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

Device:
Type: Clip, Implantable
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Ligaclip 12-l
Model#: REF ER420
Lot #: L91767

Problem:
Robotic Bladder Cystectomy Case – Ligaclip ER420 endoscopic clip applier package was opened and RN noticed a white substance on the tip of the applier which is not normal for this device. Checked another package of same item, opened package and also found white substance on the tips. Supply Chain removed the boxes from their inventory. Physician was made aware of the situation and did not recommend to be used on the patient. Resolution was to use robotic clip applier.

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Manufacturer response for 12mm Endoscopic Rotating Multiple Clip Applier, LIGACLIP 12-L (per site reporter)
======================
"Our QA department believes it is a lubricant but can't be sure without an analysis. I already called in the product so it has been officially reported. Please sequester the 10 for return as you will receive the shipper kits today and replacement product in 5-10 business days. Analysis to follow."


Device:
Type: Compressor, Cardiac, External
Manufacturer: Physio Control (Jolife AB)
Brand: Lucas 2

Problem:
The ambulance crew arrived to a call for a cardiac arrest and cardiopulmonary resuscitation (CPR)was in progress by first responders. The Emergency Medical Technician-Paramedic (EMT-P) applied the LUCAS 2 CPR device to the patient and initiated. The device showed full battery power, performed compressions for about 20 seconds and alarm/fault light occurred. The device shut off. A restart was attempted and the device alarmed immediately. The device was removed from the patient and CPR continued. (No adverse outcome to patient that was related to device failure.) Follow up: The EMT-P removed the battery and replaced the battery with a new battery. The device remained inoperable. The device was removed from the ambulance and sent to Biomedical Engineering. Biomed was unable to reproduce the reported problem condition when testing the device. The unit was ran on a CPR dummy for 15 minutes with straight compressions and 15 minutes on 30:2 compressions with each battery. The device ran fine on both batteries. Shaking of unit and wiggling of batteries did not cause the compression device to fail. No problems found - unable to determine cause of reported problem.

Device:
Type: Container, Specimen, Sterile
Manufacturer: Cardinal Health
Brand: Power
Model#: (not provided)
Lot #: (not provided)
Cat #: C8846-19SP
Other #: 02 10201

Problem:
Sterile sample cup: These cups have had issues with leaks. Cups are purchased from Cardinal Health. Problem reported across several boxes of product. This issue has been going on for three to five months.


Device:
Type: Disposable Larynoscope Blade
Manufacturer: Vital Signs, Inc.
Brand: Steelite

Problem:
Disposable GE SteeLite laryngocope blades have been recently introduced in our Anesthesia/Operating Room department. When used with Storz handles, these disposable blades provide suboptimal intubating conditions including a flickering light and/or total disappearance of light during direct laryngoscopy, as noticed by several trained clinicians in our department. During an urgent oral intubation of a patient, the patient required a rapid sequence induction. A GE SteeLite Mac 3 blade was tested before induction and was found functional. However, during a direct laryngoscopy following induction of anesthesia, the light went off. To prevent desaturation, we had to mask ventilate the patient potentially increasing the risk of aspiration of gastric content. The GE blade was replaced by a Mac 4 Storz blade and the patient was uneventfully intubated. In addition, the disposable Mac 3 GE blade damaged the rim of the light connector/button of the Storz handle. The use of questionably compatible GE blades with Storz handles may represent a serious safety concern when the margin for product failures should rarely exist.


Device:
Type: Endoscope And Accessories
Manufacturer: Ethicon Endo Surgery, LLC
Brand: Endopath Ets Articulating Linear Cutter
Model#: ATS45

Problem:
The doctor was performing a laparoscopic appendectomy on a patient with a ruptured appendix. There was much inflamed tissue and puss present in the field. The doctor requested an articulating 45mm stapler and the surgical technician verified name, size and expiration date, removed the Ethicon 45mm stapler from its packaging, and handed it to the doctor. The doctor fired the stapler in the usual fashion to staple the base of the appendix and transect the appendix only to find out that the stapler was not preloaded with staples. (It was assumed that the stapler was preloaded.) The appendix was transected without a layer of staples being fired and this resulted in a hole in the cecum. The Ethicon stapler was removed and handed off to the surgical technician who reported there was no load in the device. The surgical technician asked what color load and the doctor told him/her. The loaded stapler was handed back to the doctor. The doctor reported that finding the hole in the cecum was challenging and time consuming as the field was very inflamed. As the doctor was completing the stapling process, he/she was unable to re-articulate the stapler in a fashion that he/she could adequately come across the base of the appendix. The doctor asked for a different manufacturer's stapler, 45mm. The decision was made based on the fact that the doctor was unsuccessful with many attempts to maneuver the Ethicon and had spent 15-20 minutes attempting to turn and open the stapler to get a good grasp. The doctor reported his/her stapler of choice is the Echelon 45mm and with the Echelon, the doctor was quickly able to achieve the necessary angle to complete the stapling and the case was completed with no further complications. Because of the difficulty with the Ethicon stapler, the patient's procedure time was extended.

Follow up: The doctor does not believe that the Ethicon malfunctioned. The Ethicon stapler was disposed of after the case and so is not available for further inspection.

The Ethicon stapler does not have any sort of lock out feature that prevents the device from being fired when there are no staples loaded. (The other manufacturer's stapler features a safety lockout that prevents inadvertent firing of empty or misloaded cartridges.) Surgery staff recommends that the safety lockout feature be implemented in the Ethicon stapler.

There is a warning on the packaging of the Ethicon stapler that there is "No Cartridge Included," but there is no second warning on the stapler itself. Surgery staff recommends that the manufacturer place a tag on the inner jaw to caution that there is no cartridge included. Surgery staff also questioned why the Ethicon 35mm comes preloaded, but the 45mm does not.

Internally there were process changes and enhanced communication (verification process) so that before the stapler goes into the port, we are assured that the stapler is loaded and is loaded with the correct color cartridge.



Device:
Type: Endoscopic Tissue Approximation Device
Manufacturer: Covidien
Brand: Endostitch
Model#: 173016
Lot #: J3K2021X
Cat #: 173016

Problem:
EndoStitch handle is too stiff and is not easy for Surgeon to use. Surgeon has reported this issue numerous times to the manufacturer.


Device:
Type: Humidifier, Respiratory Gas, (Direct Patient Interface)
Manufacturer: Vapotherm Inc
Brand: Precision Flow
Model#: Precision Flow

Problem:
The Vapotherm Precision Flow high flow nasal cannula has FiO2 settings for .21, .22, .23, .24, and on up to 1.00. When the setting is changed anywhere from .21 to .23 there is no change in the output. It is deceiving to the user that they are making a change in the setting yet nothing is happening. The output remains at .21 for these settings. All serial number work this way. Vapotherm has confirmed that this is true. They are in the process of changing the directions in the operator's manual. There are very specific weaning circumstances where this becomes an issue and an alternate device needs to be used. Users need to be aware that 0.22 and 0.23 settings deliver 0.21 FiO2.

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Manufacturer response for High Flow Nasal Cannula, Precision Flow (per site reporter)
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This performance is normal and cannot be improved.


Device:
Type: Indicator, Physical/chemical Sterilization Process
Manufacturer: 3M Company
Brand: 3m Comply Indicator Steam Sterilization Tape
Model#: 14153-002
Lot #: 2015-12AF
Cat #: 1322-24MM
Other #: 14153-002

Problem:
Instruments trays were wrapped and taped and then put in the steam sterilizer for a steam cycle. After the cycle was complete and the trays were removed it was noticed that the tape had lost its adhesive and was rolled up. This happened repeated times.

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Manufacturer response for Steam Sterilization Tape, 3M (per site reporter)
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In response to similar complaints from other customers, 3M opened a Corrective and Preventive Action (CAPA) plan at the facility where the steam indicator tape is manufactured. During the investigation, a mechanical issue was identified as the root cause of the poor adhesive performance of the tape. The mechanical issue is being addressed and the team is working to ensure that the adhesive performance of the tape meets our customers' expectations.

Thank you for bringing this to our attention. I apologize for the inconvenience this issue has caused.


Device:
Type: Infusion Pump
Manufacturer: Carefusion
Brand: Alaris
Other #: 13752865 and 13836709

Problem:
The patient was on an Epinephrine infusion. While the nurse was programing high volume pump, message came across brain of system error and the entire brain and channels shut down. Epinephrine syringe was quickly changed to a separate brain and restarted however in the process the patient received a bolus and her blood pressure increased to 310/160. The bedside physician paused the infusion until the patient's blood pressure was back to a normal range for her and then restarted.


Device:
Type: Laryngoscope Handle
Manufacturer: Karl Storz Endoscopy-America, Inc.

Problem:
The Nurse Anesthetist (CRNA) and trauma surgeon were called immediately to the head of the patient's bed. The CRNA struggled to ventilate the patient via in situ trachea. A decision was made to intubate the patient's trachea from above (orally intubate the patient). The patient had an unstable neck and was stabilized with in line stabilization. A new disposable Miller 2 blade (GE) SteeLite laryngoscope blade was tested prior to airway management. However, light source failed upon insertion into the oropharynx. Copious secretions noted and the desaturation worsened. Another blade was procured and the patient was intubated. This is one example of several laryngoscope light source failures during airway management involving the new GE disposable blades. Interestingly, they are being utilized with a Storz blade handle. Do both companies contend they are compatible? Several colleagues have remarked that they have experienced similar problems.


Device:
Type: Otoscope
Manufacturer: Welch Allyn, Inc.
Brand: Welch Allyn Transformer Otoscope
Model#: 76710
Cat #: 76710

Problem:
Patient was resting in the bed. Pillow was hot. Face was hot. Mom lifted pillow and found otoscope under pillow. She picked it up and immediately dropped it as it was hot.
Findings: Mom was seen in ED. First degree burn to finger tips. No blistering. Painful to palpation. Neurovascularly was intact.


Device:
Type: Pump, Infusion
Manufacturer: Baxter Healthcare Inc.
Brand: Sigma Spectrum

Problem:
Intravenous (IV) Heparin was infusing. The nurse last checked/verified that the medication was infusing at 0430. When staff went into the patient's room at 0640, the pump was turned off. The patient was unsure how or when it was turned off. No alarms sounded. All staff on the nursing unit did not touch the pump. Staff were unable to determine out how/why the pump was in STANDBY mode. The pump was in anesthesia mode. A replacement pump was ordered and the malfunctioning pump was removed from service and returned to the outside agency rental company. This facility has requested a copy of the service report on the pump, but have not received it to-date. The patient had a recheck of blood tests related to Heparin administration, but had no injury related to the omission of the Heparin.


Device:
Type: Pump, Infusion, Pca
Manufacturer: Smith's Medical
Brand: Cadd-solis
Model#: 2100

Problem:
There appears to be a problem related to the design of the Smiths Medical, CADD-Solis ambulatory infusion pumps, models 2100 and 2110.

This problem is pervasive and has been occurring over a period of time in different stages. The problem is as follows. A black rubber piece at the end where the medication cassette reservoir is attached develops a round protuberance in its center. The original shape of this part should be completely flat. This protuberance creates a stress area in the material and a point of friction when the device is wiped for cleaning purposes. Over time this protrusion is cracking which may allow fluid infiltration and may not allow proper cleaning of the unit which could result in spread of infectious material.


Device:
Type: Set, Administration, Intravascular
Manufacturer: C.R. BARD, Inc
Brand: Powerloc Safety Infusion Set
Model#: 0651910
Cat #: 0651910

Problem:
Patient called staff to the room. Bed soaked with IV fluid, IV leaking as tubing was split/cut (not a connection). Both ends of tubing touching the bed linens and patient, thus exposing a central line to possible bacteria and germs. Patient is neutropenic as has received chemotherapy recently. Portacath de-accessed and re-accessed with new tubing and needle. Previous needle with tubing saved. Patient was alert. The two nurse coordinators for the General Medical Unit(GMU) said that if it was torn, it would have been jagged. The tubing looked like it had a straight cut. When I asked the GMU nurses if this has ever happen before, one of them stated that sometimes the tubing comes loose and she just pushes it back in. Slit is small (approx 1/4 inch long) and near the last inch of the tubing.


Device:
Type: Shunt, Central Nervous System And Components
Manufacturer: Medtronic Neurosurgery
Brand: Edms Exacta Drainage System
Cat #: 46705

Problem:
Changing CSF collection bag on EVD with another RN, per policy & procedure. Pt's EVD clamped for procedure. Difficult to unscrew connection between buritrol & collection bag. The connection snapped causing collection bag to fall off & buritrol system to need replaced which resulted in the pt's EVD to remain clamped for 5-10 minutes. Patient began to vomit and became unresponsive. Attempted to arouse while waiting for Neurosurg resident to come & reconnect drainage system. Condition C (code critical) initated. Neurosurg resident to bedside to reconnect EVD drainage system. Pt began to become arousable once drain was unclamped by MD. Notified charge RN and unit manager. No lasting harm.

Device:
Type: System, Thermal Regulating
Manufacturer: Stryker Medical
Brand: Mistral Air-plus (115v) Blower
Model#: MA1100-PM
Cat #: MA1100-PM

Problem:
Masking tape found on patient warmer wrapped around hosing. Tape caught fire and was immediately put out. No harm to patient or personnel. Warmer removed from service.

From Bio-Med: Stryker Model MA1100-PM (MISTRAL AIR) is the device we noted that nearly started a fire. What appeared to happen was there had been a split in the heater hose, which staff placed some tape on it to seal the air. That tape acted as the combustible material which then caused the purple plastic to melt.


Device:
Type: Ventilator, Continuous, Facility Use
Manufacturer: Carefusion
Brand: Avea
Model#: AVEA

Problem:
Report from nursing staff: Nurse was standing by vent when it went into failure mode. Patient did not seem to be getting any gas to breathe. Patient was removed from vent and attached to CPAP bag which let her breathe spontaneously. The vent then was removed from service. The baby was doing well enough to be extubated to a nasal cannula.

Same event, report from another staff member: RRT (Rapid Response Team) responded to a high priority AVEA alarm, "Vent Inop" and assessed that the patient was not being ventilated. He immediately disconnected the ventilator and initiated bag mask ventilation. RN, NNP, and MD were called. The baby was extubated and placed on a different modality. The ventilator was taken out of the room and sequestered until Biomed evaluated the machine and returned it to the main campus for further evaluation.

Gas Delivery Engine (GDE) replaced.

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Manufacturer response for AVEA Ventilator, AVEA (per site reporter)
======================
Called Carefusion tech support. Informed him of error codes. Issue could be either GDE or UIM.
Installed known good UIM for troubleshooting. Issue still remains.
Placing order for GDE


Device:
Type: Catheter, Intravascular
Manufacturer: Becton Dickinson InfusionTherapy Systems, Inc.
Brand: Insyte Autogard
Lot #: 4113713
Cat #: 381434

Problem:
20 gauge intravenous catheters from one lot are leaking around the hub which connects to the indwelling catheter. Several have almost broken completely, which would potentially leave the catheter stranded in the patient's vein. The Emergency Department experienced over a dozen of the same failures in the same lot. Devices are being pulled from stock throughout the organization. The distributor and manufacturer notified.


Device:
Type: Set, Administration, Intravascular
Manufacturer: CareFusion Corporation
Brand: Versasafe Split Septum
Cat #: 2110-0500
Other #: 2120-0500

Problem:
Back up primary tubing required further education on use. Medication going too quickly, but was caught by nursing staff before the patient was effected. The ER experience was that the meds backed up into the primary line. Spoke with distribution and paged director as manager on vacation. Physical examples of tubing brought to each area with paper copy of explanation. Email to be left with each charge nurse with explanation. "Please be aware that our standard Alaris tubing is on backorder and the materials department was able to secure a replacement that is slightly different. Please note the slight changes below:

Please find information on original and sub below:
2120-0500 (GREEN) = ORIGINAL
2110-0500 (RED) = SUB COMING IN ON SATURDAY
Check Valve is missing in sub, but roller clamp is the same. The sub is two inches shorter. THIS MEANS THAT YOU NEED TO CLAMP THE TUBING AT THE TOP WHEN YOU ARE GIVING A SECONDARY MED. PLEASE MAKE SURE STAFF UNDERSTAND THIS.

Device:
Type: Ventilator
Manufacturer: Datex-Ohmeda, Inc.
Brand: Engstrom
Model#: 1505-9000-000

Problem:
Attempted to place the patient on the ventilator. Ventilator alarmed "Breathing Circuit Occlusion" The patient had to be ventilated with an AMBU bag until another ventilator was obtained.

GE field service called in to perform incident investigation. The engineer found the four screws holding the back of the device in place were loose. This allowed the gas module to slide backward.

It is believed the expiratory valve that extends beyond the front cover had been dislodged when the module moved to the rear during transport to the critical care unit.

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Manufacturer response for Ventilator, Engstrom Carestation (per site reporter)
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GE field service engineer was called in to perform the investigation.

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All Actions to Date

TitleDate
Highlighted ReportsSeptember 2014
Highlighted ReportsAugust 2014
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 September 22, 2014

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