Highlighted Reports
MedSun: Newsletter #63, August 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 May 1 through May 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: Patient Circuit
Manufacturer: Vapotherm, Inc
Brand: Precision Flow
Model#: PF-DPC-LOW
Lot #: 09122110430
Cat #: PF-DPC-LOW
Other #: DWP Assembly

Problem:
While therapist was setting up Vapotherm unit, the circuit leaked. This had not been connected to the patient; problem discovered during setup. This correlates to a previous report submitted. Since this failure, Vapotherm has exchanged out all of our stock of this circuit with their newly designed version. Our opinion of this new design is that this leaking problem has been resolved and there is a more positive latching mechanism.
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Manufacturer response for Patient Circuit, Precision Flow (per site reporter)
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Manufacturer provided RGA [Return Goods Authorization] for product return evaluation.


CARDIOVASCULAR

Device 1:
Type: Catheter, Ablation, Rf, Cardiac
Manufacturer: St. Jude Medical
Brand: Safire Blu
Lot #: 3301954
Cat #: A402872
Other #: 1304-CPS-7-25-LC-BD

Device 2:
Type: Catheter, Ablation, Rf, Cardiac
Manufacturer: St. Jude Medical
Brand: Safire Blu
Lot #: 3306168
Cat #: A402872
Other #: 1304-CPS-7-25-LC-BD

Problem:
During an Atrial fib ablation, the doctor used two St. Jude Safire BLU ablation catheters. He experienced noisy signals at high energy and high power. He felt the steering ability/steering shaft of the catheter was broken during the procedure. The first catheter was used for approximately 3 hours at 29 ablations when an increase in noisy signals occurred along with the inability to steer the catheter appropriately. A second Safire BLU catheter was then used for just over one hour and 19 ablations when steering inability occurred. The physician removed this catheter and then a Blazer II catheter was used without difficulties. The patient's outcome was successful without complications. The St. Jude rep was in the room during the case and did not have any suggestions as to why the catheter was getting noisy signals. The catheters were given to the sales rep for return to St. Jude Medical.


Device:
Tye: Catheter, Intravascular, Diagnostic
Manufacturer: Merit Medical Systems
Brand: Impress, Mod. Hook Flush
Model#: 565386MHK-NB
Cat #: 565386MHK-NB

Problem:
While the surgeon was inserting the wire through the pigtail catheter it was observed that the wire went through the bottom part of the pigtail catheter, not the tip of the pigtail catheter. While trying to remove the pigtail catheter the tip of the catheter dislodged inside the sheath. The surgeon then converted the case to an open procedure and the catheter tip was removed and the artery repaired.

A possible contributing factor may include how the product is removed from the packaging tray. The catheter could be pulled out of the tray or the tray could be bent open to free the catheter.


Device:
Type: Electrode, Defibrillator
Manufacturer: Covidien, Formerly Kendall A Division of Tyco Healthcare
Brand: Medi-trace, Cadence
Model#: 22660R
Cat #: 22660R

Problem:
HeartStream equivalent pad #22660R. When pad is removed from patient's skin, the pad adhesive also removes the patient's skin.

Manufacturer response for Electrode, Defibrillator, Medi-Trace, Cadence (per site reporter): Only sales rep made aware of issue at this time.


Device:
Type: Lead, Defibrillation
Manufacturer: St Jude Medical
Brand: Durata
Model#: 7170Q/58
Other #: SJ4-LLHH

Problem:
An attempt was made to reposition a right ventricular (RV) lead in the cath lab but adhesions made it difficult to reposition the device. The plan was to remove the lead, but as the physician pulled it, the core of the lead (the tip attached to the wires) broke away from the coils and insulation. Multiple attempts to snare the lead tip were made and eventually the lead was retrieved. A new lead was then able to be placed. There was no harm to the patient as a result of this event.
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Manufacturer response for ICD lead, (brand not provided) (per site reporter)
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They would like equipment back to investigate and analyze it.


Device:
Type: Lead, Pacemaker
Manufacturer: Medtronic, Inc.
Brand: Capsurefix Novus
Model#: 5076-65

Problem:
The ventricular lead was defective. The stylet used to guide the lead did not fit the inner cannula. The inner cannula of the lead was torn by the stylet. The patient was discharged the next day and is doing well.


EAR, NOSE, & THROAT

Device:
Type: Emg Endotracheal Tube
Manufacturer: Medtronic
Brand: Emg Endotracheal Tube
Model#: 8229306
Lot #: 66466400
Other #: size 6mm

Problem:
Patient was intubated with the EMG Endotracheal Tube by the anesthesiologist and placement confirmed. Shortly after intubation the patient became very difficult to ventilate and O2 saturation began dropping and tidal volume dropped greatly. At that time the EMG tube was removed and patient was ventilated via bag mask and chest compressions were started due to drop in heart rate and BP. The patient was reintubated immediately with a standard ET tube. Once the standard tube was placed proper ventilation was achieved with good O2 saturation and improved HR and BP. Upon inspection of the EMG tube it was discovered that the tube had collapsed causing the drop in vital signs and tidal volume. The tube was secured by the OR manager. The patient's vital signs became stable and the cervical case proceeded forward without any further complications.


GENERAL & PLASTIC SURGERY

Device:
Type: Endowrist Bipolar Cautery Instrument
Manufacturer: Intuitive Surgical, Inc.
Brand: Pk Dissecting Forceps
Model#: 420227
Other #: 8mm Cautery Insrument

Problem:
The forceps worked during the surgery. The thought is that the defect occurred during the cleaning process. There is a small black wire that broke during what the staff believes when cleaned. The forceps will not open and have been taken out of service.

See device images:

Image of Endowrist PK Dissecting Forcep.  Shows forceps separated from the shaft

Image Endowrist PK Dissecting Forcep.  Shows forcep in a closed position with small black broken wire protruding from shaft.

Endowrist PK Dissecting Forcep.  Two separate images of the forecp in a closed position.  Left image shows closed forcep without the broken black wire protruding from the shaft.  The right image shows the closed forcep with the black broken wire protruding from the shaft.


Device:
Type: Endowrist Monopolar Cautery Instruments
Manufacturer: Intuitive Surgical, Inc.
Brand: Permanent Cautery Spatula
Model#: 420184
Lot #: m10101110962
Other #: 8mm instrument

Problem:
When removing Endowrist instrument from cannula, spatula was not coming out. Tip of instrument missing a piece on visualization. MD notified and inspected op site. Company representative was in room and is aware of issue. Called company. Device not radiolucent. Risk MD from company said tip will not harm patient.


Device:
Type: Spacemaker Plus Dissector System
Manufacturer: Covidien
Brand: Spacemaker Plus
Model#: SMSBTRND
Lot #: PIC 1112

Problem:
A Spacemaker Plus Dissector System was opened on back table. The patient is allergic to latex. Per the patient, latex "burns his skin". The product box or peel pack was not labeled "contains latex". Upon further investigation by the RN it was found in small print on the product insert that the product does, in fact, contain natural rubber latex. The product did not come into contact with the patient. The physician was notified along with the rest of the surgical team. The patient was given a prophylactic dose of benadryl by anesthesia at the instruction of surgeon. The patient showed no signs of anaphylaxis or distress at the end of the case and was transported to PACU.


GENERAL HOSPITAL

Device:
Type: Bed Frame
Manufacturer: Hill-Rom
Brand: Harbor Glen Furniture Collection
Cat #: 146584

Problem:
Patient was able to thread a sheet through an opening in the bottom of the bed frame, stand the bed on end and hang himself.


NEUROLOGY

Device:
Type: Neurological Stereotaxic Instrument
Manufacturer: MEDTRONIC NAVIGATION, INC.
Brand: Stealth Treon
Model#: Treon

Problem:
During movement of the machine it was noticed that the arm that holds the display was sitting at an unusual angle. Upon manipulating the arm, it came apart at one of the joints. The display is very heavy and had to be held up with a strap to prevent it from falling. There was no injury, but the display is typically located near the patient's head during surgery. There was a delay to the surgery as another machine had to be used. The joint that came apart was apparently press fitted and worked its way loose over time.

See device images:
Image of Treon Stereotaxic Instrument. Shows entire system.  Image shows the arm that holds the display sitting at an unusual angle.  Arm came apart at one of the joints.  You can see the strap that is holding display to keep from falling.

Image of the joint that came apart.  It worked its way loose over time.


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