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U.S. Department of Health and Human Services

MedSun: Highlighted MedSun Reports

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Highlighted MedSun Reports

Here you will find a small sample of the hundreds of important reports MedSun receives per month. This sample is selected based on completeness of report and perceived level of interest to the clinical community. To view all reports received in the past 30 days, see the bottom of this month’s Newsletter, and for a complete search of all MedSun reports, see the MedSun Reports page.

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 March 2014. All other reports can be searched under the ‘MedSun reports’ menu pane.

Device
Type: Bone Cement
Manufacturer: Styker Orthopaedics
Brand: Surgical Simplex PRadiopaque
Lot #: RCU048
Cat #: 6191-1-001
Other #: 306-553

Problem
Femoral neck osteotomy performed. The femoral canal was irrigated, dried, and packed. The scrub circulation technician had difficulty with a cement gun that broke due to the first two bags of cement curing too quickly. The two bags of cement that had been mixed were discarded. Subsequently, two more bags of Simplex cement with the same lot numbers were requested by the surgeon and mixed. The cement was handed to the surgeon at three minutes. The gun cement applicator was prepared and handed to the surgeon. After deploying the cement gun with 1- 1/2 squeezes, the cement gun became rigid and cement hardened at under 6 minutes of mixture. At that point the femoral canal was filled to approximately three fifths the canal volume. Surgeon asked for an additional two packs of cement to be mixed. In the next minute, the cement had cured and became solid. There was no way to simply pull out the cement. During the removal of the cement using an ultrasonic device, a periprosthetic fracture occurred and the cement was unable to be removed. Patient required a second surgery/revision and repair of the posterolateral segmental bone loss, left mid shaft femur fracture.
Discussion with the rep, who was present, anesthesiologist, RN and surgeon found no error on the technicians/circulator's part which could have led to the rapid setting of the cement. It is expected to set at 10-13 minutes per the Stryker Rep. Per mfr's response to the hospital, there might be a technique/skill issue since both batches of cement were from the same lot.


Device
Type: C-arm
Manufacturer: Siemens Medical Solutions USA, Inc.
Brand: Arcadis Orbic 3d
Model#: 10143407
Other #: Software: Syngo WinNT 5.1 Service Pack 2

Problem
During the procedure the surgeon ordered a 3-D Fluoro spin with the Siemens Arcadis Orbic ,which was performed in the operating room. The images were reviewed by the surgeon and surgical intervention was altered based on the images provided by the device. It was later discovered that the positioning imputed prior to the scan being performed was selected supine rather than prone. This resulted in laterally images being reversed when reviewed by the surgeon. Concern that the markers for right and left are small on the images produced. Question if the markers for right and left on the images could be enlarged to assist with verification of positioning. Question if an additional safety check with mandatory response could be added to confirm proper positioning has been selected prior to being able to start the scan.


Device
Type: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Manufacturer: Arrow International
Brand: Pressure Injectable Quad-lumen Central Venous Catheterization Kit With Blue Flextip, Arrowg+ard Blue Plus Catheter
Cat #: CDC-45854-XP1A

Problem
An Arrow power injectable quad lumen central venous catheter was placed in a patient. Four days later, a student nurse along with the patient's RN discovered that the catheter lumens were labeled incorrectly by the manufacturer. The brown lumen (which is the distal lumen) was printed with the words "medial 2". The blue lumen (which is the medial 2 lumen) was printed with the words "distal". No apparent patient harm. This device is part of a vascular access kit. Staff rely on the color of the ports to indicate their location on the device as well as the diameter of the lumen itself. In this case, the manufacturer's labeled port location did not match the manufacturer's assigned color location for two of the four lumens. Lumen size can be significant depending on the viscosity of the medication/fluid (eg: blood product) being administered as well as the rate at which a medication/fluid needs to be delivered. The lot number for this device is not known. Packaging was discarded after the device was inserted and the event was discovered 4 days later. The device was removed & returned to the manufacturer.


Device
Type: Enve Ventilator
Manufacturer: Carefusion 203 Inc.
Brand: Enve

Problem
The patient was intubated and placed on a ventilator. Ventilator settings: Mode: A/C Volume Control Ventilation (Volume A/C ), FiO2: 30 %, TV: 600 ml, Set Rate: 12 breaths per minute, PEEP: 5 cmH2O, VE: 12.4 L, Plateau Pressure: 15 cmH2O.
While in use for a few hours, the ventilator displayed an alarm "mechanical fault 19." The vent was still ventilating, but the patient was placed on a different vent as a precautionary measure. The vent was sent to the manufacturer for inspection and the service report indicates that the service technician was unable to verify the reported problem. The vent passed a 71 hour extended tests and no unusual alarms occurred. Review of the "Hardware Fault 19 alarm" reveals one "Hardware Fault 19 Alarm" after the last service date of 10/3/13. Event trace could not determine the root cause of this alarm. Decided to replace the hybrid board as a precaution and this was done. The vent was returned and placed back into service.
======================
Manufacturer response for EnVe Ventilator, EnVe Ventilator (per site reporter)
======================
Service repair completed.


Device
Type: Filter, Bacterial, Breathing-circuit
Manufacturer: Teleflex Medical
Brand: Hudson Main Flow Bacterial/viral Filter
Model#: 1605
Cat #: 1605

Problem
The patient was intubated without any complications and was placed on a LTV ventilator and the patient would desaturate. The ventilator would alarm "DISC/SENSE." The Respiratory Therapist (RT) thought it was the ETT cuff that was blown. The patient was re-intubated. The patient was bagged and placed back on the ventilator and the ventilator was experiencing the same issue as before-it alarmed "DISC/SENSE" again. The patient's oxygen saturation dropped into the 70's and the patient was taken back off the vent and bagged with an ambu-bag. The patient's oxygen saturation did increase once the patient was taken off the vent and was being ventilated with the ambu-bag. Another ventilator was brought in and placed on the patient without any complications and the patient's vitals were stable.

Upon further inspection of the ventilator, RT discovered that the Teleflex filter was completely occluded with a plastic web inside of the small (15mm) end. The ventilator machine was found to perform correctly with a new filter installed. Staff were instructed to inspect each and every filter that they set up until further notice. Thus far, only this one affected filter has been located. The lot number is unknown as the exterior packaging of the filter was discarded at the equipment assembly time. RT has left a message at the manufacturer's complaint division and is waiting for a return phone call.


Device
Type: Gas-machine, Anesthesia
Manufacturer: GE Healthcare
Brand: Avance
Model#: CS2 7900

Problem
The hospital recently placed a new Avance anesthesia unit into use in room 6.
One of the flow sensor transducer flappers got stuck in the up position (Part # 1503-3858-000).
This problem has been occurring frequently on the new Avance models at the hospital.
The GE field service rep and GE sales rep are both aware of this issue.

Device
Type: Electrosurgical, Cutting, Coagulation
Manufacturer: Arthrocare Corporation

Problem
Patient was having a tonsillectomy and adenoidectomy done. During follow up exam, it was noted that there was a 4-5 mm through hole in the soft palate that may require repair. First event occurred approximately 3 months ago, and recurred last month on a different patient. Manufacturers instructions were followed.
The rep was going to come by to discuss, and was going to notify the product manager immediately.

Device
Type: Tonometer, Manual
Manufacturer: Haag-Steit USA Inc.
Brand: Goldmann Applanation

Problem
During the intraocular pressure test, the Goldmann Applanation Tonometer Measuring Prism tip was applied to bilateral eyes to assess the intraocular pressures. Following this assay, the patient began to complain of discomfort and blurred vision in both eyes. After an examination of the patient's eye, it was determined the patient sustained circumferential cornea irritations, which lined up directly with the tonometer measuring prism tip used in the intraocular pressure test.
Upon review of the event and examination of the equipment, it was noted that the tonometer measuring prism tip used on the patient and several other tonometer tips appear to have cracking and erosion of the applanation tip which comes in contact with the eye. The staff has been cleaning the tips with the manufacturer's recommended cleaners (sodium hydrochlorite and hydrogen peroxide), yet the tips continue to be damaged during the cleaning process. Due this event and the quantity of damaged tonometer measuring prisms, despite following the manufacturer's cleaning instructions, we are now using disposable measuring prisms.


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All Actions to Date

TitleDate
Highlighted ReportsApril 2014
Highlighted ReportsMarch 2014
Highlighted ReportsFebruary 2014
Highlighted ReportsJanuary 2014
Highlighted ReportsDecember 2013
Highlighted ReportsNovember 2013
Highlighted ReportsSeptember 2013
Highlighted ReportsAugust 2013
Highlighted ReportsJuly 2013
Highlighted ReportsJune 2013
Highlighted ReportsMay 2013
Highlighted ReportsMarch 2013
Highlighted ReportsFebruary 2013
Highlighted ReportsJanuary 2013
Highlighted ReportsDecember 2012
Highlighted ReportsNovember 2012
Highlighted ReportsOctober 2012
Highlighted ReportsSeptember 2012
Highlighted ReportsAugust 2012
Highlighted ReportsJuly 2012
Highlighted ReportsJune 2012
Highlighted ReportsMay 2012
Highlighted ReportsApril 2012
Highlighted ReportsMarch 2012
Highlighted ReportsFebruary 2012
Highlighted ReportsJanuary 2012
Highlighted ReportsDecember 2011
Highlighted ReportsNovember 2011
Highlighted ReportsOctober 2011
Highlighted ReportsSeptember 2011
Highlighted ReportsAugust 2011
Highlighted ReportsJuly 2011
Highlighted ReportsJune 2011
Highlighted ReportsMay 2011
Highlighted ReportsApril 2011
Highlighted ReportsMarch 2011
Highlighted ReportsFebruary 2011
Highlighted ReportsJanuary 2011
Highlighted ReportsDecember 2010
Highlighted ReportsNovember 2010
Highlighted ReportsOctober 2010
Highlighted ReportsSeptember 2010
Highlighted ReportsAugust 2010
Highlighted ReportsJuly 2010
Highlighted ReportsJune 2010
Highlighted ReportsMay 2010
Highlighted ReportsApril 2010
Highlighted ReportsMarch 2010
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Highlighted ReportsDecember 2009
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Highlighted ReportsJuly 2009
Highlighted ReportsJune 2009
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Highlighted ReportsMarch 2009
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Highlighted ReportsDecember 2008
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Updated April 19, 2014

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