Highlighted Reports
MedSun: Newsletter #55, December 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 September 1 through September 30 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: Fresenius Medical Care North America
Brand: Continuous Autotransfusion System
*Same device information for all 4 machines

Problem:
C.A.T.S. [Continuous Autologous Transfer System] is a hemo cell saving device used in surgery. Staff started noticing that the scavenged blood (re-infusible blood) was at a much lower than expected volume. Example: scavenge 2700mL but could only return 300mL. Staff also noticed that the blood in the waste bag looked darker and thicker than normal. No changes had been made in accessory equipment such as tubing or fluids. We have 4 machines and problem was not confined to any one of them. The surgical procedure being done didn't seem to affect the reduced volumes. The situation caused increased use of banked blood for multiple patients.
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Health Professional's Impression
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Increased the amount of banked blood patients required due to lower usable volume of scavenged autologus blood.
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Manufacturer response for Autologus blood scavenging device, C.A.T.S.
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Terumo provides customer support - third party servicer. They have come onsite and tested the devices. They cannot determine cause. Terumo states the 4 units should be replaced and are making such arrangements.


Device:
Type: Tube, Tracheostomy (W/wo Connector)
Manufacturer: Spectrum Surgical Supplies
Brand: Jackson Improved
Model#: 34-915

Problem:
Patient had Size 5 Jackson metal tracheostomy with wheel-style inner cannula placed. Respiratory Care called to bedside for trach site care the day after placement of the trach. Unable to remove inner cannula for cleaning - it appeared that the inner cannula was fused in place. Could not remove inner cannula without injury to patient. Clinical Engineering notified of problem--4th instance of this problem at this institution in this year. Dr from SICU [Surgical Intensive Care Unit] notified immediately for trach tube change at bedside. Patient was unharmed, but had delayed discharge due to trach tube needing to be changed out. Clinical Engineering believes there may be a design issue with this "Jackson Improved" style of trach tube, where secretions can seep between the inner and outer cannula and dry up, which makes it difficult to remove the inner cannula.
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Manufacturer response for Jackson Tracheostomy Tube, Jackson Improved
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No response yet.


Device:
Type: Ventilator, Continuous, Facility Use
Manufacturer: Maquet, Inc
Brand: Servo-i
Model#: 6487800
Other #: Compressor-Model #6481779

Problem:
Brand new Servo-i ventilator failed on a patient. The ventilator compressor began overheating and alarming "high temp". Ventilator began producing a "burning smell." The ventilator was immediately removed and changed out with another to prevent patient injury.

It was determined that the burning smell was probably due to the circuit blowing out and not due to the compressor actually overheating and that there were no burn marks on the compressor.
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Health Professional's Impression
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Not sure at this point. Equipment will be serviced by vendor and will not know until after this occurs.
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Manufacturer response for Ventilator, Maquet Servo I Ventilator
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Sending person to hospital to assess equipment.


CARDIOVASCULAR

Device:
Type: External, Defibrillator
Manufacturer: Philips Medical Systems
Brand: Heartstart Mrx
Model#: M3535A

Problem:
An ICU patient went into V-fib while eating breakfast. CPR initiated and crash cart brought to room. Unable to defibrillate the patient. An "X" appeared in a window in the right upper part of the screen on an MRx defibrillator. The nurse manager (NM) attempted to reset but was unable. A second HeartStart was immediately brought to the room. The patient was connected and was defibrillated once with a return of rhythm. A newly-hired ICU patient care technician (PCT) had performed the daily check on the defibrillator earlier in the day and it passed (test strips confirm this). Although the NM instructed this PCT on checking HeartStart defibrillators during her orientation by demonstration and return demonstration of discharging the pads and then the paddles, the PCT stated that she was also oriented by another ICU PCT to check the heart stations by performing an "operational check" on the HeartStart. The day of the event; the PCT performed an operational check on HeartStart MRx and all areas passed. She then did another check seven minutes later on the same HeartStart defibrillator and all areas passed, but the pacer test failed. This created the "X" in the window. The PCT did not notify anyone of the "X" and when the HeartStart was brought to the room 20 minutes later for the code blue, it was discovered. NM interviewed the PCT and had her demonstrate how she performs her daily HeartStart checks on another HeartStart and the same area "failed" and created the "X" in the window. NM was unable to reset and biomed tech asked to come to ICU and evaluate. Tech immediately came to the ICU and identified the problem; the PCT was performing the daily HeartStart check incorrectly using the "operational check" method. She was performing 2 operational checks on both pads and hands-free cable which created the failure with the pacer test.

Biomed took the MRx HeartStart defibrillator used in the code blue to their shop for testing. NM educated this PCT and will re-educate all PCT's and RNs in the ICU that daily HeartStart checks should be done using the "discharge" method and that both pads and paddles are to be checked. No operational checks are to be done by nursing. Biomed will perform the "operational" checks on all heart stations as they always have been. The patient is currently vented and sedated.

No further follow up on HeartStart required from ICU perspective at this time.

Health Professional's Impression: Confusion of proper operation.


Device:
Type: Monitor System, Physiological, Central
Manufacturer: Philips Medical Systems
Brand: Intellivue
Model#: M3155

Problem:
Shortly after upgrading all Patient Information Centers (PIC) of a Philips IntelliVue system seven months ago, the PIC in ICU would intermittently lose the audible portion of alarms (become muted). This usually occurred during the midnight shift. During those times when alarm audio became muted, the clinical staff would enable bedside audible alarms. The on-call Biomed tech would respond to the problem, confirm the audio volume had been set (changed) to "mute" and re-boot the PIC to restore alarm audio. This situation continued intermittently for five months.
Manufacturer response for Monitor System, Physiologic, Central, IntelliVue: Visits by Field Service Engineer. Error and event logs forwarded to factory for analysis.


Device:
Type: Monitor System, Telemetry Central
Manufacturer: Philips Healthcare
Brand: Intellivue
Cat #: M3155

Problem:
On the morning of the event, a Central Monitoring Unit (CMU) tech was reordering the display of telemetry patients on the same care unit. The CMU tech inadvertently switched two patient room numbers, placing patient 'A' in room 236 and patient 'B' in room 235 (in actuality, the patients were in opposite rooms). The CMU tech was changing patient telemetry sectors when she swapped the patients between sectors 5 and 6. Later in the morning, the rhythm for patient 'A' changed as he began to exhibit significant cardiac pauses. Thus, the nursing staff quickly responded to patient 'B' in room 235. After noting that the patient name was different from the telemetry monitor display, the clinical staff raced to room 236 and attended to patient 'A', thereby averting treatment to a wrong patient while another patient was unattended for a potentially life-threatening event. Shortly after stabilizing patient 'A', a nurse noticed that the telemetry patient names did not correspond correctly for the room numbers. CMU was notified of the situation and the error was corrected. Patient 'A' was transferred to CVICU. Verified that a CMU tech did indeed transpose two patient assignments. Lacking an ADT interface (called an HAI interface by Philips); the current manual data entry method does not have a safeguard to ensure data accuracy. Hospital has budgeted for HAI interface and implemented a process of verifying patient and room locations in the Philips central system.

Health Professional's Impression: Product allowed for incorrect correlation of room numbers and patient names.


Device:
Type: Monitor, Physiological Central Station
Manufacturer: Philips Medical Systems
Brand: Intellevue Patient Information Center

Problem:
During monitoring of telemetry patients in our Cardiac Monitoring Unit, the central station display froze and would not allow the keyboard or the mouse control on the central station application. Trouble shooting the system determined that when the user switched from left central display to the right central display via an electronic Keyboard/Video/Mouse (KVM) switch, one of the monitors would lock up preventing the monitoring tech from controlling alarms and display operations. The keyboard and mouse on the M3151 Patient Information Center (PIC) units are of the PS2 connection type. Biomedical also determined that the Central Station kb/mouse control would freeze when devices were disconnected directly from the central station PC. Biomedical confirmed that when KVM switch was activated the new display selected would not have controls. Biomedical then connected the keyboard and mouse directly to the M3151 and rebooted the computer and application to get the mouse and keyboard to operate. Biomedical determined that this is the same action that all PS2 keyboards and mice exhibit when disconnected from their PS2 ports. The same was happening when the user switched the KVM switch. Occasionally the computer would lock up and not allow the user control of the PC based central station.

Biomedical has requested that Philips Medical convert the PS2 style connector to the newer plug and play USB keyboard and mice but the company stated that they had to use what was designed for the product. Biomedical could not locate any service documentation or company information on the Philips web site for the KVM switch that was supplied from Philips.


Device 1:
Type: Monitor, Physiological, Module
Manufacturer: SpaceLabs Heathcare, Inc.
Brand: Ultraview, Command Module
Model#: 91496
Other #: Software version: v2.02.04 with options 1cgnr3

Device 2:
Type: Monitor, Physiological
Manufacturer: SpaceLabs Heathcare, Inc.
Brand: Ultraview Sl
Model#: 91387
Other #: Option: 21808

Problem:
Patient found by nurse in asystole, and monitor did not sound alarm. Code called, unable to resuscitate patient. Post event print out from monitor showed that prior to event, monitor showed patient respirations with artifact. The monitor showed flat line, but obviously the patient was not asystole, because patient breathing and moving. During Code, monitor showed CPR compressions, and post code the monitor alarmed.

Health Professional's Impression: Because monitor did not alarm, Code may have been delayed for patient in asystole.


CLINICAL CHEMISTRY

Device:
Type: Vacuette 2ml Green Tubes
Manufacturer: Greiner
Brand: Vacuette
Lot #: 2200266
Cat #: 454237
Other #: B061006

Problem:
After receiving approximately eight contaminated blood samples, lab personnel tested tubes and determined they were contaminated. It appears that tubes contained wrong anticoagulant. Approximately 500 tubes were internally recalled for return to vendor. No patients were injured as result of this.
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Health Professional's Impression
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contaminated lot
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Manufacturer response for vacuette 2ml Green tubes, vacuette
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Have replaced product. Unknown if they have done internal investigation of product.


GASTROENTEROLOGY & UROLOGY

Device:
Type: Light Source
Manufacturer: Stryker Endoscopy
Brand: Stryker
Model#: X8000

Problem:
Light source went from automatic to full spontaneously. Setting for light source was on standby. The camera setting was on Laparoscopy specialty. Light source was plugged in, placed on standby and a couple of minutes later noted to be on.
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Manufacturer response for Light source, X8000
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Asked Stryker to come and evaluate device.


GENERAL & PLASTIC SURGERY

Device:
Type: Instrument, Surgical
Manufacturer: Medtronic Xomed
Brand: Incrementing Probe With Standard Prass Tip
Lot #: 67770800
Cat #: 8225825E

Problem:
The incrementing probe with standard prass tip lot# 6777800 does not seat in to the Nim machine holder to work. If you line the arrows up the instrument does not seat in to the holder. Informed RN and pulled these lot numbers from machine number. Opened a new one with lot# 67770400. It seated just fine.


Device:
Type: Needle Holder
Manufacturer: Teleflex Medical
Brand: Bulldog
Model#: 511136

Problem:
During open heart procedure (CABG), the surgeon placed the first stitch onto the graft using the needle holder. When he went to pick up the needle for the next stitich, the needle holder would not grasp the needle. Upon closer examination, it was noted that a small piece of metal was missing from the grasping part of the needle holder. Exhaustive search of the patient's surgical area was done including: manual, radiology, and use of a sterile magnet across the field. The metal piece could not be located. Disclosure was made to patient/family.

There must have been a small fracture in the metal of the needle holder that was not detectable by the naked eye during routine cleaning or by the routine PM's we have done on the equipment.


Device:
Type: Stapler, Surgical
Manufacturer: Ethicon Endo Surgery, Inc.
Brand: Endoscopic Curved Intraluminal Stapler
Model#: ECS 29
Lot #: G4RY8F
Cat #: ECS 29
Other #: 29mm

Problem:
OR Tech reports patient in OR undergoing left hemicolectomy and sigmoidectomy using the EEA Endopath ILS endoscopic curved intraluminal stapler. When the surgeon attempted to close the handle to fire the stapler the black plastic handle cover fell off of the handle. The surgeon was able to complete the case as the stapler remained functional and there was no patient harm. Unsure why plastic cover handle fell off as the bottom one remained intact. Broken handle was accidentally disposed of in the trash but stapler itself is available for evaluation purposes. After breakage surgeon did check the patient's colon reanastomosis to make sure the stapler had worked appropriately and pulled the excess "donut" pieces out and they were intact and complete. We believe the black plastic handle is for appearance and comfort only as the stainless steel handle beneath it is quite substantial.
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Health Professional's Impression
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Handle broke


GENERAL HOSPITAL

Device:
Type: Broviac Catheter
Manufacturer: Bard Medical Division
Brand: Broviac Catheter
Lot #: REUA0022

Problem:
Arrived on unit to assess new broviac catheter placed and do teaching with parent. The bedside nurse indicated catheter was leaking and that the patient's chest was swollen subsequent to attempted infusion. The patient was required to return to OR for placement of broviac catheter. There is a small hole in the line. The physician does not believe the hole was caused during the attempt to access to the line, but cause remains unknown.


Device:
Type: Catheter, Picc, Introducer
Manufacturer: Becton Dickinson and Company
Brand: Bd L-cath Picc And Bd Splittable Needle Introducer
Lot #: 9334052
Other #: Reference Number: 384061

Problem:
The introducer needle was inserted and able to insert PICC to hub. The introducer needle was withdrawn, but would not peel away. When attempted to peel, the needle broke off one side, but would not peel away. In attempts to peel away the needle, the catheter was punctured necessitating removal of the catheter and an additional venipuncture for the patient.


Device:
Type: Catheter, Port, Implanted
Manufacturer: Angiodynamics Inc.
Model#: MP-P5SAT
Lot #: 503882


Problem:
Patient scheduled to have a mediport dye study for assessment of mediport. This study was being completed due to the fact that the parents, homecare, and outside hospital were not having success with blood returns even with interventions such as altepase. After mediport accessed and an image was taken, it was noted by MD that the catheter was detached from the mediport. The tubing and port were removed and was replaced with new line.


Device:
Type: Custom Breast Support
Manufacturer: VanArsdale Innovative Products Inc.
Brand: Vip
Model#: VIP-CBS-11
Other #: Hospital PO number 1C1375606

Problem:
Patient got a burn below left breast from custom breast support remaining too hot. It is believed that the sponge frame contained too much hot water."
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Health Professional's Impression
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Hot water is necessary to form the breast support. The hot water may not have been entirely squeezed out of sponge frame.


Device:
Type: Incubator, Infant
Manufacturer: General Electric Healthcare
Brand: Giraffe Incubator

Lollipop Icon

Problem:
A loud noise and sparks were seen coming from the electrical outlet behind an isolette in the NICU. Upon inspection, there was a frayed area that had made a hole through the cord connected to the isolette plug.

BioMed contacted the manufacturer of the isolette. The manufacturer had changed the way they wrap the cord. There will be a design change made for future models.
Velcro straps were added to the cords of current isolettes.


Device 1:
Type: Infusion Pump Control Unit
Manufacturer: CareFusion 303, INC.
Brand: Alaris System
Model#: 8015

Device 2:
Type: Pca Pump Module
Manufacturer: CareFusion 303, INC.
Brand: Alaris
Model#: 8120

Problem:
An oncology patient was being infused morphine through the Alaris system PCA pump. The original volume to be infused was 30cc placed in a 35cc syringe. After aproximately 45 minutes from the syringe being hung, the nurse noticed the patient coming out of the bathroom with the pump alarming. It was noted that there was approximately 5cc left in the syringe.

Due to the pump's Guardrails dose error reduction software, the pump could not have been programmed to infuse at the rate needed to the empty the syringe in so short of a time. The pump's door and locking mechanism do not appear to have any damage.

When closing the door of the pump, there is a point where the door is hitting the door closed sensor and the pump is reading the door as closed (does not alarm, allows infusion), but the door latch is not securing the door. In this instance, the pump will infuse as normal and the door will appear secure. In fact, the door will stay closed if the pump is picked up and walked across the room. However, the door is not latched and only a little pressure is needed to open the door.

Two other PCA modules were tested. Both modules also had the same issue where the door could be closed and the pump read the door as closed, but it was not latched.
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Health Professional's Impression
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Patient had manipulated the pump in order to self medicate


Device:
Type: Infusion Pump, General Purpose
Manufacturer: Hospira Inc
Brand: Symbiq
Model#: 16026-04-83

Problem:
An ICU RN hung the initial 22:00 dose of Xigris IV piggyback per protocol, programmed IV pump and left room. Returned at 23:00 to check blood sugar and IVs; realized entire bag had infused. Rechecked Xigris rate and discovered the pump was programmed to infuse the 13.6ml rate as 13.6mcg. RN assessed patient, no bleeding found, no changes in skin tone, and neuro status. Notified ACL (attending clinician) and hospitalist. Hospitalist at bedside to assess patient. Call made to pharmacy for further instructions and ICU interventionist made aware. Post 24 hours from event, patient found to be unharmed. Complete blood count (CBC) drawn at 00:00 and 05:00, unchanged from previous. No changes in patient's condition and patient reported feeling good. Xigris held until next scheduled dose of 06:00.


Device:

Type: Phototherapy, Neonatal
Manufacturer: Datex Ohmeda/GE
Brand: Biliblanket Plus High Output
Other #: REF: 6600-0656-801

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Problem:
The patient was in a breastfeeding position when mother noticed one superficial linear abrasion along with two red linear marks on the right inner thigh. The abrasion appeared to be a scratch. Upon removing the paper covering on the tubing of the Omeda bili-blanket, it was noted by RN that the plastic cover of the Omeda phototherapy tubing was separated from the bili-blanket. A hole was noted on the outer covering and a firm piece of plastic was protruding. That bili-blanket unit was immediately replaced with an intact unit.
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Health Professional's Impression
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According to the biomedical technician, the integrity of the protective sheath on the proximal (patient-end) end of the tubing was compromised exposing a sharp protrusion (material not known/available). The exposed tip scratched the infant and caused minor injury.


Device:
Type: Picc Line
Manufacturer: Bard
Brand: Picc Single Lumen
Lot #: REUC1451
Cat #: 3174108

Problem:
During the insertion of the line into the right brachial vein, staff noted that the guide wire was not threading smoothly. The guide wire appeared to be stuck and once the stylet was removed, the guide wire remained in place. It appeared as though the product uncoiled allowing the guide wire to separate from the flexi-tip, which allowed the guide wire to remain in the patient's subcutaneous tissue. A surgery consult was obtained and the guide wire was successfully removed.

It appeared as though the product uncoiled, allowing the guide wire to remain in the patient's tissue.


Device:
Type: Smart Site Infusion Set
Manufacturer: CareFusion
Brand: Alaris
Other #: ref # 2420-0007

Problem:
Intralipid tubing found on floor beside patient bedside. Tubing disconnected spontaneously, staff did not state exactly where disconnected but looking at tubing looks like tubing disconnected from needle free valve port, needle free valve port not included in this tubing that was saved.


Device:
Type: Warmer, Infant Radiant
Manufacturer: GE Healthcare
Brand: Ohio Infant Warmer System
Model#: 4400

Lollipop Icon

Problem:
Infant placed in warmer with temp probe in appropriate place and well adhered. Setting changed to skin(servo) as per protocol. Warmer adjusted to temp of 35.6 C. Within 1/2 hr infant noted to be very red on entire back where exposed to radiant heat. Pt temperature on warmer read 35.6 C. Warmer was putting out full heat. Warmer turned off immediately, infant cooled with cool water and placed in isolette. Infant's color on back returned to normal within 30 minutes.
The temperature probe was retrieved by BioMed the next day to use for testing with the warmer and no problems were identified. They were unable to replicate any malfunctions with the system. No other means of temperature monitoring was used on this infant. The temperature probe was taken to the isolette with the infant and functioned correctly. Question whether an actual problem with the equipment or if the infant simply had hyper-reactive skin to the radiant heat. No problems developed after this incident with the infant.


NEUROLOGY

Device:
Type: Catheter, Thrombus Retriever
Manufacturer: PENUMBRA INC.
Brand: Penumbra
Model#: Reperfusion Catheter 032
Cat #: psc032

Problem:
The patient is a middle-aged woman with little medical history and apparently no medications previously, who presented to the emergency room last month with symptoms of acute CVA. She was evaluated emergently per the code stroke protocol and given t-PA for her symptoms suggestive of acute uncomplicated stroke. She was refractory to t-PA and taken for angiography and attempted aspiration of an MCA distribution clot the following day. Each time the clot was aspirated, the area rethrombosed, and ultimately, the procedure was abandoned. She went on to infarct that area of her brain and developed malignant cerebral edema requiring craniectomy procedure, also this day. The patient has had a stormy hospital course with issues, including inappropriate antidiuretic hormone secretion syndrome (SIADH), pleural effusion, hospital pneumonia, and what appears to be a state of coma with respiratory failure requiring full ventilator support. She remained on norepinephrine vasopressor to maintain a target mean arterial pressure for adequate perfusion of her brain until family chose to make the patient a DNR and have life support removed.

At pathologic exam, the pathologist noted that the patient appears to have material in the cerebral vessel. There has been recent literature suggesting that hydrophilic polymer emboli can result from diagnostic cerebral angiography (Modern Pathology, (2010)23: 921-930). The pathologist is questioning if the material in this patient's vessels was the result of polymer shedding from the catheters used during the cranial angio. (Several catheters and guidewires from a variety of manufacturers were also used).
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Health Professional's Impression
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There has been recent literature suggesting that hydrophilic polymer emboli can result from diagnostic cerebral angiography (Modern Pathology, (2010)23: 921-930). The pathologist is questioning if the material in this patient's vessels was the result of polymer shedding from the catheters used during the cranial angio.
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Manufacturer response for cranial reperfusion catheter, Penumbra
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The neurointerventionalist contacted the manufacturer after speaking with the pathologist regarding findings of material in the cranial vessels.


Device:
Type: Holder, Head, Neurosurgical (Skull Clamp)
Manufacturer: PRO MED INSTRUMENTS, Inc.
Brand: Doro
Other #: Doro MRI compatible Head Fixation Device

Problem:
Patient's head positioned in MRI neuro headrest (Doro Fixation Device) with pins. Immediately after positioning the head slipped and one of the pins caused a laceration adjacent to the pin site. The laceration was sutured and the patient's head repositioned for sub-occipital craniotomy.


OBSTETRICS/GYNECOLOGY

Device:
Type: Clamp, Circumcision
Manufacturer: Centurion Medical Products
Brand: Circlamp
Lot #: 2010042601

Lollipop Icon

Problem:
This involved a infant undergoing circumcision by OB/GYN. MD placed clamp, tightened it, and began procedure. About half way through circumcision the clamp slipped causing a penile laceration. A urologist was contacted and repaired the laceration with sutures.
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Health Professional's Impression
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The clamp slipped and caused a laceration which required sutures.


ORTHOPEDIC

Device:
Type: Prosthesis, Hip, Metal/polymer
Manufacturer: Stryker
Brand: Custom Device
Model#: SHELL ACETB TRDNT E OD54MM HMS

Problem:
Patient for right hip replacement Femoral head trials were performed sequentially until adequate soft tissue tension, range of motion, stability and leg length were visualized intraoperatively. Upon placement of a 5 trial head there was excellent stability in the range of motion. Upon routine dislocation however, physician was unable to locate the femoral head trial. Several attempts made to locate the head with C-Arm (fluoroscopy) guidance and the trial head could not successfully be retrieved. To be safe, given the neurovascular structures within and since the trial head had migrated, a decision to remove the trial implant with an additional incision was made and performed by two other surgeons who quickly and efficiently located and removed the trial head via separate incision using a retroperitoneal approach.

By design the trial head is to come off, the purpose of this report is to warn of this possibility and the potential migration of the device into the retro peritoneum as it did in this case.


PHYSICAL MEDICINE

Device:
Type: Medication Cart
Manufacturer: InterMetro Industries Corp.
Brand: Lionville Lock Alert Ii
Model#: 800 series

Problem:
The batteries are not able to charge due to power supply failure which causes the cart not to function. Patient care is adversely affected because medication can not be distributed to patients in a timely manner due to maintenance constantly being performed on medication carts.
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Manufacturer response for Medication Cart, Lock Alert II
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The manufacturer sent a replacement power supply and wiring harness.


Device:
Type: Nurse Call System
Manufacturer: RAULAND-BORG CORPORATION
Brand: Responder
Model#: Responder IV
Other #: FAMS - Fire Alarm Module

Problem:
Biomedical engineering responded to a call from a nursing unit in our new bed tower concerning intermittent "AUX" alarms. Investigation revealed two Rauland "FAMS" (fire alarm module)that were hot to the touch. Removal of the "FAMS" restored normal function. The "FAMS" had been "ty-rapped" together during installation. The vendor service rep replaced the devices and noticed that when the "ty-rap" was cut, the RJ-45 connector pins had pushed through the heat-shrink insulation on both "FAMS". These punctures resulted in an unintended electrical connection between the devices. Last week, one of our biomedical techs compared the construction of a faulty "FAM" to a NCSSPLIT4 from the same manufacturer and noticed that Rauland has incorporated a piece of puncture-resistant insulating material into the splitter insulation. The tech has speculated that perhaps someone at Rauland recognized the potential for problematic punctures in the production packaging of the splitter. However if that is true, it was not applied to the production of "FAMS". Our facility has 440 of these devices in use currently in our new bed tower.

See device image:
RJ-45 connector pins pushed through the heat-shrink insulation on the FAMS.



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Lollipop IconSpecial 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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