Highlighted Reports
MedSun: Newsletter #53, October 2010

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 July 1 through July 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.

ANESTHESIOLOGY

Device:
Type: Apparatus, Autotransfusion
Manufacturer: Haemonetics
Brand: Orthopat System

Problem:
OrthoPAT machines have had intermittent problems. Recently, it has come to our attention that the issues are that the machine is not fully charging and when the staff uses the equipment, the lack of battery charge causes machine to turn off or not function properly. When biomeds test machine, they cannot always reproduce the problem. We discovered that the machine not only has to be plugged in but also turned off when it is in storage in order to charge fully. This is not intuitive as most staff think plugging in is enough. Also the on/off switch on the back is not clearly marked, so staff has a difficult time determining if the machine is off or not when they put it is storage.
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Health Professional's Impression
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Poor instructions on the need for plugging machine in and turning it off during storage in order to get a full charge.


Device:
Type: Apparatus, Autotransfusion
Manufacturer: Stryker
Brand: Cbcii Constavac Blood Conservation System

Problem:
Patient underwent a right femoral removal of hardware and right knee reconstruction on a previous date. During procedure, patient had a constavac drain put in. Post op [operative] day 3, the resident received orders to remove the drain. Upon trying to remove the drain, the resident met with some resistance and stopped the procedure.

Consulted with surgeon because the resident thought the drain tubing may have been stitched in. The resident was instructed by the surgeon to remove the drain tubing as it had to come out.

Upon 2nd attempt when removing the drain, it appeared a small piece of the tube remained lodged in the patient. The resident ordered x-rays and the results of the x-ray confirmed that there was a residual of the tube. This was discussed with the patient. The surgeon decided the small tubing residual would remain in the patient and they would monitor the patient closely.
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Health Professional's Impression
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It is believed that the tubing may have been sewn in during the OR procedure.


CARDIOVASCULAR

Device:
Type: Cardiopulmonary Resuscitation Aid Kit
Manufacturer: Cardinal Health
Brand: Crash Cart Kit
Cat #: OM5410346B

Problem:
Material Services employees noticed a pre-packaged crash cart kit with a recalled item as one of its contents. The kit was marked with an overlabel, instructing users to "Immediately upon opening this kit remove the recalled component". The recalled component was a Shiley tracheostomy tube (Cat#s 6DCT and 8DCT). Upon further review, it was also noted that the kit contained a packing slip which showed an expiration date of 4/30/2012, while many items within the kit expire well before this date.

Material Services is in the process of removing all such kits from this facility and working with the vendor to ensure this does not occur again.


Device:
Type: Catheter, Ablation, Cardiac, Rf
Manufacturer: Biosense Webster
Brand: Ez Steer Thermocool Nav
Lot #: 14119991
Cat #: BNI75TCDFH

Problem:
Poor packaging design allowed device handle to fall below sterile line and become contaminated. The plastic pieces of packaging become disconnected from one-another. The handle is relatively heavy (compared to the catheter shaft) and the plastic piece that holds it is on the bottom of the connection, so it just falls off. When the catheter fell out of the sterile package (the handle side is where it is opened) it remained in the short plastic tray.
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Health Professional's Impression
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Weight-bearing portion of break-away packaging is on the bottom, as packaging open in this case it was not well engaged into the shaft-portion and hung dependent, pulling the catheter out. With nothing to retain it, the catheter fell to the floor. Pictures will be forwarded for clarification.

Please see device images:
Carto Thermoc NAV Packaging 1: Weight-bearing portion of break-away packaging is on the bottom, as packaging open in this case it was not well engaged into the shaft-portion and hung dependent, pulling the catheter out. With nothing to retain it, the catheter fell to the floor.

Carto Thermoc NAV Packaging 2: Weight-bearing portion of break-away packaging is on the bottom, as packaging open in this case it was not well engaged into the shaft-portion and hung dependent, pulling the catheter out. With nothing to retain it, the catheter fell to the floor.

Carto Thermoc NAV Packaging 3: Weight-bearing portion of break-away packaging is on the bottom, as packaging open in this case it was not well engaged into the shaft-portion and hung dependent, pulling the catheter out. With nothing to retain it, the catheter fell to the floor.


Device:
Type: Ecg Management System
Manufacturer: Phillips Medical Systems
Brand: Tracemastervue
Model#: M5100

Problem:
It was discovered that multiple ECGs were reconciled to one order in our Electronic Medical Record (EMR). The ECG request is placed in the Epic EMR, sent to the Philips Trace MasterVue. The ECG is recorded on an electrocardiography cart and then reconciled in the Trace MasterVue to the Epic order number. When more than one ECG is reconciled to a particular order, the latest ECG reconciled to the order will link to that order in the EMR. Specifically, if a patient has an ECG at 8 am (and it is reconciled to Order #1) and then has a second ECG that day at 12 p.m., it should be reconciled to Order #2 (given the clinician entered a second order for the patient.) If the second ECG is reconciled to Order #1, it will link to that order and replace the first ECG. A second issue recognized is that on occasion ECGs from different patients were reconciled to the same order causing patient mismatches. There were 10 cases identified, all were investigated and resulted in no patient harm.
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Health Professional's Impression
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Manufacturer is aware of patient mismatch when order is re-used but do not have a solution.


Device:
Type: Lead, Defibrillation
Manufacturer: St. Jude Medical
Brand: Durata
Model#: 7121Q/58

Problem:
The patient was having a right ventricular lead revision. The cardiologist inserted a stylet provided by the St. Jude rep into right ventricular lead, but was unable to remove the stylet from the lead. The thoracic surgeon was consulted; he came into the EP lab, examined the patient and recommended capping and abandoning the lead in the patient. Another ventricular lead was inserted into patient. The patient was discharged home without further complication.


Device 1:
Type: Monitor, Physiological
Manufacturer: GE Healthcare
Brand: Dash 4000

Device 2:
Type: Monitor, Physiological
Manufacturer: GE Healthcare
Brand: Dash 3000
Model#: Dash 3000

Lollipop Icon

Problem:
Nurses were at two different patient's bedsides on two occasions providing care when they looked up to note that the two different monitor screens were blank. No alarm notification occurred. Biomedical Engineering called and removed the monitors and replaced with another monitor.
Health Professional's Impression: In response to the Dash 3000 monitor, Biomedical Engineering responded on-site and found that the display was blank, but the monitor appeared to have power and a network connection. The device was swapped out and tested. The device performed to manufacturer specifications and the problem could not be duplicated by Biomedical Engineering in a testing environment. The device has been sent to GE for further testing. In response to the Dash 4000 the screen only had a service message in the corner of the screen about an invalid Ethernet connection.

Update two weeks later for the Dash 3000 by GE reported that the error was most likely caused by software issue on a chip on the main circuit board. This was remedied with a reload of the software according to GE service. A request and activity number were issued.
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Manufacturer response the first Monitor, Physiological, Dash 3000
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GE reported that the error was most likely caused by software issue on a chip on the main circuit board. This was remedied with a reload of the software.
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Manufacturer response for the second Monitor, Physiological, Dash 4000
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GE reported that the system board had to be replaced.


Device:
Type: Pacemaker, Implantable
Manufacturer: Medtronic, Inc.
Brand: Adapta Dr
Model#: ADDR01

Problem:
Pacemaker checked via trans-telephonic monitoring and found to be demonstrating elective replacement behavior. The last clinic visit from three months ago had battery with estimated longevity of 7.5 years. The clinic visit today confirmed elective replacement behavior. The company was contacted for troubleshooting. Technical support indicated this is known issue that is remedied by a "special lab programmer". The condition is in the hardware for measurements. The device locks up and returns a battery voltage of zero and measurements are affected, after 12 hours, the device goes to ERI. The software fix will only unlock the hardware issue; however there is no indication thus far whether the issue will resurface. They have unlocked 12 devices so far and of those none have had a re-occurrence. If patient develops pacemaker syndrome, Medtronic recommends device change out. The programmer is being shipped to the local representative within the month. The patient was evaluated and found to be asymptomatic and verbalized understanding of symptoms that require immediate attention. The patient was discharged to home.
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Health Professional's Impression
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No adverse event as yet.


Device:
Type: Physiological Monitor, Mri
Manufacturer: Medrad Inc.
Brand: Veris
Model#: 8600

Problem:
Ongoing issues with artifact on the MRI images that appear to correspond with use of MedRad Veris MRI monitoring system. A "line" or "grainy" appearance has been noted on the MRI images when the monitors are in use in the room only. Concerns for patient safety due to additional scanning causing delays in patient care and decreased image quality.
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Health Professional's Impression
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Multiple tests have been done per clinical engineering that seem to point to monitor interference. There is no artifact in either MRI rooms unless the MedRad monitor is in use in the room.


Device:
Type: Transducer, Blood-pressure, Extravascular
Manufacturer: Edwards Lifesciences
Brand: Pressure Monitoring Kit
Lot #: 58857993
Cat #: PXVK225

Problem:
Anesthesia technician reports upon opening a Pressure Monitoring Kit the device was found to have come apart within the packaging. No injury to patient as defect was found prior to use. New kit obtained and used with no further concerns. This kit is a custom kit made for our facility.

It is my understanding a new custom kit was created for our facility as this was not the first incident of this defect, although it was the first reported to our office.


EAR, NOSE, & THROAT (ENT)

Device:
Type: Acoustic Head Phones
Manufacturer: Philips
Brand: Philips Slimline Head Phones
Model#: 104885

Problem:
As technician was in the process of putting the acoustic headphones on the patient, the headphones snapped in two pieces right in the patient's face. One of the broken pieces touched the area just to the left of her left eye. The skin was not broken but the patient was visibly upset.
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Health Professional's Impression
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The technician stated that this happens frequently and is probably due to cheap plastic.


Device:
Type: Handswitch
Manufacturer: Stryker Instruments
Brand: Core Universal Handswitch
Model#: 5100-009-700

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Problem:
Stryker-Core hand piece safety switch is very loose causing the saw to shut off or come on depending on motion of device or positioning of device. This had previously been reported to company rep and old hand piece switch was replaced; however new switch is just as loose and could cause same problem.


Device:
Type: Sinus Balloon Catheter
Manufacturer: Acclarent, Inc.
Brand: Acclarent Relieva Solo Pro
Model#: BC0716SP
Lot #: 100202F-CM
Other information: Only 1 package saved...it is felt both devices came from same lot and were the same model #.

Problem:
The patient was taken to surgery for sinus septoplasty and submucous resection. The ENT MD attempted to place the Acclarent Sinus Balloon Catheter and inflate it when he noticed it had burst. MD removed device, replaced it with a second device which also ruptured. Two balloons of same make/model both failed. A third balloon catheter was obtained and worked appropriately. The two ruptured devices were retained and it is unknown why they failed. There is a question whether they were defective or if it is possible the patients bone could have lacerated the balloons causing the failure. No injury to patient with these events. Surgeon was able to complete the procedure and patient was taken to PACU for recovery.


GASTROENTEROLOGY & UROLOGY

Device:
Type: Light Source
Manufacturer: Stryker
Brand: Stryker
Model#: X7000

Problem:
During a laparoscopic procedure the light source on a Stryker tower inadvertently shut off during the surgery. After a few moments of confusion the device was turned back on and the case continued until completion with no reported patient harm. After the case the unit was sent to Biomed for evaluation with a note saying a nurse had bumped the unit while controlling another device, but it should not have been hard enough to shut off unit. The light source was tested extensively in Biomed and no problem was found.
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Health Professional's Impression
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After further investigation in conjunction with the surgical department it was found that our towers were originally set up in two differing formations, one for laparoscopy and one for arthroscopy, which could have caused confusion as to which device was being controlled in the low light environment of the OR suite. Biomed in conjunction with the surgical department has now standardized the tower layout.
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Manufacturer response for Light source, Stryker
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Manufacturer representative also noted varied arrangement of towers and suggested standard arrangement.


GENERAL & PLASTIC SURGERY

Device:
Type: Stapler, Surgical
Manufacturer: Covidien LP
Brand: Endo Gia Universal
Lot #: N0C0593
Cat #: 030449

Problem:
Covidien Endo GIA Universal Autosuture stapler #030449 was inserted into chest and placed over lung tissue to be excised. Upon firing, the device snapped, did not form staples properly and cut tissue resulting in tear of lung. The Lung tissue was too thick. Device sent to Biomed for examination. Biomed will return to Covidien for analysis.


Device:
Type: Table, Operating
Manufacturer: MIZUHO Orthopedic Systems Inc
Brand: Jackson Table
Model#: JST2000
Other #: ORTSYS / JST2000

Problem:
A patient was supine and asleep on a Jackson Spinal Table. The Physician was operating on the patient's cervical spine. Suddenly, the Jackson Table jerked hard and made and up and down motion with a loud noise.
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Health Professional's Impression
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There was not adverse event but, the potential for one if the table was not stable during the procedure. They suspected some type of mechanical defect in the lift system.
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Manufacturer response for Jackson style OR table, ORTSYS / JST2000
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Manufacturer could not duplicate the issue of table moving / dropping on its own.


GENERAL HOSPITAL

Device:
Type: Catheter, Umbilical Artery
Manufacturer: Utah Medical
Lot #: 1091919

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Problem:
UAC (umbilical artery catheter) was placed in the infant. Bleeding continued from around UAC of unknown origin. There was no air seen in UAC, and placement was a little high. When the RN was pulling back line, line snapped in half. The nurse had control of both ends of the line at all times, and the line was removed from baby. The umbilical artery was clamped.


Device:
Type: Pump, Infusion, Implanted, Programmable
Manufacturer: Medtronic Neuromodulation
Brand: Synchromed Ii
Model#: 8637-40

Problem:
Pt has had intrathecal pump to treat back pain for 4 years. He had a "rotor stalled" and failure of the pump this week. Fentanyl had been turned up in response to the pump and not getting pain relief before they realized that the pump was not working. The plan is to replace the pump and start at a lower dose of Fentanyl.

Comment from FDA: Please see information published by MedTronic about SynchroMed® EL & SynchroMed II Pump Corrosion from Nonindicated Drug Formulations Resulting in Permanent Pump Stalls online available at: http://professional.medtronic.com/wcm/groups/mdtcom_sg/@mdt/@neuro/documents/documents/pump-corrosion.pdf


NEUROLOGY

Device:
Type: Shunt, Central Nervous System And Components
Manufacturer: MEDTRONIC NEUROSURGERY
Brand: Becker
Model#: Becker EDMS II
Lot #: 10763695
Cat #: 46128
Other #: BECKER EXTERNAL DRAINAGE/MON SYS

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Problem:
The External Drainage Monitoring System (EDMS) tubing was unclamped for routine emptying of cerebral spinal fluid (CSF) from the drainage chamber into the drainage bag. The tubing below the drain chamber became disconnected. This connection is supposed to be permanent and should not come apart. The disconnection caused 7 ml of CSF to pour onto the floor. There was no harm to the patient.


RADIOLOGY

Device:
Type: Ultrasound Machine, Diagnostic
Manufacturer: Philips Ultrasound, Inc.
Model#: iE 33
Other #: Feller USA (power cord)

Problem:
Ultrasound testing was being performed on a patient in the ED. The ultrasound machine has its own power cord which was plugged into the wall socket. While performing the test, the technician heard a pop, and plumes of smoke and sparks came out of the outlet/plug (plugged into the wall).

BioMed inspected and took pictures of the plug that was burned. The Ground Pin was bent. BioMed inspected the ultrasound machine which functioned properly following an electrical cord change. BioMed opines that the plugs overheat because the blade to wire connection fractured due to abuse. When the connections fracture, excess heat is generated.

This is a highly used device in many areas of the hospital, so it is connected to power outlets several times a day.
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Manufacturer response, according to reporter, for Ultrasound machine, diagnostic -
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They requested that the cord be returned to them for further testing.

Please see device images:

Burned Feller Power Cord: close up view

Burned Feller Power Cord compared to non-burned power cord


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Special Note:
The lollipop icon distinguishes highlighted reports that describe medical device events involving neonatal or pediatric patients, or those events involving a medical device that is indicated for use in neonatal and pediatric patient populations. FDA defines pediatric patients as less than 21 years of age.


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