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U.S. Department of Health and Human Services

MedSun: Newsletter #49, June 2010

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Newsletter #49, June 2010

Articles

Follow CDRH on Twitter

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FDA's Center for Devices and Radiological Health (CDRH) recently created a new Twitter account that provides information and news on device recalls, safety issues and other general interest device and radiation-emitting product topics. The new Twitter account address is www.twitter.com/FDADeviceInfo.

Additional Information:

FDADeviceInfo Twitter Account. Information and news on device recalls, other safety issues, approvals, and other device and radiation-emitting product topics.
www.twitter.com/FDADeviceInfo

FDA CDRH News and Events Website. Follow Us On Twitter.: CDRH Twitter. May 12, 2010.
http://www.fda.gov/MedicalDevices/NewsEvents/ucm177150.htm

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GE Healthcare Aisys and Avance Anesthesia Systems: Recall

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FDA MedWatch Safety Alert

GE and FDA notified healthcare professionals of a Class I Recall of specific lots of the Aisys and Avance Anesthesia Systems. The control board wiring harnesses have a defect which can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring.

Additional Information:

FDA MedWatch Safety Alert. GE Healthcare Aisys and Avance Anesthesia Systems: Recall. May 12, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm211918.htm

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Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570) - Recall

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FDA MedWatch Safety Alert

FDA and Teleflex Medical notified healthcare professionals of a worldwide voluntary recall affecting certain lot numbers of the Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (HCH) (catalog number 1570), a passive humidifier indicated for use to effectively warm and humidify inspired gas during mechanical ventilation. The 22cm connector on the flex tube may not fit securely within the endotracheal tube (ET) connector. This may result in the product becoming disconnected from the patient ET tube.

Additional Information:

FDA MedWatch Safety Alert. Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570) – Recall. May 6, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm211153.htm

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Baxter Colleague Infusion Pumps - FDA Ordering Recall

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FDA MedWatch Safety Alert

FDA notified healthcare professionals and consumers that it has ordered Baxter to recall and destroy all of its Colleague Volumetric Infusion Pumps (Colleague pumps) currently in use. This action is based on a longstanding failure to correct many serious problems with the pumps. The FDA believes there may be as many as 200,000 of those pumps currently in use. FDA is ordering Baxter to recall and destroy all Colleague infusion pumps, reimburse customers for the value of the recalled device, and assist in finding a replacement for these customers. Hospitals and other users of Baxter’s Colleague pumps will be receiving further instruction and information from Baxter and the FDA regarding their transition.

Additional Information:

FDA MedWatch Safety Alert. Baxter Colleague Infusion Pumps: FDA Ordering Recall. May 4, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm210695.htm

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LabNet

10 Safety Tips for Using an Oil Bath

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Lab Manager Magazine

A few years ago, a fire was started in a chemical fume hood when a researcher attempted to heat an oil bath on a hot plate. Nobody was injured during the incident, and it was small enough to be smothered by a fire extinguisher. The researcher had never used this hot plate and oil bath combination. Also, the person who previously used the oil bath forgot to label its contents. In this article you will find 10 safety tips for using a hot oil bath.

Additional Information:

Lab Manager Magazine. 10 Safety Tips for Using an Oil Bath. April 23, 2010.
http://www.labmanager.com/stips.asp?ID=113

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12 Scalding Hot Safety Tips for Using an Autoclave

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Lab Manager Magazine

The physical hazards of using an autoclave involve heat, steam, and pressure. The biological hazards involve potential exposure to viable human pathogens. This article focuses on proper autoclave operating procedures, safety practices, maintenance, and testing for effectiveness.

Additional Information:

Lab Manager Magazine. 12 Scalding Hot Safety Tips for Using an Autoclave. April 29, 2010.
http://www.labmanager.com/stips.asp?ID=115

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A New Definition of Gestational Diabetes: Will Revised Diagnostic Criteria Help or Hurt?

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AACC Clinical Laboratory News

The muddled diagnostic picture for gestational diabetes soon may become much clearer, thanks to several ground-breaking clinical trials and careful deliberations by the International Association of Diabetes and Pregnancy Study Groups (IADPSG), an umbrella organization created to facilitate collaboration between regional and national groups with a focus on diabetes and pregnancy. In March, the IADPSG released recommendations for diagnosing gestational diabetes that the group hopes eventually will lead to one world-wide standard, as well as further research that will clarify cost-effective treatment strategies for the condition, optimal glycemic treatment targets, and appropriate post-natal follow-up of mothers and children.

Additional Information:

AACC Clinical Laboratory News. A New Definition of Gestational Diabetes: Will Revised Diagnostic Criteria Help or Hurt? May 2010.
http://www.aacc.org/publications/cln/2010/may/Pages/CoverStory2May2010.aspx

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Patient Safety Focus: Patient and Family-Centered Care

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AACC Clinical Laboratory News

In this article, the core values of patient- and family-centered care and how they can be implemented in various areas of healthcare, including the lab are discussed.

Additional Information:

AACC Clinical Laboratory News. Patient Safety Focus: Patient and Family-Centered Care. April 2010.
http://www.aacc.org/publications/cln/2010/april/Pages/safety1.aspx

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HeartNet

MedSun Seeks to Work with Physician Practices to Improve Patient Safety

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The Medical Product Safety Network (MedSun) is pleased to announce that HeartNet is expanding to include cardiac catheterization labs and independent physician practices. As a subnetwork of MedSun, HeartNet was originally developed because FDA was interested to learn about user experience and other issues with the medical devices used in cardiac electrophysiology (EP) labs.

With this expansion, FDA hopes to detect and evaluate emerging device signals even earlier. To help ensure comprehensive device surveillance, reported information may include device problems detected during ongoing cardiac care, such as during outpatient device interrogation, as well as other signs and symptoms of possible device-related problems noted during patient follow-up. FDA believes this proactive approach gives the clinical community, FDA and the manufacturers the ability to efficiently recognize and address issues to help mitigate risk to patients.

Participation in HeartNet also allows reporters to contribute to special studies, share their knowledge, and receive information from their colleagues on device issues. If you are already a part of MedSun it’s easy to join HeartNet. FDA is also eager to include other hospitals and independent physician practices who want to join this important patient safety program.

For more information on this initiative or to participate in HeartNet, contact us toll free at 1-800-859-9821 or via email at medsun@s-3.com.

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HomeNet

Time to Listen: A Review of Methods to Solicit Patient Reports of Adverse Events

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PubMed Abstract

BACKGROUND: Patients have been shown to report accurate observations of medical errors and adverse events. Various methods of introducing patient reporting into patient safety systems have been published with little consensus among researchers on the most effective method. Terminology for use in patient safety reporting has yet to be standardised. METHODS: Two databases, PubMed and MEDLINE, were searched for literature on patient reporting of medical errors and adverse events. Comparisons were performed to identify the optimal method for eliciting patient initiated events. RESULTS: Seventeen journal publications were reviewed by patient population, type of healthcare setting, contact method, reporting method, duration, terminology and reported response rate. CONCLUSION: Few patient reporting studies have been published, and those identified in this review covered a wide range of methods in diverse settings. Definitive comparisons and conclusions are not possible. Patient reporting has been shown to be reliable. Higher incident rates were observed when open-ended questions were used and when respondents were asked about personal experiences in hospital and primary care. Future patient reporting systems will need a balance of closed-ended questions for cause analysis and classification, and open-ended narratives to allow for patient's limited understanding of terminology. Establishing the method of reporting that is most efficient in collecting reliable reports and standardising terminology for patient use should be the focus of future research.

Additional Information:

PubMed Abstract. Time to Listen: A Review of Methods to Solicit Patient Reports of Adverse Events. April 19, 2010.
http://www.ncbi.nlm.nih.gov/pubmed/20351164

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KidNet

Premedication for Non-Emergency Endotracheal Intubation in the Neonate

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PubMed Abstract

Endotracheal intubation is a common procedure in newborn care. The purpose of this clinical report is to review currently available evidence on use of premedication for intubation, identify gaps in knowledge, and provide guidance for making decisions about the use of premedication.

Additional Information:

PubMed Abstract. Premedication for Non-Emergency Endotracheal Intubation in the Neonate. March 2010.
http://www.ncbi.nlm.nih.gov/pubmed/20176672

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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 March 1 through March 31 2010. 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.


GENERAL HOSPITAL

Device:
Type: Iv Catheter
Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.
Brand: Insyte Autoguard

Problem:
This report corresponds to a previous report that was filed last month. We have an additional four (4) IV Catheters where the catheter would not deploy completely into the vein as it was difficult to separate from needle.

Manufacturer response (as per reporter) for IV Catheter, Insyte Autoguard

We are contacting the mfg's rep and asking that he /she replace all catheters with a different lot number.

Device:
Type: Iv Bag
Manufacturer: Hospira Worldwide
Brand: Visiv
Lot #: 84-251-JT
Cat #: 0409-7953-48

Problem:
Sterile processing department technician discovered leaking IV bag in warming cabinet in OR. Tech removed leaking bag and quarantined it.

Device:
Type: Monitor, Blood Pressure, Transducer
Manufacturer: Utah Medical Products, Inc.
Brand: Deltran Plus Needleless Arterial Blood Collection System
Model #: ABC-550NP
Lot #: 1092386

Problem:
This report includes three different instances of the following issue. Nurse had flushed the tubing, then attached the tubing to the umbilical arterial line. Blood started backing up in the tubing. The nurse then proceeded to flush the tubing and during this procedure, the tubing broke where there is a five inch piece of tubing attached at the end, which is not at a connection (this is where the blood draw port is located). Approximately two (2) cc of blood loss occurred; however, no harm to the patient.

Utah Medical was contacted and replaced all the current lots in the facility.

Device:
Type: Infusion Set
Manufacturer: Alaris/Cardinal Health
Brand: Alaris
Model #: 2200-0500
Lot #: Not Available

Problem:
I.V. Pump alarming "Air in Line", alarm would not clear. Tubing removed from pump chamber to clear air from line. Noted hole above cartridge in tubing that was leaking primary fluid.

Device:
Type: Tray, Exchange Transfusion, Stopcock
Manufacturer: Cardinal Health
Cat #: 4110B

Problem:
Zero day old infant with positive Coombs and elevated bilirubin level needed an exchange transfusion. The setup was completed for the procedure and connected to the patient. When initiating the exchange transfusion, the blood tubing became disconnected. Since the physician was sterile, the assisting physician replaced the blood tubing with sterile tubing and the decision was made to prime it to the waste fluid collection bag. The stopcock contained in the Cardinal Health Exchange Transfusion tray operates in a manner opposite of the standard stopcock used in the organization. The physician reviewed the stopcock, thinking the port was closed to the patient, when it was actually open to the patient. The patient received a large unknown quantity of air. Due to the pt having a large ventral septal defect (VSD), the pt sustained a potentially significant ischemic brain injury.

Human Factors modeling related to the stopcock design. The 4 way stopcock in the kit indicates the open port to the pt with an arrow on the stopcock lever. The stopcock is white as well as the markings on the stopcock lever. The standard stopcock used in the organization functions with the lever indicating it is OFF to the pt. The lever is blue and imprinted with OFF and an arrow. The stopcock in the kit operates exactly opposite of a standard stopcock. The kit stopcock does not state "off" it just contains an arrow. It is recommended that the stopcock in the kit be redesigned to more clearly indicate positioning of the port.

Device:
Type: Luer Connector, Netural
Manufacturer: ICU Medical, Inc.
Brand: Microclave
Model #: B3300
Lot #: 1786595

Problem:
RN reports as she went to flush a pt's PICC line, which had a microclave luer lock attached to the end of it, as the saline pushed through the line the luer lock pressure pushed the syringe off of the lock and sprayed saline out of the lock itself. No injury to patient. RN removed the luer lock and replaced it with another Microclave luer lock and used it without incident. This device is an item our facility is trialing for potential implementation. This is the 2nd incident of this type reported to FDA. Previous occurrence happened the day prior to this incident. No further issues have been reported to our office as of this date.


Device:
Type: Pca Infusion Pump
Manufacturer: Baxter Healthcare Corp
Brand: Syndeo
Model #: 2L3113
Other #: hospital control (BMI) #16449

Problem:
End-stage adult cancer patient was prescribed Hydromorphone at 1mg/mL concentration for pain management using the Syndeo PCA infusion pump. Two nurses, working together, correctly programmed the pump for 0.6 mL PCA dose, basal rate 0.6 mg/hr, a lockout interval of 15 minutes and a 1-hr limit of 3.00 mg. The nurses incorrectly entered and confirmed a drug concentration of 0.1 mg/mL.

During the next 2 hrs 23 minutes, four PCA deliveries occurred, each providing 6mg instead of the expected 0.6 mg of hydromorphone. This combined with the continuous basal infusion to give approximately 38.3 mg total drug in that time. The patient became obtunded, and her respiration rate and oxygen saturation dropped. Narcan was administered, and the patient was transferred to the critical care unit. The patient recovered within one day and was transferred out of critical care. She was discharged the next day to hospice care at home.

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Health Professional's Impression
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The pump's display appearance or menu sequence may have allowed the nurses to overlook the difference between 1 and 0.1 mg/mL, but this is unknown. This model pump has no stored drug library to enforce consistent concentration settings, unlike standard infusion pumps at our hospital.

Comment from FDA: Please see Class II recall online available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=40398&CREATE_DT=2005-08-16


Device:
Type: Unit, Neonatal, Phototherapy System
Manufacturer: General Electric Healthcare
Brand: Giraffe Spot Pt Lite
Model #: 6600-0833-800

Problem:
Several Giraffe SPOT PT Lite systems were brought down to the biomedical services department for repair. The biomedical services technicians noted that in some of the systems the orientation of the compact light was not correct. Therefore, the treatment of the infants' jaundice may not be effective. The biomedical services technicians checked the other Giraffe SPOT PT Lite systems in the NICU; and they found that 36 out of the 41 systems had a similar problem.

According to the biomedical services technicians, the compact light (bulb) was not installed properly. The compact light socket (bulb's ceramic base) has UP printed on it; and it must face upward. The light socket (bulb's ceramic base) will fit in the holder either upward or downward. In the Giraffe SPOT PT Lite, the light socket (bulb's ceramic base) was not oriented in the proper direction when it was checked. The orientation of the bulb/plug (bulb/electrical connector) is everything. The bulb can only be plugged in one way, as the prongs are different sizes, to fit the holes in the plug (electrical connector). The staff checked the Giraffe SPOT PT Lite and the socket (bulb's ceramic base) was found to be installed with UP. It could be read by looking at it and UP was found in the downward position.

Device:
Type: Iv Tubing Injector
Manufacturer: Carmel Pharma
Brand: Phaseal
Lot #: 9370457 (occurs with all lots)

Problem:
Nursing administered chemotherapy via central line utilizing Phaseal safety device. Blood return checked easily without PhaSeal device. Line flushed easily with PhaSeal, but extremely difficult to obtain blood return once PhaSeal device was used. Nurse had to have patient sit all the way forward and attempted to get blood return numerous times. Small flash was received with difficulty. Checked blood return again without PhaSeal without difficulty. The nurses have to go into the patient's central line an extra time which is a concern for central line infections.

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Manufacturer response for injector, PhaSeal
======================
No response yet

Device:
Type: Picc, Catheter
Manufacturer: Covidien
Brand: Argyle
Lot #: unk
Cat #: 43303
Other #: reference # 43303

Problem:
A neonatal PICC was placed in an infant. The pigtail was noted to be leaking approximately 1 cm from where the pigtail joins the luer connector. The catheter was removed after several unsuccessful attempts to replace it. The infant was taken to the operating room for surgical placement of a central venous catheter.

Of note, this is the 13th similar occurrence of leaking in the same area of the 1.9 fr catheter over an 18 month period of time. During the process to determine if the leaking was a practice or product related issue, we examined our practices related to PICC insertion, care, and use. We could not find any common threads. As a result, we provided the rep with 3 (of the 13) catheters to be examined microscopically for clues to any product inconsistencies or reasons identified for the leakage. In the meantime, we have removed the product from our storeroom and substituted a product from another manufacturer. We don't know, but given that we examined our own practices for the possibility of user error, it is possible that there is a device quality control issue.

Device:
Type: Extension Set, 7Inch With 0. 2Micron Filter
Manufacturer: Hospira, Inc.
Brand: Microbore
Lot #: 83039NS
Other #: List No.: 12437-18

Problem:
Micron filters that can be used for either medication therapy or Total Parenteral Nutrition (TPN) administration indicated it had occluded. Filter(s) replaced and occlusion resolved. Occlusions were rare in the past. Manufacturer has pulled Lot and replaced.

There has NOT been any adverse patient outcomes. The occlusion has occurred multiple times.

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Health Professional's Impression
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Physicians have increased the amount of calcium prescribed which in turn increases the amount of particulate matter in the calcium. As advised by Pharmacy (who mix the TPN)

======================
Manufacturer response for Micron Filter, Microbore extension set, 7 inch with
0.2 micron filter
======================
Manufacturer has replaced the lot in question.


Device:
Type: Sterling Nitrile Powder Free Exam Gloves -Small
Manufacturer: Kimberly Clark
Brand: Kimberly-clark
Model #: KC300
Lot #: sc92775Lx

Problem:
Employee noted blood on her hand after de-gloving after a patient procedure. The glove integrity was checked for any tears and holes with none noted. Another set of gloves from the same box was tested with ink to verify glove integrity with saturation break through evident again.


CARDIOVASCULAR

Device:
Type: Catheter, Angioplasty, Peripheral
Manufacturer: Bard Peripheral Vascular Inc.
Brand: Dorado
Lot #: 93FT0218
Cat #: DR13572

Problem:
A male was admitted for an elective procedure to angiogram bilateral legs with the possibility of percutaneous transluminal angioplasty (PTA) to the left superficial femoral artery for peripheral vascular disease (PVD). Dorado balloon 7mm X 2cm x 135cm was used for the PTA to the left superficial femoral artery. The activated clotting time (ACT) was 193 and 2000 units of additional Heparin were administered so the PTA could be completed. The Dorado device was inserted and inflated once to three (3) atmospheres (atm) for 18 seconds. At the end of the procedure, the physician had difficulty removing the balloon. The shaft of the catheter broke at the junction of the balloon and catheter so the sheath and balloon had to be removed as a unit with the high ACT. Protamine was administered to reverse the Heparin. No apparent injury noted. The patient remained overnight for monitoring and was discharged in the morning without any problems.

Device 1:
Type: Lead, Pacemaker
Manufacturer: St. Jude Medical
Brand: Tendril St Optim
Model #: 1888TC

Device 2:
Type: Lead, Pacemaker
Manufacturer: St. Jude Medical
Brand: Tendril St Optim
Model #: 1888TC, 52cm

Problem:
A dual chamber pacemaker was implanted. When analyzed by the pacemaker rep the next morning, the atrial lead was noted to have low impedance. During the lead revision, the lead was noted to be defective at the proximal portion. The lead was removed intact and a new lead was inserted (Tendril 1888TC, 52cm) and this lead was also noted to be defective at the same proximal portion. The lead was removed intact. The leads were cracked approximately 8cm from the proximal end. A third lead was inserted (Tendril 1888TC, 46cm) with no defects noted. It has not been determined if the crack was in place before implantation or occurred during implant. The patient spent an extra day in the hospital. The outcome was positive and the patient was discharged home.

Manufacturer response: Both leads were visually cracked. Waiting on additional analysis of leads.

Device:
Type: Catheter, Angioplasty, Peripheral
Manufacturer: EV3
Brand: Evercross Balloon Catheter
Model #: AB35W10040080
Lot #: 8084691

Problem:
During balloon venoplasty of a dialysis fistula, 10mm x 40mm Evercross balloon ruptured. Part of the balloon remained in the patient's subcutaneous tissue. The interventional radiologist immediately informed patient and family. He said this would not cause any harm to the patient.

Health professional's impression:
Ruptured balloons should not break into separate pieces as this one did.

Device:
Type: Oxygenator, Cardiopulmonary, Bypass
Manufacturer: Medtronic Perfusion Systems
Model #: 1500
Cat #: 61399400891

Problem:
The pt was born with a Congenital Diaphragmatic Hernia with a poor prognosis. The parent requested everything to be done. The infant continued to deteriorate and the parents consented to ECMO. After cannulating the pt, air was noted in the circuit. It is unclear if air reached the pt. The ECMO flow was immediately stopped. The pt was coded and placed on LVAD as a temporary measure. The infant was stabilized on LVAD. The parents were notified by the MDs and requested to continue the support of the infant. The infant was transitioned back to a different ECMO circuit the next day without incident. The parents elected to transition the pt to comfort care, and approximately an hour later, the infant expired. The ECMO circuit was tested by the MD & RN. The oxygenator gas was capped off, there was no air entering the circuit; however, when flow was restarted, air entered the circuit. The healthcare professionals suspected there may have been a breach between the gas path and blood path of the oxygenator. There was no evidence that the infant actually suffered an air embolism as a result of the event. There was a head ultrasound done the next day and it did not show any injury (hemorrhage or infarct) compared to the ultrasound that was done prior to ECMO. Even if a tiny bit of air may have gotten into the infant's system, the underlying disease dictated the subsequent course of events.


RADIOLOGY

Device:
Type: Cr Reader
Manufacturer: Fujifilm Medical System USA, Inc.
Brand: Fuji Cr
Model #: CR-IR 362

Problem:
An X-ray was taken that was double exposed and should have been repeated. The autocropping did not detect a previous exposure on the image plate and cropped to the second exposure. In the future, the autocropping feature will be disengaged.

This issue was revealed when, during a QA review process for collimation, an image was pulled up from the Fuji CR Reader and the cropping removed. Upon removing the cropped area it was noticed that there was a doubled exposure on the image plate. The CR Reader's auto cropping had cropped the second exposure and eliminated the area where the technologist would notice the variance. The Image was repeated in this instance with no known negative out comes.

After noticing this issue a test was performed, resulting in the same outcome. Auto-cropping was requested to be turned off, so that this issue would not occur again. The Technologist will still be able to manually crop the images; however, they can review the entire plate to see if there has been a double exposure and repeat the image. This will prevent missed diagnosis that could possibly occur unintentionally.

See device image:

Film exposures with autocropping error. The autocropping did not detect a previous exposure on the image plate and cropped to the second exposure.


Device:
Type: Mri, 1. 5t
Manufacturer: Siemens
Brand: Siemens
Model #: Symphony

Problem:
The patient entered the MRI department with a mesh glove covering the entire foot, just above the knee. The patient was screened prior to being scanned in the MRI department. He denied any dermal patches of any kind on his body. He also signed a screening questionnaire prior to the procedure. After the conclusion of the exam, the patient complained of a burning sensation to his foot which was wrapped in the mesh glove. Upon examination, the staff noted a foil patch underneath the glove. The patient sustained a minor superficial burn to the affected foot.

Device:
Type: Software, Radiation Treatment Planning, Hdr
Manufacturer: Nucletron Corp
Brand: Nucletron Oncentra Masterplan Hdr V3
Model #: HDR V3
Other #: Software version 3.3.1.3

Problem:
The treatment unit was the Nucletron HDR V3. The event was an under dose for 2 fractions (BID). The dose prescription per fraction was 4 Gy. The dose delivered per fraction was 0.4 Gy. The total under dose was 7.2 Gy. The event was caused by a software bug that updated the isodose lines upon changing the normalization, but did not update the dwell times. This was the first time we had used this particular normalization method with this planning system so other patients would not have been affected by this bug. The event was discovered during our QA check for the patient on Feb 11th. Patient QA involves reloading the patient's plan each day and recalculating the dwell times. The dwell times were updated after the plan was reloaded and the error was discovered. The attending was notified and the prescription modified to account for the deficit. Nucletron was contacted to report the software bug.

Device:
Type: Pet Ct Scanner
Manufacturer: Philips Medical Systems North America, Inc.
Brand: Gemini Gxl 16 Power
Model #: Gemini GXL 16 Power

Problem:
Patient underwent a scheduled outpatient brain CT scan. The technician programmed the machine at 800 mA instead of 80 mA. The Department of Health Services Radiation Department did not require a report to be filed.


GENERAL & PLASTIC SURGERY

*Device:
Type: Prep Solution, Surgical
Manufacturer: 3M
Brand: Duraprep
Cat #: 8630

Problem:
The patient was prepped and draped for an esophagastrectomy. Staff used DuraPrep to initially prep the site. During the procedure, the surgeon determined that he needed to access an additional area on the neck and requested that the surgical field be expanded. The drape was cut and the expanded field was prepped with DuraPrep (Catalog # 8630--26ml). Staff report that the field was dry and that sterile towels were used to wall off the edges of the expanded surgical field. Because the surgical site was on the neck, a clear barrier was not put down. The surgeon used a blade to extend the incision followed by a bovie to cauterize bleeders. The surgeon reports that immediately after, he felt his finger burning and staff report seeing a flame on the field. The surgeon began to pat out the flame and the staff immediately poured normal saline on the site. The patient sustained first and second degree burns on the neck (redness and blisters).

Wound Care evaluated the patient and recommended a topical cream. The patient's hospitalization was not extended from this event and he has since been discharged to an extended care facility. There was no apparent scarring and the skin healed well. The surgeon's hand had a first degree burn and required no medical treatment. The operating room team believes that fumes from the prep were caught in the drapes, which ignited when the bovie was activated.

*Device:
Type: Electrosurgical Pencil
Manufacturer: Megadyne
Lot #: 92959
Cat #: 0035H

Problem:
During the procedure, the Bovie needle tip caught fire with a small flame. Surgeon immediately pulled the Bovie out of the patient's mouth - no harm to patient.

*Comment from FDA: Please see safety information about Operating Room fires posted in previous issues of the MedSun Newsletter
FDA MedSun Newsletter. Practice Advisory for the Prevention & Management of Operating Room Fires. February 2009. Online Available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=33#6

FDA MedSun Newsletter. Fire Safety and Oxygen: A Patient Guide. January 2009. Online Available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=32#7


Device:
Type: Trocar
Manufacturer: SterilMed, Inc.
Brand: Ethicon Endopath Xcel
Model #: B11LT
Lot #: F4PT8N
Cat #: H208B11LT13

Problem:
Introducer cap of trocar broke in half while MD was inserting into the patient's abdomen.

Device:
Type: Clip, Implantable
Manufacturer: Boston Scientific
Brand: Resolution Clip
Lot #: 0ML9060303 and 0ML9040604
Cat #: M00522610
Other #: Ref 2261

Problem:
Attending physician noticed two small silver foreign bodies in the duodenal area after three (3) Resolution clips were deployed. Items appeared small enough to pass out of the GI tract normally so they were not retrieved. Validated today with vendor representative that they appear to be the hinge mechanism from the Resolution device. Representative states he has seen this before.

Device 1:
Type: Laparoscope, General And Plastic Surgery
Manufacturer: Ethicon Endosurgery, Inc.
Brand: Ssl Access
Model #: Single Site Laparoscopy Medium (4 cm) Fixed Length Retractor)
Cat #: SSL02FLR

Device 2:
Type: Laparoscope, General And Plastic Surgery
Manufacturer: Ethicon Endosurgery, Inc.
Brand: Ssl Access
Model #: Single Site Laparoscopy Seal Cap with Accessories
Cat #: SSL3P

Problem:
During use, the product ripped in half, with half remaining inside patient. The device pieces were able to be retrieved with minimal increase in surgery time. It was understood that the retractor is inserted and then the seal cap is locked into place to maintain the pressure. During the procedure, the mfg. representative noted that the retractor appeared to be buckling and the physician had not wanted to increase the size of the initial incision beyond 1.5cm and this is why he removed the retractor protector. The rep. did remember stating that its use was not mandatory. Per the rep. the incision was 1.5cm which according to the IFU is the minimum size for insertion of the retractor.
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Health Professional's Impression
======================
It is possible that the device contributed to the event. There is a retractor protector for use with this device (the retractor itself is like a sleeve, but thin) that may be used, but according to the mfg. representative, its use was optional. According to the physician, the retractor protector was used for most of the case but not the entire procedure. When removing the device it was observed that the retractor (sleeve) had broken in half (looks torn), the torn half was retrieved with no harm to the patient. It was felt that the hard inner sleeve should be a requirement for use, and may need to be longer.

Addendum per the Health care professional:
The 1.5cm incision was made as instructed. Though understanding that it could be bigger, it was left it at 1.5cm. The inner seal cap, the rigid portion, did buckle some but it was determined that the device would not be removed to avoid the possibility of making the incision bigger; and in doing so making it too big, thus creating the potential that a leak would develop. The inner rigid portion was removed, feeling that there was not enough range of motion with it remaining in. The outer thin portion did tear and this was noted. We proceeded on. We had too limited range of motion so two other ports were added and the procedure was finished. When pulling out the ethicon single site port it was noted that the part was not there. The physician went back in with the camera and pulled it out. It added very minimal time to the procedure, about one (1) minute. It came out in total.

The physician decided to remove the inner port for range of motion, and tore the outer port. The rigid inner piece IS longer then the outer thinner diaphragm port, which was noted incorrectly before. The physician did not like the port for limited range of motion and would not use it again.

Device:
Type: Laser, Surgical, Co2
Manufacturer: Lumenis, Inc.
Brand: Sharplan
Model #: 1055S

Problem:
Report of patient having cautery procedure of her vaginal condyloma and excision of vulvar condyloma with a Sharplan CO2 laser. Prior to the case the laser was tested by two RN's. During the test the laser showed 2 red aiming beams instead of the usual one beam. When the beam was fired on the test stick only the left aiming beam burned the stick. The doctor came in and looked at the laser prior to the case to determine whether or not he still wanted to use it. He decided that he did and proceeded with case. Upon doctor's first attempt at using laser on affected condyloma, the laser did split into two beams and caused vaporization of tissue in both locations, rather than one as on the test stick.

This resulted in a minor burn to pt's left labia majora as well as the intended condyloma. Laser use was discontinued and OBGYN assessed the burn. MD and OR staff again inspected the laser and could not determine why laser beam had bifurcated. Case proceeded with use of electrocautery to condyloma and other lesions. Device sent to Clinical Engineering for evaluation. Manufacturer's tech came onsite a few days later and realigned beam and made some slight adjustments. Device will be placed back into service once our office receives a service report from mfg. tech. Patient was discharged later the same day without any further issues or complaints.

Device:
Type: Robot, Surgical
Manufacturer: Intuitive Surgical, Inc.
Brand: Davinci
Model #: 380030-09

Problem:
Robot was being tested prior to patient being brought into the Operating Room.
The robotic arms didn't move like they should. The over-ride button was pushed, and the same issue occurred. The surgery was cancelled. The robot was rebooted and worked correctly but daVinci repair technician advised not to use robot until arm could be replaced.

Device 1:
Type: Instrument, Endowrist
Manufacturer: Intuitive
Brand: Hot Shears
Cat #: 420179
Other #: Davinci S robot purchased 12/2008 EMMC #208050

Device 2:
Type: Robot, Surgical
Manufacturer: Intuitive Surgical
Brand: Davinci S

Problem:
A patient was undergoing laparoscopic total hysterectomy in the Main Operating Room using robotic equipment. The surgeon was exchanging the devices to allow for cautery of a small bleeder. The iliac artery was nicked in error. A vascular surgeon was called and arrived quickly to repair the vessel. The patient was transferred to the Intensive Care Unit for observation. The patient is doing well.

Note: During the case at the very end with insertion of robotic laparoscopic scissors through the right robotic sleeve, there was injury to the right external iliac artery. This resulted in laparotomy and repair by vascular surgery.

The surgical assistant physician is a seasoned surgeon but was not trained in Robotic Surgery. The estimated blood loss for the patient was 3 liters.

======================
Health Professional's Impression
======================
User error, training


CLINICAL CHEMISTRY

Device:
Type: Analyzer, Chemistry
Manufacturer: Siemens Healthcare Diagnostics
Brand: Centaur
Model #: Advia Centaur

Problem:
Laboratory personal noticed several high troponin results in a row. Another personal checked the wash one reagent level on Centaur and found that it had depleted, although the low level alarm did not go off. Both personal ran the low control, which was high so they stopped running troponins.

Wash one was replenished, primed, controls reran, and then reran all values in question. The problem was only limited to four patients, and the reports were corrected to each of the four patient's caregivers.

Device:
Type: Analyzer, Chemistry
Manufacturer: Siemens Healthcare Diagnostics
Brand: Exl1
Model #: EXL1

Problem:
There was a problem with the EXL1 chemistry analyzer giving level sense errors. The previous laboratorian did a sample probe clean with bleach but that did not fix it. The oncoming technician checked the alignments which did correct problem. The error log was checked and an earlier error code was found. A level sense detect test was performed and a sample probe was not going into the tube at all, but stopping about 1/2 inch above it. The technician then checked the sample arm circuit board and wires for loose wires and bad connections. All connections reseated to the circuit board and retested which fixed the level sense error. The technician proceeded to load the patients that could not be run on the EXL2. All tests gave negative values and assay errors. The service technician at Siemens was contacted and directed to run a system check. The first system check failed. The Siemens technician also questioned if the film had been changed recently. There was a Cuvette count of only 400 noted, so it was thought to have been changed on the previous shift. The film was checked and an apparent left strip had not been loaded and was stuck in the loading area. Therefore, all reagents and serum were running out of the cuvettes. The technician proceeded to reload the left strip. A 100 cuvettes were made and the system check was performed. All passed and pending tests were completed.

Device:
Type: Reagent, Chemistry Analyzer
Manufacturer: Siemens Healthcare Diagnostics
Brand: Vista
Lot #: 09190AA

Problem:
There was an erroneous result reported for lipase. Duplicate orders were placed and two specimens were collected. The second sample had a normal result and both results were reported. A recollect sample was obtained for verification. The patient was not treated based on the erroneous result. Therefore, no harm was done to the patient. A reagent error is suspected. The lot was sequestered and sent back to the company for testing.

Device:
Type: Analyzer, Chemistry
Manufacturer: Beckman Coulter, Inc
Model #: DXC 600I

Problem:
Incorrect sodium result released. A sodium result was reported as high at 151. The MD called the lab questioning the result. A repeat specimen obtained and was within the normal limits of 138. It was then discovered that there was an issue with the instrument and the initial result was corrected. There were a total of seven patients that had incorrect sodium results posted and then corrected that same day. The other six were outpatients that were corrected within 14 minutes to 3 hours and no patient care decisions were made on any of those patients. None of the patients had labs repeated. All the initial results that were high (149-153) were corrected with all results being within normal limits (136-141).

The difference between the initial and corrected results ranged from 10 to 16 points. The lab had been complying with all recommendations and requirements related to maintenance of the electrode module that had been released over the past several months by Beckman and the FDA.


MICROBIOLOGY

Device:
Type: Microtest Multi-micromedia (H1n1 Swab)
Manufacturer: Remel
Lot #: unk

Problem:
Patient swabbed per guidelines for rule out. Swab inserted into right nare by RN. Upon removal of swab, cotton covered wire curette was no longer attached. SCC notified and attempts to remove by suction were unsuccessful. Ocean nasal spray ordered, but thus far curette is still lodged in nares.


ANESTHESIOLOGY

Device 1:
Type: Breathing Circuit
Manufacturer: Teleflex Medical
Brand: Hudson Rci
Cat #: 780-07

Device 2:
Type: Humidifier
Manufacturer: Teleflex Medical
Brand: Concha-column
Cat #: 385-40

Device 3:
Type: Neptune Conchatherma
Manufacturer: teleflex medical
Brand: Hudson Rci

Problem:
The ventilator circuit with dual limb heated wires apparently overheated and started to melt the plastic tubing. The RT was notified and found the inspiratory and expiratory tubes stuck together with an approximate 6 cm area of deformed plastic that looked like it had melted but not perforated.

See device images:

Shows how the inspriatory and expiratory limbs lay when the breathing circuit is attached to the patient.

Shows how the inspriatory and expiratory limbs lay when the breathing circuit is attached to the patient.



Device:
Type: Anesthesia Gas Module
Manufacturer: Philips Medical
Brand: Agm
Model #: M1019A

Problem:
The watertrap on it needs to be replaced frequently, most of the time the manifold seal comes out attached to the watertrap. It is a little piece that is not easy to see. This produces a leakage and the unit does not read the value of the gas measured. We contacted Philip to address this issue.

Manufacturer response (as per reporter) for Anesthesia Gas Module, Philips AGM

They will look into this complaint.

Device:
Type: Adapter For Ventilator Inline Suction
Manufacturer: Carefusion Airlife
Brand: Verso Airway Access Adapter
Model #: CE0086
Lot #: 09060014

Problem:
Pt. in ICU on ventilator. While patient was being turned the Nurse heard air leak. The verso adapter had snapped in two and part of it remained in the patient. The pt. became disconnected from the ventilator. One nurse held on to the adapter and keeping inline suction together while another was using ambu bag to ventilate patient. Piece was removed from patient's throat with forceps without injury. Inline suction was replaced.

======================
Health Professional's Impression
======================
No adverse event. Inline adapter snapped, opening the closed system

======================
Manufacturer response for adapter for ventilator inline suction, Verso AIrway
Access Adapter
======================
"We have had only one Verso snap before..." It was tested and appeared fine. Making several modifications to device.

Device:
Type: Closed System Catheter
Manufacturer: CareFusion 211, Inc.
Brand: Airlife

Model #: CE0086
Lot #: 09091049

Problem:
Patient was noted by ICU nurse to be de-saturating while on ventilator. Nurse initiated ambu bag. "Disconnect" alarm was going off of ventilator. Respiratory therapist was called and arrived. Found "inline suction catheter" to be locked in the OFF position but still continuing to suction causing a decrease in tidal volume and oxygenation. New Inline suction catheter was attached and patient put back on ventilator. No apparent harm.

======================
Health Professional's Impression
======================
No pt. harm. In line suction device was suctioning when it was in the off position, causing lowered Oxygen and tidal volume.

Device:
Type: Cell Saver
Manufacturer: Sorin Group USA, Inc.
Brand: Brat2

Problem:
All of our new fleet of Sorin BRAT2 (for Baylor Rapid Autologous Transfusion aka cell saver machines) intermittently give false positive alarms for air detection in the tubing set and then display a "Reservoir Empty" message on the display. This causes the pump to shut down while blood is being centrifuged or reinfused requiring the operator to restart the device costing valuable time.
======================
Health Professional's Impression
======================
The air detector seems to be the culprit but the company, despite numerous service calls, has not been able to rectify the situation.

======================
Manufacturer response for Cell Saver, BRAT2
======================
They sent an engineer and service rep about a week after the event occurred.

Device:
Type: Cpap For Home Use
Manufacturer: ResMed Corporation
Brand: S8
Model #: 33007

Problem:
Patient's CPAP machine was turned on but the patient had taken off her mask and head gear to go to the bathroom. Her roommate noticed a small fire at the back of the unit. They placed a blanket over the device to smother the fire. The fire department was not notified as the fire was quickly extinguished.

When the health care facility was notified a few days after the event took place, an employee went to the patient's apartment and took several photographs, however the patient refused to relinquish the device. There was soot on the back of the unit near where the AC cord connects - there was some melted plastic. There was some black marks on the table beneath the device. The tubing, headgear and mask were examined and there was no evidence of smoke, heat or fire damage.

A new device (different manufacturer) was provided to the patient (at no charge), when we found our about the event, with new mask, headgear and tubing.

======================
Health Professional's Impression
======================
There was a known voluntary recall on this particular unit / model # for a short circuit in the power supply (with some reports of minor thermal damage), however this particular unit had not been identified as part of the recall. The unit had been issued to the patient two years ago, a few days prior to the recall notice. The recall was issued prior to this patient's unit / serial # being loaded into the computer system - so when they searched for affected serial #'s, this patient's unit did not come up.

======================
Manufacturer response for CPAP for home use
======================
Requested that the patient send the unit back to the manufacturer -patient refused.


EAR, NOSE & THROAT

Device 1:
Type: Bronchoscope, Pediatric
Manufacturer: Olympus America, Inc
Model #: BFXP160F

Device 2:
Type: Disinfection System, Flexible Scope
Manufacturer: Steris
Brand: Steris System 1

Device 3:
Type: Bronchoscope, Pediatric
Manufacturer: Olympus America, Inc.
Model #: BFXP160F

Problem:
Pediatric flexible bronchoscopes (both Olympus, model # BFXP160F), during pre-use and cleaning inspection, noticed flaking and peeling of the outer sheath of the bronchoscope insertion tube (similar to previous reports we have filed). Steris System 1 was the device used to clean the scopes. Past investigations led to suspicion of peracetic acid being the most probable culprit.

If this flaking/peeling was not detected prior to use on a patient, it is possible that a piece could break off and lodge in patient's lungs.

Manufacturer response (as per reporter) for Pediatric Flexible Bronchoscopes &
Steris System 1, Olympus Pediatric Flexible Bronchoscopes & Steris System 1

Olympus field service representative inspected, and scopes were sent in to Olympus headquarters for evaluation. In the past this type of damage was considered consistent with "chemical damage" (linked to peracetic acid used in Steris System 1 scope washer).

Comment from FDA: Please see information and recommendations regarding the use of the STERIS System 1 online available: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm194411.htm

Device:
Type: Cochlear Implant
Manufacturer: Cochlear Americas
Brand: Nucleus 5
Model #: C1512
Lot #: Z209051

Problem:
Cochlear implant (Nucleus 5) placed upside down. The clinical team realized the error approximately 1 month after implantation, when they tried programming the device for the first time. The magnet was not operating properly due to the fact that the wrong polarity was facing the transmitter, and as such the team realized the implant was in the wrong orientation. There is no manufacturer or clinical data to suggest the device is not functioning well. The device has no clear indicator showing proper magnet polarity. This shows the potential for similar errors to occur in the future.


ORTHOPEDIC

Device 1:
Type: Implant, Hip
Manufacturer: Depuy Orthopaedics, Inc.
Brand: Asr
Model #: 9998-00-756

Device 2:
Type: Implant, Hip
Manufacturer: Depuy Orthopaedics, Inc.
Brand: Asr
Model #: 9998-00-249

Problem:
I was notified from a DePuy representative, concerning an increase in hip failure rate. According to him, the failure rate of a hip is approximately 2-3%, and with this system, it was increased to 8-9%. The rep also alerted MD of this increase in failure rate. A copy of the alert letter was given to individual in Risk Management as well as a copy of the implant record.

•Equipment/Supplies:DePuy ASR Size 56 Acetabular Cup
Manufacturer:DePuy
Model Number:9998-00-756
Equipment/Supplies secured for review:No/Unknown
Equipment/Supplies taken out of service:No/Unknown
Implanted Device:Yes
Explanted Device:No/Unknown

•Equipment/Supplies:DePuy ASR Uni Femoral Implant Size 49
Manufacturer:DePuy
Model Number:9998-00-249
Equipment/Supplies secured for review:No/Unknown
Equipment/Supplies taken out of service:No/Unknown
Implanted Device:Yes
Explanted Device:No/Unknown

Comment from FDA: MedSun has received additional reports with this product


GASTROENTEROLOGY & UROLOGY

Device:
Type: Gastric Band
Manufacturer: Ethicon
Brand: Realize
Model #: RLZB32
Lot #: ZKMBBN
Cat #: RLZB32

Problem:
During the case, the gastric band was passed off to the scrub technician and then placed on the mayo stand. The scrub technician attempted to inflate the band and noted that it didn't fill properly. As the scrub technician filled the band with 8-11cc of air to check for leaks, and the band did not fill completely. It took 25cc of air to fill the band completely and this had not occurred prior to this case. The surgeon also attempted to fill the band with the same results. The lap band was never near any needles, sutures, or blades.

Device:
Type: Catheter Dual Lumen, Curved Extensions, Laser-cut Side Slots
Manufacturer: Kendall/Tyco Healthcare group
Brand: Mahurkar
Model #: 8830415003
Cat #: 8830415003

Problem:
The patient had a new apheresis catheter placed in Interventional Radiology. She returned to her room. The apheresis was set up and initiated. The patient became unresponsive within 18 minutes and presented with symptoms of a stroke. A head CT scan showed an air embolism. The patient had a patent foramen ovale (PFO). The exact cause of the embolism is unknown and expected to be human error. Upon review of the case, we did note that the catheter used did not have a connection that would allow for the standard pheresis tubing or needless adaptor to screw completely onto the hub. There is a 1/4 turn on the connection, not a full turn seen with most other catheter connections. The exposed grooves could potentially act as a source for infection. Simulation of the connection with the pressure of apheresis did demonstrate a tight seal. However, the connection can come undone easily if not tight enough. It can also be difficult to remove if secured too tightly. In addition, the clamps used on the catheter have been reported by the RN staff to pop open easily. It is not always easy to see that they are open.

See device images:

Non-tunneled apheresis catheter.  Red connector and tubing does not screw on completely but the standard cap issued with the catheter does screw on completely.

Aphereis Catheter - catheter connection with needless adaptor that partially screws on

Aphereis Catheter - Cap that comes with catheter screws completely

Open white clamp on aphereis catheter

Closed white clamp on aphereis catheter

PHYSICAL MEDICINE

Device:
Type: Pack, Hot Or Cold, Disposable
Manufacturer: Coldstar International
Brand: Medichoice)
Model #: Warm pack 6" x 9"
Lot #: 34409
Cat #: 148069951FC

Problem:
The nurse was preparing a warm pack to use for a patient. She shook the bag so that the contents settled to the bottom and squeezed it to activate the chemicals inside so that it would heat up. However, the bag burst, spilling its contents all over the front of the nurse's clothes and arms. The nurse washed off her skin immediately (direct skin contact was only on the arms) and changed into a new set of scrubs. None of the solution came in contact with her eyes.

The nurse said that her skin that did come into direct contact with the solution was tingly and started to turn red. However, less than 5 minutes after washing with running water and soap, the tingling and redness went away. No medical intervention was required. No patient was involved in this event. The RN reported that the warm pack did not appear to be defective prior to use and that the usual amount of force to burst the pack had been used (one hand used to squeeze it). The pack was not leaking prior to activating the chemicals and had been stored inside the department in a temperature controlled environment. Staff have not had this experience with this product in the past. The RN obtained another warm pack (same lot number) and was able to activate it without incident. Upon closer examination of the burst pack, it appears that the seal across the bottom of the pack was incomplete. There is a small area of discoloration (<1cm) along the bottom edge of the pack that staff did not see prior to activating the pack. We have inspected other devices from the same lot and those that are from a different lot. No other packs have been identified with the defect.

See device images:

MedChoice Hot Cold Pack with a small area of discoloration (<1cm) along the bottom edge of the pack

MedChoice Hot Cold Pack with a small area of discoloration (<1cm) along the bottom edge of the pack

MedChoice Hot Cold Pack with a small area of discoloration (<1cm) along the bottom edge of the pack.

MedChoice Hot Cold Pack with a small area of discoloration (<1cm) along the bottom edge of the pack.



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Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events With Fallopian Tubal Occlusion Devices (TOD)

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The Devices that will be included in the analysis below include: Essure by Conceptus, Inc., Filshie Clip System by Femcare-Nikomed, LTD, and the Falope-Ring Band System by Gyrus/ACMI. A contraceptive tubal occlusion device (TOD) and introducer is a device designed to close a fallopian tube with a mechanical structure, e.g., a band or clip on the outside of the fallopian tube or a plug or valve on the inside. The indications for use of these devices is permanent female sterilization, to prevent pregnancy [1].

Over the past 2 years, MedSun has received 20 adverse event reports associated with the Essure device, manufactured by Conceptus, Inc.; 3 reports associated with the Falope-Ring® Band System, manufactured by Gyrus Medical Inc.; and 2 reports associated with the Filshie Clip System manufactured by Femcare-Nikomed, LTD, and distributed by Cooper Surgical. The 25 reports were submitted by 11 hospitals between May 2008 through April 2010. The majority of reports indicated device deployment issues. The deployment issues included, failure to deploy, malfunction after deployment, and difficulties with proper deployment.

The actual reported Essure™ device problems were:
• Device Problem 1: 12 reports of deployment issues
• Device Problem 2: 4 out of box issues, which included 3 reports with bent tips, and 1 report which mentions difficulty during loading of the device
• Device Problem 3: 2 reports of perforation
• Device Problem 4: 1 report mentions defective device
• Device Problem 5: 1 report mentions that the broke inside the uterus during deployment

In four of the above listed events, patient injuries were reported. Descriptions of the reported injuries are provided below:
• Patient Problem 1: 2 reports mention perforation. One involved perforation of the fallopian tube, which then resulted in the procedure converted to a laparoscopic tubal ligation. The other report mentions a uterus perforation discovered during a later laparoscopic procedure.
• Patient Problem 2: An improperly deployed Essure device resulted in a conversion to a laparoscopic procedure for completion of the sterilization.
• Patient Problem 3: Another report mentions abdominal pain experienced by the patient, resulting in diagnostic laparoscopy preformed. During the diagnostic laparoscopy, it was discovered that the Essure device had migrated to the bowel.

The actual reported Falope-Ring® Band device problems were:
• Device Problem 1: 1 report of misfire
• Device Problem 2: 1 report of deployment issue
• Device Problem 3: 1 report of malfunction

The actual reported Filshie Clip System device problems were:
• Device Problem 1: 1 report which lists 4 unintended pregnancies following the procedure
• Device Problem 2: 1 report of device migration

Given that the three devices are used for female permanent sterilization, all of the reports involved female patients. The age range for the patients, under this review, was all of the patients were over the age of 21.

These MedSun reports contributed to FDA awareness of the device problems. The FDA continues to follow-up with the manufacturers.

The following table lists the MedSun reports that are described in the device problem summary above.

Device Problem Table: Essure
DeviceDevice Identifier Event Description
Conceptus, Inc Essure™ Cat. #ESS305, Lot#20227514 The device was removed from an intact Essure™ box with no visible damage to the box or inner package. The device was visible through the clear plastic package insert where upon removal from the box it was noted the device tip was malformed in a bent elbow position. The device should be straight.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot#685785 The device failed to deploy.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot#20210352 The patient who was desiring permanent sterilization underwent placement of the Essure™ device. During the procedure the Essure™ deployed. Per the operative note, the Essure™coil did not properly deploy.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot#654830 During a hysteroscopy procedure, the first Essure ™device obtained from the kit was apparently defective with a bent tip with the second Essure™ device obtained from the kit apparently unsuccessful; questionably related to the patient's anatomy. Procedure converted to a laparoscopic tubal ligation with another device.
Conceptus, Inc. Essure™ Lot #646522 As the surgeon was attempting to place the Essure™ resistance was met. The surgeon did not "feel" that they had proper placement so they attempted to remove some extra tissue and saw some bleeding. The surgeon then explored the fallopian tube and saw a perforation; therefore did not place the Essure™. They stopped the procedure and did a laparoscopic bilateral tubal ligation with another device.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot #20183089 While performing a hysteroscopic tubal ligation, the Essure™ device was found to be defective. It was noticed on the monitor while inside the patient. The device was removed immediately.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot #619695 Device failed to discharge properly.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot #637215 and Lot #638494 On a first attempt to place the Essure™ on the patient's right side, physician experienced a "failure to deploy". There was a second attempt made to place an Essure™ with a different Lot#. With this second attempt the physician experienced "subsequent difficulty with visualization. Once placement located the second Essure™ didn't expand." The procedure was aborted with a hysteroscopic time of 40 min. Both sets of Essure™ devices with packaging were to return to the company.
Conceptus, Inc. Essure™ Lot #628434 An initial procedure was performed several months ago on the patient. At the time of this procedure, detachment of a 2cm endometrial fibroid was via cautery was attempted. The removal of the fibroid was very difficult. Several attempts were made to remove the fibroid without success and the decision was made to leave it in place. Then months later an Essure™ placement was then attempted. A difficult visualization was reported on the right fallopian tube as the tubal ostium was somewhat occluded by endometrial tissue and on the left fallopian tube the tubal ostium was occluded by area of dissection of the previous fibroid. Three days after this procedure the patient returned to surgery for abdominal pain. At this time a diagnostic laparoscopy was preformed. The Essure™ spring was identified partially imbedded in the patient's bowel. The physician successfully removed the spring and the patient tolerated the procedure well.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot #627301 The Essure™ device did not deploy. During the deployment attempt, the surgeon was not able to "thumbwheel" back a second time after depressing the button. The surgeon then successfully withdrew the device. No injury to the patient was noted.
Coneptus, Inc. Essure™ Cat. #ESS305, Lot #626975 The Essure™ device did not deploy. The surgeon was not able to roll the thumb wheel back because it became stuck. The surgeon withdrew the device successfully. No patient injury was noted.
Coneptus, Inc. Essure™ Cat. #ESS305, Lot #627751 Upon opening the package, the device had a bent tip and surgeon was unable to place the device successfully. The surgeon removed the device from tube. No patient injury noted.
Coneptus, Inc. Essure™ The Essure™ device was placed in patient a year ago. Follow-up x-rays showed proper placement two months post operatively. Approximately 13 months later, the surgeon was performing a laparoscopic procedure on the patient. The surgeon found the Essure™ device that had been put in the patient had failed by extruding through her uterus. The surgeon called the company during surgery but there was no response from company. Company responded to our Risk Department several days following the procedure.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot #627310 Coil on the Essure™ device did not release as expected.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot #627310 Coil on the Essure™ device did not release as expected.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot #626625 Attempted to use the Essure™ device, but device would not deploy.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot #626625 The surgeon attempted to deploy the device on the right side, but it did not deploy. The surgeon then attempted to deploy the device on the left side. The device came out after it was inserted. There was no harm to the patient.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot #624001 Surgeon was trying to load the Essure™ device prior to the procedure and the spring would not unload. Item was replaced. No patient harm.
Conceptus, Inc. Essure™ Cat. #ESS305, Lot #626218 The surgeon implanted the Essure™ device and the device broke inside the uterus. All pieces were recovered.
Conecptus, Inc. Essure™ An Essure™ device improperly deployed into the right tubal ostium. This resulted in the conversion to a laparoscopic procedure, where the entire device was successfully removed. With the right tube under direct visualization the Essure™ device was slowly advanced through the tubal ostium. Upon trying to release the device per manufacturer's specifications, the device did not deploy properly. The device was withdrawn. There was some residual wire left within the tube. This was grasped with a grasper and removed entirely. No lasting sequelae for patient. The Essure™ sales rep was present in the OR and took the device. We do not have knowledge of the lot number.



Device Problem Table: Falope-Band
DeviceDevice Identifiers Event Description
Falope Ring® Band System Lot #8191088, Other device #005280 901 ACMI Gyrus Falope-Ring® band misfired -- caused no injury, but a second kit was required to be opened to complete the procedure.
Falope Ring® Band System Lot #1521075H, Catalog #005280-901/Lot #110766GB, Catalog #005280-901 A Disposable Falope-Ring® Band Applicator was passed to the physician. This was the first band that was to be placed for laparoscopic tubal ligation. Placement was incomplete when physician stated that the device did not "deploy" appropriately and the fallopian tube was "cut." A second Disposable Falope Ring® Band Kit (different style kit and Lot. #, but same style applicator) was obtained with the same result when physician attempted to deploy. The physician then stated that he would complete the procedure the "old fashion way!" Both Disposable Falope-Ring® Band Applicator Kits were given to Purchasing to return to ACMI.
Falope Ring® Band System Catalog #000940-501 During the procedure, the surgeon attempted to use the fallopian ring band applicator and noticed it wasn't working. The fallopian tubes had to be burned with another device instead. The fallopian tube bander was repaired and returned to service. This procedure was an outpatient procedure and did not require a hospitalization for the patient. The device was sent to an external repair company who cleaned and reset the tip of the device as it was "a little bit off".




Device Problem Table
DeviceDevice Identifiers Event Description
Filshie Clip System No information provided During a laparoscopic procedure, a loose Filshie clip was found lying inside the operative site. The patient had not had previous surgery at this facility. Unknown date and facility for previous procedure. No patient harm.
Filshie Clip System Lot #20561, Catalog #AVM851, Other Device #FE0105 Four unintended pregnancies were reported from patients and physicians who underwent a tubal ligation procedure during a 13-month period with the Filshie Clip System. The Filshie Clips used in the procedures were from the same lot number.

Additional Information:

1. Code of Federal Regulations Title 21, Part 884.5380. Contraceptive tubal occlusion device (TOD). Retrieved May 21, 2010. Online Available:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=884.5380&SearchTerm=%20tubal%20occlusion%20devices

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Updated June 1, 2010

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