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U.S. Department of Health and Human Services

MedSun: Newsletter #72, May 2012

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Newsletter #72, May 2012

Articles

The Preventing Surgical Fires Initiative announces a Free Educational Webinar

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FDA Safe Use Initiative

On June 12th, FDA is offering a free educational webinar about Surgical Fire safety to raise awareness about this 'hot' topic. During the webinar titled, "Practical Advice for Preventing Surgical Fires: Safety Strategies from the Front Lines," we will learn about three hospitals’ experiences with surgical fires and the prevention strategies they initiated. We will also learn about the FDA Preventing Surgical Fires Initiative that was launched in October 2011.

The FDA Preventing Surgical Fires Initiative website has been updated with information about the webinar and also provides you with many safety resources, tools and articles.

Additional Information:

Webinar: Practical Advice for Preventing Surgical Fires: Safety Strategies from the Front Lines. FDA Safe Use Initiative.
http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/PreventingSurgicalFires/ucm301411.htm

Preventing Surgical Fires - Collaborating to Reduce Preventable Harm. FDA Safe Use Initiative.
http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/PreventingSurgicalFires/default.htm

Resources and Tools for Preventing Surgical Fires. FDA Safe Use Initiative.
http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/PreventingSurgicalFires/ucm272680.htm

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Roche Diagnostics Operations Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays: Recall

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FDA MedWatch Safety Alert

With certain types of plasma samples, doctors may receive a falsely low result (up to a maximum of 50% lower than the actual concentration of Troponin I). These incorrect results may cause serious adverse health consequences, including death. The affected lot numbers are 163176 and 163177.

Additional Information:

FDA MedWatch Safety Alert. Roche Diagnostics Operations Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays: Recall. April 24, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm301483.htm

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Other-Sonic Generic Ultrasound Transmission Gel: Safety Communication - Risk of Bacterial Contamination

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FDA MedWatch Safety Alert

FDA notified health care professionals and facilities to STOP using Other-Sonic Generic Ultrasound Transmission Gel manufactured June though December 2011, because of bacterial contamination with the bacteria Pseudomonas aeruginosa and Klebsiella oxytoca. The contamination was found in lot numbers 060111, 090111, and 120111. These lots are sold in 250 milliliter (mL) bottles and 5 liter (l) dispensing containers.

Additional Information:

FDA MedWatch Safety Alert. Sonic Generic Ultrasound Transmission Gel: Safety Communication - Risk of Bacterial Contamination. April 18, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm300873.htm

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Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS): Recall

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FDA MedWatch Safety Alert

Recall due to detachment of the bend relief from its intended position around the proximal outflow graft may allow the graft to kink or deform, resulting in reduction of blood flow from the HeartMate II LVAS pump, pump/graft thrombosis, or perforation of the outflow graft. Additionally, the metal end of the bend relief may be sharp and cause erosion and cutting of the outflow graft. This product may cause serious adverse health consequences, including death.

Additional Information:

FDA MedWatch Safety Alert. Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS): Recall. April 4, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm298710.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 February 1 through February 29, 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: Vent Cuff Adaptor
Manufacturer: Hudson RCI
Brand: Universal Cuff Adaptor 22mm I. D.
Model#: 1421
Lot #: 02G1100486

Problem:
Nursing staff in the ICU report that they are seeing problems with a piece on the ventilator cracking. ICU staff estimate they have seen this happen on at least 10 patients. No patients were harmed or had changes to their medical treatment plan. When the cracked adaptor was noted, respiratory therapist (RT) was called to replace it. Upon discussion with the RTs, the universal cuff adaptor is cracking. RT staff have seen this occur on patients who have various levels of humidity added to their vent settings. It does not appear to be lot related and not all devices crack. Upon further investigation, it was found that the universal cuff adaptor made by Hudson RCI has a very snug fit to the end of the AeroVent CHC (Collapsible Holding Chamber). While both devices do fit together, a small amount of force is required to get the adaptor onto the AeroVent. To the end user, it appears that these two devices should work together. In a test, we were able to reproduce the cracked universal cuff adaptor without having any equipment connected to a patient and without having a ventilator in use. The manager of the RT Department contacted both companies. Neither had problems reported with their devices. The AeroVent rep came on-site and met with the RT manager and staff. We have changed to an AeroVent product designed to fit on the end of their device. Since the change, we have had no issues with cracking adaptors.

Please note: The device lot numbers and model numbers provided in this report are for the one test that we ran. No lot numbers or other device specific data is available from the other cases.
======================
Manufacturer response for Vent cuff adaptor, Universal Cuff Adaptor 22mm I.D. (per site reporter)
======================
The RT department manager contacted the manufacturer. There have been no other reported problems with this device.

See device image:

Image of the universal cuff adaptor, which is cracked where the cuff adaptor and holding chamber connect. A large piece of plastic is cracked and a portion is missing at the juncture.


CARDIOVASCULAR

Device:
Type: Catheter, Ablation, Surgical, Cryo, Cardiac
Manufacturer: Medtronic CryoCath LP
Brand: Freezor Xtra 3
Model#: 227F3
Lot #: 07611

Problem:
One of the poles on the catheter would not register a proper signal and there was also a clicking sound in the handle. We changed out the cables and did some troubleshooting before opening another catheter, which performed as needed/expected. No harm to the patient. Rep of company will credit for this catheter which was sent back.


Device:
Type: Catheter, Percutaneous
Manufacturer: Arrow International
Brand: Multi-lumen Central Venous Catheterization Kit With Blue Flextip Arrowg+ard Blue Plus
Model#: CDC-45703-A1A
Lot #: RF1083607
Other #: 2013-06

Problem:
Emergent central line placement. A sealed Arrow pre-packaged CVC kit was opened and the kit was missing the blue clip #12. Another sealed kit was opened in order to obtain the missing part and complete the line placement. No harm to patient.


Device:
Type: Catheter, Recording, Electrode, Reprocessed
Manufacturer: Stryker
Brand: Stryker/ascent
Model#: 81531
Lot #: 421580

Problem:
Electrophysiology (EP) cath failed during the procedure. The device was on reuse cycle 1 of 4. Failure mode is not specified but cath lab staff has spoken to the rep. Failure extended the case by 20 minutes. There was no harm to the patient.


Device 1:
Type: External Defibrillator
Manufacturer: Philips Medical Systems
Brand: Heartstart Xl
Model#: M4735A

Device 2:
Type: External Defibrillator
Manufacturer: Philips Medical Systems
Brand: Heartstart Xl
Model#: M4735A

Problem:
Code was called and a defibrillator was brought in. When the unit was turned on the screen displayed "system error 10003". The unit would not function. A second unit was brought in of the same model and it displayed the same malfunction. Third unit of the same model worked correctly. An after evaluation indicated the data card kept the units from working although it did not indicate the data card was full or was there any other indications leading to the data card. Philips did send us a service bulletin regarding a change to the data card. We have removed all data cards from use until the cause for this malfunction has been determined by Philips.


Device:
Type: Filter, Intravascular, Cardiovascular, Jugular
Manufacturer: Cook Medical
Brand: Gunther Tulip
Lot #: 32805822
Cat #: IGTCFS-65-1-JUG-TULIP

Problem:
Radiologist was placing a jugular vena cava filter. The filter did not deploy correctly and had to be retrieved and a second filter used. When initially deploying the first filter, it angled into a renal vein. It was recaptured and repositioned, still angled. Recaptured again and when repositioned did not open. When removing the device it then did open in the superior vena cava (SVC) where it was ultimately retrieved and a suprarenal filter placed. Both filters were from the same lot number.


Device:
Type: Filter, Intravascular, Cardiovascular, Jugular
Manufacturer: Bard Peripheral Vascular
Brand: Meridian
Lot #: GFVK0316
Cat #: MD800J

Problem:
Meridian vena cava filter was placed by MD. Radiopaque marker became loose from inner sheath and exited the delivery sheath and was eventually positioned within the left pulmonary. Follow-up CT chest demonstrated the metallic density with the peripheral aspect of the posterior lung, stated in MD procedure report. No negative outcomes due to the incident are expected for the patient.


Device:
Type: Injector, Contrast, Disposable Hand Control Accessory
Manufacturer: Medrad, Inc.
Brand: Avanta
Model#: AVA 500 HC
Lot #: 117971

Problem:
During set up first time use for this product- received message that hand controller was not seated well when the SPAT (single use patient set) was purged. Then unhooked and plugged in several times, shut system down and brought it back up, which did not solve the issue. Got a new hand controller and it worked fine. Checked the machine for contrast build-up, but it was clean.


Device:
Type: Kit, Contrast Injection, With Syringe
Manufacturer: Medline Industries, Inc.
Brand: Judkins Cath-lf
Model#: DYNJ22313D
Other #: Coer, Inc., 150ml A-series syringe w/J-tube, 77-150269

Problem:
Staff report that the physician was doing an aorta gram when they heard a cracking noise from the injector syringe. Immediately afterward, the tubing popped off of the injector. As a result, dye and blood was splashed on the patient and the physician. There was no injury to the patient, physician, or staff. No exposure to bloodborne pathogens as patient and staff/MD were appropriately gowned/gloved/masked/shielded with Personal Protective Equipment. There was no change to the patient's plan of care. Another product kit was obtained, set up, and the procedure continued. Staff does not know why this occurred. They report that there was no obvious defect to the device when it was removed from the packaging and that the packaging was intact. Afterward, staff could see that the piece of tubing that connects to the syringe was cracked. The equipment was easily assembled. All staff involved in the case is very experienced and have used this type of equipment many times. The device is stored in a temperature controlled environment. Staff reports they have seen this approximately 3 other times with this equipment. In this case, no product or packaging was saved.

The Coeur, Inc. syringe with tubing, used in this case is contained within a kit made by MedLine called Judkins Cath-LF. The manufacturer has been notified. We are awaiting their response.


Device:
Type: Lead, Defibrillation
Manufacturer: Medtronic, Inc.
Brand: Sprint Quattro Secure
Model#: 6947

Problem:
Patient with past medical history (PMH) of ischemic cardiomyopathy, ejection fraction (EF) of 25-30% status post ICD implant 5 months ago was admitted for revision of his ICD system. A recent interrogation revealed that the atrial lead was dislodged and the thresholds in the right ventricle were quite high. Upon testing of the ventricular lead, the lead appeared to be in the adequate position however the threshold was high, over 2.5 at 0.5 milliseconds. The lead was repositioned into a different spot into a more septal position. However there was difficulty in deploying the active fixation mechanism in spite of multiple attempts; possibly due to tissue between the helix which was the reason for impeding the deployment of the active fixation screw. The decision was to explant the right ventricular lead (RVL) and implant a new RVL, model #6947. The lead was tested. The remainder of the procedure was performed without incident.
======================
Manufacturer response for Ventricular Lead; right, unknown (per site reporter)
======================
Did not speak with Manufacturer directly however device was returned to Manufacturer by EP lab staff.


Device:
Type: Probe, Thermodilution
Manufacturer: Argon Medical Devices
Brand: Criticath
Model#: SP5107H
Lot #: 108178
Cat #: 680048

Problem:
When an ICU clinician went to retrieve a thermodilution (TD) catheter from the supply station she could not locate any packaging labeling that the device contained latex or stated that the device was latex free. Clinician contacted Central supply (CS) and after searching in the product's main case, the CS manager located a detached "leaflet" stating that the product contained natural rubber latex. The TD catheter came packaged in a case of 5 and no latex warnings were provided for the individual packages. The leaflet was placed into the product Instruction ‘For Use’ sheet as an apparent addendum. The were no instructions for use guides provided with the individual TD packages. The end user would have been unaware that the product contained latex. The ICU nurse was concerned that this TD catheter could have been inadvertently placed into a latex sensitive patient. Catheter product sent to Biomedical for reporting.
======================
Manufacturer response for Thermodilution Catheter, Criticath (per site reporter)
======================
Left voice mail to regulatory agent rep.


Device:
Type: Syringe, Contrast Injection
Manufacturer: Medrad, Inc.
Brand: Avanta
Model#: AVA 500 MPAT
Lot #: 113401

Problem:
Vent cap fell off of the contrast tubing while changing the contrast bottle. This caused the contrast to shoot out all over the equipment and the nurse changing the contrast. The nurse then had to hold the bottle while the contrast filled into the syringe - this took some time which caused a delay during the procedure. Upon the completion of this report, I am hearing that this happens a lot. Our products person has been "in touch" with the company.


GENERAL & PLASTIC SURGERY

Device 1:
Type: Accessory, Robotic Surgical, 4Arm Drape Kit
Manufacturer: Intuitive Surgical, Inc.
Brand: Da Vinci S
Lot #: D113185A
Cat #: 420291

Device 2:
Type: Accessory, Robotic Surgical, 4Arm Drape Kit
Manufacturer: Intuitive Surgical, Inc.
Brand: Da Vinci S
Lot #: D113185A
Cat #: 420291

Problem:
RN scrub nurse noticed holes in the sterile arm drape. Discarded it and a second drape was opened. RN noticed holes in second sterile drape also. It was discarded and a third drape opened. Third drape was satisfactory. Case proceeded without incident.

Device:
Type: Instrument, Robotic Surgical, Monopolar Curved Scissors
Manufacturer: Intuitive Surgical, Inc.
Brand: Endowrist Hot Shears
Model#: 420179
Lot #: M10111101284

Problem:
During surgery, the instrument began to lose conductivity. It would not cut or coagulate. The ground dispersive pad was changed, and the monopolar cable was changed, both without fixing the problem. Then the surgeon noticed that the instrument began to break apart. The surgery was paused and the instrument was replaced. The patient was inspected for signs of injury, and there were no signs of injury. The surgery was completed with another instrument.


Device:
Type: Instrument, Robotic Surgical, Monopolar Curved Scissors
Manufacturer: Intuitive Surgical, Inc.
Brand: Da Vinci S
Lot #: M11120103
Cat #: 420179

Problem:
Curved Scissor designed to have 10 uses; reportedly dull after 5 uses. Surgeon refuses scissor due to dullness. New curved scissor opened to the field and procedure continues without incident. No documented injury sustained in surgeon's post-operative note.

Device:
Type: Instrument, Robotic Surgical, Tip Cover Accessory
Manufacturer: Intuitive Surgical, Inc.
Brand: Microtek Da Vinci
Lot #: C11304
Cat #: 400180
Other #: Label Part No. 500281-06

Problem:
While dissecting the right side pelvic lymph nodes, with the arm of the da Vinci, an arc occurred at the site of the tip cover ("Tip cover Accessory") causing a small hole in the patient's vessel. The surgeon repaired the injury with a stitch. Electrical surgical unit was set at 40 and then turned down to 35. The ESU appears to be working fine - per the clinical engineer.


Device:
Type: Instrument, Robotic Surgical, Tip Cover Accessory
Manufacturer: Intuitive Surgical, Inc.
Brand: Da Vinci
Lot #: M1011208
Other #: ver -12

Problem:
During the surgical procedure, a small tear was noted on the distal end of the silicon tip cover while being used inside the patient. The tip was inspected prior to incision and no tear was detected at that time. Once the tip tore past 1mm, it was removed from the patient and replaced with a new tip. No injury to the patient. Cautery settings: 35 Cut/35 Fulgurate Coag. New style tip cover. Traditional approach for robotic partial nephrectomy.


Device:
Type: Instrument, Robotic Surgical, Tip Cover Accessory
Manufacturer: Intuitive Surgical, Inc.
Brand: Da Vinci
Model#: 400180
Lot #: M10111214
Other #: Ver -12

Problem:
Resident noted tear in clear silicone of accessory tip cover. Did not extend into dark gray area. Valleylab ESU set at 35 cut/ 50 coag on Desiccate. No arcing noted; no unintended tissue burning noted. Tip cover in use for 1 hour 45 min prior to tear being noticed.


Device:
Type: Instrument, Robotic Surgical, Tip Cover Accessory
Manufacturer: Intuitive Surgical, Inc.
Brand: Da Vinci
Model#: 400180
Lot #: M10111214
Other #: Ver -12

Problem:
After 2 hours and 45 minutes of use, it was noted that there was a tear in the clear silicone of the accessory tip cover. Valleylab ESU set at 35 CUT/ 50 COAG, set on Desiccate. No arcing noted. Tip changed out as soon as tear was noticed. No known patient harm.


Device:
Type: Instrument, Ultrasonic Surgical, Long Bone Handpiece
Manufacturer: Stryker Instruments
Brand: Sonopet Long Bone Handpiece (Omni)
Model#: HB-15L

Problem:
Patient underwent an orbital decompression of the lateral and medial wall for Graves disease. The instrumentation (Sonopet handpiece) is routinely used in the lateral wall surgeries. This is the second time the surgeon has used the handpiece for the medial wall, which is a tight space. The handpiece generates heat and burned the patient's upper lid.


Device:
Type: Instrument, Ultrasonic Surgical, Spetzler Claw Tip
Manufacturer: Stryker Instruments
Brand: Sonopet Spetzler Claw Tip
Lot #: 1030888
Cat #: 5450-800-207
Other #: For use with sonopet 25Khz handpieces

Problem:
Sonopet power unit required multiple re-boots/resets due to frequency issues involving standard claw disposable tip (Spetzler Claw Tip for use with sonopet 25Khz handpieces).

Follow up with Stryker Rep: Console tested and was operating within manufacturer's specs. Per Stryker Rep, issue was identified to be related to a bad lot of tips.


Device:
Type: System, Surgical, Computer Controlled Instrument
Manufacturer: Intuitive Surgical, Inc.
Brand: DaVinci Sl
Model#: DaVinci Sl
Other #: Other DaVinci SH-0937

Problem:
The patient safety concern regarding the DaVinci robot is a possible product design issue. The patient suffered a compartment syndrome of the right lower extremity (RLE) after the robotic-assisted laparoscopy (with procedures). It is felt that the robotic arm, while docked on the right side of the patient, either bumped and/or rested on the patient's RLE. This was a 7 hour procedure. The patient required emergency, 4-compartment fasciotomy followed by another surgery for skin graft (plus Wound Vac) and wound closure.


GENERAL HOSPITAL

Device:
Type: Catheter, Intravascular, Short-term
Manufacturer: Becton Dickinson
Brand: BD Insyte Autoguard
Lot #: 1154215
Cat #: 381423

Problem:
Shielded IV catheter unable to be screwed onto the blue clave due to uneven protruding surfaces on the rim of the IV catheter. Thus IV cannot be connected to clave and then to IV tubing for IV fluid (IVF) administration during CT scan. The CT tech stated this recently happened a total of 3 times and all are from the same lot.
======================
Manufacturer response for BD Insyte Autoguard 22 GA 1.00 IN 0.9x 25 mm, BD Insyte Autoguard (per site reporter)
======================
A message was left for the manufacturer. Await response.


Device:
Type: Catheter, Intravascular, Short-term
Manufacturer: B Braun
Brand: Introcan Safety
Cat #: 4251628-02
Other #: ce0123

Problem:
The RN was removing the patient's left arm intravenous line (a saline lock). The line removed easily. However, the RN immediately noticed that the catheter was not intact. The catheter tube was approximately 2mm long. RN visually inspected and palpated the insertion site, but was unable to locate the remaining portion of the catheter. The bandage covering the IV site was inspected and also did not reveal the catheter. The physician was notified and the patient underwent chest, radius/ulnar, and humerus x-rays--all of which were negative. An extremity ultrasound was performed and was negative. An upper extremity chest CT and a chest CT were performed--all were negative. The patient had no shortness of breath and no change in neurologic function. There were no complaints of pain or discomfort. The saline lock IV site had been flushed with normal saline to keep the line patent, but there were no signs of infiltration, redness, swelling, pain, etc. at the site. The patient has since been discharged to home and her physicians are following her medical care. Staff does not know how this occurred and has not had this experience in the past. Because the remaining catheter length is so short, staff believes that if the line was flushed when it was not intact, the dermis and epidermis would have appeared infiltrated. The staff member who inserted the IV would have recognized immediately that there was a problem with the catheter and it would not have been able to thread into a vein. When the IV line was started, it was without difficulty, had good blood return, and flushed easily. The device itself is a safety needle--it is not possible to remove the needle from the cannula and then re-insert the needle, so staff does not believe that the catheter could have been sheared off. We use a needless system--no needles were introduced into the IV catheter. The saline lock was flushed at least once per shift (every 8 hours) with at least 3cc of normal saline. Upon visual inspection of the broken device, it appears that the edge of the remaining cannula is jagged. The lot number of the device in this report is unknown as the packaging was discarded. We were unable to duplicate this event with a sample of the same product. No other staff members have had a similar experience with this device and there have been no problems reported with defective IV catheters at our facility.
======================
Manufacturer response for IV catheter, Safety IV catheter 22g (per site reporter)
======================
We have notified the manufacturer and are awaiting their response.

See device images:

Close up mage of defective intravenous (IV) catheter.  Image shows that the silver edge of the remaining cannula is jagged.

Close up image of defective intravenous (IV) catheter next to a centimeter ruler.  Image shows the blue catheter next to a black ruler to show how small the catheter and tip really is.


Device:
Type: Catheter, Intravascular, Short-term
Manufacturer: B. Braun Medical, Inc.
Brand: Introcan Safety
Lot #: 0L02258302
Cat #: 4251687-02

Problem:
The IV catheter chosen for venipuncture on a laboring patient was taken to the bedside. It was a B. Braun Introcan Safety catheter. When the nurse prepared to start the IV, she noted the bevel was up. Upon insertion, the nurse noted that the catheter was difficult to pass through the skin. She stopped the procedure and inspected the catheter. The catheter was over almost the entire needle, with only a very small point of the tip of the needle exposed. She noted that this catheter was "covering the needle" more than she typically sees out of the package. She called another nurse to the bedside that brought her another catheter and restarted the IV insertion successfully. The only injury to the patient was a small pinpoint abrasion to the outer layer of the skin and required no follow-up treatment. Upon further inspection of the catheter by the second nurse at the bedside, the safety mechanism was triggered, making the problem difficult to visualize/duplicate at the present time. It is difficult to determine if it was a packaging issue or a defect.


Device:
Type: Catheter, Intravascular, Short-term
Manufacturer: Becton Dickinson
Brand: Bd Insyte Autoguard
Model#: 381423
Cat #: 381423

Problem:
A nurse inserted a 22G 1.0 in 0.9 x 25mm BD Insyte Autoguard in a patient's vein without any difficulties. After removing the guide (hard wire) wire she flushed the catheter to insure the patency of the catheter with normal saline flush. While flushing the catheter she noticed the saline leaking at the site. At first she thought it was the site but when she was not flushing the catheter there was no leak. She tried flushing again and saline leaked out again. She eventually removed the catheter and inserted a new one using same size needle at another site and there was no problem with the flushing. She tested the needle to see where the leak was coming from. She discovered while she was flushing the catheter it was leaking at the junction of the blue hub and the catheter. This was a brand new catheter straight out of the package and she did not have any difficulty inserting the needle. Unfortunately, the nurse was not able to save the packaging.


Device:
Type: Catheter, Intravascular, Short-term
Manufacturer: Cook Medical
Brand: Redo TPN
Model#: G07935
Lot #: 2765746
Cat #: G07935
Other #: 5 French 65 cm

Problem:
Toddler with complex medical history including mitochondrial metabolism disorder. A double lumen 5 French catheter was placed for long term access for total parenteral nutrition (TPN) approximately 2 months ago. Leaking from the catheter was noted and it was thought to be coming where the 2 lumens were becoming one. Attempts to secure a repair kit from the company were unsuccessful. Patient required a return to the OR for removal of the defective catheter and replacement.


NEUROLOGY

Device:
Type: Cerebral Aneurysm Coil
Manufacturer: Penumbra, Inc.
Brand: Penumbra 400 3mm X6 Mm Curve Extra Soft
Model#: 4006U0306
Lot #: F22299
Other #: 3mm x6 mm Curve extra soft

Problem:
The patient was undergoing a cerebral angiogram and coiling of an un-ruptured cerebral aneurysm. The patient had two aneurysms identified on intracranial angiography: Right ICA partially thrombosed 27mm aneurysm and Left ICA aneurysm approximately 10mm in the largest dimension. The left ICA aneurysm was dysmorphic in shape and did not have a thrombus formed. Three coils were deployed without difficulty. However, when the physician attempted to deploy the fourth coil, it fractured. The loose part of the coil embolized to the inferior division of the left MCA. An inferior frontal infarct of the left hemisphere resulted. The neurosurgeon consulted with his partner as well as other neurosurgeons at our facility and colleagues at a nearby University. It was agreed that due to the risks retrieval posed to the patient, the fractured piece of the coil would be left in place and that the patient would be treated with conservative medical management. The patient was taken to the ICU and awakened. Post operatively, the pt has gait ataxia, R hemiparesis, expressive and language aphasia. She was subsequently discharged to skilled nursing care. The manufacturer's representative was present in the OR at the time the coil broke. The physician is very experienced using this equipment and has not had a coil break like this previously. There were no visual defects prior to using the device and no indication that the device was going to fracture. The physician reports he did not use excessive force or torque on the device. He does not know why it broke.

The manufacturer's representative was present during the procedure and is aware that the coil broke.

Device 1:
Type: Adhesive Remover, Medical
Manufacturer: Mavidon Medical Products
Brand: Mavidon

Device 2:
Type: Collodian, Usp
Manufacturer: Mavidon Medical Products
Brand: Collodion Usp

Device 3:
Type: Conductive Paste, EEG Monitoring
Manufacturer: D. O. Weaver and Company
Brand: Ten20 Conductive Paste
Cat #: Ten20 Conductive Paste

Problem:
Patient wrote complaint letter to the hospital stating that she had experienced significant hair loss where the EEG electrodes had been glued to her head (on the seizure monitoring unit). Patient had been hospitalized for 8 days and noted the hair loss after she was home from the hospital. Patient also e-mailed several pictures of the bald spots on her head (where electrodes had been glued). Patients sign a form describing the risks of epilepsy monitoring, which specifically states that "...small patches of hair are sometimes lost." However, the patient's pictures show more than small patches of hair were lost.


Device:
Type: Holder, Head, Neurosurgical, Skull Clamp
Manufacturer: Integra Neurosciences Corporation
Brand: Mayfield Infinity Skull Clamp System
Cat #: M-1500

Problem:
While placing the Mayfield pins and attaching the headrest in the OR, the surgeon attempted to lock the device into place but the lock malfunctioned and the device slipped, causing possible trauma at the bilateral pin sites. CT scan ordered postop to assess area. In speaking with the surgeon, he also stated that the tightening screw did not maintain its position, allowing patient's head to slip causing a small laceration. 2 stitches were needed to close small laceration in right scalp by Mayfield pin which is sharp.


Device 1:
Type: Lead, Spinal-cord Stimulation, Implanted
Manufacturer: Medtronic Neuromodulation
Brand: Prime IPG Advanced
Model#: 3550-63

Device 2:
Type: Stimulator, Spinal-cord, Implanted, Pain Relief
Manufacturer: Medtronic Neuromodulation
Brand: Prime IPG Advanced
Model#: 37702

Problem:
The patient has both cervical and thoracic spinal cord leads and stimulator as well as a lumbar spinal cord stimulator with a generator implanted in late 2010 and has done quite well until recently when she has noticed tenderness around her generator and the accumulation of some fluid. This was cultured and grew Staph epidermis and decision was made to remove it. There has not been any problem with the other side.

OPERATION: Removal of percutaneous spinal stimulator leads (X2) and removal of an infected internal pulse generator for spinal cord stimulation.

PROCEDURE: Patient to OR, placed under general endotracheal anesthetic. Thoracic incision was opened and dissection made down to the leads. The anchors were identified and released. Had to dissect all the way down to the thoracic spine to find the Prolene holding one of the electrodes and released this. The other electrode came out easily. This wound was vigorously washed with the surgical lavage with bacitracin irrigation. Wound closed and skin was Dermabond closed. The tips of the electrodes were sent for culture and sensitivity.

We then opened up the hip incision and dissected down to the generator which was removed with the additional wire. The pocket was filled with purulent material and this was drained. The Prolene sutures were released in order to remove the generator. The wound was debrided of avascular tissue and then was irrigated with the surgical lavage and debrided further until it appeared clear. Hemostasis was obtained with electrocautery and then the wound was closed with vertical mattress sutures of 2-0 nylon. The wound was dressed and the patient was sent to recovery in stable condition.


Device:
Type: Shunt, Central Nervous System, Programmable Valve
Manufacturer: Codman & Shurtleff, Inc.
Brand: Certas
Model#: 82-8804
Lot #: CMMBIL

Problem:
Codman CERTAS valve placed in patient with unrelenting headaches and VP shunt, craniosynostosis, in attempt to improve headaches. This was done, with ICP monitoring to help evaluate the cause of the headaches. We did eventually resolve her headaches, but attempts to read and reprogram the CERTAS valve in situ failed. We involved the company representative and some senior engineers from Codman.

Company representative states that inability to read or reset the valve may be a result of thick edematous scalp over the shunt valve.

OBSTETRICS/GYNECOLOGY

Device:
Type: Clamp, Circumcision
Manufacturer: Mogen Circumcision Instruments
Model#: 102
Lollipop Icon

Problem:
A three day old baby underwent circumcision using a Mogen clamp. Physician did not note anything unusual during procedure: Placed clamp and pushed penis down to obtain foreskin. The physician believed she had obtained foreskin and removed foreskin. Immediately after removal, baby started bleeding. Pressure applied with surgicel. Patient transferred to NICU where it was noted that 1/3 of the glans had been removed and urethra damaged.


Device:
Type: Uterine Fibroid Removal Device
Manufacturer: Hologic
Brand: Myosure
Cat #: 10-500/disposable 10-401

Problem:
Our facility with two other system hospitals is participating in a trial evaluation of the Hologic MyoSure Hysteroscopy Device. During this patient's procedure, 7000 ml of normal saline was infused into the patient while using this device. When the fluid was returned there was approximately a 3000 ml discrepancy. This resulted in the patient's oxygen saturation dropping requiring temporary ventilator support in the recovery room. Patient was discharged in stable condition following recovery room. Following observation in the operating room as well as conversations with the manager of manufacturer's representative, we are concerned that the manufacturer representative who was in attendance for the surgery may have not been adequately trained in the product and its use. We do not know if the product itself failed. Two similar events occurred with patients at another system facility.


OPHTHALMIC

Device 1:
Type: Lens
Manufacturer: Alcon
Brand: Acrysof Lens
Other #: SN 60WF

Device 2:
Type: Monarch
Manufacturer: Alcon
Brand: Monarch Cartridge
Other #: 10-800-072-004

Device 3:
Type: Monarch
Manufacturer: Alcon
Brand: Monarch Cartridge
Other #: 10-800-072-004

Problem:
Patient undergoing phacoemulsification for IOL placement. When inserting lens noted a cartridge was defective. Removed from eye and cartridge had stress fx, and lens had crack. New cartridge and lens used. When lens inserted, and cartridge removed noted there was a crack in the cartridge.

ORTHOPEDIC

Device:
Type: Fixation, Spinal
Manufacturer: Medtronic Spine
Brand: Top Loading X10
Model#: 8110717

Problem:
The pt was at home and had vomiting. She felt something "pop" in the area of her previous spinal fusion. The crosslink was at a high load bearing region (T12/L1). When the pt vomited, additional stress was placed on this area.


Device:
Type: Intervertebral Disc
Manufacturer: Medtronic Sofamor Danek
Lot #: 0135108W
Cat #: 6961460

Problem:
Implant case was not fitting properly into its components. The cage was not holding together so it was unable to be used. The surgical technician was preparing the device when it was noted to be having a problem.
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Manufacturer response for Disk ARTF CERV 6x14mm, (brand not provided) (per site reporter)
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Rep took device the same day of the surgery.


RADIOLOGY

Device:
Type: Brachytherapy System
Manufacturer: Nucletron Corp
Brand: Microselectron
Model#: MicroSelectron C3

Problem:
The patient was being treated with Accuboost Applicators and the Nucletron HDR system. At the end of treatment it was noted that (A) the estimated treatment time ended prior to completion of the treatment, and (B) the end of treatment report indicated that none of the treatment had been given. However, all other indications (time of treatment, radiation indicators, console progress indicators) showed that the treatment had been given as prescribed.

Manufacturer's service representative was on-site the following morning and reviewed the machine logs. These indicated that the treatment was delivered to the patient as prescribed. A communication failure between the delivery unit and the console resulted in the incorrect reporting. After investigation, the service rep reported that the manufacturer was aware of the software issue and that a fix was in process for release later this year. The software issue was solely one of reporting, no error in treatment is associated with the issue.


Device:
Type: System, X-ray, Mammographic
Manufacturer: GE Healthcare
Brand: Senograph Ds
Model#: Senograph DS

Problem:
Mammography tech compressed breast of patient, and when she released the compression foot pedal, it continued to compress. Emergency off switches were not utilized. Patient pulled her breast out during compression.

GE found no problems when doing test and calibrations. However, found the cable to the footswitch was twisted and caught on switch, not allowing it to deactivate. For precautionary purposes, rep replaced all related components and recalibrated. Cable was shortened and made impossible to get hung under switch.


Device:
Type: X-ray System, Video Display Assembly
Manufacturer: Philips Healthcare
Brand: Flexvision
Model#: Flexvision

Problem:
The Philips FlexVision system allows signals from multiple video sources to be displayed in a variety of ways on a single, large screen. It is controlled by a laptop-sized device that is mounted to the table. The big screen is mounted in a frame which is supported by a ceiling-mounted track system and telescoping actuator. This makes it fully locatable and height adjustable within the field of the table. After only three uses, something in the actuator failed to hold the weight of the monitor and frame and they came down hard upon the foot end of the table. Thanks to the table, the telescoping actuator did not fully extend before the monitor was stopped. This likely means that the ceiling track system was spared the shock of suddenly stopping the monitor's fall. It did land on the controller device and break it and its adjustable support arm but those were the only visibly broken things. The patient was in the room but had not been transferred onto the table yet.

Philips uses SKF USA, Inc. actuators for their suspended monitors. They have contacted SKF about what appears to be a failure of their product.

They were on site very quickly. They are taking the situation very seriously because a failure of this kind was not expected. There are hundreds of these systems throughout the U.S. so they want to understand what happened and prepare a strategy for dealing with them.


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Lollipop IconSpecial 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 May 1, 2012

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