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U.S. Department of Health and Human Services

MedSun: Newsletter #81, February 2013

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Newsletter #81, February 2013

Articles

Hamilton Medical, Inc., HAMILTON-T1 Ventilators with Software Versions 1.1.2 and Lower

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FDA MedWatch Safety Alert

During ventilation of small pediatric patients with high airway resistance and low lung function, there may be unexpected high internal oxygen consumption by HAMILTON-T1 ventilators with software versions 1.1.2 and lower. This may cause miscalculation of the required oxygen needed for long time applications with limited oxygen supply.

Additional Information:

FDA MedWatch Safety Alert. Hamilton Medical, Inc., HAMILTON-T1 Ventilators with Software Versions 1.1.2 and Lower. February 7, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm338789.htm

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Vycor Viewsite Brain Access System (VBAS): Class 1 Recall - Unidentified Fiber Found on Device

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FDA MedWatch Safety Alert

Vycor Medical recalled its' VBAS because an unidentified black fiber was found on the device. Vycor Medical called their customers requesting that they place products of Model # TC171105, Lot # VM83450 into quarantine until further notice.

Additional Information:

FDA MedWatch Safety Alert. Vycor Viewsite Brain Access System (VBAS): Class 1 Recall - Unidentified Fiber Found on Device. January 30, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm337475.htm

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Bausch and Lomb 27G Sterile Cannula Packed in Amvisc and Amvisc Plus Ophthalmic Viscosurgical Devices (OVD): Class I Recall - Cannulas May Leak or Detach From the Syringe

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FDA MedWatch Safety Alert

The OVD is a sterile gel-like substance (viscoelastic preparation) supplied in a disposable glass syringe either 0.5 or 0.8 mL of thick solution with water-retention properties (sodium hyaluronate). Bausch and Lomb advised customers to discontinue the use and either destroy or quarantine the product under refrigeration pending a sales representative visit to your site.

Additional Information:

FDA MedWatch Safety Alert. Bausch and Lomb 27G Sterile Cannula Packed in Amvisc and Amvisc Plus Ophthalmic Viscosurgical Devices (OVD): Class I Recall - Cannulas May Leak or Detach From the Syringe. January 23, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm336466.htm

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Metal-on-Metal Hip Implants: Safety Communication - Updated Safety Recommendations

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FDA MedWatch Safety Alert

FDA notified healthcare professionals that it is providing updated safety information and recommendations to patients and health care providers, based on the FDA’s current assessment of metal-on-metal hip implants, including the benefits and risks, the evaluation of the published literature, and the results of the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel meeting.

Additional Information:

FDA MedWatch Safety Alert. Metal-on-Metal Hip Implants: Safety Communication - Updated Safety Recommendations. January 17, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm336069.htm

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Fisher and Paykel Healthcare Reusable Breathing Circuit: Class I Recall - Pinholes in Tubes

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FDA MedWatch Safety Alert

FDA notified healthcare professionals that the Fisher & Paykel Healthcare Reusable Breathing Circuit, Model 900MR068, was recalled due to pinholes in the tubes used in the reusable breathing circuit. If these pinholes are not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the intended ventilation therapy.

Additional Information:

FDA MedWatch Safety Alert. Fisher and Paykel Healthcare Reusable Breathing Circuit: Class I Recall - Pinholes in Tubes. January 7, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm334446.htm

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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 November 2012. 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.


Device:
Type: Analyzer, Chemistry
Manufacturer: Beckman Coulter, Inc
Brand: Unicel Dxc
Model#: 680 or 600

Problem:
Recently a patient's urine drug screen came back positive and the patient insisted that she was not taking tricyclics. A recollected urine came back negative for tricyclics. An investigation followed involving recalibrating using the current calibrator in use. The calibration was used. We recalibrated using new calibrator and new reagent and new controls. This time the calibration was acceptable. Upon review of the records, we saw that the previous calibrations on 10/9, (600), 10/12 (680), 10/15 (600), 10/21 (600) were possibly too low, although the control values were acceptable. We keep urine specimens for seven days and were able to retrieve the drug screen specimens from 10/15 through 10/21 for repeat testing. Of those twenty specimens, eleven specimens were found to have been reported as falsely positive for urine tricyclics, and nine specimens were originally reported as falsely positive for urine tricyclics, and remained positive upon repeat testing. Eleven specimens were unable to be rerun due to having been discarded (older than 7 days). Corrected reports were sent to the ordering physicians for the affected patients.


Device:
Type: Assay
Manufacturer: Microgenics, Inc
Brand: Dri Tricyclics Serum Tox Assay
Lot #: 59729835

Problem:
Recently a patient's urine drug screen came back positive and the patient insisted that she was not taking tricyclics. A recollected urine came back negative for tricyclics. An investigation followed involving recalibrating using the current calibrator in use. The calibration was used. We recalibrated using new calibrator and new reagent and new controls. This time the calibration was acceptable. Upon review of the records, we saw that the previous calibrations on 10/9, (600), 10/12 (680), 10/15 (600), 10/21 (600) were possibly too low, although the control values were acceptable. We keep urine specimens for seven days and were able to retrieve the drug screen specimens from 10/15 through 10/21 for repeat testing. Of those twenty specimens, eleven specimens were found to have been reported as falsely positive for urine tricyclics, and nine specimens were originally reported as falsely positive for urine tricyclics, and remained positive upon repeat testing. Eleven specimens were unable to be rerun due to having been discarded (older than 7 days). Corrected reports were sent to the ordering physicians for the affected patients.


Device:
Type: Calibrator
Manufacturer: Microgenics, Inc.
Brand: Dri Serum Tox Negative Calibrator
Lot #: 59682419

Problem:
Recently a patient's urine drug screen came back positive and the patient insisted that she was not taking tricyclics. A recollected urine came back negative for tricyclics. An investigation followed involving recalibrating using the current calibrator in use. The calibration was used. We recalibrated using new calibrator and new reagent and new controls. This time the calibration was acceptable. Upon review of the records, we saw that the previous calibrations on 10/9, (600), 10/12 (680), 10/15 (600), 10/21 (600) were possibly too low, although the control values were acceptable. We keep urine specimens for seven days and were able to retrieve the drug screen specimens from 10/15 through 10/21 for repeat testing. Of those twenty specimens, eleven specimens were found to have been reported as falsely positive for urine tricyclics, and nine specimens were originally reported as falsely positive for urine tricyclics, and remained positive upon repeat testing. Eleven specimens were unable to be rerun due to having been discarded (older than 7 days). Corrected reports were sent to the ordering physicians for the affected patients.


Device:
Type: Calibrator
Manufacturer: Microgenics, Inc
Brand: Dri Serum Tox
Lot #: 5975728

Problem:
was not taking tricyclics. A recollected urine came back negative for tricyclics. An investigation followed involving recalibrating using the current calibrator in use. The calibration was used. We recalibrated using new calibrator and new reagent and new controls. This time the calibration was acceptable. Upon review of the records, we saw that the previous calibrations on 10/9, (600), 10/12 (680), 10/15 (600), 10/21 (600) were possibly too low, although the control values were acceptable. We keep urine specimens for seven days and were able to retrieve the drug screen specimens from 10/15 through 10/21 for repeat testing. Of those twenty specimens, eleven specimens were found to have been reported as falsely positive for urine tricyclics, and nine specimens were originally reported as falsely positive for urine tricyclics, and remained positive upon repeat testing. Eleven specimens were unable to be rerun due to having been discarded (older than 7 days). Corrected reports were sent to the ordering physicians for the affected patients.


Device:
Type: Calibrator
Manufacturer: Microgenics, Inc
Brand: Serum Tox Calibrator 4
Lot #: 59776879

Problem:
Recently a patient's urine drug screen came back positive and the patient insisted that she was not taking tricyclics. A recollected urine came back negative for tricyclics. An investigation followed involving recalibrating using the current calibrator in use. The calibration was used. We recalibrated using new calibrator and new reagent and new controls. This time the calibration was acceptable. Upon review of the records, we saw that the previous calibrations on 10/9, (600), 10/12 (680), 10/15 (600), 10/21 (600) were possibly too low, although the control values were acceptable. We keep urine specimens for seven days and were able to retrieve the drug screen specimens from 10/15 through 10/21 for repeat testing. Of those twenty specimens, eleven specimens were found to have been reported as falsely positive for urine tricyclics, and nine specimens were originally reported as falsely positive for urine tricyclics, and remained positive upon repeat testing. Eleven specimens were unable to be rerun due to having been discarded (older than 7 days). Corrected reports were sent to the ordering physicians for the affected patients.


Device:
Type: Catheter
Manufacturer: Boston Scientific
Brand: Cutting Balloon
Cat #: PCB802090

Problem:
The patient is an infant with Tetralogy of Fallot (TOF) and left pulmonary artery (LPA) stenosis who was brought to the catheterization lab in the fall of 2012 for cardiac catheterization and pulmonary artery rehabilitation. Baseline hemodynamic data was obtained with the patient intubated, under general anesthesia, and mechanically ventilated on 21% FIO2. The interventional cardiologist gained access through the right groin: right femoral artery and right femoral vein ( RFA, RFV). Angiography showed severe stenosis of the proximal LPA, with improvement post balloon dilation with an 8mm cutting balloon angiographically and no extravasation or aneurysm seen. On inflation of the 8mm cutting balloon in the LPA, the balloon would not deflate. Repeated attempts to deflate the balloon were not successful. The balloon was pulled to the inferior vena cava (IVC) and a puncture with wires was attempted without success.

Access to the left groin was obtained and a catheter needle was utilized to puncture the balloon. There was no extravasation of contrast after removal of the 8 mm cutting balloon from the IVC, but there was fusiform irregularity to vessel wall suggesting abrasion. The guide wire was through the sheath next to the catheter needle. Upon removal of the guide wire and the needle, the soft platinum tip of the guide wire was sheared off by the needle. A snare was obtained to retrieve this wire, but given patient instability and possible damage to pulmonary artery (PA) and IVC, further attempts to retrieve the wire were abandoned. The tip of the wire was seen in the right ventricle (RV) on the last angiogram.

The patient was subsequently admitted two weeks later for pseudo-aneurysm of left groin which self thrombosed. No additional intervention was required. The current patient plan of care is for monthly follow-up/imaging and catheterization in next several months.


Device:
Type: Defibrillator, Implantable Cardioverter
Manufacturer: Boston Scientific Corporation
Brand: Cogins 100-d
Model#: N119

Problem:
Upon routine interrogation of her Boston Scientific COGNIS 100-D implantable defibrillator an unexpected warning alert reporting that voltage is too low for the projected remaining battery capacity. Boston Scientific technical support recommended generator change as the stated remaining longevity is not correctly calculated and that there may be a current loss in the system. This prompted her to be scheduled for removal of the old ICD and implantation of a new device.


Device:
Type: Et Tube Fastener
Manufacturer: Hollister
Brand: Anchor Fast
Model#: 9799
Cat #: 9799

Problem:
Anchor Fast strap came apart while attempting to secure endotracheal (ET) tube. This has happened 3 different times while attempting to secure ET tube. It seems that the company redesigned the Velcro strap and made it narrower because of skin issues with the original wide version. However, in this design, the glue holding the Velcro piece to the cloth failed. There doesn't appear to be enough surface area for the glue to really adhere to the cloth. We believe the company is going back to the old design.


Device:
Type: Flowmeter
Manufacturer: Precision Medical, Inc
Brand: Dial Flowmeter
Model#: 7MFA1005PTO
Lot #: 0812 and (10291200058)
Cat #: 7MFA1005PTO

Problem:
O2 flow meter was assembled incorrectly at the manufacturing facility. The high pressure take off line for a ventilator had an AIR fitting installed where there should be an O2 fitting. Manufacturer claims only the 4 mistakenly received by our facility are affected. No patients involved: events were discovered prior to the device being used on a patient. This event was found when the staff member noticed the wrong part was on the assembly. It is possible that a user not paying attention (human factor) could mistakenly hook up an air supply line to an O2 flow meter which would then provide an inappropriate air/O2 blend to the patient.


Device:
Type: Gauze Sponge
Manufacturer: Cardinal Health
Brand: Ray-tec
Cat #: SRIHMPSLB
Other #: Order# 881393

Problem:
Surgeon was performing a procedure to reposition a shunt. He had made a small incision into the abdomen, and pushed a Ray-tec gauze into the incision to clear up fluid so the abdominal cavity could be viewed. When he attempted to remove the Ray-tec it split in half, and the other half remained inside the abdomen. The remaining Ray-tec was removed. Another Ray-tec was tested and it tore in half with little effort. We immediately counted the Ray-tec and removed them off the field.


Device:
Type: Implant, Intragastric
Manufacturer: Allergan
Brand: Allergan Lap-band Ap Std With Access Port Ii
Cat #: B-2260

Problem:
Patient had a laparoscopic adjustable gastric banding performed three years ago. The implant was an Allergan Lap-Band AP STD with Access Port ll, ref: # B-2260. History and physical states "presents with apparent erosion of the Lap Band on CT scan". Patient recently had surgery for removal of adjustable gastric band, intraoperative EGD, closure of suspected fistula tract in mesocolon and on lesser curve of the stomach, and abdominal abscess cultures x2. The pre-op diagnosis was "possible erosion of the lap band, abdominal abscess". The post-op diagnosis was "infected lap band with suspected fistula". Admitting diagnosis to hospital was "abdominal abscess, infected lap band".


Device:
Type: IV Start Kit
Manufacturer: Owens & Minor
Brand: Medichoice

Problem:
Chlora-prep from IV start kits was used to cleanse patient's skin before IV insertion. A small piece of from the chlora-prep kit was noted to be poking through the soft surface and scratched patient's skin during the cleansing process. Patient noted to have multiple scratches around antecubital area and forearm with small amount of blood. Patient states "I thought it felt rough but I didn't want to say anything." RN apologetic and states she will follow up with appropriate patient safety reports. Patient's skin was wiped clean and patient offered an ice pack. Patient states she is okay and states "...the fact that you feel so bad reassures me that you did not do it on purpose. Stuff just happens, I'm fine." This RN gave defective product to charge RN. MD aware and will place order for bacitracin. Bleeding quickly stopped, no obvious signs of distress.


Device:
Type: Lift, Patient
Manufacturer: Tollos (formerly T.H.E. Medical)
Brand: Pinnacle
Model#: Pinnacle

Problem:
1,000 pound capacity overhead lift was employed to reposition a patient of approx. 725 pounds in weight. The overhead lift failed to function appropriately resulting in 7-8 staff members having to manually reposition the patient. Tollos, Inc. notified, assessed lift system and determined it was a manufacturer problem. Per the Clinical manager, the lift has not been physically removed but has been placed out of order. The service manager has ordered 2 new units (U34 &U35) and will replace it when it is available from the manufacture. The patient and no staff members were harmed in this event.
The lift is a T.H.E Pinnacle 1000 lbs capacity ceiling mounted lift. The lift was installed approximately two months ago by the manufacturer's subcontractor. The patient was on the lift when staff noticed it did not lift the patient high enough from the bed to perform nursing care. These lifts are new and have not had any problems. We have no idea why this happened. The service manager determined the malfunction to be due to the lift strap not going all the way to the top. Specifically, they made note of part #3000-378 Ceiling lift control module Gen. 3, on the service report.


Device:
Type: Microscope, Surgical
Manufacturer: Leica Microsystems, Inc.
Brand: Leica Oh 5Ic Green
Model#: OH5

Problem:
When IC green mode was selected, an error was reported on the system which required the microscope to be turned off and restarted. Dr. stated that the Leica company knows about the glitch in the computer program and has been here previously to fix the program. This was a Leica Microscope OH 5 IC Green.


Device:
Type: Oxygenator, Cardiopulmonary Bypass
Manufacturer: MAQUET, INC.
Brand: Sweep Tubing For Jostra Quadrox D
Model#: UNK
Lot #: UNK
Cat #: JOSTRA QUADROX D
Other #: OXYGENATOR, CARDIOPULMONARY/ECMO

Problem:
Patient acutely desaturated to 60% spO2 shortly after xray. Increased FiO2, ETT suction, administered packed red blood cells x1 (for decreased hematocrit and low O2 sat), fentanyl given. Found to have disconnected sweep line to #1 oxygenator; reconnected sweep line resulting in progressively improving saturation with complete recovery of oxygenation 99% within approximately 3 minutes.
There are two design concerns: no alarm to alert when there is a disconnection in sweep line, and/or a latching mechanisms


Device:
Type: Pump, Infusion
Manufacturer: Iradimed
Brand: Mridium
Model#: Model 3860

Problem:
The magnetic resonance imaging (MRI) infusion pump had been turned off. Channel A had an infusion of dexmedetomidine and Channel B was loaded with Phenylephrine
When turning pump back on to administer dexmedetomidine, the free flow of phenylephrine infusion (seen via flowing drip chamber) was observed. The green light on Channel B was not flashing; Channel B was not set for any infusion.

REPORTER UPDATED INFORMATION
-----------------------------

This has been seen at least once with a patient. As part of investigation by Biomed engineers the following was seen: Reviewing the pump log, no infusion was deliberately started on channel B of the pump in question. The original condition of the tube set is unknown. Whether or not the tube set was loaded while the pump was powered on, is unknown. Whether or not the tube set was successfully loaded is unknown. It is presumed that the tube set was loaded in channel B at the time of the event. The event of inadvertent infusion occurred while the pump was powered off is based upon the patient data recorded in Metavision. It is reported that the observed flow was a drip and not a free flow. (A gravity, full, "free-flow" would empty a 250 mL bag of Phenylephrine in 2 1/2 minutes, therefore the conditions for that did not exist.)

The "missed latch" condition is described as follows:
The "missed latch" is a result of defeating a mechanical interlock (switch) on the inside of the door. This can occur by incidental contact by the user, or if the door latch handle is not FULLY retracted (upward). Only a full retraction resets the interlock. If the reset doesn't occur, a condition can exist where the latch is set but not engaged properly to the pump housing. The result is that the door is not fully closed and a partial flow can exist. However if the pump is powered on, any door position that would cause actuation of the "free flow prevention" clamp (flow through the pump) will be detected and the alarm will sound. It is a speculation that this condition contributed to this event because it has been stated that an improperly closed door would have been observed. It is a fact that if the pump was powered on, this condition would have been detected. (We were not able to recreate conditions to detect this.) The patient status not known, but there is no long term harm associated with the device.


Device:
Type: Set, Administration, Intravascular
Manufacturer: B. Braun Medical
Brand: Safeline Extension Set With T-connector
Cat #: NF1330

Problem:
RN was at bedside nursing/caring for the infant. RNC-NIC (Manager) was called by the RN to look at the IV; Lipids/TPN were leaking at the T-connector.


Device:
Type: Set, Administration, Intravascular
Manufacturer: B. Braun Medical
Brand: Caresite
Cat #: 415122

Problem:
RN was at bedside nursing/caring for the infant. RNC-NIC (Manager) was called by the RN to look at the IV; Lipids/TPN were leaking at the T-connector.


Device:
Type: Set, Administration, Intravascular
Manufacturer: Becton Dickinson Infusion Therapy Systems Inc.
Brand: Nexiva
Lot #: 0308458
Cat #: 383537

Problem:
During surgery, IV catheter became disconnected dumping fluid into patient bed causing patient to miss some medications. Doctor reported that he actually watched the SDS (same day surgery) nurse start this IV. When he pulled the drape back, the IV was unhooked and had been running into her bed the whole case, along with some of her meds. Propofol drip was connected to the other port on the catheter. Luckily this was the case because if the Propofol drip had become disconnected the patient could have woken up during surgery. No apparent injury to the patient was reported. This catheter has two removable ports that have a silicone insert that make it so the port seals after removing the tip of the tubing. When the tubing tip is inserted into the port the silicone insert kind of pushes it back out, so it does not take much to shake the tubing tip loose. If the removable port is first removed and the tubing tip is inserted into the catheter "Y" the connection is quite secure. Of course then the clinician would have to attach a cap of some kind because the self-sealing aspect will be defeated. The IV tubing also has a collar that can be screwed down on the port to secure the tip in the port; however the port only has one screw thread to hook into the tubing collar. It is very easy to cross thread the collar. If the collar is cross threaded the connection will not hold and can also become disconnected quite easily.


Device:
Type: System, Hypothermia, Intravenous, Cooling
Manufacturer: Alsius Corporation
Brand: Icy Catheter
Model#: IC-3893A8700-0657-01
Lot #: 34827

Problem:
Alsius catheter placed and approximately eight hours later the port occluded while being infused with Magnesium Sulfate. MD notified. The following day, after returning from IR, the RN noted the Alsius alarmed air in the air chamber. Saline bag used to prime lines almost empty. Pt disconnected from Alsius, lines re-primed with NS, pt reconnected and Alsius re-started. Approximately 30-40 minutes later the same alarm sounded, NS bag almost empty. MD notified. Decision made to change Alsius line for possible balloon rupture. MD attempted line change over wire but was unsuccessful due to a clotted port. Line removed and replaced. New set for Alsius primed and connected to new line.


Device:
Type: Trocar
Manufacturer: St. Jude Medical, Inc.
Brand: Brk
Cat #: 407200

Problem:
The patient is an infant with Tetralogy of Fallot (TOF) and left pulmonary artery (LPA) stenosis who was brought to the catheterization lab in the fall of 2012 for cardiac catheterization and pulmonary artery rehabilitation. Baseline hemodynamic data was obtained with the patient intubated, under general anesthesia, and mechanically ventilated on 21% FIO2. The interventional cardiologist gained access through the right groin: right femoral artery and right femoral vein ( RFA, RFV). Angiography showed severe stenosis of the proximal LPA, with improvement post balloon dilation with an 8mm cutting balloon angiographically and no extravasation or aneurysm seen. On inflation of the 8mm cutting balloon in the LPA, the balloon would not deflate. Repeated attempts to deflate the balloon were not successful. The balloon was pulled to the inferior vena cava (IVC) and a puncture with wires was attempted without success.

Access to the left groin was obtained and a catheter needle was utilized to puncture the balloon. There was no extravasation of contrast after removal of the 8 mm cutting balloon from the IVC, but there was fusiform irregularity to vessel wall suggesting abrasion. The guide wire was through the sheath next to the catheter needle. Upon removal of the guide wire and the needle, the soft platinum tip of the guide wire was sheared off by the needle. A snare was obtained to retrieve this wire, but given patient instability and possible damage to pulmonary artery (PA) and IVC, further attempts to retrieve the wire were abandoned. The tip of the wire was seen in the right ventricle (RV) on the last angiogram.

The patient was subsequently admitted two weeks later for pseudo-aneurysm of left groin which self thrombosed. No additional intervention was required. The current patient plan of care is for monthly follow-up/imaging and catheterization in next several months.


Device:
Type: Vascular Closure Device
Manufacturer: Abbott Vascular Devices
Brand: Perclose Proglide
Lot #: 20810J1
Cat #: 12673

Problem:
Patient underwent cardiac cath. During deployment of the Perclose suture device, there was a device failure and a small piece of the foot process of the device appeared to have broken off. Xray of the device was peformed and the plastic segment appeared to be radiolucent. Xray of the femoral area post-procedure did not show any radiopaque abnormalities. The patient had an excellent femoral pulse and distal pulse. The patient was kept overnight, treated with antibiotics and watched for vascular complications with consults from ID (infectious disease) and vascular surgery. No known harm to patient. Post discharge patient will be monitored for signs and symptoms of infection or occlusive complications from tiny piece of plastic. Disclosure to patient on event and follow-up plans.

======================
Manufacturer response for Vascular closure system, Perclose ProGlide Suture- Medicated Closure System 6F (per site reporter)
======================
Have asked Abbott to share results of their evaluation with us and will share with MedSun if/when received.


Device:
Type: Ventilator, Continuous, Facility Use
Manufacturer: CareFusion 2200, Inc.
Brand: Avea
Model#: Avea Std

Problem:
The Avea ventilator stopped ventilating the patient. Alarms were sounding and light flashing (EXT High Peak/Safety Valve/High Peak/Low Min Volume/Apnea Interval/Low Tidal Volume). The patient was suctioned for small amount of sputum. The circuit and filters were inspected and no fault was found. The housing for the expiratory filter was slightly ajar and was removed and replaced properly with no correction to problem. The ventilator was removed form service and replaced. Throughout this process the patient was being bag ventilated by the nurse. No change to patient's condition; no harm. The ventilator was removed from service and the Carefusion service representative inspected and repaired the ventilator. The service rep. findings: Found that the expiratory port was not seated squarely in the housing that holds the port, water trap and filter together. Also found that the delivered PEEP level was decreasing between the end of one breath and the beginning of another. The tech performed OVP (Operational Verification Procedure)after resolving these issues. Action: The humidifier was mounted too close beneath the port causing the staff to have to insert the port/water trap filter assembly at an angle which causes the filter and port to become misaligned. The tech repositioned the humidifier out of the way. Also, found that the exhalation diaphragm had been pinched by the exhalation port and was not making a good seal. The tech replaced the diaphragm.


Device:
Type: Ventilator, Emergency
Manufacturer: Carefusion
Brand: Pulmonetic Ltv 1200
Model#: LTV 1200

Problem:
During venting a patient the vent stopped working when power stopped. The event occurred on the ambulance. There was no patient harm. The patient was bagged manually until arrival at the facility. During checking by the biomed tech he noticed that the external battery was connected to itself and not connected to the vent or external power. The same type connections are on the input and output of the battery causing the operator to bypass the vent. Pictures are available of this connection. It is possible that this has occurred before, approximately two months ago, but we are unable to confirm it.


Device:
Type: Wire, Guide, Catheter
Manufacturer: Boston Scientific
Brand: Choice
Cat #: 12135-01J

Problem:
The patient is an infant with Tetralogy of Fallot (TOF) and left pulmonary artery (LPA) stenosis who was brought to the catheterization lab in the fall of 2012 for cardiac catheterization and pulmonary artery rehabilitation. Baseline hemodynamic data was obtained with the patient intubated, under general anesthesia, and mechanically ventilated on 21% FIO2. The interventional cardiologist gained access through the right groin: right femoral artery and right femoral vein ( RFA, RFV). Angiography showed severe stenosis of the proximal LPA, with improvement post balloon dilation with an 8mm cutting balloon angiographically and no extravasation or aneurysm seen. On inflation of the 8mm cutting balloon in the LPA, the balloon would not deflate. Repeated attempts to deflate the balloon were not successful. The balloon was pulled to the inferior vena cava (IVC) and a puncture with wires was attempted without success.

Access to the left groin was obtained and a catheter needle was utilized to puncture the balloon. There was no extravasation of contrast after removal of the 8 mm cutting balloon from the IVC, but there was fusiform irregularity to vessel wall suggesting abrasion. The guide wire was through the sheath next to the catheter needle. Upon removal of the guide wire and the needle, the soft platinum tip of the guide wire was sheared off by the needle. A snare was obtained to retrieve this wire, but given patient instability and possible damage to pulmonary artery (PA) and IVC, further attempts to retrieve the wire were abandoned. The tip of the wire was seen in the right ventricle (RV) on the last angiogram.

The patient was subsequently admitted two weeks later for pseudo-aneurysm of left groin which self thrombosed. No additional intervention was required. The current patient plan of care is for monthly follow-up/imaging and catheterization in next several months.


Device:
Type: Electrosurgical, Vein Harvesting System
Manufacturer: Maquet Cardiovascular
Brand: Vasoview 6
Model#: VH-2000
Lot #: 25063006
Cat #: VH-2000

Problem:
An Endoscopic Vein Harvesting device was used to harvest the greater saphenous vein from the leg which was of a slightly "large" caliber. User of device reports that "the cutter became stuck on the carrier as the cutter went into the beveled area of the carrier". Device was removed from the sterile field and replaced with another. No patient injury.


Device:
Type: Electrosurgical, Vessel Harvesting System
Manufacturer: MAQUET Cardiovascular
Brand: Vasoview Hemopro
Lot #: 25061099
Cat #: VH-3000

Problem:
While taking vein during a CABG procedure, Vasoview Hemopro had a "C-ring failure" which resulted in having to open another Vasoview Hemopro device VH-3000.

NOTE: This is the THIRD event with this device since the beginning of year.


Device:
Type: Foz :Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Manufacturer: Argon Medical Devices Inc.
Brand: Picc Line
Lot #: 11021438

Problem:
PICC Line inserted on NICU infant broke just below the oval (Argon Medical Devices label). The distal portion of the line did not migrate into infant and there was no harm to patient.

This is the 4th report on this product that has been reported as breaking adjacent to the oval in 2012.


Device:
Type: Syringe, Prefilled, Lovenox
Manufacturer: Sanofi-Aventis US, LLC
Model#: Lovenox 40mg/0.4ml syringe
Lot #: 2LF14R

Problem:
When the syringe is depressed all the way, the safety lock is supposed to deploy - this did not happen on this syringe. The nurse did not notice that the safety device did not deploy and scratched herself with the used syringe. There have been reports of difficulties with getting the safety device to deploy on Lovenox, potentially with different doses. I do not have the particular syringe that was involved, however, the nurse in charge thinks the Lovenox syringes in our automated supply station system are the same lot number as the involved syringe. So I will be using the lot number of one of those syringes in this report.


Device:
Type: Stimulator, Autonomic Nerve, Implanted For Epilepsy
Manufacturer: Cyberonics Inc.
Brand: VNS Therapy
Model#: 103

Problem:
It was thought at first to be the lead see Medical Record:

"I decreased the stimulation down to 0.5 milliamps as the generator indicates it's delivering less than 0.25 milliamps due to lead difficulties."

When generator was tested, however, it was found to be defective.

Medical Record:
"Tested the device prior to surgery beginning and High Impedence was the result. Generator was removed from chest. Neurosurgery disconnected the generator from the lead and then put them back toghether and retested but still got high impedence. Tried a second time with the same result. Then disconnected the lead from generator and tested with resistor and high impedence was again the result. Retested one more time and still had high impedence. Discussed with physician who agreed with the plan to put new generator in and test. New generator was tested and the patient information was programmed prior to placement by neurosurgery. After placement Lead Test was performed, heart rate ranged from 62 to 65 during the lead test. No bradycardia was noted and the lead test was ok."

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Updated February 1, 2013

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