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U.S. Department of Health and Human Services

MedSun: Newsletter #70, March 2012

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Newsletter #70, March 2012

Articles

Flight Medical Innovations Ltd. Provides Update on Recall of Ventilator Remote Alarm Cable

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FDA Medical Device Recalls

The recalled remote alarm cable may negatively affect Newport HT50 ventilators manufactured prior to 2007. Affected units may shutdown unexpectedly.

Additional Information:

FDA Medical Device Recalls. Flight Medical Innovations Ltd. Provides Update on Recall of Ventilator Remote Alarm Cable. February 28, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm293753.htm

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Nemschoff Chairs Perinatal Pediatric Hospital Bed (Bassinet): Class 1 Recall - Risk of Injury to Patients

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FDA MedWatch Safety Alert

The doors and drawers may inadvertently open while the bassinet is in motion and the product may be difficult to maneuver due to its swivel caster configuration. If either of these events were to occur, there is the potential for injury to the patient, including death and other serious health consequences.

Additional Information:

FDA MedWatch Safety Alert. Nemschoff Chairs Perinatal Pediatric Hospital Bed (Bassinet): Class 1 Recall - Risk of Injury to Patients. February 24, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm293179.htm

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CareFusion Cortical Stimulator Control Unit: Class I Recall - Software Malfunction and Short Circuit

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FDA MedWatch Safety Alert

The device's software incorrectly indicates stimulation is delivered to a different electrode than the one selected and a short circuit may develop between the cortical stimulator control unit and the stimulus switching unit amplifier. Both of these issues may result in the surgeon resecting the wrong brain tissue. The surgeon may also fail to resect pathological tissue, potentially leading to continued pathologic processes and the need for re-operations.

Additional Information:

FDA MedWatch Safety Alert. CareFusion Cortical Stimulator Control Unit: Class 1 Recall - Software Malfunction and Short Circuit. February 23, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm292975.htm

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Spinbrush Powered Toothbrush by Arm and Hammer or Crest: Safety Communication - Choking Hazard and Serious Injuries

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FDA MedWatch Safety Alert

While turned on, the brush head of the Spinbrush has either "popped off" or broken off in the user's mouth or near the face, causing cuts, chipped or broken teeth, swallowing and choking on the broken pieces, and injuries to the face and eyes. When the unexpected release of any part of the powered toothbrush occurs, there is a potential for serious injury. This risk is higher for unattended children or adults who may need assistance while using this device.

Additional Information:

FDA MedWatch Safety Alert. Spinbrush Powered Toothbrush by Arm and Hammer or Crest: Safety Communication - Choking Hazard and Serious Injuries. February 16, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm292239.htm

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Salter Labs 7600 Bubble Humidifier Used with Supplemental Oxygen Therapy

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FDA Medical Device Safety

An internal manufacturing defect was discovered which indicated that, in certain lots of the 7600 Bubble Humidifiers, the humidifier lids failed to pop off at the intended pressure. This may cause the humidifier to leak. A humidifier leak will potentially interrupt the flow of supplemental oxygen to the patient. Hypoxemia may develop resulting in death or serious adverse health consequences.

Additional Information:

FDA Medical Device Safety. Salter Labs 7600 Bubble Humidifier Used with Supplemental Oxygen Therapy. February 13, 2012.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm291785.htm

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Hand-held Dental X-Ray Units: FDA Safety Communication - Unreviewed Products May Not Be Safe or Effective

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FDA MedWatch Safety Alert

FDA notified healthcare professionals about the illegal sale of hand-held dental X-ray units that have not been reviewed by the FDA. The FDA is aware of hand-held dental X-ray units being sold online by manufacturers outside the U.S. and directly shipped to customers in the U.S. These devices may not be safe or effective and could potentially expose the user and the patient to unnecessary and potentially harmful X-rays.

Additional Information:

FDA MedWatch Safety Alert. Hand-held Dental X-Ray Units: FDA Safety Communication - Unreviewed Products May Not Be Safe or Effective. February 10, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm291539.htm

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Smiths Medical Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes - Inadvertent Dislodgment - Class I Recall

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FDA Medical Device Recalls

Some customers have experienced difficulty disconnecting accessories from the connectors of the affected tubes. If excessive force is used to detach the accessory, the tracheostomy tube may dislodge from the patient. This could lead to serious patient injury or death, especially if no replacement tube is immediately available.

Additional Information:

FDA Medical Device Recalls. Smiths Medical Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes – Class I Recall. November 28, 2011.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm293062.htm

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Radiography Resources for Pediatric Patients

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The Alliance for Radiation Safety in Pediatric Imaging, Image Gently and FDA

Educational materials and a safety checklist for using plain film radiography on pediatric patients.

Additional Information:

Digital Radiography Pediatric Checklist. FDA and Image Gently. February 2010.
http://www.pedrad.org/associations/5364/files/Attachment%20D.CR.DR%20%20checklist.pdf

Implementation Manual Image Gently® Digital Radiography
http://www.pedrad.org/associations/5364/files/Attachment%20C.FINAL%20Implementation%20Manual.pdf

Radiography Resources. Image Gently. February 2010.
http://www.pedrad.org/associations/5364/ig/index.cfm?page=775

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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 December 1 through December 31, 2011. 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: Breathing Circuit, Adult
Manufacturer: Vital Signs, Inc. Div. of GE Healthcare
Brand: Adult Breathing Circuit
Model#: A-4F123xx
Lot #: 11260A

Problem:
Patient required ventilator support. When attempting to set up the equipment including the breathing circuit it was noted that the package label was not correct. Package stated "pediatric breathing circuit" but was actually "ADULT" circuit. Inaccurate labeling of critical product could lead to delay in patient management.


Device:
Type: Circuit, Breathing, Anesthesia, With Gas Sampling
Manufacturer: Westmed, Inc.
Brand: Westmed
Model#: 8204
Lot #: unk

Problem:
The anesthesia circuit for CO2 readings during procedure failed. Circuit had to be exchanged emergently during procedure. More than one circuit has failed in similar manner but packaging was not saved to produce lot numbers. On close examination of CO2 line it was discovered that the Luer adaptor at the detector end was crimped. It appears to be a manufacturing defect caused by the way the tubing was attached to the Luer lock.

See device image:

Image has a blue background and features a close up of the faulty Westmed anesthesia breathing circuit.  There is a white arrow pointing to the crimped end of the Luer adaptor with text that reads ‘The failed device had a crimp in this connector that prevented use of the C02 detector’.


Device:
Type: Nasal Cannula, Co2 Sampling
Manufacturer: Teleflex Medical
Brand: Hudson RCI
Model#: 1844
Lot #: $02L1100921A and $02L1100920A
Other #: ETCo2 Nasal Cannula

Problem:
The staff, including the anesthesiologists, noted a problem that is related to new cannulas. When the 02 rate is increased the C02 monitor no longer detects the patient C02 level. Biomed has checked our equipment and it is not the monitors. Also, a few old cannulas were located and the monitors worked fine with them.


Device 1:
Type: Ventilator
Manufacturer: Draeger Medical Systems, Inc.
Brand: Evita C-500
Model#: C-500

Device 2:
Type: Ventilator, Expiratory Filter
Manufacturer: Draeger Medical Systems, Inc.
Model#: MP01780-02

Device 3:
Type: Ventilator, Expiratory Flow Sensor
Manufacturer: Draeger Medical Systems, Inc.
Model#: 6871980-03

Device 4:
Type: Ventilator, Expiratory Valve
Manufacturer: Draeger Medical Systems, Inc.
Model#: 8416750-08

Problem:
Vent saying "expiratory flow calibration failure" with zero Tidal Volume and Apnea Ventilation. Patient was bagged while the expiratory filter was changed out. There was no desaturation and no patient injury. Ventilator now functioning normally. Suspected defective expiratory filter given to Biomed to investigate.

The vent was not in question. It was the expiratory filter/expiratory valve that was suspected of generating this incident. RT has added a pre-filter to the expiratory filter to minimize any future occurrences and is currently working with the manufacturer on product improvements to the expiratory filter.


Device:
Type: Ventilator
Manufacturer: Draeger Medical Systems, Inc.
Brand: Evita Infinity
Model#: Evita Infinity V500

Problem:
Rapid Respond Team (RRT) was informed by nurse that vent (Draeger) was malfunctioning. When RT arrived at the room the nurse was bagging the patient and the vent screen was reading "Insert Disk Reboot" and "Cockpit Failure". The ventilator still appeared to be ventilating the patient despite message on screen - screen was black with instructions to insert disk and reboot. Respiratory Therapist turned the monitor (cockpit) off and then back on and was able to reset the alarms. Within 2-3 seconds it again said "Cockpit Failure" and went black. Got it back on again and put it in standby. A new vent was brought to the room and quickly replaced the malfunctioning equipment. Patient was hooked up to the new vent and resting comfortably.


Device:
Type: Ventilator
Manufacturer: Hamilton Medical, Inc.
Brand: G-5
Model#: G-5

Problem:
Patient was left in PSV (Pressure Support Ventilation mode) and, upon arrival back to the room for a routine ventilator assessment, the patient was found in SIMV/PRVC (Synchronized Intermediate Mandatory Ventilation / Pressure Regulated Volume Control mode) with changes in ventilator parameters and alarms. Changes were not made by myself and did not appear to be the result of any outside operator input.

There was a software update to the G-5 models in April. This ventilator was removed from use. Investigation was started.


Device:
Type: Ventilator
Manufacturer: Hamilton Medical, Inc.
Brand: G-5

Problem:
During the vent check in the afternoon, it was discovered that the ventilator was in PSV (Pressure Support Ventilation mode) when previously it was in CMV (Controlled Mechanical Ventilation). No mode change was made by any respiratory therapist. Looking at the event log on the vent it did not show that a mode change was made. This is the 2nd incident of this nature on the G-5 ventilators in 7 months. Most G-5 ventilators were replaced as a precaution and increased surveillance on all ventilators was initiated.


Device:
Type: Ventilator
Manufacturer: Drager Medical Systems, Inc.
Brand: Evita Infinity V500
Model#: Evita Infinity V500

Problem:
A suction tube fell off the suction canister in the room. The student nurse took the tubing and thought it was from the ventilator and inserted it into the exhaust port on the front of the ventilator causing a back pressure to be detected by the ventilator. This caused the ventilator to alarm and stop ventilating the patient.

The ventilator responded as expected with the obstruction. The technician was surprised that the nursing student was able to find the exhaust port and stick something in it.


Device:
Type: Ventilator Circuit, Heated Wire
Manufacturer: Teleflex Medical
Brand: Hudson Rci Comfort Flo
Cat #: 2410

Lollipop Icon
Problem:
Product is called Comfort Flo Humidification System. The 22mm angled connector on the heated-wire Hudson RCI patient circuit is detaching during use. This causes a water leak which makes the Neptune humidifier overcompensate and heat up and/or alarm. This is a potential burn hazard for the infant patient.

The technician reported to the representative that this has happened multiple times and with different lot numbers.


Device:
Type: Ventilator Circuit, Heated, Dual Limb
Manufacturer: Teleflex Medical
Brand: Hudson Rci
Model#: 780-35

Lollipop Icon
Problem:
Recently, the hospital switched to a new heater and new disposable ventilator tubing. RN went into room because AVEA vent was alarming circuit disconnect. When RN entered room, there was no part of the vent disconnected. RN found a hole burnt in tubing and tubing to be very hot. RN tried to hold tubing to cover hole so infant would get ventilator breaths but tubing was too hot to touch with the hand so a wash cloth was wrapped around tubing until another RN made it to the room to change the circuit. RN opened two new pediatric tubing sets which were both found to have holes when taken out of the package so an adult circuit that was intact was used. All settings on the heater were checked and found to be correct. This same scenario occurred again within less than 24 hours on this patient. The organization has decided to stop using the Neptune Humidifier/heater and disposable ventilator tubing from Teleflex Medical. We will return to the product we previously used.


Device:
Type: Ventilator, Bipap Ventilatory Support
Manufacturer: Philips Respironics, Inc.
Brand: Bipap Vision Ventilatory Support System

Problem:
While BIPAP unit was on patient, respiratory therapist noted that the machine still had flow, but the screen display went blank before going into an auto test mode. BIPAP switched out for another. There was no delay of care to the patient.


Device:
Type: Ventilator, High Frequency
Manufacturer: Bunnell, Inc.
Brand: Whisperjet Patient Box
Model#: 312

Problem:
Per nursing documentation: "Patient placed on HFJV (High Frequency Jet Ventilation) and jet kept alarming "Cannot meet PIP" (Peak Inspiratory Pressure) and the "Ready" light would not highlight. Box changed after troubleshooting for other possible errors. Box for jet changed and no further incidents occurred. PIP was met and the ready light highlighted."

Biomedical Engineering connected patient box to vent and operated the unit on default settings. Unit came up to PIP and stayed in tolerance for 4 hours. Upon further examination of the pressure port on the patient box, Biomed could unscrew the port connector with fingers and it should not be possible to do this. A loose pressure port connector can cause a big enough leak to cause the PIP not to read correctly.

BioMed is discussing event with manufacturer. Possibility exists that there was a blow to the port connector - not certain.


Device:
Type: Ventilator, Transport
Manufacturer: Smiths Medical ASD, Inc.
Brand: Pneupac Parapac Medic 200d Ventilator
Model#: 200D

Problem:
An intubated patient was transported to MRI and the patient was connected to a Pneupac paraPAC Medic 200D ventilator (MRI compatible). After the patient was placed in the MRI scanner, the respiratory therapist noticed that the patient's saturations were dropping. The respiratory therapist entered the scanning room to troubleshoot and the patient became bradycardic and there was no chest rise. The patient's face was blue. The therapist began bagging the patient, moved him out of the scanner and switched him over to the transport monitor. The patient's heart rate showed as irregular in the 90's, sats in the low 90's, blood pressure 120/60. Patient's coloring was better. There was no adverse outcome for the patient.

Respiratory Therapy Follow up: The circuit on the paraPAC vent was assembled incorrectly preventing patient ventilation. Equipment design is such that both transposed tubings have 22mm diameters allowing for incorrect assembly. The procedure step for final set-up for use (pre-use check) was not completed / validated as operating correctly. The respiratory therapist set up the device for use and indicated that the lighting in the MRI room is poor which compromised visualization. The paraPAC vent's alarm system (battery operated) was not noted to alarm during this situation.

Biomedical Engineering received the paraPAC ventilator and noted that the circuit was assembled incorrectly. The technician tested the unit with the circuit assembled correctly and the vent worked properly with no problems noted. The vent alarmed appropriately. The technician reassembled the circuit as was set-up in the occurrence (incorrectly) and the unit did not deliver breaths, but the pressure was sufficient within the circuit so that no alarms were triggered. The technician shared the information and demonstrated the event and the findings to the Respiratory Therapy leadership. This information and a demonstration were presented at the Respiratory Therapy department's monthly staff meeting.


CARDIOVASCULAR

Device:
Type: Catheter, Mapping, Cardiac
Manufacturer: Bard Electrophysiology
Brand: Dynamic Xt
Model#: 201101
Lot #: GFVD3054

Problem:
The patient was undergoing a cardiac ablation procedure. The MD removed the catheter from sterile packaging and tried to deflect the curve. The catheter did not perform as expected and was returned to the Manufacturer's Rep who was present in room. It was not placed in patient.


Device:
Type: Electrocardiograph
Manufacturer: Mortara Intstrument, Inc.
Brand: Veritas
Model#: ELI 350
Other #: WLNG-AN-MR502

Problem:
Patient admitted to Emergency Department (ED) with A-fib (atrial fibrillation) with history of V-Tach (ventricular tachycardia).

ELI 350 electrocardiograph was turned on, and the patient data entered; staff applied electrodes, hooked up and turned on the WAM (wireless module). Staff then went back to the machine, approx 15 feet away, to find the display showing "square waves" onscreen: meaning; it sees the WAM but not the patient waveform. The WAM icon displayed "3 bars" of signal and a 'good' battery.' Staff went back to the patient to check connections and saw an amber light on the WAM; so powered it 'off,' then back 'on.' The WAM LED was now green.

When staff went back to the machine at 14:18:14, the printer was printing "square waves" not EKG rhythms. The staff did not hit the print button. The printer was 'on' and there were 'no options' to stop it. The display showed: 1) the normal 'acquire EKG screen' but was showing "square waves", 2) the printer was running and won't shut off, no option to stop.

The staff hit the power button once to stop the printer, the display screen went to the "logo" page and froze/locked up and they were unable to turn off the machine by closing and opening the lid. The screen stayed frozen for about 5 minutes. The machine was still connected to the WAM, the green WAM LED maintained throughout, until Biomed used the 7 second power down. Biomed powered back up, patient data was gone but "square waves" were still on the screen until the "settings" were changed from 'WAM' to a 'direct cable' then back to 'WAM'. Staff then went to the patient and powered the WAM 'off' then back 'on.' We now had, at 14:29, an EKG waveform and needed to put the patient data in. The total elapsed time was 11 minutes. "Door to EKG" time is a required 10 minutes for MI (myocardial infarction).
======================
Manufacturer response for ELECTROCARDIOGRAPH, ELI 350 (per site reporter)
======================
Mfg will evaluate the device.


Device:
Type: Electrode, Defibrillator, External
Manufacturer: Zoll Medical Corporation
Brand: One Step Complete
Model#: 8900-0214-01
Lot #: 2011
Cat #: 8900-0214-01

Problem:
Gravely ill patient went asystole. Zoll defibrillator pads (electrodes) placed on patient but unable to see a rhythm on the Zoll monitor. ICU cardiac monitor still attached to patient and displayed V-Fib. Zoll pads changed out and new set placed on patient. New set functioned without event, rhythm appeared on the monitor as V-Fib, shock was delivered to the patient, and subsequent shocks as well; equipment functioned as intended. The patient ultimately expired, but upon case review the delay in delivering the first shock did not contribute to the patient's outcome. Biomedical engineering tested the defibrillator pads and determined that there was a user error in opening the pad set. There are clear directions on the outer packaging on how to open the pads, and a warning label that states the product will not function properly if opened incorrectly. In this case, when the pad was opened the shorting pins were left in place which prevented the defibrillator from showing a waveform. It is our understanding that this design allows staff to connect the pad set to the defibrillator monitor, and allows for daily testing so that they are "ever ready" for a code and only need to open the packaging when the are ready to use it. Improved vendor training or a different type of product design might reduce the problem.


Device:
Type: Electrode, Electrocardiograph, Neonatal
Manufacturer: Vermed
Brand: Tender-trode Plus
Model#: A10055-SRT
Cat #: A10055-SRT

Lollipop Icon
Problem:
Skin discoloration noted when leads are removed. The baby was seen in follow up several weeks after discharge and still had visible discoloration at site of EKG leads.


Device:
Type: External Defibrillator
Manufacturer: Zoll Medical Corporation
Brand: Propaq MD
Model#: Propaq MD

Problem:
While transporting a patient to the hospital, the automatic blood pressure cuff on the Zoll Propaq MD (monitor/defibrillator) failed. It was set for every 5 minute readings and when the automatic reading did not happen, the flight crew member attempted to cycle the blood pressure cuff automatically. The screen read "NIPB Fault" and "Disabled". The crew member turned off the monitor and turned it back on and the blood pressure cuff cycled without a problem. There was also another instance where the screen read "Service Required NIBP Fault" and "NIBP Disabled". It also had a large button that read "Acknowledge" that needed to be clicked on. At that moment, the crew member turned off the machine and turned it back on to get BP reading. The NIPB cuff functioned and cycled as expected and functioned without further problem. Zoll contacted Clinical Engineering in reference to the machine (monitor/defibrillator). They (Zoll) stated that the main processor on the unit sends out a signal when the NIBP is being used. After 400ms the unit will shut down if the signal is not received. The only way to resolve this issue is to reboot the unit. They (Zoll) are working on a software upgrade to resolve the problem. They stated that it should be unlikely this problem will occur again.


Device:
Type: Lead, Defibrillation
Manufacturer: Guidant/Boston Scientific
Brand: Endotak Reliance G
Model#: 0184

Problem:
A Guidant/Boston Scientific Endotak Reliance G Model 0184 right ventricular (RV) defib lead was placed into the right ventricle with placement verified and tested. When it was time to connect the lead to the Bi-Ventricular ICD generator, it appeared that there was a buckle or nipple protruding from the side of the lead located near where the lead connects to the generator.
Since the patient's underline rhythm is Complete Heart Block, the physician did not feel comfortable leaving it. The lead was removed and a new lead was placed. The patient did well.


Device:
Type: Lead, Pacemaker, Drug-eluting
Manufacturer: Medtronic, Inc.
Brand: Capsurefix Novus Mri
Model#: 5086MRI

Problem:
MRI conditional ventricular lead placed with no known complications. Later in the same day, the echocardiogram showed a pericardial effusion due to perforation from the right ventricular (RV) lead. RV revision performed.


Device:
Type: System, Endovascular Graft, Aortic Aneurysm Treatment
Manufacturer: Medtronic, Inc.
Brand: Talent With Captivia Delivery System
Cat #: TF4040C114CT

Problem:
A stent graft was to be placed for a leaking thoracic aneurysm. The Talent Captivia device was passed, under direct supervision, up the aorta, placed into the arch and was then advanced to the site of the subclavian. The device was deployed without difficulty by the surgeon certified on the use of this device. The second stage of the device was then attempted to be deployed; however, the release mechanism for the captured tip would not fire. The delivery device remained attached to the distal portion of the graft. The trigger mechanism was manipulated in an attempt to get the device to fire and was unsuccessful. The entire handle of the delivery device was then disassembled exposing the inner cannulas. An attempt to manually deploy the captured portion was unsuccessful. The graft was unable to be freed from the device with gentle rotation. The wire was fully retracted into the body of the graft. The decision was made to proceed with a sternotomy for device extraction. The patient was placed on cardiopulmonary bypass and the graft was subsequently removed. The patient was transferred to the Intensive Care Unit following surgery. The patient was hemodynamically intact but confused for several days and required two days of intubation. Patient was discharged to home and arrangements made for the patient to follow-up at a hospital closer to his home.

The clinical rep from Medtronic was present the entire time during the case. He was also in contact with multiple other clinical reps to ask about this problem and possible resolutions.
======================
Manufacturer response for Medtronic Talent Captiva Stent, (brand not provided) (per site reporter)
======================
No response as yet.


EAR, NOSE, & THROAT

Device:
Type: Implant Cochlear
Manufacturer: Cochlear Americas
Brand: Nucleus 5
Model#: Nucleus 5

Problem:
Cochlear Americas confirmed that there is a hard device failure on an already implanted Nucleus 5 device. This device was not indicated as a part of the September 2011 Cochlear Americas recall. Patient was implanted 7 months ago. The external equipment will not even communicate with the internal device. This means there is no perception of sound.


GENERAL & PLASTIC SURGERY

Device:
Type: Instrument, Manual, Surgical
Manufacturer: unk

Problem:
When cleaning the instruments sent to Sterile Processing, staff noted a missing piece on the long handle needle holder. The surgeon and scrub tech confirm that the needle holder was not used on the patient for which the tray was opened. It is unknown what happened to the metal piece.


Device:
Type: Instrument, Ultrasonic Surgical, Curved Shears
Manufacturer: SterilMed, Inc.
Brand: Ethicon Harmonic Ace
Model#: ACE36E
Other #: Job # 1066782

Problem:
The protective insulated coating started to pull away from the reprocessed harmonic scalpel handpiece. It was a SterilMed Harmonic ACE instrument, 5mm x 36cm. Central Processing received device from OR, and will return to Sterilmed for analysis.


Device:
Type: Instrument, Ultrasonic Surgical, Curved Shears
Manufacturer: SterilMed, Inc.
Brand: Ethicon Harmonic Ace
Cat #: ACE36E
Other #: Job# 1146521

Problem:
Reprocessed Sterilmed Harmonic ACE handpiece was being used during a case. Surgeon set down handpiece after use, and tips of device were so hot that they burned a hole in the drape and contaminating the tip of the device. This has potential to be a fire hazard in the OR.


Device 1:
Type: Stapler, Reload, Surgical
Manufacturer: Covidien
Brand: Endo Gia Roticulator
Model#: 030451
Lot #: N1H0263LX
Cat #: 030451

Device 2:
Type: Stapler, Surgical
Manufacturer: Covidien
Brand: Endo Gia Universal
Model#: 030449
Lot #: N1G0317X
Cat #: 030449

Problem:
While doing a donor nephrectomy an Endo GIA stapler failed to cut and shot the staples all over the place. Wrappers (packaging) and stapler and load were all saved, placed in biohazard bag with notifications made.


GENERAL HOSPITAL

Device 1:
Type: Catheter, Intravascular
Manufacturer: Becton Dickinson
Lot #: 1189443
Cat #: REF 381444

Device 2:
Type: Catheter, Intravascular
Manufacturer: Becton Dickinson
Lot #: 1224838
Cat #: REF 381444

Problem:
Nurse stated that upon starting patient's IV, the plastic catheter was very difficult to advance into the patient's vein. The patient's skin was pink where IV was inserted. Nurse stated it was as if the diameter of the catheter was too large to advance into the vein. RN states this has happened many times.


Device:
Type: Catheter, Iv
Manufacturer: Smiths Medical

Problem:
When advancing the 20 gauge angiocath, the needle is going straight and the plastic catheter is bending up and splitting from the needle. The needle is being left behind and the catheter is being pulled back and found to be split. The ED nurses are reporting several similar incidents. No patients were harmed.


Device:
Type: Isolette, Neonatal
Manufacturer: Drager Medical Systems, Inc
Model#: 8000

Lollipop Icon
Problem:
Twin infants were transferred from a twin admit room to a single patient room. When they were moved their isolettes were unplugged and re-plugged in, in the next room. The nurse was unaware that once the isolette is unplugged the temperature of air control defaults back to 35 degrees. The patients had been in a 31.6-32.5 degree bed for the previous 24 hours. The patients were moved to the room at 1700 at which time the temp was ranging from 98.1-99.1. 99.1 was the temp at 1700 so the isolette temp was decreased to 31 degrees. The next temperature was taken at 2050 and revealed an axillary temperature for this patient of 104.2 degrees. (This also occurred to the twin brother, but his temp reached only 100 degrees). The physician was notified and a CBC was obtained. Parents were present and the physician came to talk with the family. Because this isolette defaults back to the temperature of 35 degrees celsius it has the potential for error and risk to the patient. In speaking to the staff, this has occurred on many different occasions.


Device:
Type: Port, Catheter, Implanted
Manufacturer: AngioDynamics
Brand: Power Injectable Smartport
Model#: CT80STPD
Lot #: LOG74280

Problem:
The patient complained of pain in port site. Upon explant, the surgeon noted that the port had fluid around it and that the port had migrated downward toward breast from original implant site in left subclavian. The physician explanted the port and attempted to check for any leaks in the device by closing distal end of catheter with a hemostat and using a syringe with NaCl to push fluid into the port. He could not duplicate any leakage of fluid.


RADIOLOGY

Device:
Type: Scanner, MRI
Manufacturer: GE Healthcare
Brand: Optima
Model#: Optima MR450w GEM

Problem:
Fire in the MRI. Initial reports are that staff first detected smoke followed by visible flames. Staff and patient evacuated the MRI without injury. MRI technologist returned to the room to quench the magnet's cryogen to remove the magnetic field. Fire department responded and extinguished fire. Because of smoke conditions in the adjacent areas, seven Emergency Department patients were transferred to another hospital for continued care. Additionally, ICU patients located on the second floor above the MRI were moved laterally without incident. The Emergency Department went on divert.

The manufacturer responded immediately to a service call initiated at the time of the event. They identified the location of the source of the fire at a connection on the high current cable on the bore.


Device:
Type: Transducer, Ultrasonic, Diagnostic, Tee
Manufacturer: Sonosite, Inc.
Brand: Teex Probe

Problem:
At the end of a surgical procedure the doctor placed a femoral nerve catheter and attempted to perform a sciatic nerve block. The ultrasound M-Turbo unit and TEEx probe did not function and both were immediately removed from service. There was a brief delay while another ultrasound unit and probe were obtained and set up so the doctor could perform the sciatic nerve block. Biomedical Engineering received the M-Turbo unit and TEEx probe and was told that the TEEx probe button does not work. Biomed set up and powered up the M-Turbo unit, and when the probe was connected to the unit, an error code 9071 was displayed. The manufacturer technician support service was contacted and the action taken was to exchange the TEEx probe with a new one. The M-Turbo was placed back in service with the new probe.


Device:
Type: X-ray System, C-arm, Portable
Manufacturer: Hologic, Inc.
Brand: Fluoroscan Insight 2
Model#: Insight 2

Problem:
During a surgical procedure, the user attempted to activate and expose the Fluoroscan C-Arm via the X-ray collimator assembly keypad. The expose key on the keypad assembly would not respond and the image could not be taken. This is a repeated failure of this key. The users are aware that the key has to be depressed 2 times in rapid succession, similar to a double mouse click. Several keypad assemblies as well as manufacturer service support and visits could not find failures. This is the fifth time that this exact failure has occurred during a procedure requiring the unit to be switched out. In addition this same failure has occurred in our other C-arms of the same model prompting us to MedWatch report.

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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 March 1, 2012

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