Highlighted Reports
MedSun: Newsletter #40, September 2009

This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period June 1 through June 30. 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 & PLASTIC SURGERY

Device 1:
Type: Laser, Ktp
Manufacturer: American Medical Systems, Inc.
Brand: Aura Xp

Device 2:
Type: Bronchofiberscope
Manufacturer: Olympus America, Inc.
Brand: Bf-p40

Device 3:
Type: Fiber, Laser, 600 Micron
Manufacturer: American Medical Systems, Inc.

Problem:

An adolescent patient was admitted to the hospital with three-month history of persistent pneumonia. CT scan showed calcified mass obstructing the right middle lobe takeoff intraluminally. A surgical procedure was scheduled for direct laryngoscopy, bronchoscopy and biopsy of mass with KTP laser.

Patient was initially intubated and a flexible adult fiber optic bronchoscope was placed through ETT. Biopsies were obtained using a flexible biopsy forceps through the bronchoscope. The KTP laser was used to control bleeding. The patient had initially been ventilated with 21% FiO2 at the start of the case, but with continued desaturations secondary to airway leak around the bronchoscope, the FiO2 was increased to 100%. The surgeon was unable to remove the mass so the flexible bronchoscope was removed.

A rigid bronchoscope was then placed and attempts to remove the mass were unsuccessful. Rigid bronchoscope was removed and patient was reintubated. Several more specimens were obtained using the flexible bronchoscope through the ETT. Bleeding was stopped using the KTP laser. Attempts were also made to ablate the mass with the KTP.

A general surgeon was called to discuss the possibility of a transthoracic approach to remove the mass. The primary surgeon used the KTP to demonstrate to the general surgeon the hardness of the mass. As the laser was engaged the light of the bronchoscope went off. The laser was put on standby and the bronchoscope removed. Patient was extubated, oxygen turned off, anesthesia circuit disconnected and changed, patient masked and then reintubated. A small amount of smoke was noted in the ETT that was removed. Upon examination of the bronchoscope, it appeared as though one side of the scope had been melted.

This examination revealed evidence of melted plastic verses vaporized plastic from the end of the flexible bronchoscope. The patient was transferred from the operating room to the Pediatric Intensive Care Unit. The patient remained intubated until 2 days after the procedure, when she was successfully extubated. The patient remains hospitalized and is scheduled to return to the operating room for removal of the mass.


Device:
Type: Suture, Vicryl Coated
Manufacturer: Ethicon, Inc.
Brand: Vicryl
Model #: J544P31
Lot #: BC6625
Cat #: J544

Problem:

While suturing the eye muscle, the 6-0 Vicryl suture started to fray as it was being pulled through the eye muscle. Suture was replaced with the same lot# and surgery was completed without further suture problem.


Device:
Type: Retractor, Illuminated, Surgical
Manufacturer: Electro Surgical Instrument Company
Brand: Lighted Retractor
Cat #: 08-0195G

Problem:

An illuminated retractor was connected to 300W light source. Patient burned from hot retractor. Patient sustained 3rd degree burns. Manufacturer states to use 150W maximum light source on labeling. However, once the device is sterilized and repackaged, it no longer retains the manufacturer's label. OR management is planning on creating their own labeling for the new packaging and light sources to include 150W maximum light source recommendation.


Device:
Type: Snare, Surgical, Ivc Filter
Manufacturer: Bard Peripheral Vascular, Inc
Brand: Recovery Cone Removal System
Model #: FBRC G2X
Lot #: GFTD1559

Problem:

During removal of an IVC filter the radiopaque marker on the IVC retrieval catheter loosened. When the IVC filter and retriever was removed from the right IJ incision site, the 4mm marker ring dislodged and remained just below the skin.


Device 1:
Type: Trocar
Manufacturer: Applied Medical Resources Corp.
Brand: Optical Separator System
Model #: C0152
Lot #: 1079076
Other #: +H699C015210H

Device 2:
Type: Trocar
Manufacturer: Applied Medical Resources Corp.
Brand: Optical Separator System
Model #: C0116
Lot #: 1080786
Other #: +H699C011610H

Device 3:
Type: Trocar
Manufacturer: Applied Medical Resources Corp.
Brand: Optical Separator System
Model #: C0116
Lot #: 1079080

Problem:

A physician was placing the initial trocar, model C0152, during a laparoscopic procedure, when he noticed through the camera, a white particle inside the distal tip of the obturator. The scope and inner trocar were pulled out. The scope was cleaned before proceeding. The white particle was inside the obturator and did not enter the patient.

Similar incidents happened during surgeries a few days previous and on one approximately a month earlier.

In the surgery a few days earlier, the physician was placing the initial trocar, model C0116, during laparoscopy, when he noticed multiple white particles falling into the distal tip of the obturator. Particles collected inside the tip. This was seen through the camera and a photo was taken showing multiple white particles. The trocar and scope were removed to prevent particles from entering patient.

Also, during a case approximately a month earlier, the physician was placing a disposable trocar, model C0116, during a laparoscopic procedure. He noticed multiple white particles falling into the distal tip of the obtruator. The white particles collected in the distal tip of the obturator. A photo was taken showing multiple small white particles. The obturator and scope were withdrawn. No particles entered the patient. A different scope was used to proceed with the procedure.

See device images

White particle inside obturator

White particle inside obturator


CARDIOVASCULAR

Device 1:
Type: Pump, Cardiovascular, Roller
Manufacturer: Sorin Group USA, Inc.
Brand: Stockert SIii Encore Pump Module
Model #: S3
Cat #: 10-60-00

Device 2:
Type: Tubing, Bypass, Ecmo
Manufacturer: Medtronic Inc.
Brand: Intercept Custom Tubing Pack
Cat #: 2A95R10

Problem:

ECMO was activated for a patient who had a cardiac arrest and was receiving CPR. While the ECMO circuit was being set up, the ECMO circuit was placed into the roller head of the pump incorrectly. The circuit was placed in the pump raceway backwards which caused the circuit to fill with air. The circuit was clamped, the problem identified and the circuit was de-aired. Estimated length of time from until issue was identified was about 5-6 minutes. This incident occurred prior to being used on the patient. The user was very familiar with the device. We have not seen this occur previously at our facility. We are currently taking steps to prevent this from happening in the future such as labeling the tubing, and the pump with directional arrows as well as doing a time out to check the tubing for proper placement. We suggest that there should be a better manufacturer design, such as color coding the lines with red for arterial and blue for venous. Additionally, more information is needed to guide the user in the correct circuit placement. The tubing does not currently come with instructions for loading the pump.


Device 1:
Type: Ventricular Assist Device, Power Unit
Manufacturer: Thoratec Corporation
Brand: Heartmate Ii Power Base Unit

Device 2:
Type: Ventricular Assist Device, Power Unit
Manufacturer: Thoratec Corporation
Brand: Heartmate Ii Power Base Unit

Device 3:
Type: Ventricular Assist Device, Power Unit
Manufacturer: Thoratec Corporation
Brand: Heartmate Ii Power Base Unit

Device 4:
Type: Ventricular Assist Device, Power Unit
Manufacturer: Thoratec Corporation
Brand: Heartmate Ii Power Base Unit

Device 5:
Type: Ventricular Assist Device, Power Unit
Manufacturer: Thoratec Corporation
Brand: Heartmate Ii Power Base Unit

Device 6:
Type: Ventricular Assist Device, Power Unit
Manufacturer: Thoratec Corporation
Brand: Heartmate Ii Power Base Unit


Problem:

Thoratec Heart Mate II (PBU) swapped at patient home to have routine maintenance performed. Hospital Product technician observed a disconnected back-up battery on the unit. After the initial discovery, 5 other units were found to have the same problem. Process for set-up: Hospital orders PBU from Thoratec, who then ships it to us (battery cord typically tucked behind circuit board during shipping), we contact Thoratec's contracted company, who then does the installation of the PBU prior to patient set-up.
No back-up power supply in the event of a power failure, would leave patient with no power to the LVAD device which could lead to death or serious injury.


Device:
Type: Defibrillator, External
Manufacturer: Medtronic Inc., Medtronic Emergency Response Systems
Brand: Lifepak 12 3DBiphasic
Model #: LifePak 12

Problem:

The patient was in full arrest and CPR was in progress. The patient was shocked (defibrillated) X 2. The staff charged the machine to 200J, but the defibrillator failed to deliver the shock. This was attempted X 3. The red service light appeared as well as error code D00D. The staff turned the machine off, then back on, recharged it and was able to deliver shock. The patient continued in full arrest with asystole and was pronounced 9 minutes later.


Device 1:
Type: Catheter, Electrode Recording
Manufacturer: St. Jude Medical
Brand: Livewire Steerable, Duo-deca
Model #: 401904 20
Lot #: 2767420

Device 2:
Type: Catheter, Electrode Recording
Manufacturer: St. Jude Medical
Brand: Livewire Steerable, Duo-deca
Model #: 401904 20
Lot #: 2767420

Device 3:

Type: Catheter, Electrode Recording
Manufacturer: Ascent Healthcare Solutions
Brand: Livewire Steerable, Duo-deca
Model #: 401904

Problem:

The physician opened a new steerable electrode diagnostic cardiac EP catheter. The catheter was then introduced to the right atrium via the right femoral vein and inferior vena cava. When the catheter was attached to electrical recording equipment it was found to have a faulty electrode pair. The catheter was removed from the patient and a second new catheter was introduced into the patient. This catheter also had a non-functioning electrode pair and was removed. These catheters have the same lot numbers. A third catheter, which had been reprocessed was opened and was found to have a structural abnormality. These reprocessed catheters are to be tested by Ascent prior to returning the catheter for use. This catheter was not placed in the patient but was bagged to be replaced. A fourth catheter (another new catheter) was opened and was utilized without incident. The case was completed successfully.


Device:
Type: Monitor, Physiologic
Manufacturer: GE Healthcare
Brand: Solar 9500
Model #: Solar 9500

Problem:

Patient was induced and shortly after, the sternotomy a "lead fail message" was displayed on the monitor as one of the ECG leads (lead V) disappeared. The monitor was adjusted to display two of the limb leads (lead II & lead III) instead. All of the ECG leads and electrodes had been carefully placed and covered, so it was considered unlikely that a pad (electrode) had come loose. The cable connection near the patient was also checked. The CVP pressure tracing at the same time was noted to exhibit significant noise artifact and this did not improve after replacing the pressure cable. A few minutes later, it was observed that the arterial line tracing would disappear suddenly from the screen without anyone disturbing or changing anything. Then the arterial line tracing would reappear. This did not improve after changing the pressure cable several times and changing the transducer, so it was assumed that the problem was with the physiologic monitor. In view of the fact that the monitor was critical to the surgical procedure, it was opted to use a transport monitor to display the patient's physiologic information.


Device:
Type: Catheter, Peripheral Dilation
Manufacturer: Abbott Vascular Devices
Brand: Viatrac14 Plus
Lot #: 8080651
Cat #: 1008201-20

Problem:

Balloon burst when expanded to 26 atmospheres. Catheter pulled out of body and balloon dislodged off wire and was found under fluoro to be in iliac. Retrieval device used to retrieve balloon. Manufacturer’s recommendation is not to go above 14 atmospheres for the rate of burst.


Device:
Type: Catheter, Snare
Manufacturer: EV3 Inc.
Brand: Snare Replacement Catheter
Lot #: 6227491
Cat #: MC4000
Other #: 4 FR 102 cm

Problem:

#4 French end hole snare catheter advanced into the proximal aspect of left SVC following which an attempt at removing the existing guide wire was unsuccessful due to small caliber of the vessel. Catheter then withdrawn with minimal difficulty, although platinum marker remained within the vessel for unknown reasons. Target vessel was inadvertently embolized with marker. Post angiography demonstrated successful occlusion of target vessel with marker. Position unchanged. No apparent patient injury


Device:
Type: Defibrillator, External
Manufacturer: ZOLL Medical Corporation
Brand: MSeries Cct
Model #: CCT

Problem:

A staff member was retrieving a Zoll CCT defibrillator to use for a transport when the handle snapped away from the defibrillator. This caused the defibrillator to fall and strike the caregiver in the upper leg. The handle broke on both pivot hinges completely separating from the defibrillator. The staff member complained of pain and bruising but did not want to pursue medical intervention. The defibrillator was removed from service for Biomedical evaluation and analysis. This is the third incident of these carrying handles breaking away from this model of defibrillator and the second MedSun report from this facility. The weight of the defibrillator with the battery is approximately 16 pounds.

Manufacturer response (as per reporter) for Defibrillator Monitor, Critical Care, Zoll CCT

Manufacturer requesting that handle assembly be sent back to them for analysis. A replacement handle was sent from Zoll.

See device images

Zoll defibrillator handle

Zoll defibrillator handle

Zoll defibrillator handle


Device:
Type: Vascular Closure Device
Manufacturer: Abbott Vascular Devices
Brand: Starclose
Lot #: 740266 H

Problem:

After sheath was changed to StarClose sheath, device was inserted through sheath. It was properly snapped to sheath and raised up to begin splitting, but splitting did not work. It was then noticed that a leaflet on the end of StarClose was kinked and would not advance any further. After several attempts at pulling out system with no success, emergency release button was used and StarClose was aborted.

Manufacturer response: the device will be replaced


GENERAL HOSPITAL

Device:
Type: Infusion Pump
Manufacturer: Smiths Medical MD, Inc.
Brand: Medfusion 3500 Syringe Pump
Model #: 3500

Problem:

When nurse was trying to program a drug bolus, she typed in a “2” and the screen displayed a “5.” If she typed a “1,” it displayed a “4” on the screen. Then, the pump started failing to recognize the type of syringe we utilize.

The pump was taken out of service. There was no harm to the patient.

An in-house safety inspection was completed on this pump. It was found to have a non-functional keypad assembly. The cause of the problem is unknown outside of "general use." It should be noted that this unit was not part of the recent safety recall for keypad replacement, nor did it have the faulty part within it as indicated in the safety recall. The unit's keypad and topcase, as one unit, were replaced. All functional testing was completed yielding values that were within the acceptable range.


Device:
Type: Pre-filled Syringe
Manufacturer: Sanofi-Aventis
Brand: Lovenox
Lot #: 19391

Problem:

Nurse injected prefilled syringe of Lovenox to patient, enabled the safety device which failed and the needle fell out of the syringe and to the floor. The nurse picked the needle up off the floor and as was placing it in the sharps container it slipped and stuck the nurse through the glove on the left thumb. Blood did seep from the site.
Nurse was seen in the ER, baseline HIV, Hep C and Hep B labs were drawn on the source patient and the employee.

Additional information obtained from the site:
It was injected subcutaneously. There was an audible click, the nurse said it was like it over activated and then fell apart.


Device 1:
Type: Enteral Feeding Set
Manufacturer: Covidien Kendall
Brand: Kangaroo Joey
Cat #: 772055

Device 2:
Type: Enteral Feeding Pump
Manufacturer: Covidien Kendall
Brand: Kangaroo Joey

Problem:

Feeding pump was delivering up to 30% more milk than specified. Two incident reports were filed and Clinical Engineering found the problem to be a bad batch of feeding bags (disposables). We were able to replace all bags at our hospitals and we will be checking the new lots prior to use.

We informed the manufacturer of our problem and they provided us with new bags. They were not aware of this issue prior to us informing them of it.


Device:
Type: Syringe Pump
Manufacturer: Smiths Medical MD, Inc.
Brand: Medfusion 2001
Model #: 2001

Problem:

The syringe pump had not delivered any dopamine after running for 3 hours. Further investigation indicated that the syringe drive on this pump had sustained physical damage from being dropped or struck. The damage was visible on the syringe pump's housing. The impact from being dropped or struck damaged the drive mechanism and cracked the housing.

Device:
Type: Iv Infusion Needleless Access Device
Manufacturer: Becton Dickinson
Brand: Interlink Threaded Lock Cannula
Model #: 303369
Cat #: 303369

Problem:

A nurse was changing lines on a vasoactive infusion. She was using a needleless access device used by the hospital. After making the change, the patient was noted to have a precipitous drop in blood pressure and heart rate despite a seemingly uneventful change. The nurse then noted that there was leaking at the site of the needleless access. Upon further investigation, she found that the access device, while appearing intact and screwing on to the needleless port, was actually broken off and never made access to the needleless cap. Thus, the patient was not receiving any of the medication.


Device:
Type: Hospital Bed
Manufacturer: Hill Rom Company, Inc.
Brand: Total Care General Care
Model #: TOTALCARE GC

Problem:

A loud clatter was heard, and a male voice shouting. Staff went to check it out. The tech, (confirmed by patient and family), stated that the patient was using the side rail as support to get up, and it gave out. He jerked to the side, but didn't fall. He complained of pulling and severe pain. Nurse Practitioner and Biomedical engineering was notified. We received order for STAT morphine, which relieved most of the pain (from 8/10 down to 2/10), and patient was taken for STAT lumbar CT (which he was already scheduled for).

Manufacturer response (as per reporter) for Regular hospital bed, Total Care General Care

The “false latching” concern of the site, was duplicated by slowly & gently raising the siderail and holding it up just before the latch makes full engagement onto latch-pin. The “false latch” is defined as, “A siderail remaining in the up position without being fully latched and not capable of supporting the full design load.”


Device:
Type: Needle, Hypodermic, Single Lumen
Manufacturer: Smiths Medical
Brand: Gripper Plus
Lot #: 078X39
Cat #: 21-2767-24
Other #: Non-coring (Huber) safety needle

Problem:

Nurse was removing Huber needle from implanted port. Safety device did not engage in locked safety position - needle came up further than it should have. Neither patient nor nurse sustained injury from malfunction.

Additional information obtained from the site:

There is no patient information and it has no bearing on the incident. It has happened a few times in the past year or so - I may have submitted previous reports on it. All users are oriented to proper use of the device.
This device been in use in our facility at least 5 years (probably longer) and there has not been any design changes to the device.

The person removing the needle was a staff nurse in our ambulatory clinic. They are trained by the educator and their preceptor during new hire orientation to use it properly. The patient/family had nothing to do with managing the device.


Device:
Type: Enteral Feeding Pump
Manufacturer: Moog Medical Devices Group (Zevex)
Brand: Entralite Infinity

Problem:

Patient's mother set the pump for an overnight feeding. She checked the patient at 6 am and found the bag was empty and the device continued to pump air into the infant. The patient's mother vented the patient (released the air in the child's abdomen via G-tube) and observed no harm or discomfort. Another pump was sent out and the malfunctioning pump was shipped back to Moog for testing.

This is one of six events our facility is aware of that involve improper administration of tube feeds by this make and model of pump. The pump either delivered product too early or too late (by hours at a time) in vulnerable populations.

Our facility has discussed this problem with the manufacturer, and they have stated in previous reported cases that they could not identify a problem with the product. However, the problem continues with this type of pump. In addition, most cases involve "highly viscous" feeds. The manufacturer used water to test the pumps, and this may have contributed to a false negative with regard to product defects.


ANESTHESIOLOGY

Device:
Type: Air/ O2 Blender
Manufacturer: Cardinal Health/Bird
Brand: 3800 Microblender
Model #: 3800A

Problem:

The medical air supply was connected to the medical air input on the blender and the oxygen supply was connected to the primary output not the oxygen input. The blender was set to deliver 21% oxygen but when the auxilary outlet oxygen concentration was tested it was 100%. A flow meter was connected to the auxilary output. The flowmeter was delivering blended gas to the baby via a nasal cannula.

OBSTETRICS/GYNECOLOGY

Device:
Type: Catheter, Balloon, Transcervical
Manufacturer: Gynecare Worldwide
Brand: Thermachoice Iii
Lot #: BCMG05

Problem:

Uterine balloon therapy had been in progress for approximately four minutes (out of eight total) when the machine recorded heating error 6506. The manufacturer rep was present in the OR suite at this time. The procedure was stopped and the device was removed, a small defect was noted in the balloon. A second balloon was then inserted and the same problem was reported six minutes into the procedure with same error message. The procedure was stopped at this point and the device removed. The physician was satisfied; the goal of the procedure had been achieved and the patient withstood the procedure with no adverse outcome.


Device:
Type: Manipulator, Uterine
Manufacturer: Cooper Surgical
Brand: Rumi System
Model #: UMB678
Lot #: 45169

Problem:

Patient undergoing laporoscopic lysis of pelvic adhesions when the Rumi uterine manipulator, the surgeon was using, somehow lacerated a part of the pt's cervix. Apparently, the surgeon noted vaginal bleeding so the edges of the cervix were grasped and examined. The surgeon identified a cervical laceration for which she placed some sutures to stop the bleeding. The bleeding did not stop, so the surgeon utilized a cystoscope which allowed visualization of 2 additional areas of bleeding which was cauterized to stop the bleeding. Patients’ procedure was completed and patient was taken to recovery. After procedure, surgeon visually examined the device and noticed a 2mm barbed area of irregular material which she feels may have produced traumatic injury to pt's cervix.


Device:
Type: Birthing Bed
Manufacturer: Hill-Rom Company, Inc
Brand: Affinity
Model #: Affinity 4

Problem:

Visitor sat on end of bed. When he stood up, the bottom half of the bed fell to the floor. The rest of the bed dropped into reverse trendelenburg. Two bolts and a bracket were found under the foot of the bed. Patient and visitor were unharmed. Patient weight-166 lbs. Visitor weight unknown. During repair of bed it was noted that 12 other beds in our system had the same loose bolt and were at risk of collapse. The Hill-Rom service repairman stated that it was a common problem.

Manufacturer response (as per reporter) for Birthing bed, Affinity:

It is a problem that has been seen frequently at other locations as well. Our site had a total of 26 affected beds that had to be repaired in the same way. Bolts were loose and had to be replaced.


Device:
Type: Female Surgical Contraception
Manufacturer: Cooper Surgical
Brand: The Filshie Clip
Lot #: 20561
Cat #: AVM851
Other #: FE0105

Problem:

Reported unintended pregnancies (4) from patients and physicians who underwent a tubal ligation procedure during a 13 month period. The filshie clips used in the procedures were from the same lot number.


CLINICAL CHEMISTRY

Device:
Type: Calibrator
Manufacturer: Bio-Rad Laboratories, Inc.
Brand: Anti-borrelia (Lyme) Eia
Lot #: 082132
Cat #: 503231

Problem:

While analyzing the data from a recent run of specimens, the technician noticed that the positive control was not as high as expected, but still within acceptable range. During the investigation of this, BioRad was contacted. It was discovered a "scaling factor" should have been entered into the instrument for this test with each run. Scaling factor not printed on calibrator so technician did not know to enter it. The scaling factor is supposed to be printed on the vial when required for a procedure. The vial did not contain the factor label. Nine patients had lab results reported to them that were incorrect. The patients will have to come in for a second test.


Device:
Type: Chemistry Analyzer
Manufacturer: Siemens Medical Solutions Diagnostics
Brand: Dade Rxl
Model #: DADE DIMENSION RXL
Lot #: BC0069
Cat #: RF421C

Problem:

ER physician called and notified the lab director that he thought we were having trouble with our troponins. Troponin I results were falsely elevated, resulting in a patient being transferred from our facility to another for cardiac catherization. Upon arrival at other facility, Troponin I performed with a negative result being obtained. Cardiac catherization not performed. During the resolution process, we discovered a precision problem with the instrumentation and had the instrument decontaminated. Recalibration of the assay was performed and quality control was acceptable. No shifts in quality control were noted prior to notification of a suspected problem by the ER physician. Patients were repeated on alternate analyzer and amended reports were issued. Troponin I testing was discontinued on patients until problem was resolved.


Device:
Type: Glucometer
Manufacturer: Roche Diagnostics Corporation
Brand: Accu-chek Inform
Model #: Accu-Chek

Problem:

Nursing dropped the glucometer and broke it. The glucometer was taped together with scotch tape and ran for patient results. Nurse obtained a critical value and treated patient with insulin. At change of shift, the new nurse noted patient was cold and unresponsive. The patient had a blood sugar of 15. Glucose performed in the laboratory. No documentation of controls being performed after the meter was broken. Other patients were tested, but values obtained were within normal ranges. Patients were retested by oncoming shift with a different meter.


PATHOLOGY

Device:
Type: Powder/reagent
Manufacturer: SIGMA-ALDRICH
Brand: Sigma Hyaluronidase Powder

Problem:

Hyaluronidase powder from Sigma was contaminated with yeast. Order#=H3506-5G, lot#=029K7001. Bottle was opened. A second bottle also showed contamination. We had two joint fluids that had yeast reported from the cytospin slide; however, cultures were negative. Cytospins were then performed using (1) sterile saline & (2) sterile saline mixed with hyaluronidase confirming the contamination.

Sigma does not claim sterility of this product. We have not had any previous problems with this product. Company has recently switched packaging from glass to plastic bottles. Company is investigating.


EAR, NOSE & THROAT

Device:
Type: Cochlear Implant
Manufacturer: Cochlear Americas
Brand: Nucleus Freedom
Model #: Nucleus Contour device

Problem:

Patient with a history of traumatic brain injury and hearing loss status post his trauma. He had minor benefit after cochlear implantation and the implant was found to have defective electrodes.


GASTROENTEROLOGY & UROLOGY

Device:
Type: Lithotripter, Ultrasonic
Manufacturer: Medispec LTD
Brand: Lithotripsy Unit Sw-7 Medspec
Model #: 16-230A

Problem:

Extracorporeal Shock Wave Lithotripsy (ESWAL) malfunctioned. Troubleshooting done by staff and BioMed. Lithotriper misfired. Staff removed spark plug; no damage. Changed water. Within ten shots, the malfunction happened again. Call Medispec, and trigger changed for ECG to SLOW. Problem still existed. KV output to 15. Misfired, but not at the same frequency. MD was able to get through the case.

The rep from Medispec came in to complete repair. He replaced the high voltage generator. It should be replaced every 1 million shots. Meter read 1,699,000 and was overdue. He also replaced the membrane. Now fully operational.

Device:
Type: Hemodialysis Machine
Manufacturer: Gambro Renal Products, Inc.
Brand: Phoenix
Model #: Phoenix

Problem:

Bicart motor mounts failed and caused the motor to bind and not pump properly.


Device:
Type: Duodenoscope
Manufacturer: Olympus America, Inc.
Model #: TJF 160VF
Other #: Cook Stent #SPSOF-5-2.5

Problem:

An ERCP was being performed. Multiple products were introduced into the scope. Then a balloon was introduced and a pancreatic stent was pushed out of the scope. The stent was lodged in the scope from a previous patient. The stent entered the current patient's duodenum only and was retrieved immediately.


Device:
Type: Endoscopic, Biopsy Port Cap
Manufacturer: Boston Scientific Corporation
Brand: Microvasive Rx Biliary System Locking Device And Biopsy Cap
Lot #: 12369655
Cat #: 4526

Problem:

Item periodically used during ERCP procedure. It is a disposable biopsy port cap with sponge disc inside that endoscopic accessories pass through. This incident is the second time in recent weeks that the sponge disc has been pushed into endoscope working channel - requiring significant effort and time to remove.

Concerns are:
1. No foreign body should remain inside scope - inhibits further use of working channel during that case and follow-up reprocessing.
2. Infection control risk if disc should remain behind.
3. Risk for scope injury with effort required to dislodge.
4. Scope out of circulation and unavailable for clinical use.

Manufacturer has communicated with the site that they are investigating.


NEUROLOGY

Device:
Type: Ventricular Catheter
Manufacturer: Medtronic Neurologic Technologies
Brand: Bioglide
Cat #: 27782B

Problem:

A Medtronic Bioglide VP shunt malfunction was retrospectively identified. The patient had come in ~8 months ago for a shunt malfunction. Since then, our facility had sent out a recall letter to the patient, alerting them that the manufacturer had initiated a device recall. The patient’s mother believed that the shunt malfunction that occurred was related to the disconnection problem identified in the recall. Upon reviewing the operative report, this was confirmed. Per the operative notes:

The patient was brought to the operating room. We went to remove the reservoir snap assembly and it was apparent that the shunt had broken off at the attachment of the ventricular catheter to the reservoir dome and the catheter was lodged in the brain. At this point, we tested the distal shunt runoff and found there was no runoff. Therefore, we opened up the abdominal incision and began the process of finding the proximal ventricular catheter. Had to widen the bone opening around the area of the shunt insertion site, dissect down through the brain parenchyma approximately 1cm into the parenchyma until the distal ventricular catheter could be found. It was removed without difficulty.

Please see two recalls online available at: http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm126620.htm
and
http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1238091091955&lang=en_US


Device:
Type: System, Hypothermia, Intravenous, Cooling
Manufacturer: INNERCOOL therapies
Brand: Rapidblue
Lot #: 8197-0011
Cat #: RapidBlue

Problem:

The Innercool on-call representative was contacted by the ICU nurse because the Rapid Blue machine was re-warming the patient too quickly. The Innercool folks say that it was determined that initially, the patient was being warmed at the MAX rate, rather than 0.2 degC/hr. MAX is the default setting. In attempting to correct this problem, the rep also instructed the RN to turn off and re-start the machine. When this was done, the "Accutrol" mode was inadvertently accepted as the catheter type on the start up menu. We only use "Standard" catheters, not "Accutrol", but Accutrol is the default setting. This resulted in a malfunction error alarm that is only related to the Accutrol mode. It is unclear exactly when and if they figured out that the setting was wrong, and when and if they figured out that this was the cause of subsequent malfunction error messages. Once this alarm had been triggered, the rep and RN agreed to switch back to the old console to avoid further frustration and alarms. The patient achieved stable condition.

Our facility is now putting a note on the new console reminding staff not to rewarm at the max rate and not to use the accutrol setting. We have informed the company that changing the default setting is necessary for our facility to accept the new console.

In our discussions with the company, we learned they had identified the following:

This particular error has been identified as a software anomaly that surfaced during beta-site testing of the console in the Accutrol mode. The error is cleared by shutting down and re-starting the machine. It is not a consistent issue and only surfaces once in a while. In any event, a software fix was identified and a revision was implemented just a few weeks ago in all units being tested at "Accutrol" sites.


PHYSICAL MEDICINE

Device:
Type: Stimulator, Muscle, Powered
Manufacturer: Chattanooga Group Inc
Brand: Forte
Model #: FORTE 400 Combo

Problem:

Patient received electrical stimulation to right shoulder. Shortly after application, he reported it was "hot." Device was turned down to comfort level.


Device:
Type: Hip And Knee Arthroplasty Table
Manufacturer: Mizuhosi
Brand: Hana
Model #: 6875
Cat #: #6875

Problem:

The "fracture table" or Arthroplasty table is shaped like an ironing board. The patient's head is at the wide end with the hips at the pointed end. A perineal post is inserted between the legs to prevent the patient from rolling. There is also an abdominal safety strap. The legs are placed in boots with traction applied, and are unsupported from below. This allows the legs to move on pivots to give greater surgical access and improve limb positioning. The patient was 80 Kg. A sheet was placed beneath the patient at the beginning of the procedure to help with transfer back onto a stretcher for extubation at the end of the case. (The table is considered unsafe for intubation and extubation should emergency procedures arise). The perineal post was removed. The feet were removed from the boots and were being held by the surgeon. The anesthesiologist was holding the sheet at the head of the table. There was an RN on each side of the patient. An RN removed the abdominal strap, and turned momentarily to pull the stretcher (which was right beside her) up against the table. When the RN turned and took her hand away from the patient he began to slide to the floor. The weight of his hips was displaced to one side of the point in the table. Because three people were still holding the patient when the 4th RN turned quickly, the patient had a controlled fall/slide to the floor.

The table does not have adequate support or features to ensure safe transfer of patients to a stretcher. The transfer board offered by the manufacturer is difficult to use and has limited instructions for use that do not seem to cover all instances of transfer.

Manufacturer response (as per reporter) for Hana Hip and Knee Arthroplasty table, the manufacturer rep is coming to evaluate the product with us and attend a staff in-service.


ORTHOPEDIC

Device:
Type: Reamer, Orthopedic
Manufacturer: Stryker Orthopaedics
Brand: Bixcut Fixed Head -Modified Trinkle Fitting
Lot #: 0123K754848
Cat #: 0227-6100

Problem:

Stryker reamer Size 10 uncoiled while surgeon was reaming bone. Surgeon stopped surgery to remove all pieces of reamer.

See device image

Size 10 Reamer

Device:
Type: Cannula Delivery System For Cement
Manufacturer: Jupiter Surgical Systems
Brand: Jupiter Low Pressure Delivery System
Other #: Item # JS-LPSDS-01

Problem:

Physician performed a vertebraplasty on thoracic eight and thoracic nine. The physician used the Jupiter Low Pressure Delivery system to gain access and deliver the cement to the proper vertebral body. Upon completion of the case it was noted on the C-arm image that the tip to one of the cannulas was missing. These tips are not supposed to be able to come off. However, the tip broke off in the patient. The patient's incision was already closed and the surgeon had left the room. The patient was still intubated and on the surgery bed. The surgeon was notified immediately and returned to the surgery room. Physician reopened the incision to remove the tip. There was minor harm to the patient.


RADIOLOGY

Device:
Type: X-ray System, Cath/angio
Manufacturer: Siemens Medical Solutions USA, Inc.
Brand: Mpu
Model #: 05904433

Problem:

An injury was noticed by a patient care tech assistant. This was noticed after the procedure. There was blood on the blanket. Initially we thought that the IV pulled out after we moved the patient from exam table to stretcher. Examination of the right hand showed about a 1x1 cm skin break/abrasion on the center back of right hand which might have been caused by moving the patient. The hand may have gotten caught in the gap between the table and stretcher. The side bar of the X-ray exam table has a sharp corner. Usually we cover it with a blanket to prevent such an injury.

See device images

Siemans X-ray table closeup of sharp edge

Siemans X-ray table closeup of sharp edge






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