelvic films were taken on a patient. The techs went to pull the images up and the machine brought up an error message. Could not find the images on the machine and the images were repeated. What is the health professional's impression of how the device may have caused or contributed to the adverse event? Images were taken on the machine; we were unable to retrieve those images. Images had to be repeated.

Device:
Type: Software, Radiation Therapy
Manufacturer: Impac Medical Systems, Inc.
Brand: Impac, Multi Access Version 6. 10 G4

Problem:
IMPAC device lost communication during the delivery of 123 mu's. Impac stated 35 remained when the LINAC computer displayed 45, which was the accurate number. The very observant therapists noticed the discrepancy and delivered the correct dose. The patient was not harmed.

It appears that a software upgrade resolved this issue.


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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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