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U.S. Department of Health and Human Services

MedSun: Newsletter #78, November 2012

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Newsletter #78, November 2012

Articles

Webinar: The Value of UDI Implementation for Healthcare Systems and Providers

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FDA Medical Devices - Workshops and Conferences

In July 2012, The Food and Drug Administration (FDA) released a proposed rule that most medical devices distributed in the United States carry a unique device identifier, or UDI. A UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help identify product problems more quickly, better target recalls and improve patient safety. Healthcare professionals and staff from hospitals and other healthcare facilities are invited to find out more about the potential impact of UDI by participating in this free webinar, hosted by the Engelberg Center for Health Care Reform at the Brookings Institution, in cooperation with FDA’s Center for Devices and Radiological Health (CDRH).

Additional Information:

Webinar: The Value of UDI Implementation for Healthcare Systems and Providers – November 5, 2012. FDA Medical Devices – Workshops and Conferences. October 29, 2012.
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm326136.htm

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Hospira Symbiq Infusion System Touchscreen: Class I Recall - May Not Respond to Selection

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FDA MedWatch Safety Alert

These devices may not respond to user selection, may experience a delayed response or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a delay or interruption in therapy or over delivery or under delivery of medication if the user does not confirm the programmed values on the pump's confirmation screen before starting the infusion. All serial numbers for these models are affected by this recall.

Additional Information:

Hospira Symbiq Infusion System Touchscreen: Class 1 Recall - May Not Respond to Selection. FDA MedWatch Safety Alert. October 29, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm326080.htm

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Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra): Safety Communication - Reports of Serious Tissue Damage

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FDA MedWatch Safety Alert

Healthcare providers should NOT to use the Neptune 1 Silver Waste Management System or the Neptune 2 Ultra Waste Management System unless there is no alternative suction device or waste management system available. Facilities should evaluate the risks and benefits of using the Neptune 1 Silver or the Neptune 2 Ultra. If your facility does not have an alternative means for surgical waste disposal during surgery, you must complete the Certificate of Medical Necessity and send it back to Stryker.

Additional Information:

Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra): Safety Communication - Reports of Serious Tissue Damage. FDA MedWatch Safety Alert. October 26, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm322811.htm

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Ethicon Endo-Surgery Circular Stapler Sets: Class I Recall - User Difficulty With Firing Stapler Devices

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FDA MedWatch Safety Alert

FDA notified healthcare professionals of a Class I Recall of these products because of difficulty users have firing the stapler devices, resulting in incomplete firing stroke and incomplete staple formation. Failure to complete the firing stroke of the stapler can result in severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, and occlusion of the rectal canal. Failure to complete the firing stroke can also result in poor staple formation, dehiscence of the rectal wall staple line and bleeding.

Additional Information:

Ethicon Endo-Surgery Circular Stapler Sets: Class I Recall - User Difficulty With Firing Stapler Devices. FDA MedWatch Safety Alert. October 26, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm325965.htm

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Fungal Meningitis Outbreak

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FDA MedWatch Safety Alert

The updated list of customers (consignees) who were shipped product on or after May 21, 2012 from the New England Compounding Center's (NECC) Framingham, MA facility is now posted at the FDA website. You can obtain information about the outbreak by calling the FDA's Division of Drug Information line at 855-543-DRUG (3784) or send an email to druginfo@fda.hhs.gov.

Additional Information:

Fungal Meningitis Outbreak. FDA MedWatch Safety Alert. October 24, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm323946.htm

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Accutron, Inc. Ultra PC% Cabinet Mount Flowmeters for Nitrous Oxide-Oxygen Sedation Systems: Class I Recall - Flowmeter May Continue To Release Nitrous Oxide Gas When The Oxygen Is Turned Off

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FDA MedWatch Safety Alert

Accutron voluntarily recalled the product after learning through two customer complaints that the flowmeter was flowing nitrous oxide gas without any oxygen gas flow. When not mixed with oxygen, inhaling nitrous oxide can lead to temporary and permanent brain damage and death. Consumers with the affected flowmeters should stop using and return the flowmeters to Accutron for a free replacement. The company notified distributors and customers of this recall by mail and is arranging for return and replacement of all recalled products.

Additional Information:

Accutron, Inc. Ultra PC% Cabinet Mount Flowmeters for Nitrous Oxide-Oxygen Sedation Systems: Class I Recall - Flowmeter May Continue To Release Nitrous Oxide Gas When The Oxygen Is Turned Off. FDA MedWatch Safety Alert. October 16, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm324120.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 the period August 1 through August 31, 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.


ANESTHESIOLOGY

Device:
Type: Device, Fixation, Tracheal Tube
Manufacturer: Hollister
Brand: Anchor Fast
Model#: 9799
Cat #: 9799

Problem:
After placing a new Hollister Anchor Fast on a patient to secure the endotracheal tube (ETT), the velcro spontaneously broke off of the fabric that secured the device around the patient's head. If the patient were to be moved without this being secure, the ETT could potentially become dislodged.


Device:
Type: Gas, Machine, Anesthesia
Manufacturer: GE Healthcare
Brand: Adu
Model#: ADU

Problem:
We had replaced this anesthesia delivery unit (ADU) two days before this event. We did our standard machine checkout in the morning and everything checked out satisfactory. We brought out open heart patient to OR, attached our monitors, and did our induction of anesthesia. After the patient was intubated we attached him to our ventilator and noticed that we did not have any end tidal CO2, tidal volumes, or anesthetic delivery agent showing up on our monitor. This of course can happen for other reasons. We auscultated the patient’s lungs and knew that the patient had been successfully intubated as we had used the glidescope (so we had visualized the endotracheal tube passing thru the vocal cords on the screen attached to the glidescope). Please note that this patient had the potential to be a very difficult intubation. We did quickly get our portable ETCO2 monitor to monitor ETCO2. After we determined that the patient was safe, we tried to replace the gas module (that gives us all of this information) and we immediately called biomed to take a look at the machine. In the meantime we had to tell our open heart surgeon that we would have to delay the start of the case until we either got the current machine operating correctly or we brought in a new machine. Thankfully I had another CRNA, MDA, and anesthesia technician to help me get a new anesthesia machine into the room. Had this been on a weekend or off shift when we have limited staffing the potential for harm to the patient would have been much higher. This was not easy to transfer machines while the patient was asleep and required extensive monitoring. We got a new ADU into the operating room after the patient was hooked up to an auxiliary monitor and was attached to an ambu bag and 100% oxygen and was hand ventilated until we got the new machine into the OR. The malfunctioning machine was immediately taken to be checked out by biomed. Subsequently the new machine that they brought in to replace the malfunctioning machine also had a circuit board that ended up needing to be replaced after our case was done. In the open heart room we have multiple TV monitors that show our vital signs so that the perfusion team, physician assistants, and surgeons can see exactly what is happening with the patients vital signs at any second based on how they are manipulating the heart. The 2nd machine would not display the vital signs onto the monitors. Biomed was able to configure something temporarily to get us thru the case and then replaced the circuit board after the case was over. Biomed assessment: The monitor (Datex Ohmeda ADU) was intermittently displaying" Gas Measurement Removed" which prevented any ETCO2 measurements from being displayed on the ADU. Biomed replaced the Gas Module during the procedure but it did not remediate the problem. The ADU was removed for service and the error logs were checked which did not indicate any specific error codes that would identify the cause of problem. After the machine was powered off and brought in to Biomed the problem could not be duplicated. Biomed contacted GE tech support and followed and performed all the recommended testing procedures and self diagnostics. The cause of the problem could not be identified. GE tech support thinks it's possible that resetting the power to the machine by turning the monitor off and then on again cleared the problem and was a temporary software glitch. The 2nd ADU that was brought in as a replacement for the machine noted above was monitoring the patient and delivering anesthesia properly itself but it was not sending data and waveforms to the slave displays in the room which are also viewed by the surgeon and perfusionist. The problem was caused by a faulty output display board (BDISP) which was replaced after the procedure and resolved the problem with the machine. No harm to patient.


Device 1:
Type: Humidifier, Respiratory Gas
Manufacturer: Teleflex
Brand: Aquapak Bubble Humidifier

Device 2:
Type: Humidifier, Respiratory Gas
Manufacturer: CareFusion
Cat #: cat#ALP2002

Problem:
I came in to give my patient a breathing treatment and noticed that since the last time I was in the room that there was a bubble humidifier now set up. I also noticed that it was not bubbling and the patient was on four liters which would normally make it bubble at the full level. I took it off the flow meter to verify that the seal was punctured and indeed it was not. It looked as if it was because the screw on and all the pieces matched and were flush, however the seal had not been punctured and the patient was not receiving oxygen. I told the nurse and also educated her about this defect in the product. Minor Injury. Bubble humidifier issues consistent with previous devices. Phone call was made to vendor representative regarding issue. Device was a Teleflex AquaPak Bubble Humidifier & Carefusion spike cap (Cat #ALP2002).


Device:
Type: Patient Circuit, Cap/diaphragm, Hfov
Manufacturer: Viasys RespiratoryCare Inc
Brand: 3100a High Frequency Oscillatory Ventilator
Model#: 3100A
Lot #: 0000456327, 0000433115
Cat #: 766895, 766896

Problem:
Our Clinical Engineering department has received several calls about the CareFusion/Viasys 3100A high frequency oscillatory ventilator patient circuit not calibrating properly. Before the ventilator is placed on a patient the respiratory therapist does a check out and calibration of the patient circuit. On the side of the vent the calibration step 5 says, "observe mean pressure display and adjust patient circuit calibration screw for a reading of 39-43cm H2O." When this failure has occurred the readings obtained were between 20 and 35cm H2O maximum pressure. We traced the problem to the diaphragm cap which, during use of the ventilator, blocks value ports on the patient circuit. If a malfunctioning cap is placed on the limit valve port of the patient circuit (photos available) the circuit will never reach the 39-43cm H2O pressure. This oscillatory vent is used on infants in our nursery and to date we have not had any type of patient injury. The problem has been caught during ventilator set up.


Device:
Type: Ventilator
Manufacturer: Draeger
Brand: Babylog

Lollipop Icon

Problem:
Called by nurse to patient's bedside for neonatal flow sensor alarm on Drager Babylog ventilator. Upon arriving to patient's room nurse was bagging patient and ventilator was alarming neonatal flow sensor inop. Replaced flow sensor three times and flow sensor cable once and still alarming flow sensor inop. Patient was placed back on ventilator once oxygen saturation improved, but according to the nurse and nurse practitioner at bedside ventilator not cycling and not providing the patient with any breaths. Patient desaturation and nurse practitioner bagged patient while ventilator was changed out. Patient placed on new ventilator. Biomed obtained ventilator but there are no flow sensors provided with the ventilator.

Respiratory Therapist informed Biomed that this patient is trached and has secretions that clog the flow sensor, which causes it to stop functioning. Even though the flow sensor is not functioning the ventilator will not stop ventilating. Nursing staff believes the ventilator stopped ventilating, but Biomed cannot confirm or deny this. Reviewed error logs and did observe issues with the flow sensor being soiled, and appears after the flow sensor was replaced there were flow sensor calibration issues. Biomed did not observe any errors or alarms indicating the ventilator had stopped ventilating or ventilator failures. Biomed ran ventilator for over five days without any errors or stopping of ventilation. RT again states secretion in the flow sensor caused the flow sensor failure and the ventilator never stopped ventilating. Ventilator had multiple flow sensor failures and attempts to replace the flow sensor and calibrations failed. RT has been having multiple sensor issues. Biomed checked flow sensor function and did not find any errors. The ventilator was returned to NICU for use.


Device:
Type: Ventilator, High Frequency, Tubing, Diaphragm/cap
Manufacturer: CAREFUSION 207, INC. dba CareFusion
Brand: Viasys Sensormedics
Lot #: 0000437628
Cat #: 766896
Other #: M0117668890

Problem:
A Respiratory Therapist had difficulty in completing an operational verification of an oscillator vent prior to use. The vent would not pressurize fully during a calibration step. Eventually the fault was determined to be in the white "diaphragm caps" attached to the breathing circuit. Replacement caps were obtained from stock, which also failed. Only when caps were taken from another vent already prepared for use was the calibration successful.

The manufacturer was contacted, and they admitted that problems had been found with the blue inner diaphragm of some caps, although specific lot numbers were not identified. We had received no notice of that problem until we called. Our lot number has been pulled from stock, and mfr is shipping replacements.

A similar problem occurred previously in May of 2012. At that time, the manufacturer admitted sporadic problems with the caps, but could not identify any specific lot numbers.

We think there should have been notification to users of potential problems with these caps. We should not have had to learn of the problem by calling the manufacturer about our experience.

The manufacturer has confirmed a problem in molding or other processes involving the blue inner diaphragm of some of these caps, but specific lot numbers were not identified.


Device:
Type: Ventilator, Neonatal
Manufacturer: Draeger Medical Systems, Inc.
Brand: Babylog
Model#: VN500

Lollipop Icon

Problem:
Error message--ventilator failure.
======================
Manufacturer response for Ventilator, Neonatal, Babylog (per site reporter)
======================
Sent error logs to manufacturer. Set up conference call on all the issues we've been having are all similar. Had a conference call and manufacturer feels that the expiratory diaphragm are not being sterilized properly and/or need to be changed out on a annual basis. Ventilator tested within normal operating limits and was put back into service.


Device:
Type: Ventilator, Neonate
Manufacturer: Draeger Medical Systems Inc.
Brand: Babylog
Model#: VN500

Lollipop Icon

Problem:
Ventilator failed to send a message/information.
======================
Manufacturer response for Ventilator, Neonate, Babylog (per site reporter)
======================
Software: M7 = 1.31
PB characteristics = 00001
Errors in log:
For a one month period prior to the event, there are multiple valve drive over temperature and valve drive ready for use messages. Occurs 23 times during this time period.
0337.00020 – Valve drive over temperature

Failure: Monitoring of over temperature of valve drive has been activated. The M15.1 control has detected an excessive increase in temperature via the drive current monitoring. The driver current is reduced to 0.6 A.
Possible causes:
1. Leakage in M15.1 diaphragm -> crater
2. Faulty valve drive

Remedies: 1. Perform ventilation system leakage test in device check. 2. Start the test mode, and then test the valve drive using the HIT software. Call up the "PI expiratory valve" product page for the V500, and then check the valve drive via the expiratory valve test. 3. Check valve drive according to "Valve drive M15.1" repair instructions.

There are several alarms where the messages Fluid in expiratory valve or pressure measurement failure & Pressure measurement inaccurate – these occurred for the last two days.

The first question is this:
1. Does this unit have a PS500? If not there is no problem with the characteristics. If it does, they need to be reset to 01034 and M7 software should be taken to 1.34.
2. I found a number of problems with the expiratory valve M15. There are a number of messages that indicate fluid in the expiratory valve, pressure measurement failure or pressure measurement inaccurate. These occur approximately the same time as 0337.00020 faults that indicate that the valve drive for the expiratory valve is drawing too much current (M15.1). Around the same time there are multiple M1.3 resets which could be a sign that the unit is trying to clear the problem with the M15.1 valve.
A. Check the expiratory valve for fluid or other build up materials
B. Check the seating of the diaphragm at the rear of the valve and check the crater on the valve.
C. Check the Valve Drive, replace if necessary.

I did not see a shutdown or any type of reboot with this unit.

Had a conference call and manufacturer feels that the expiratory diaphragm are not being sterilized properly and/or need to be changed out on a annual basis. Ventilator tested within normal operating limits and was put back into service.


CARDIOVASCULAR

Device:
Type: Blanket, Warming
Manufacturer: Arizant, Inc.
Brand: Bair Hugger
Model#: 750

Problem:
During a total hip replacement, staff noticed a burning smell. CRNA immediately noticed smoke coming from Arizant bair hugger (Model 750) upper body warming blanket. She removed it immediately from the pt. At this time the electrical panel alarmed. The CRNA unplugged the bair hugger generator and the alarm ceased. All equipment and warming blanket are at the control desk. No injury to pt. The occurrence took place while a surgical procedure was in progress. Members of the surgical team noticed a "burning smell" in their OR. Then the CRNA noticed smoke coming from the upper body Bair Hugger blanket and immediately removed the blanket from the patient. Subsequently, an alarm from the electrical panel in the OR was heard. The Bair Hugger machine was unplugged and the alarm ceased. No injury to the patient was identified. The Bair Hugger device and the blanket were sequestered and set aside for evaluation by the Biomed department. The Arizant Bair Hugger model 750 was taken apart and inspected. Obvious signs of overheating and burning on the main internal circuit board where the main power enters the device were noticed. Biomed could not determine the cause or the exact component that had failed. Biomed verified with Arizant that they have not received other reported incidents of this occurring. Pictures of the damaged board were taken to document the incident. The service engineering dept will report back their findings once they have determined the root cause. After searching our equipment database, we have confirmed that we have not experienced a similar issue with any of our other Bair Hugger Forced Air Warming devices. We have contacted the manufacture to see if any similar events have occurred nationally with this product. The company's technical support department confirmed they have not experienced this issue.

We are also sending this device back to the manufacture for a root cause analysis of the failure. Once we receive the report we will let the group know the outcome of the investigation.

Device 1:
Type: Catheter, Intravascular, Diagnostic
Manufacturer: Edwards LifeSciences
Brand: Multimed
Cat #: M3720HI

Device 2:
Type: Set, Administration, Intravascular
Manufacturer: Baxter
Brand: Interlink
Lot #: GR291922
Cat #: 1C8581S

Problem:
Patient was being reinfused with autologous stem cells using hub-to-hub method (direct Luer connection as opposed to split-septum cap and blunt cannula). Infusion RN noted that there was leaking between the tubing set and the hub of the patient catheter. The infusion was stopped then restarted with new tubing set from the same box with no further problem. The incident was caught immediately and total loss of product was 1-2ml.

See device image:

This comparison of two Luer connections shows male tapered fittings from two Baxter blood tubing sets on the right and female tapered fittings from two Edwards MultiMed central line catheters on the left.  The white fitting of the upper connection is from a set that was used on a patient while the lower one is from an unused set.  The lower connection (yellow bracket) shows that the male fitting has gone in a ways and then stopped.  At this point the surfaces of the two fittings will form a tight seal as the inner plastic tries to expand the outer plastic.  The upper connection shows that the male fitting has NOT gone in as far as it can (yellow arrow) but, instead, has bottomed out.  This means that it is not tight enough to form the seal described above.


Device:
Type: Catheter, Ultrasound, Intravascular
Manufacturer: Volcano
Brand: Eagle Eye Gold
Model#: 85900
Cat #: 85900

Problem:
When the IVUS catheter was turned on, the patient complained of 10 out of 10 chest discomfort. The patient was even able to pinpoint where the pain was. Vitals were very high (blood pressure and heart rate were elevated). The procedure was performed and when the catheter was removed, the patient said that pain had subsided and vitals returned to baseline/normal.


Device:
Type: Monitor, Physiological
Manufacturer: GE Healthcare
Brand: Transport Pro
Model#: Transport Pro
Cat #: 2020155-001

Problem:
Over the past three years, there have been multiple complaints regarding the loss of communication between the GE TRANSPORT PRO and the attached TRAM Module. The complaints have stated that the patient data and waveforms would drop out and no longer be recorded while the patient was in transport around the hospital. This can be a particularly hazardous event, especially when the patients are under intensive care and require a high level of monitoring to ensure their health and safety.

Initially, the units were tested in an attempt to reproduce the issue, but no apparent problem was identified, and the devices were returned to service. After another complaint, the unit was removed from service and replaced with a spare, and no further issues were reported. The only noticeable difference between the original unit and the spare was the software versions. The original device had a software version 2.0, while the spare had version 2.1.
======================
Manufacturer response for Monitor, Physiological, Transport Pro (per site reporter)
======================
Unit was returned to the manufacture for evaluation. They could not reproduce the reported problem but they reloaded the system software on the unit.


Device:
Type: Pacemaker, Implantable
Manufacturer: Biotronik
Brand: Evia Dr
Model#: 359524
Cat #: 359524

Problem:
Over one week ago, the patient came into the Cath Lab to have his expiring dual-chamber pacemaker exchanged for a new one due to his existing battery expiring. Today, the patient returned because the pacemaker placed a week ago appears to have been defective. The Cath Lab staff is not certain that the first device was really defective but, rather, one of the leads may not have been completely seated in the female connecting port header of the device thereby causing the pacing problem (abnormal atrial lead impedance). The patient came back because he felt continuously tired and unable to engage in normal activities like before the first generator a week ago. The Cardiologist decided to replace the device with a new pacemaker to make sure the device itself wasn't at fault to avoid having a similar problem again requiring yet another opening of the tissue to check the device. His report shows that the impedance on both the atrial and ventricular leads was excellent (better than 2500 ohms) so the leads themselves were ruled out as the problem. Thus, the header could have been at issue, the distance to which the lead was inserted into the header could have been the issue, or there could have been something with the device itself sensing or generating current to the atrial lead header which could have been the issue. Pacemaker was removed and returned to sales rep.
======================
Manufacturer response for Pacemaker, Dual, Biotronic (per site reporter)
======================
Staff in the Cath Lab contacted the sales rep.


Device:
Type: Pacemaker, Implantable
Manufacturer: St. Jude Medical
Brand: Accent Dr Rf
Model#: 2210

Problem:
The patient was referred to the office today to follow up on a device interrogation from two months ago which showed a new, 7 hour episode of atrial fibrillation two months prior. Initially, the pacemaker was checked at home using the St. Jude Medical Monitoring System remote follow-up service. It also showed several episodes of noise on the atrial lead causing the device to mode switch. The device was interrogated in the office today: "since last Merlin transmission from 2 months ago, stored arrhythmic events recorded 2 brief mode switch episodes due to intermittent noise on the atrial lead and 7 episodes of SVT up to 175 bpm lasting 10-17 seconds". The patient was evaluated in the office by the electro physiologist. Sensing, thresholds and atrial/ventricular lead impedances were within normal limits (WNL). The pacemaker was reprogrammed by turning 'Atrial Tachycardia Detection' rate from 160 bpm to 140 bpm and 'Auto Mode Switch' from DDIR to VVI with 'Max Sensory Rate' set at 120 bpm to avoid atrial pacing above max sensor rate. Patient with trans-telephonic monitoring (TTM) follow-up in 3 months and EP Device Clinic follow-up in 6 months." As per the electro physiologist, "The pacemaker mode switched because of atrial arrhythmias to DDIR mode. The maximum sensor indicated rate was programmed to 120 bpm (500 msec cycle length). The pacemaker utilizes atrial based timing. At the sensor indicated interval of 500 msec, when the patient is active, a programmed atrio-ventricular (AV) delay of 300 msec, the atrial escape interval was calculated to be 200 msec. The patient had intact atrioventricular (AV) conduction and therefore, with a native PR interval of 150 msec + a calculate atrial escape interval of 200 msec, the atrial interval will actually be 350 msec or 171 bpm. The patient was being paced at that (interval) rate. This has been previously reported in the Heart Rhythm Journal 2005 (volume 2 issue 2) 210-211."


Device:
Type: Stent, Superficial Femoral Artery
Manufacturer: CR Bard
Brand: Lifestent Xl
Model#: EX061703CS
Lot #: ANVE0347

Problem:
The patient was admitted with a documented left SFA (Superficial Femoral Artery) occlusion which required percutaneous intervention (PTA and stent placement). Over the next several months the patient began to complain of increasing claudication - noninvasive studies were suggestive of severe restenosis. The patient returned for angiography and possible intervention of the left SFA (aprox. 8 months after previous procedure). Angiography revealed a 99% focal lesion at the site of a stent fracture (distal to the stent additional restenosis of 60-70% identified). Physician's dictated report, from repeat angiography indicates three distinct fractures were seen in the left SFA stent.


Device:
Type: Stent, Superficial Femoral Artery
Manufacturer: CR Bard, Inc.
Brand: Lifestent Xl
Model#: EX061703CS
Lot #: ANVF2129
Other #: 6x170;130

Problem:
Patient was admitted for increasing claudication, R>L in October of 2011. Patient was scheduled for peripheral angiography with possible vascular intervention. Angiography revealed a complete occlusion of the right SFA (Superficial Femoral Artery) at which point the physician proceeded to PTA and stent placement. Over the next several months the patient complained of increasing claudication. Repeat angiography approximately 8 months later revealed severe restenosis with multiple stent fractures. The patient was admitted once again for repeat peripheral angioplasty with stent placement.


CLINICAL CHEMISTRY

Device:
Type: Kit, Test, Pregnancy
Manufacturer: Alere North America
Brand: Hcg Combo Rapid Test
Lot #: hcg2050019
Cat #: B1077-23

Problem:
Patient presented in the ED with abdominal pain. A urine specimen was obtained and sent to the lab for a qualitative pregnancy test. The test kit showed a negative result. The patient was then sent for a CT scan of the abdomen where the technician noticed a fetus of approximately 17 weeks gestation. A quantitative serum hcg (pregnancy) test was ordered with a result of over 67,000 IU/L. The urine pregnancy test was repeated giving the same negative result. On further research, it was discovered that some methodologies give false negative results when the serum hcg concentration is high due to excessive hcg beta core fragments (study by the University of Washington reported in "Clinical Chemistry" 55:10, 2009). In this study, when patients' urine is diluted 1:10, the qualitative result is clearly positive. The department supervisor then performed the qualitative test with the patient's diluted urine as per the study and produced a clearly positive result.


GASTROENTEROLOGY &UROLOGY

Device:
Type: Tube, Feeding
Manufacturer: Philips Children’s Medical Ventures
Brand: Oral Enteral Syringe
Lot #: 85310

Problem:
Sharp plastic shard found in 60cc feeding syringe, noticed immediately and was not given to patient. Lot # 85310
======================
Manufacturer response for 60 mL Oral syringe, 60 mL Oral Syringe (per site reporter)
======================
will evaluate when product is returned

See device images:

Image of oral syringe laying on top its packaging.

Image of orange synringe vial showing the plastic shard.  Shard is taped on the vial and circled and pointed out by an arrow drawn in black pen.



Device:
Type: Tube, Gastrostomy
Manufacturer: unk

Problem:
Patient found with PEG tube not intact and laying on patient's stomach. The balloon appeared to have ruptured. No harm to patient. After following up on this investigation, the nurse manager has learned from conversations with the author that the medication was actually put through the peg tube in error. Her nursing staff has been very up-front and informative about this event. Clinical engineering attended a meeting regarding a different but related variance with a misconnection. It was determined that the hospital will trial "enteral-only" syringes from BD that would not allow this type of misconnection to occur (since the air line in the PEG tube is a Luer slip connection, and the enteral syringes would not fit). After the trial, the hospital did switch to the enteral only BD syringes to avoid this issue in the future. Brand, model and lot# of PEG tube that was involved in the incident are not available.


Device:
Type: Tubes, Gastrointestinal (And Accessories)
Manufacturer: MAQUET
Brand: Maquet
Lot #: 92040814

Problem:
Plastic on the NAVA (neurally adjusted ventilatory assist) catheter separated from the Nasogastric tube (NG) exposing insulation around NAVA wires. This occurred after three days of use. The manufacturer recommends changing the catheter at 5 days. Due to wire exposure we needed to replace the NAVA catheter with a new one.
======================
Manufacturer response for NAVA NG 6 French x 50 cm catheter, Maquet (per site reporter)
======================
The manufacturers are requesting the device for follow up and inspection. The Maquet representative has taken pictures of the device and found them to be inadequate for their evaluation.

See device images:

Image of the catheter and nasogastric tube.

Close up image of the catheter and nasogastric tube.  Black wires are clearly seen indicating that the insulation is exposed.


GENERAL & PLASTIC SURGERY

Device:
Type: Surgical Pack, Vascular, Custom
Manufacturer: Cardinal Health
Brand: Presource
Model#: STRL VASCULAR PACK (Custom)
Other #: Navilyst 65232142

Problem:
The patient was scheduled for a lower extremity arteriogram to be performed in Interventional Radiology. The pressure tubing was connected on the proximal end to the pressure injector while the distal end was connected to the diagnostic catheter. The pressure injector was set for 1200 PSI (confirmed with vendor that pressure tubing is rated for 1200 PSI) and with the injection, the distal portion of the tubing broke-free causing contrast to spray the sterile drape and the imaging equipment. Neither the patient nor the staff was exposed to the contrast spray.

** The pressure tubing is packaged in a "Navilyst Medical, Namic Conversion Kit" which in included in a custom pack for Interventional Radiology. There are five potential lot numbers (4406508, 4359110, 4406508, 4359110, 4402114) that may be involved. The specific packaging for the conversion kit was not retained; however the custom pack information was saved.

Device:
Type: Catheter, Irrigation
Manufacturer: Bard Peripheral Vascular
Brand: Navarre
Cat #: NNU8LPT

Problem:
The drainage catheter was originally put in the patient for perinephric/perihepatic abscesses last month. He was being evaluated in CT scan for progress of the drainage when the broken hub was noticed. They determined that the catheter would only be needed for another day so they made do with the broken hub by slipping it inside the collection tubing and securing it with tegaderm.


Device:
Type: Electrosurgical, Cutting And Coagulation And Accessories
Manufacturer: Maquet Cardiovascular, LLC
Brand: Vasoview Hemopro
Lot #: 25058543
Cat #: VH-3000

Problem:
Maquet Vasoview Hemopro Endoscopic Vessel Harvesting System was used. There are two components: Vasoview Harvesting Cannula and Vasoview Hemopro Harvesting Tool.

While in use, the Harvesting tool became stuck in the "ON" position. The tool was inside of the patient's right upper leg. Smoke was noticed inside of the leg while directly viewing endoscopically. The tool was removed. Smoke was seen coming out of the distal portion of the tool. The tool was disconnected from the light source, Hemopro power supply and the Storz (endoscope) unit. This tool was immediately removed from the field and a new harvesting system was used.


Device:
Type: Gauze/sponge, X-ray Detectable
Manufacturer: Surgicount
Brand: Lap Sponge

Problem:
Lap sponges were rolled up and placed inside solution warmer which was filled with 0.9% normal saline set to 110 degrees Fahrenheit. While attempting to scan out one of the sponges during the procedure it was discovered that half of the scanable tag was missing. When searching the back table for the remaining half, it was discovered that the tag was stuck to the bottom of the warmer drape and was unable to be removed. The lap was sequestered and manually entered out at the end of the procedure. The portion of the warmer drape with the tag stuck to it was collected and both items were sent to Biomed. POD manager was notified.


Device:
Type: Instrument, Robotic Surgical, Tip Cover Accessory
Manufacturer: Intuitive Surgical
Brand: Da Vinci
Model#: 400180
Lot #: C112345

Problem:
Device involved was an Intuitive Surgical DaVinci Monopolar Tip Cover Insulator Accessory. During robotic laparoscopic total hysterectomy, surgeon noted arcing coming from the robotic scissor tip cover from tip to the uterus; instrument removed and scissor tip cover replaced with new one; item returned to supervisor for evaluation by company. Procedure resumed with no further incident. Tip Insulator part # 400180 that was used during the procedure was sent back to manufacturer for evaluation.


Device 1:
Type: Stapler, Surgical
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Echelon Flex 60
Model#: EC60A

Device 2:
Type: Stapler, Surgical, Reload
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Echelon Flex 60
Model#: ECR60W
Other #: J4AN53

Problem:
Following laparoscopic kidney removal, the patient began to bleed profusely. The surgery had been completed (stapled and cut), was not bleeding, and as soon as tissue was lifted, broke loose. Patient's artery and vein was closed separately (2 physicians), but patient lost an extreme amount of blood. Transfusion was given, however patient died later that day. Surgeon "suspected" that staple gun only fired 1 row of staples instead of 3.


GENERAL HOSPITAL

Device:
Type: Bed, Hospital
Manufacturer: Sizewise
Model#: BSWRP280

Problem:
Large intensive care patient was receiving physical therapy at bedside administered by physical therapist and occupational therapist. Patient assisted to sit to dangle at side of bed. The bed wheel brakes checked to be engaged and locked. Patient assisted to stand for several seconds and then returned to sitting on side of bed. The exercise was repeated a second time without incident. Upon third repetition, a pop heard when patient returned to sitting, the bed brakes disengaged and bed moved backwards away from patient. Staff members on each side of patient had arm under patient's shoulders and assisted patient to the floor. This resulted in a skin abrasion injury to patient's left buttocks, which was the size of a quarter.
======================
Manufacturer response for patient bed, Sizewise (per site reporter)
======================
Advised rental company of concern and bed replaced


Device:
Type: Blanket, Warmer
Manufacturer: Getinge Castle USA

Problem:
Device involved was a Getinge/Castle USA Blanket Warmer, Model 5540. The MOU med room began filling up with smoke. Smoke was found to be coming from the blanket warmer. Security and maintenance were notified and responded ASAP. Pt's needed to be moved from that area to another part of MOU. The casing for the warmer was removed during service to identify the source of the problem. A 120 Volt, 15Amp Solid State Relay (15SA ) that controls the heating cycle was found to be charred and showed obvious signs of overheating. The wiring and all other components on the circuit boards were visually inspected and showed no signs of overheating or damage. There was no fire during the incident but the overheating of the relay was the cause of the smoke and odor that was reported by MOU. The work order histories for the other 3 warmers of the same model 5540 in our inventory were reviewed for similar problems or complaints and none were found. The manufacturer of the warmer, Getinge/Castle USA, was also contacted to report the problem. They checked their records to verify that there were no other reported problems or issues with this occurring on other units and suspected this was an isolated problem. The relay was replaced with a new one. The warmer passed all functional and electrical safety testing. The warmer was left on in the service shop over 36 hours to verify its performance before it was returned back to the department.


Device:
Type: Port, Catheter, Implanted
Manufacturer: Smiths Medical
Brand: Port-a-cath Ii
Model#: 21-4055-24

Problem:
A patient recently diagnosed with promyelocytic leukemia presented to outpatient surgery to have port catheter inserted under fluoroscopy and bone marrow aspiration. A port catheter II was inserted into the right subclavian vein. Significant ectopy was noted when positioning the patient for the bone marrow aspiration. A chest x-ray indicated the tip of the catheter was in the right atrium. This catheter was removed and replaced with another catheter cut at the appropriate length with fluoroscopy confirmation of placement. There was no evidence of ectopy after this was done. The patient was having an echocardiogram for evaluation of cardiac function prior to chemotherapy. During the echo a catheter was observed in the right ventricle extending into the apex that did not appear to communicate with the port catheter. The patient was taken to the cardiac cath lab for successful retrieval of plastic catheter approximately 6 inches in length from the radius/right ventricle using biopsy forceps and than an "egg beater" type snare in the right iliac vein. All pieces were removed. A subsequent fluoroscopy demonstrated no pieces left behind and the port catheter appeared to be in normal position. The surgeon who placed the port identified the retrieved object as the introducer sheath.

Device:
Type: Stretcher, Hyberbaric
Manufacturer: Sechrist Industries
Brand: Hbo Monoplace Chamber Stretcher
Model#: 21483F

Problem:
After patient completed Hyperbaric Oxygen treatment, the gurney was attached to the HBO chamber and then the stretcher with patient was removed and locked onto gurney. The entire unit was moved to the patient changing area in the HBO treatment room. Wheels were then locked and unit elevated to allow it to be lowered for patient to transfer off. The stretcher was lowered to allow patient to transfer off. HBO technician moved to side to lower side rail. The patient began to sit up and move toward the foot of the unit. The stretcher portion tilted down towards the foot end and sled until the foot end of the stretcher hit the floor. The patient slid toward the foot of the unit but did not fall to the floor. Initially, patient reported no discomfort or injury.
======================
Manufacturer response for HBO Monoplace Chamber Stretcher, Sechrist (per site reporter)
======================
responded and attempted to determine if a product malfunction occurred.


Device:
Type: Wrap, Sterilization
Manufacturer: Kimberly-Clark
Brand: Kimguard Pan Filter
Model#: 68507

Problem:
Small barely discernable holes were found in pan filter upon opening and inspection by OR staff. Multiple filters found with similar holes throughout CSPD assembly area. The pans with defective filters required IUS and caused case delay. Filter supply was examined and defective filters removed from circulation.


NEUROLOGY

Device:
Type: Shunt, Central Nervous System
Manufacturer: Codman & Shurtleff, Inc.
Brand: Hakim
Model#: 82-3113
Lot #: CJFB71
Cat #: 82-3113

Problem:
Patient came in to have an MRI of her brain/pituitary. Patient scanned, ran the 3pl lov, the sag T1, started the DWI sequence. The patient squeezed the call ball, she told me that her shunt area was heating, immediately took the patient out of the scanner. The neuro radiologist (NR) come down to evaluate the patient. The neuro radiologist spoke to the patient and called her Neurosurgeon (NS). Sent the patient up to NS to be evaluated.

NS evaluated patient. Patient's VP shunt found to be working. Patient advised not to have 3 Tesla MRIs in future.

Of note, patient has had 1.5 Tesla MRIs in past without issue.


Device:
Type: Stimulator, Spinal-cord, Implanted
Manufacturer: Medtronic Neuromodulation
Brand: Interstim Ii
Model#: 3058
Lot #: NJY10619H

Problem:
Patient previously underwent placement of a InterStim stage I and II procedure in 2007 for apparent neurologic disconnect of bladder. Patient had urge incontinence with no known intrinsic renal problems. The patient subsequently developed longstanding pain secondary to the InterStim device. Patient complained of pain in right hip/buttock area, which was exacerbated by palpation. Patient desired removal of the device due to pain.


OBSTETRICS/GYNECOLOGY

Device:
Type: Tubal Occlusion
Manufacturer: Conceptus, Inc.
Brand: Essure
Lot #: 927081
Other #: ref ESS305

Problem:
Two Essure devices had issues. First Essure device was deployed, and when applicator was removed, the coils came out also. Second Essure device was deployed and after applicator was removed, part of a coil was observed floating in uterus (it was retrieved).


Device:
Type: Uterine Manipulator
Manufacturer: Coopersurgical, Inc.
Brand: Rumi Ii
Model#: UMH650
Lot #: 1111108

Problem:
Patient was undergoing Total laparoscopic hysterectomy and bilateral salpingo-oophorectomy for enlarging 14-16 weeks size fibroid uterus. The RUMI system was placed into the uterus through the vagina after the uterus was dilated and sounded to 14 cm. The uterus was positioned in antevert to facilitate removal of uterus. The handle broke off of the shaft of the instrument. The blue plastic handle appears to be broken where it rotates on the shaft.

There was no patient injury.


OPHTHALMIC

Device:
Type: Intraocular Lens
Manufacturer: Alcon Laboratories, Inc.
Model#: CZ70BD

Problem:
Patient was undergoing a lensectomy of the left eye with planned sutured lens placement. After multiple attempts to implant the lens, the lens was removed. Surgeon stated that the haptic was defective. Suture would not stay on haptic. Lens could not be centered and was removed. Incision was closed and patient will return for lens replacement at later date.


Device:
Type: Vitrectomy Machine
Manufacturer: Alcon
Brand: Constellation

Problem:
Alcon Constellation machine failed during case: approximately 15 minutes into 23 gauge vitrectomy four error messages appeared on monitor. One message was "adjust pressure"....and second message was "bubble in line." Gas tank is full. Fellow MD says this has happened three times to him. Staff switched out machine with another Constellation delaying case ten minutes. No harm to patient. Ongoing issues with these machines have led hospital to replace them early this year.


ORTHOPEDIC

Device:
Type: Cerclage, Fixation, Sternal
Manufacturer: Synthes CMF
Brand: Synthes Sternal Zipfix With Needle
Lot #: 7795456
Cat #: 08.501.001.05S

Problem:
One Zipfix band broke upon wrapping around sternum.


Device 1:
Type: Reamer, Orthopedic, Handle
Manufacturer: DePuy Orthopedics, Inc.
Brand: Monobloc Reamer

Device 2:
Type: Reamer, Orthopedic, Handle
Manufacturer: Biomet, Inc.
Brand: Modular Flexible Reamer System
Cat #: 31-476798

Problem:
Unable to verify efficacy of cleaning process due to design. Does not come apart for cleaning. Contaminated surgical field from debris that has fallen out of the collar on the neck of this device. Increases the risk of surgical infection to the patient and implant failure.


Device:
Type: Shaver, Arthroscope
Manufacturer: Arthrex, Inc.

Problem:
The 5.0 Arthrex End cutter that the surgeon was using caused metal shavings to be left within the knee of the patient. The metal shavings were irrigated out by surgeon but we wanted the manufacturer notified of this problem. Product was given to management appropriately. The OR Nurse Manager met with the sales rep from Arthrex to discuss the incident. From past experience with similar complaints it is suspected that the cause of the metal shavings were caused by operator technique and too much pressure may have been applied. The Arthrex rep will meet with the surgeon to go over the proper technique.


PHYSICAL MEDICINE

Device:
Type: Wheelchair, Mechanical
Manufacturer: Otto Bock Healthcare, LP
Brand: Kimba
Model#: Kimba Spring
Cat #: HR 32931000-027

Problem:
Patient in wheelchair was buckled at waist and shoulder straps were fastened securely. Patient was being wheeled into the room and a wheel hit the door. The entire chair portion of the wheelchair fell off of the base, forward onto the floor with patient in it. Patient landed on face. Vital Signs and neurologically Within Normal Limits.


RADIOLOGY

Device:
Type: Mri Machine
Manufacturer: Siemens

Problem:
The Environmental Services (ES) attendant was cleaning the Magnet room in MRI #2 in the imaging center. He is not the usual ES attendant and was asked to cover this area due to call-ins. There was a meeting that evening and he felt hurried. He has completed MRI safety CBT (computer based training) and has access to this area. He removed all ferrous objects prior to entry into the magnet room from inner control. He heard the metal detector in the doorway alarm and did not realize he had the metal garbage bag holder in his hand. It was at that moment it was drawn into the magnet and became lodged. He immediately contacted his supervisor and appropriate personnel were contacted. The Siemens rep came in and the magnet will be ramped down and therefore out of service for the next 1 to 2 days. Employee had a lapse. He was fully aware of the requirements and there was not a lack of knowledge. No patient was involved in this incident. This is a staff education issue. The equipment did not malfunction. However, it is notable that the staff member heard the metal detector go off, but ignored it. Therefore, we will report this to the FDA for nationwide awareness purposes.


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Special Note: The lollipop icon distinguishes highlighted reports that describe medical device events involving neonatal or pediatric patients, or those events involving a medical device that is indicated for use in neonatal and pediatric patient populations. FDA defines pediatric patients as less than 21 years of age.

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Updated November 1, 2012

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