Highlighted Reports
MedSun: Newsletter #69, February 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 November 1 through November 30, 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: ET Tube Holder
Manufacturer: NeoTech Products, Inc
Brand: NeoBar
Cat #: N715F
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Problem:
We have had previous issues with NeoBar, which was entered to FDA. Since that report, we have had 2 more events in which the hard component of the NeoBar had come detached from the adhesive on the infant's cheek. The alarm had gone off indicating that the infant's oxygenation level was decreasing (desaturating). The NeoBar was replaced without extubating the infant. In both cases, there was no harm to the patient; however, the risk of potential harm is great.
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Manufacturer response for ET Tube Holder, NeoBar (per site reporter)
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They previously sent NICU [Neonatal Intensive Care Unit] a "Clinical Complaint Questionnaire."


Device 1:
Type: Ventilator, Critical Care
Manufacturer: GE Healthcare, Datex Ohmeda Inc
Brand: Engstrom Carestation
Model#: Engstrom Carestation
Other #: 400529262

Device 2:
Type: Ventilator, Critical Care
Manufacturer: GE Healthcare, Datex Ohmeda
Brand: Engstrom Carestation
Other #: 400529275

Device 3:
Type: Ventilator, Critical Care
Manufacturer: GE Healthcare, Datex Ohmeda
Brand: Engstrom Carestation
Other #: 400529272

Device 4:
Type: Ventilator, Critical Care
Manufacturer: GE Healthcare, Datex Ohmeda
Brand: Engstrom Carestation
Other #: 400529264

Device 5:
Type: Ventilator, Critical Care
Manufacturer: GE Healthcare, Datex Ohmeda
Brand: Engstrom Carestation
Other #: 400529278

Problem:
The power cord that goes from the wall to the base of the ventilator keeps sliding out of the plug and does not conduct power to the unit. When power is not being conducted to the ventilator, it will not charge the internal battery. If this should happen while on a patient, then there is not a special alarm to signal that it is on battery back up and has the potential to shut down.


CARDIOVASCULAR

Device:
Type: Catheter, Intracardiac Mapping, High-density Array
Manufacturer: Boston Scientific
Brand: Constellation
Lot #: 14374434
Cat #: US8060U

Problem:
Constellation catheter broke inside of the patient. Multi-polar mapping catheter; one of 8 spines of the catheter appears frayed and damaged after it was removed from the patient during the procedure.


Device:
Type: Electrode, Electrodcardiograph, Neonatal
Manufacturer: MedLine Industries, Inc.
Brand: 1. 5Mm Radiotranslucent
Model#: MDS61115R
Lot #: 110521
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Problem:
A patient in the ICU was "coding". The leads did not pick up the heart rhythm. The nurse had to hold the green lead against the baby's skin to pick up a tracing. The nurses tried a lead from the same lot number on another patient and they slipped off. The patient was not diaphoretic or clammy, etc. The skin was not prepped and the leads were on less than 6 hours.


Device:
Type: External Defibrillator
Manufacturer: Physio-Control, Inc.
Brand: LifePak 20
Model#: LifePak 20

Problem:
During the daily clinical performance check on the LP20 defibrillator the clinician noted that the defibrillator would not exit the automated external defibrillator (AED) mode when the door was opened. The defibrillator is designed to operate in the manual mode when the control panel access door is opened. Several attempts were made to switch to manual mode by re-opening the door. The defibrillator was removed from service and sent to Biomed for repair.
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Manufacturer response for External Defibrillator, LifePak 20 (per site reporter)
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Manufacturer provided product complaint number. Biomedical informed field service engineer that defibrillator would be returned to factory for analysis.


Device:
Type: External, Defibrillator
Manufacturer: Physio-Control, Inc.
Brand: LifePak 20
Model#: LifePak 20
Cat #: 3202487-000

Problem:
Our facility has 36 LifePak 20 defibrillators. Over the last few months we have had 6 units with a defective Power Module printed circuit board that enables the battery to be charged. When the unit is unplugged to be used, the battery fails. The unit failed during the routine daily check.


Device:
Type: Filter, Intravascular, Cardiovascular
Manufacturer: Cook Medical
Brand: Cook-celect-venacava-filter Jugular Approach
Model#: IGTCFS-65-1-JUG-Celect
Cat #: IGTCFS-65-1-JUG-Celect

Problem:
The MD went to deploy the inferior vena cava (IVC) filter but when he tried to deploy it, the device would not release per the manufacturers instructions. The device was removed and a new IVC filter was inserted with successful deployment. The device was sent to the manufacturer for evaluation.


Device:
Type: Transducer, Blood Pressure, Extravascular
Manufacturer: Smiths Medical
Brand: Transtar
Model#: MX20984

Problem:
Patient was admitted at around 1700. RN came on night shift and had to change out the normal saline +0.5 units of heparin flush that was running through the arterial line at 3 ml per hour and the CVP (central venous pressure) line which was started at around 2200. So the patient should have been getting a total of 6 ml per hour between the 2 lines. RN changed it out at around 2300 and had to change it again 3 hours later. It was then that the RN realized that something was wrong with the system. The patient had gotten 1L of fluid and 500 units of heparin. RN had the tech change out the entire arterial line/CVP system to remedy the problem. Further investigation revealed that the arterial line transducer was leaking a large amount of fluid, much faster than the CVP or than would be expected. If this had been a 10 kilo baby the outcome could have been much different.

The transducer was sent to clinical engineering for testing, and the following results were found:

Tested both transducers, the first was the Red labeled transducer. Flow rate should be 3ml/Hr. Tested and found flow rate to be 291 ml/Hr. Tested the Blue transducer. Flow rate should be 3ml/Hr and the flow tested to be 4.5mL/hr. The same pressure bag that was used with these transducers was used in testing. The bag was inflated to the black line in the green zone. The results indicate there is a manufacturing defect in the red transducer which is the one that infused too quickly.

The manufacturer's quality control department will be following up with the reporter.


GENERAL & PLASTIC SURGERY

Device 1:
Type: Accessory, Robotic Surgical, Bifurcated Light Cable Guide
Manufacturer: Intuitive Surgical, Inc.
Brand: Da Vinci
Model#: 951021
Other #: also s/n's sf1045105, sf1049030

Device 2:
Type: Drape, Surgical
Manufacturer: Intuitive Surgical, Inc.
Brand: Drape

Problem:
Procedure: Prostatectomy, radical, with robotic assistance.
During placement of the da Vinci instrumentation, one of the bifurcated light guide cables became loose. This was discovered, but not before six small burns occurred in the first layer of the blue drapes. There was no smoke or flame observed. There were cloth towels placed beneath the drape and a towel prevented the patient's skin (face/chest) from being burned. There was no injury to the patient or staff. The MD was notified and the procedure continued.

Device thought to be ignition source: bifurcated light guide cable. Device thought to be the fuel source: da Vinci drape. The patient was intubated (endotracheal tube) and receiving oxygen via a ventilator.

It is believed by surgery staff that this occurrence resulted from human error. The light cable connections were not double checked to assure that they were secure. One person set up the procedure and another person came in and did the case.

Surgery leadership was asked to review information regarding the "Preventing Surgical Fires" initiative on the FDA website online available at: http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/PreventingSurgicalFires/default.htm


Device:
Type: Clip Applier
Manufacturer: Ethicon Endo-Surgery Inc.
Brand: Ligaclip
Model#: ER320
Lot #: H43Z6W
Cat #: ER320

Problem:
Patient undergoing laparoscopic cholecystectomy. The surgeon encountered a "mis-firing" incident with a 10mm endoscopic rotating clip applier (ER320). The ligaclip applier spit out two clips at once. The surgeon was able to retrieve the second clip, but did not feel comfortable with the continuous use of this device, so opted to sequester it and obtain a new device of same make/model. The case was continued and finished with no further issues. There was no injury to the patient. The device is available for evaluation purposes.


Device:
Type: Clip Applier
Manufacturer: Stryker Sustainability Solutions
Brand: Ethicon
Model#: MCM30
Lot #: 857188
Cat #: MCM30
Other #: size med/long

Problem:
Prior to procedure the surgical technician attempted to load cartridge in reprocessed device. The cartridge would not load into device. The device was immediately removed from field and replaced with new device, which was also reprocessed and worked appropriately. There was no injury to the patient as the device never reached the surgical field. This was caught before use.


Device 1:
Type: Clip Applier
Manufacturer: Covidien
Brand: Covidien
Lot #: P1H0351
Other #: REF 134046

Device 2:
Type: Clip Applier
Manufacturer: Covidien
Brand: Covidien
Lot #: P1G0465
Other #: REF 134046

Device 3:
Type: Clip Appliers
Manufacturer: Covidien
Lot #: P1H0351
Other #: REF 134046

Problem:
The hospital has recently switched over to Covidien supplied vascular clip appliers 9.0mm width. Today, with use of this device, there was a white residue that was discharged from the tip of the clip applier into a sterile neck wound. On closer examination the entire tip of the clip applier was covered in a white residue with intermittent areas of exposed steel. I tried this off the field with nursing staff and we saw gross residue come out. Given that this constituted a foreign body I immediately stopped use of this device. We opened two more devices with the same problem. I discussed with rep who said that this is "Teflon coating". I responded that I have used clip appliers for a long time and have never seen this. Unless Covidien is willing to take responsibility for a Teflon related infection we should remove this product from our shelves.


Device:
Type: Gauze, Sponge
Manufacturer: Covidien
Brand: Tendersorb
Model#: 9194A
Lot #: 110001344862
Cat #: 9194A

Problem:
Wound Care RN reports opening up a Kendall Tendersorb Wet Pruf abdominal pad (8x10 inch in size) and noted there was a large insect trapped between the padding and the netting. Obviously, this occurred during manufacturing. The pad was saved for evaluation purposes. The pad was not applied to the patient. RN caught prior to procedure.


Device:
Type: Instrument, Ultrasonic Surgical, Curved Shears
Manufacturer: Stryker Sustainability Solutions
Brand: Ethicon Harmonic Ace
Model#: ACE 36E
Lot #: 1595151

Problem:
When disposable harmonic handpiece device was about to be used, the harmonic machine kept giving the error message "tissue in jaws". Device jaws were inspected, no tissue found and jaws were wiped off. Device used again only to have the same error message appear, and still no tissue was found in jaws. A new disposable harmonic handpiece had to be opened to use for the remainder of procedure.


GENERAL HOSPITAL

Device:
Type: Catheter, PICC
Manufacturer: Medcomp
Brand: 1. 9Fr X50 Cm Single Lumen PICC
Lot #: MBGA440
Cat #: MR17011

Problem:
PICC line had a crack in the tubing right below the connection with the white hub. This catheter was inserted prior to the receipt and implementation of the new 1.9 F PICC lines with the redesigned hub.
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Manufacturer response for 1.9 Fr x 50 cm Single Lumen PICC, 1.9 Fr x50 cm Single Lumen PICC (per site reporter)
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No response. Awaiting delivery of newly designed PICC lines.


Device:
Type: Catheter, Umbilical Artery
Manufacturer: Covidien
Brand: Kendall Argyle Polyurethane Umbilical Catheter With Luer Lock Hub
Lot #: 031607
Cat #: 8888 160333
Other #: 0.15ml 3.5 Fr/Ch(1.1mm) x 15 in.(38cm)
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Problem:
An umbilical venous catheter and an umbilical artery catheter were placed for monitoring and support in a newborn with respiratory distress. It was noted three hours after placement that the umbilical artery catheter was leaking from just under the Luer connection. The catheter was removed.


Device:
Type: Closed IV Catheter System
Manufacturer: Becton, Dickinson and Company
Brand: Nexiva
Cat #: 383537
Other #: 20 G

Problem:
IV was started in ER, pt went to CT scan. After contrast for CT was injected, tech noted that IV catheter tubing was bulging and reported to ER nurse upon pt return to ER.

Defective catheter removed, replaced with another IV heplock. This is the first report we have of the bulging in the tubing after use in CT scan.

See device images:

Image shows catheter against a blue background.  Catheter has traces of contrast inside clear tubing.  Tubing bulge is evident closest to the needle.

Close up image showing catheter against a blue background. Catheter has traces of contrast inside clear tubing. Tubing bulge is clearly seen - this image zooms in on it.


Device:
Type: Indicator, Biological Sterilization Process
Manufacturer: Advanced Sterilization Products (ASP)
Brand: Sterrad Cyclesure Biological Indicator
Lot #: 264117

Problem:
The product is an ampule with a small amount of bacteria and a medium in a vial, packaged in a tyvek pouch and placed in the sterilizer with other items as a test. The sterilant (Hydrogen Peroxide) is supposed to penetrate the ampule and kill the bacteria. After the sterilizer cycle is complete, we "crack" the vial of medium and mix it with the bacteria. It is incubated and it the sterilizer works, nothing will grow.
The sterilization cycle was complete. The employee was emptying the sterilizer and when she picked up the tyvek pouch which is not very visible, the vial had broken and the contents leaked on her hands. The employee complained of white discoloration and a burning sensation on her hands.
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Manufacturer response for Sterrad Cyclesure Biological Indicator (per site reporter)
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They requested additional information and recommended gloves be worn. In hindsight, the instructions state "use of gloves as peroxide burns can occur".


Device:
Type: Port, Catheter, Implanted
Manufacturer: Bard Access Systems, Inc

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Problem:
Patient has severe hemophilia and receives factor infusions at home. Patient's mother accesses the port and administers product. Recently, the patient's mother accessed his port and had difficulty infusing the product. The home health company was called. The RN came to the home and had difficulty with the port flushing after it was re-accessed. A dye study was performed which showed that the needle had pierced the posterior side of the port. The current port will need to be surgically removed and a new port inserted. Patient will require increased factor and hospitalization following a new port placement.


Device:
Type: Software, Health Information Technology
Manufacturer: Siemens Medical Solutions USA, Inc.
Brand: Invision Clinicals LCR Medication Management
Model#: INVISION Clinicals
Other #: Software version v.27.3 (and above)

Problem:
The medication dosage form value was not synchronized between the First DataBank (FDB) data, the Common Vocabulary Engine (CVE), the INVISION Service Master, and the relevant INVISION profiles. This resulted in dosing clarifying information, such as CR (controlled release), ER (extended release) and Enteric Coated being omitted from the printed prescription.


Device:
Type: Warmer, Infant Radiant
Manufacturer: Drager Medical Systems
Brand: Babytherm
Model#: 8004

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Problem:
Radiant warmer canopy would not move from the center position, or would only move a short distance one direction due to failed swivel joint. The same thing has occurred on four units for the same model and age within the last year. The swivel joint failed, but the canopy remained securely attached and otherwise functional. Four serial numbers of failed units are included in this report. Two were found during routine inspections, and two others were discovered and reported by users.


PHYSICAL MEDICINE

Device:
Type: Pack, Hot Or Cold, Disposable
Manufacturer: HOSPITAL MARKETING SERVICES CO., INC.
Brand: Col-press Instant Ice Cold Compress
Lot #: 8405-1

Problem:
Multiple reports in past week within this facility for leaking ICE PACK after activation. All leaks identified to one lot number 8405-1. One exposure to eyes occurred requiring follow-up through employee health. Contents: Ammonium Nitrate and Water. No patient involvement. Manager reports that the pack appears to be leaking from back seam of bag.


RADIOLOGY

Device:
Type: Imaging Coil, MRI
Manufacturer: GE Medical Systems, LLC
Model#: 1.5T 16CH BRAIN-SPINE NEUROVASCULAR ARRAY COIL

Problem:
The patient was tubed in order to perform an MRI. The procedure usually lasts two to three hours and the patient felt pain and discomfort which was followed with a bald spot on the top of the head. As in hair cell production rest.

The 16 channel brain-spine neurovascular array coil was used.

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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.

Additional Information:

Preventing Surgical Fires - Collaborating to Reduce Preventable Harm. FDA Safe Use Initiative. October 13, 2011.
http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/PreventingSurgicalFires/default.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun