• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MedSun: Highlighted MedSun Reports

  • Print
  • Share
  • E-mail

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

Print Item
E–mail Item

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

Device :
Type: Insufflator, Hysteroscopic
Brand: Fluidsafe Fluid Management System
Model#: 080CE 657

Unit noted to be malfunctioning during procedure. Fluid deficit amount reported by machine noted to be inaccurate when compared to amount of fluid used. Machine alarming that fluid bag not connected when it was. Calculations done manually. Unit removed from service. Manufacturer to evaluate unit and provide report to facility.

Device 1:
Type: Laryngoscope, Rigid
Manufacturer: King Systems Corp.
Brand: King Vision Portable Video Laryngoscope Kit
Model#: KVLKIT3
Cat #: KVLKIT3

Device 2:
Type: Laryngoscope, Rigid
Manufacturer: King Systems Corp.
Brand: King Vision Portable Video Laryngoscope Kit
Model#: KVLKIT3
Cat #: KVLKIT3

There were two device-related occurrences of the King Vision portable video laryngoscope in a three-day period. The first occurrence was that the crew member attempted to use the King Vision to intubate a patient and observed that the battery compartment cover was off. The crew member placed the cover back on and the scope would not turn on. The scope was set aside and intubation was completed with standard laryngoscope. There was no adverse outcome to the patient. Follow up: One of the three batteries had been placed in the wrong direction. Experienced staff indicated contributing factors to be poor equipment design, excessive distractions and haste. On a different day, The King Vision was found to be inoperable during the treatment of a multi-trauma patient. There was another King Vision available on a second rig that was at the scene and so that one was used to intubate the patient. The non-operational scope was pulled from service. Inspection of the device revealed that the batteries were incorrectly inserted and that is why the unit did not work. Experienced staff listed contributing factors as being a poor equipment design, excessive distraction and haste.
Further follow up: Changing batteries in the device was part of the training, but the device is not used frequently and so staff may be not recall the correct steps.
The black strip (ribbon) must be placed properly under all three batteries (3 AAA size alkaline batteries) to assure ease of removal. Staff have experienced problems with the black strip and have found that if it is just pushed down, the batteries may not make correct contact and that the bottom battery has to get dug out. Also, if the batteries are not in proper place, the cover is hard to open. It was reported that some staff are using a coin to open the compartment when it is difficult to open. Staff involved received follow up and training. This device is not new to this facility.

Device 1:
Type: Laser, Benign Prostatic Hyperplasia
Manufacturer: AMS (American Medical Systems, Inc)
Brand: Greenlight Hps Laser System
Model#: 0010-0070

Device 2 :
Type: Powered Laser Surgical Instrument
Manufacturer: AMS (American Medical Systems, Inc)
Brand: Fiber Optic Greenlight Hps Bph
Model#: 10-2090
Lot #: 10-2090-318H
Cat #: 10-2090

Device 3 :
Type: Powered Laser Surgical Instrument
Manufacturer: AMS (American Medical Systems, Inc)
Brand: Greenlight Hps Bph Fiber
Model#: 10-2090
Lot #: 10-2090-316H
Cat #: 10-2090

Laser tested before procedure: laser ready. Laser then stopped "171" message received, ready and functioned again. Laser stopped and went into safety shutdown. Laser fiber changed: again ready. Laser again went into shutdown error "171","210", "172". Surgeon noted tip of laser fiber disintegrated, removed fiber from patient and separated tip removed from patient using flexible grasper. No additional medical intervention required once separated tip was removed.

Device 1:
Type: Set, Administration, Intravascular
Manufacturer: USA Medical
Brand: Microclave Neutral Displacement Connector
Cat #: MC100

Device 2:
Type: Set, Administration, Intravascular
Manufacturer: USA Medical
Brand: Microclave Neutral Displacement Connector
Cat #: MC100

Patient has Mediport with a the Microclave Connector. When RN went to use it, the spiral white part which is normally inside the tip/shaft of the connector was sticking out of the connector. Connector was replaced. The following evening, the spiral portion again found pulled out. Parent reported seeing the child sticking her fingers in it. Item replaced and parafilm placed over it in attempt to keep child from getting to it. It is believed child is able to get her small fingers in the tip and tug on the white spiral piece pulling it out.

Type: Set, Administration, Intravascular
Manufacturer: Baxter Healthcare Corp.
Brand: One-link Needle-free Iv Connector With Neutral Fluid Displacement, Power Injectable
Model#: 7N8399
Cat #: 50085412091780

This involves new Baxter One-Link Needle Free IV Connector used on IV ports and central lines. Baxter IV Connectors prevent adequate flow through PIVs and central lines. Staff have noted similar events on multiple patients.
Brought patient to CT to scan with contrast. Noted that PIV was no good because of bad flow and/or flush; technicians encountered difficulty in flushing and were unsure if contrast could be inserted at adequate pressure. When cap was removed and flushed directly at hub of PIV, PIV flushed with no resistance. Baxter connectors have a type of negative pressure (resistance) within, creating increased difficulty of rapid infusion of fluids/ blood, or even quick flush. In this case, the test could be completed without the cap and without having to restart another IV line. However, in some cases, the IV may be restarted because the provider believes that the line is not adequate, when in fact it is.

Type: Support, Patient Position
Manufacturer: SAGE Products LLC
Brand: Prevalon Turn And Position System
Cat #: 7200

Patient went to MRI at 1300. Prior to leaving, temperature was documented at 1200 as 36.9. Upon return from MRI at 1500, temperature was documented as 39.0. Patient was on the Prevalon Turn and Position system during MRI. No apparent injury. Patient monitored. Device instructions for use do not indicate that the device cannot be used in the MRI suite. No indications regarding MRI compatability are listed on the device information sheets.

Type: System, Balloon, Intra-aortic And Control
Manufacturer: Datascope Corp.
Brand: Cardiosave
Model#: D998-00-0800-53
Other #: Hybrid

An elderly patient had hypertension (HTN), a myocardial infarction (MI) and was in shock. The patient had major vessel occlusions and was catheterized and resuscitated, but required an intra-aortic balloon pump (IABP). The flight team was requested from our facility to pick the patient up at the outside facility and transport them back to our facility for extracorporeal membrane oxygenation (ECMO). The transport team arrived and attempted to switch the patient to the Maquet Cardiosave hybrid IABP. The team could not get an electrocardiogram (EKG) tracing on the IABP regardless of using alternate cables, connectors, etc., and therefore, were not able to transport the patient who required an inflight EKG tracing for balloon pump management. The patient ultimately was transported by another carrier by ambulance, coded en route and was returned to the sending hospital where she died.
Manufacturer response: They could not duplicate the problem; however, they did determine that the unit displayed corrupt date and time on the log printout, and they replaced the executive processor board.

Type: Ventilator, Continuous, Facility Use
Brand: Engstrom Carestation
Model#: RT
Other #: 9067

Patient's ventilator stopped giving breaths suddently with one alarm that was silenced; then there were no further alarms while it slowly counted down from set rate of 24 to 20, 16,10,9 then a flat line with no breaths being given. Despite checking all tubing being connected and vent plugged in, no breaths were given despite ventilator screen still lit. No further alarms despite no functioning by the ventilator. Performed super user calibrations and unit passes all testing. Ventilator was removed from service. The RN was in the patient's room at the time, and was able to bag the patient. Patient was not injured.

Device :
Type: Catheter, Angioplasty, Peripheral, Transluminal
Manufacturer: Boston Scientific
Lot #: 15979839
Cat #: PCB802090

Patient underwent successful re-channeling of iliac artery stenosis on the left, but developed bleeding at the site of the 7FR sheath on her left groin. Changed to a new 7FR sheath and bleeding slowed but did not stop. The initial 7FR sheath was noted to have a split in its length when it was removed. This believed to be due to the cutting balloon. Patient required a trip to the OR for open left femoral artery repair. The laceration required two sutures.

Type: Shunt, Central Nervous System
Manufacturer: Codman and Shurtleff, Inc.
Brand: Codman Eds 3Drainage System

On at least two occasions the base of the ventricular drainage system sampling port has cracked. This caused small amounts of CSF to leak and is an infection risk to the patient, as it is a closed system with direct access to the patient's brain.

Type: Accelerator, Linear, Medical
Manufacturer: Varian Medical Systems, Inc.
Brand: Trilogy Delivery System
Other #: 3404

Male patient with UT3 N1 M0 moderately differentiated invasive rectal carcinoma was undergoing adjuvant radiotherapy to treat his tumor prior to low anterior resection. Patient placed on belly board. Treated the posterior-anterior (PA), right and left lateral fields. Planned to treat the anterior-posterior (AP) field. Noticed the table had shifted from the treatment position that they had set up. Realigned the patient and treated the anterior-posterior (AP) field.

Device :
Type: Pump, Infusion
Manufacturer: Baxter Healthcare Corporation
Brand: Baxter Sigma Spectrum Infusion Pump
Model#: 35724
Cat #: 35724

While reviewing the pump Event History Log, we noticed there were entries of the pump going into "Sleep Mode" following a downstream occlusion. We are not familiar with this mode and after calling Baxter/Sigma they too were not able to define what this mode was. We have several hundred of these pumps and never saw this.

Type: System, Surgical, Computer
Manufacturer: Intuitive Surgical, Inc
Brand: Endowrist
Cat #: 420172

Difficulty 3x loading instrument into the second robotic arm. Once loaded, it wouldn't advance so had to be manually advanced and struck a vessel causing 500ml bleeding and vessel injury. Had to convert to open in order to control bleeding.

From staff-written description on Intuitive Surgical complaint form: The robot was docked and the resident assisting the surgeon attached* the endowrist Maryland into the second robotic arm. It did not load** properly, however, and he had difficulty reloading it so he withdrew the instrument and loaded it again. The instrument did not advance and he manually advanced the instrument, striking and injuring a vessel in the process. Estimated 500ml blood loss but bleeding was controlled even though a definitive vessel injury was not found.
*Attachment means the motion transfer wheels of the instrument are coupled to the motor-driven wheels of the arm via a cartridge.
**Load means the laparoscopic insertion of the instrument into the patient via a trocar.

Type: Heart-valve, Non-allograft
Manufacturer: Medtronic Heart Valves
Brand: Mosaic Mitral Bioprosthetic Heart Valve
Model#: 310 Cinch
Cat #: 310C29

A Mosaic mitral valve was opened. As surgeon was loading it onto the valve holder, the valve separated from the blue carrier and we noticed the suture was broken. We opened an identical valve which was implanted without incident. The rep was notified, so he is aware of the situation. We are working on getting a replacement for our stock.

Device 1:
Type: 12 Mm Endo Gia Ultra Universal Stapler
Manufacturer: Covidien
Brand: Endo Gia Ultra Universal Stapler
Lot #: P4D0019X

Device 2:
Type: Reload, Staple, Implantable
Manufacturer: Covidien
Brand: Endio Gia Black Articulating Reload
Lot #: N4C0428KX
Cat #: EGIA60AXT

The lung contained multiple nodules and the parenchyma was thickened. On coming across the lower lobe for the wedge biopsy, the Covidien stapler with 60 mm black load completely locked on the lung tissue, and the surgeon was unable to back out the blade or remove it, even with measures recommended by the Covidien representative. Another stapler was fired behind this stapler to free up the specimen, however, the tissue was so thick at that point that there was bleeding from the lung parenchyma and he decided to open and complete the lower lobe wedge resection and control the parenchymal bleeding. A sliver of the specimen was left in the staple cartridge as it was simply impossible to remove it even after the stapler was removed and trying to push back the blade manually.

Manufacturer response for Black Articulating Reload with Tri-Staple Technology, Endio GIA Black Articulating Reload with Tri Staple Tech. (per site reporter)
The Covidien Rep is sending us a container to return the device in. The hospital will be holding onto the device for a while. Not sure when it will be returned.

Type: Electrosurgical, Cutting &Coagulation &Accessories
Manufacturer: MAQUET Cardiovascular LLC
Brand: Vasoview Hemopro 2

Approximately two years ago in the late fall, patient underwent coronary artery bypass graft. A vessel was harvested from the right leg and used successfully in the graft. Approximately 16 months later, in the spring, the patient experienced itching and discomfort in her right calf. The patient experienced discomfort that she described as 'like a splinter' and discovered a small splinter-object protruding from her calf. The patient used a pair of tweezers to remove the object and removed a piece of tubing approximately 4" long from her calf.
The patient presented to the surgeon for follow up care approximately 4 days later. No other issues were noted.
Originally, the patient kept the piece of tubing and did not turn it over to the hospital for investigation. The hospital received the tubing two months later.

Return to Top

Return to Medsun Home

All Actions to Date

Highlighted ReportsJuly 2014
Highlighted ReportsJune 2014
Highlighted ReportsMay 2014
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
Highlighted ReportsFebruary 2010
Highlighted ReportsJanuary 2010
Highlighted ReportsDecember 2009
Highlighted ReportsNovember 2009
Highlighted ReportsOctober 2009
Highlighted ReportsSeptember 2009
Highlighted ReportsAugust 2009
Highlighted ReportsJuly 2009
Highlighted ReportsJune 2009
Highlighted ReportsMay 2009
Highlighted ReportsApril 2009
Highlighted ReportsMarch 2009
Highlighted ReportsFebruary 2009
Highlighted ReportsJanuary 2009
Highlighted ReportsDecember 2008
Highlighted ReportsNovember 2008
Highlighted ReportsOctober 2008
Highlighted ReportsSeptember 2008
Highlighted ReportsAugust 2008
Highlighted ReportsJuly 2008
Highlighted ReportsJune 2008
Highlighted ReportsMay 2008
Highlighted ReportsApril 2008
Highlighted ReportsMarch 2008
Highlighted ReportsFebruary 2008
Highlighted ReportsJanuary 2008
Highlighted ReportsDecember 2007
Highlighted ReportsNovember 2007
Highlighted ReportsSeptember 2007

Updated July 23, 2014

Return to MedSun: Medical Product Safety Network