Highlighted Reports
MedSun: Newsletter #59, April 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 January 1 through January 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: Endotracheal Tube
Manufacturer: Medtronic XOMED Inc.
Brand: Nim Emg
Lot #: 69371500
Cat #: 8229306

Problem:
Upon removal of Medtronic XOMED NIM EMG Endotracheal Tube from the packaging, it was noted to have a red wire fault. The device was not used on the patient.


Device:
Type: High Flow Heat And Humidification Device
Manufacturer: Vapotherm Inc
Brand: Precision Flow

Problem:
Vapotherm alarmed, indicating a problem with the disposable water path. Unit was not delivering flow, so supplemental oxygen was given during this time. Vapotherm water path was changed out along with the circuit. User continued to receive faulty water path alarm. Also unit was not delivering flow. Unit was completely changed out.


Device:
Type: Video Laryngoscope
Manufacturer: Verathon Inc
Brand: Glidescope
Model#: Ranger
Lot #: 0125-0495-00-51
Other #: rm072326

Problem:
While the MedEvac crew was preparing to intubate a patient on a scene call, the Glidescope's screen initially had a clear screen but then became very grainy and then faded to black and would not turn back on. Instrument was then set aside and not used on patient. Crew proceeded with intubating the patient without the scope. After patient care, crew member placed the Glidescope back on the charger. The next shift's crew attempted to turn the scope on but it would not turn on and screen remained black.


CARDIOVASCULAR

Device 1:
Type: Cable, Connector
Manufacturer: Biosense Webster
Brand: Redel Cable
Cat #: C10MRMSTKS

Device 2:
Type: Cable, Extension
Manufacturer: St. Jude Medical
Brand: Response
Lot #: 3195384
Cat #: 401661

Device 3:
Type: Catheter, Ablation, Cardiac, Rf
Manufacturer: Biosense Webster
Brand: Navistar Thermocool
Model#: N175TCFH
Other #: REF # 34H57M

Device 4:
Type: Catheter, Mapping
Manufacturer: St. Jude Medical
Brand: Reflexion Hd
Lot #: 3210542
Cat #: D402864

Device 5:
Type: Generator, Ablation, Cardiac, Rf
Manufacturer: Biosense Webster
Brand: Stockert

Device 6:
Type: Computer, Diagnostic, Cardiac, Mapping
Manufacturer: Biosense Webster
Brand: Carto Xp

Problem:
The connector for a Biosense Webster Navistar Thermocool ablation catheter fit into a SJM Reflexion HD catheter. This led to the Reflexion HD being directly attached to the Stockert generator. The connector of both the Reflexion HD as well as the Navistar Thermocool has the same type of "end" that allows it to be connected to either catheter. The other end of the connector is very different for each catheter. The Reflexion HD has "tails" while the NaviStar has a "redel" connector. Unfortunately, the end of the connector was not observed by the physician before the connection was made since it was hidden by the sterile drape.

Even though RF energy was not delivered, the Stockert generator, which sends out 50hz signals @ baseline sent energy through the Reflexion HD catheter which resulted in the heating of blood in the left atrium which appeared as echo contrast "bubbles" on the ICE catheter. Additionally, the ECG signal was abnormal due to the incorrect connector. Once both these issues were identified by the physician, the procedure was aborted, all catheters removed and the patient evaluated for sequelae. The patient developed no apparent problems due to this incident. After the procedure, the physician did a "bench test" of the same catheter set up that was in the patient and was able to reproduce the same "bubbles" in a water bath.
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Health Professional's Impression
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By connecting the Reflexion HD to the Stockert generator, "energy" was delivered even though the RF delivery button was not pushed. This was probably due to the fact that the Stockert generator always sends out a 50 HZ signal when the machine is turned on in the standby mode. This "energy" heated the blood in the patient's left atrium and caused the "bubbles" the physician saw on echo.
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Manufacturer response for Connectors, Reflexion HD and Biosense NaviStar Thermocool catheter and Stockert generator
======================
They asked about details of situation as well as patient condition.

See device images:

Image of Thermocool Connector

Image of St Jude and Biosense Connector Ends


Device 1:
Type: Cable, Temporary Pacing, Disposable
Manufacturer: Remington Medical, Inc
Brand: Disposable Screw-down Extension Cable
Model#: FLl-601-97
Lot #: 102717

Device 2:
Type: Pacemaker, External
Manufacturer: Medtronic, Inc.
Brand: 5388 Dual Chamber
Model#: 5388

Problem:
The patient had a temporary pacemaker from a prior CABG surgery 3 days ago. The patient was scheduled for permanent pacer insertion. At the time the MD was placing the permanent pacemaker lead into the chest, the temporary pacer quit working and the patient flat lined, requiring immediate chest compressions. The permanent pacemaker lead was placed and the patient started capturing the pacemaker rhythm.

The MD notes from the operative report read: "The permanent ventricular lead was passed into the ventricle. At the time that it was tested, the patient became asystolic. The temporary pacemaker at that time was not pacing either and chest compressions were carried out while the ventricular wire was being placed and the screw was activated on the ventricle. At this time the patient proceeded to capture and the ventricular lead threshold was tested down to 1.5 millivolts and felt to be adequate with adequate resistance. Following this, the permanent pacemaker generator was placed on the permanent ventricular lead and the permanent atrial lead was then placed and tested. The P-wave on the atrial lead was 2 millivolts and active fixation was used to fix that. The permanent pacemaker was a Medtronic Adapta, model #ADDR1 was implanted in the pocket and secured with a stitch. The pocket was then closed in three separate layers." The permanent pacemaker insertion was completed and the patient tolerated the entire procedure satisfactorily and left the operating room in stable condition.
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Health Professional's Impression
======================
The RN who wrote the report wrote "It was noted the temporary ventricular wire does not stay snuggly fit within the temporary pacemaker device. It is also noted that within the external pacer device is a 3 prong connection whereas the pacing cables are 2-pronged. The atrial cable appears to be fitting correctly without issue."

See device images:

Image of Temporary Ventricular Cable

Image of Pacemaker connector


Device 1:
Type: Catheter, Intravascular, Diagnostic
Manufacturer: AngioDynamics Inc
Brand: Soft-vu Omni Flush
Lot #: 511742
Cat #: 10732204
Other #: 5F 90cm

Device 2:
Type: Catheter, Intravascular, Diagnostic
Manufacturer: AngioDynamics Inc
Brand: Soft-vu Omni Flush
Lot #: 511742
Cat #: 10732204
Other #: 5F 90cm

Problem:
Device had just been opened but broke in preparation of procedure. A second identical device was opened and the same issue occurred (both were set aside before being used on patient so no patient harm occurred with the exception of a slight delay in procedure). A third identical device was opened and was successfully used with patient. Prep and drape of both groins; micropuncture technique was utilized to access the left common femoral artery without difficulty. A 5Fr sheath was then introduced followed by an omniflush catheter and with this we were able to successfully cannulate the right iliac system with an angled 0.035 Glidewire".
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Health Professional's Impression
======================
Nurse who handled the three devices said the first two essentially fell off upon opening of the packages and the third was fine and was used in procedure.


Device:
Type: Compressor, Cardiac External
Manufacturer: Zoll Medical Corporation
Brand: Autopulse
Model#: Model 100

Problem:
The AutoPulse device was initiated for chest compressions during resuscitation. The AutoPulse device functioned for approximately 5 minutes before it quit. Manual compressions were then initiated. The battery was replaced and the AutoPulse used again but the device only operated for 2-3 minutes. Manual compressions were resumed and used for the duration of resuscitation.


Device:
Type: Coronary Drug-eluting Stent
Manufacturer: Boston Scientific
Brand: Taxus Liberte Monorail
Model#: 38936-3235
Lot #: 13114285
Other #: 32mm Stent System

Problem:
Balloon at the end of catheter did not inflate. When the physician attempted to remove catheter, it became stuck at the sheath. Physician advanced catheter in an attempt to release stent. When unsuccessful, the physician removed the delivery system and the balloon was noted to have broken off system. The balloon and stent remained in the vessel. The balloon and stent were retrieved from within patient using a snare device. The patient tolerated the procedure, but a stent was never placed.
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Health Professional's Impression
======================
Balloon did not inflate and then broke off the delivery system while in vessel.


Device:
Type: Defibrillator External Paddle Set
Manufacturer: Philips Medical Systems
Model#: M3542A
Cat #: M3542A

Problem:
Top covers of the paddle handle separates from either the sternum or the apex handle.


GENERAL & PLASTIC SURGERY

Device:
Type: Clip Applier
Manufacturer: Ethicon Endo-Surgery
Brand: Ligamax 5
Model#: EL5ML
Lot #: G4UA0G
Cat #: EL5ML

Problem:
During an endoscopic procedure a multiple clip applier jammed while surgeon was working in patient's abdomen. Surgeon stated clip applicator jammed and he was unable to disengage the jaw in order to release the vessel. He had to pull the device off of the vessel which caused some shearing to the vessel wall.
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Manufacturer response for 5mm Endoscopic Multiple clip Applier, Ligamax 5
======================
Return to manufacturer for analysis in pre-paid return carton. Manufacturer to provide our hospital with analysis report.


Device:
Type: Tray, Surgical
Manufacturer: Medline
Brand: Medline Sterile Laceration Tray
Lot #: 10IB4116
Cat #: DYNDL1228

Problem:
We are reporting a total of 10 devices of the same lot and from the same manufacturer with this one report. MD reports that he opened a laceration tray and had difficulty opening and closing the hemostat needle holder in the kit. Another tray was opened and the same difficulty was encountered. There appears to be nothing wrong with the device visually. There are no problems with any of the other contents of the tray. A total of 10 laceration trays were found with this same problem. All were from the same lot number. The 11th tray that was opened had no difficulties. As expected, the hemostat needle holder opened and closed smoothly without difficulty. The 11th kit also was from the same lot number. None of the affected devices came into contact with the patient and there was no patient harm involved in this event.
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Health Professional's Impression
======================
The staff feels that the bolt/screw used to keep the two pieces of the device together may have been put on too tightly.
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Manufacturer response for Needle holder hemostat, Medline sterile Laceration Tray
======================
Manufacturer was contacted. We are currently awaiting return instructions and plan to send the device back to the manufacturer for their inspection and analysis.

Device:
Type: Sponge, Gauze
Manufacturer: Covidien
Brand: Vistec
Model#: 7318
Lot #: 100000153962

Problem:
Black "metal" appearing fleck on tape around sponges inside of the sterile packaging noted on room set-up.

See device image:

Image of black debris appearing fleck on tape around sponges inside of the sterile packaging noted on room set-up.



GENERAL HOSPITAL

Device:
Type: Catheter, Picc
Manufacturer: Navilyst Medical
Brand: Xcela (Custom Kit)
Lot #: 4073476 & 4076684
Cat #: 60M210407

Problem:
Staff discovered that there is "communication" between the lumens in our dual lumen PICC line kits. The fluids are commingling between the two lumens when fluids are pushed through the hub of product. The device in some form or fashion has become compromised and is leaking fluid to the other lumen.
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Health Professional's Impression
======================
The device in some form or fashion has become compromised and is leaking fluid to the other lumen.
======================
Manufacturer response for Dual Lumen PICC LIne Kit, Xcela (Custom Kit)
======================
The manufacturer is planning to examine the PICC lines that have been explanted. They will also take samples of the new product from the lots in question and test for infiltration/compromise.


Device:
Type: Port, Implanted, Catheter
Manufacturer: AngioDynamics
Brand: Vortex Tr Vascular Access Port
Model#: SSAX-16-1

Problem:
Five months ago a port (Angiodynamics 9.6 FR model SSAX-16-1) was removed from a patient who had completed cancer treatment. Unbeknownst to the surgeon at the time, the strain relief sleeve was retained subcutaneously in the soft tissue of the patient's left upper chest wall. The strain relief sleeve is a piece of silicone tubing about 2cm long that fits over the connection of the port reservoir stem and the catheter. No record could be located for the port lot number. However at the time the operating room was using the above model for that size port exclusively in patients on the pediatric service. Recently the surgery team was first made aware that the patient was complaining of discomfort from an object under the skin medial and adjacent to the port incision scar. The shape of the object matches the size of the catheter sleeve seen on the chest x-ray.


NEUROLOGY

Device:
Type: Cap, Cooling, Infant
Manufacturer: Natus Medical
Brand: Cool Cap

Lollipop Icon

Problem:
Infant in re-warming phase when cool cap machine made a "pop" noise. A burning smell was noted near the machine and the screen went black. The device was immediately unplugged from the wall outlet. All probes were removed from the infant and away from the bed. Infant was placed on cooling blanket to continue therapy.
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Health Professional's Impression
======================
Second incident of same circumstances within four month period. Unknown cause. No patient injury.


Device:
Type: Device, Monitoring, Intracranial Pressure
Manufacturer: CODMAN & SHURTLEFF, INC.
Brand: Codman Microsensor Ventricular Catheter Kit Sensor With Icp Sensor
Model#: 82-8653

Problem:
Our facility is concerned that we were not informed of the MRI incompatibility of the Codman Microsensor ICP transducer. Approximately 6 years ago, it was believed the device was safe for use in the MRI environment. Three years later, there was a memo sent from Codman Regulatory Affairs stating that the compatibility of the device with MRI was not determined by FDA. Most recently, we have noticed the device package insert states MRI compatibility not determined. We have been imaging patients with Codman Microsensor ICP transducer without incident. Approximately 10 patients per year.


Device:
Type: Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Manufacturer: Medtronic Neuromodulation
Brand: Restore Ultra
Model#: 37712

Problem:
Device was explanted. Approximately 3 weeks prior to explantation, patient had an MRI at a medical facility (other than ours). After the MRI, the device stopped working.



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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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