Highlighted Reports
MedSun: Newsletter #76, September 2012

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 June 1 through June 30, 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 1:
Type: Tracheostomy Tube, Cuffed
Manufacturer: Covidien
Brand: Shiley

Device 2:
Type: Tracheostomy Tube, Cuffed
Manufacturer: Covidien
Brand: Shiley
Lot #: Lot 110901541x

Problem:
Two separate boxes of 10fr Shiley trach tubes were opened for procedure. Both were sequentially placed into newly created trach stoma and both were unable to be inflated. Upon inspection of each removed trach tube, it was found that both had holes in the cuff. Third Shiley trach tube successfully inserted and cuff inflated. Procedure was lengthened by approximately 20 minutes on a critically ill ICU patient.


CARDIOVASCULAR

Device:
Type: Catheter, Flow Directed
Manufacturer: Edwards LifeSciences
Brand: Hi-shore
Lot #: 59219795
Cat #: 143HTF7

Problem:
Unable to pass a standard .021 or standard .025 J wire through the lumen of the catheter's distal port. The Swan-Ganz had to be changed out with another manufacturer's product to complete the case. There was no harm to the patient. This same issue had been noted with a previous lot number which was involved in a recent Edward LifeSciences Recall dated May 10, 2012. Another Edwards LifeSciences catheter was also taken out of the package and tested, again the same issue was noted-this lot number is 59219796, REF 143HTF7.
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Manufacturer response for Swan Ganz Catheter, Swan-Ganz (per site reporter)
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Manufacturer had not yet received any reports of problems with this particular lot number. The issue appears too similar to the problem noted in the recall dated May 10, 2012- "void in the distal lumen" causing the J wire to get hung.


Device:
Type: Compressor, Cardiac, External
Manufacturer: ZOLL Medical Corporation
Brand: Autopulse

Problem:
AutoPulse was put in place for cardiac compression during resuscitative efforts. The system shut off when the keypad was touched to change to a continuous mode. Our clinical engineering department was unable to reproduce the occurrence. Clinical engineering noted the system turned itself on when the battery was installed which seemed unusual.
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Manufacturer response for AutoPulse Non-invasive Cardiac Support Pump, Auto Pulse (per site reporter)
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Item shipped back so they can evaluate it.


GASTROENTEROLOGY &UROLOGY

Device:
Type: Fiberoptic Light Cable
Manufacturer: Stryker Endoscopy
Brand: Stryker
Model#: 233-050-064

Problem:
The patient was undergoing an elective laparoscopic cholecystectomy. The surgeon and the first assistant asked for the C02 gas to be turned on. Normally, the light cable is not turned on until it is attached to the lens. However, in this case, when staff turned on the gas, they also turned on the light at the same time. The light cable was not attached to the lens yet. The nurse said she thought it was attached and that the surgeon was ready for the light source to be turned on. The light cable was actually lying on top of the surgical field on the patient's left thigh. Staff estimates that a few minutes passed by when they smelled something burning and noticed smoke coming from the drapes at the patient's left thigh. They immediately unplugged the light source, removed the drapes, and put a wet cold towel over the site. There was a small hole estimated to be the size of a cigarette burn and less than the size of a dime on the drape and the towel beneath it. There were several layers of blankets and sequential compression hose underneath before reaching the patient's skin--none of these layers were affected and the patient's skin remains intact. There was no injury to the patient or to the staff. Staff did not see a visible flame. Their first alert that something was wrong was a burning odor. The staff and surgeon involved in the case have used this equipment before: this was their first experience with a surgical fire. We recently completed surgical fire drills in the OR (operating room), which staff indicated were helpful to them in knowing how to quickly handle the situation. Staffs were able to correctly identify that all three elements of the fire triangle were present in this case. BioMed was contacted and evaluated the equipment involved in the case. The light source and cable were fully functional and were returned to use. The packaging from the drape material and the drape was discarded. The towel also was discarded.


GENERAL &PLASTIC SURGERY

Device:
Type: Adhesive, Tissue
Manufacturer: Ethicon
Brand: Ethicon Dermabond Advanced
Model#: DNX12
Lot #: ECP787

Lollipop Icon

Problem:
Nurses in the ED decided to test Dermabond Advanced on their unbroken skin on their arms before using it on a toddler. Three out of five employees developed intense burning shortly after application and superficial burns with lingering pain. Concern is the use of this product on open wounds of children (or adults for that matter) in the ER, which needs to be closed with skin adhesive. The manufacturer was notified of incident and rep will come to check on product. The mfr's rep investigated the incident and in-serviced the staff on the proper use/application of the adhesive. The rep tested the product on staff and no burning sensation was felt when applied properly. The ED MDs will also be in-serviced.


Device:
Type: Clip Applier
Manufacturer: Applied Medical
Model#: CA090
Lot #: 1161366

Problem:
While using a direct drive disposable laparoscopic clip applier for laparoscopic cholecysectomy case, the clip applier misfired. The clips would drop off tissue and also refused to fire. Three clip appliers were used to complete the case with the third one being successful.


Device:
Type: Instrument, Robotic Surgical, Tip Cover Accessory
Manufacturer: Intuitive Surgical, Inc.
Brand: Da Vinci Endowrist
Model#: 400180
Lot #: M10120321
Other #: Version 12

Problem:
Multiple (5) Version 12 tip covers did not adequately form to the tip of the monopolar hot shears, resulting in a loose fit and/or loss of integrity. In one case, the tip fell off into the patient's abdomen, but was retrieved.


Device:
Type: Instrument, Ultrasonic Surgical, Curved Shears
Manufacturer: Stryker Sustainability Solutions
Brand: Ethicon Harmonic Ace

Problem:
End of harmonic burned off while in use.
No patient harm done and no further interventions involving the incident. The Harmonic scalpel was not grasping or holding tissue when the incident happened. Per physician, had there been tissue in the scalpel, it quite possibly could have caused a tear/perforation that would have involved more intervention.
Manufacturer took information. We will keep product until further notice. Manufacturer can come view and take pictures while risk management is present.


GENERAL HOSPITAL

Device:
Type: Catheter, Intravascular
Manufacturer: BD Medical
Brand: Saf-t-intima
Cat #: 383323

Problem:
Nurse was putting in an IV. She was using a BD Saf-T-Intima 22ga X 0.75in. She got the first intima in right away, but when she went to extract the needle it poked through the cannula. After removing the intima she attempted to try again with the same results. On third try she used same item, but different lot number with no problems.


Device:
Type: Catheter, Iv
Manufacturer: B. Braun
Brand: Introcan Safety Iv Catheter
Lot #: 2A07258317
Cat #: 4251628-02

Problem:
Nurse attempting to start an IV. She found several needles that were bent making them unusable. She only saved one to be sent to the manufacturer as an example.


Device:
Type: Catheter, Picc
Manufacturer: Bard Access Systems, Inc.
Brand: Groshong Nxt Catheter With Sherlock Tip Location System (Tls) Stylet
Lot #: REVJ1016
Cat #: 9927508D

Problem:
Patient presented to Outpatient Center for PICC line replacement due to leakage at site. A new PICC line was placed in the left arm. As the nurse was pulling the internal guide wire out, it broke. A chest x-ray was performed to determine the line location and how much wire was left inside the line. The PICC was clamped so that the wire would not move. The radiologist was unable to determine the exact distal aspect of the guide wire. The line was removed. Patient was taken to the Emergency Department for further evaluation.

See device images
This image is showing the wire passing through the plastic molded track when it is not stuck at that point.  This is a hollow area - it is a molded track.

Image has an arrow which indicates the point where the guide wire is getting stuck.


Device:
Type: Catheter, Picc
Manufacturer: Bard Access Systems, Inc.
Brand: Groshong Nxt Catheter With Sherlock Tip Location System (Tls) Stylet
Lot #: REVJ1016
Cat #: 9927508D

Problem:
As the nurse was pulling out the internal stylet wire, the nurse heard a snap and saw that the guide wire broke off with part of the wire retained in the PICC line. The patient was transferred to radiology to confirm the amount of wire retained. Approximately 15cm was confirmed. The internal stylet outside the patient measured approximately 61cm in length. The PICC was replaced with a Groshong PICC from a different lot number without incident. The patient was discharged home without further issues.


Device 1:
Type: Catheter, Picc
Manufacturer: Vygon
Brand: Nutriline 2fr Picc Catheter
Model#: 1262.30
Lot #: 035467

Device 2:
Type: Catheter, Picc
Manufacturer: Vygon
Brand: Nutriline 2fr Picc Catheter
Model#: 1252.35M
Lot #: 130411GA

Problem:
Lot #130411GA-Patient developed a 2cm band of induration from PICC insertion site to over the shoulder, with a .5cm band of pink/red in center of induration that follows the length of induration.

Lot #035467-Patient developed a wedge of induration that started approximately 3cm above PICC insertion site to over the shoulder, in a widening path.


Device:
Type: Catheter, Picc
Manufacturer: NeoMedical
Brand: Neomagic
Lot #: 1020
Cat #: 1955-1615

Problem:
PICC line placed. The line has peel away sheath that is removed by snapping two small "wings" together which breaks the top and allows you to peel the sheath away. When performed, one wing broke off making it impossible to peel away the sheath and the line needed to be removed. Additional attempts to gain IV access were unsuccessful.
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Manufacturer response for Single Lumen PICC w/Stylet, NeoMagic (per site reporter)
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The manufacturer was made aware of the issue and is arranging to pick up the defective product.


ORTHOPEDIC

Device:
Type: Spine Fusion Systems: Instruments X8In 5Different Trays
Manufacturer: Nuvasive
Cat #s: 340035, 7771175, 3400018, 6850120, 7270072, 7771176, 7771163, 7270013

Problem:
"Nuvasive Spine Systems are manufactured in a way that prevents adequate cleaning and disinfection". All instruments listed have either excessively fine cannulation or had an inner shaft that rotates with an external shaft: the instrument cannot be disassembled to allow each piece to be cleaned. This makes it next to impossible for the staff in CSP to ensure that the instrumentation is clean and able to be sterilized for the next patient." These are quotes by CSP personnel at this facility.
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Manufacturer response for Spine Fusion Systems: Instruments x 8 in 5 different trays, (brand not provided) (per site reporter.
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Vendor rep offers Nuvasive Central Sterile Processing Staff to visit our facility and work with our Central Sterile Processing staff for information sharing and education; Both CSP departments can discuss common issues, frustrations and share techniques.


RADIOLOGY

Device:
Type: Dosimeter, Radiation, Diode Detector
Manufacturer: Sun Nuclear Corporation
Brand: Qed
Model#: 1136
Other #: also s/n 511732020070

Problem:
The patient complained of a burning feeling during the treatment, and when the doctor looked over the patient he noticed a few burn marks in the areas where the radiation dosimeter diodes were placed.

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Lollipop Icon
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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