Highlighted Reports
MedSun: Newsletter #75, August 2012

This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period May 1 through May 31, 2012. 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.

CARDIOVASCULAR

Device 1:
Type: Pacemaker, External, Temporary
Manufacturer: Medtronic, Inc.
Brand: 5348 Single-chamber
Model#: 5348

Device 2:
Type: Cable, Pacemaker, Disposable
Manufacturer: Remington Medical, Inc.
Brand: Adap-2000
Model#: ADAP-2000

Problem:
The nurse was attempting to insert a pacemaker adapter cable into the pacemaker. Adapter had obvious malformation that prohibited cable from fully inserting into the pacemaker.


Device 1:
Type: Cable, Pacemaker, External, Single Use
Manufacturer: Medtronic Cardiac Rhythm Disease Management
Model#: 5487
Lot #: 5015301

Device 2:
Type: Cable, Pacemaker, External, Single Use
Manufacturer: Medtronic Cardiac Rhythm Disease Management
Model#: 5487
Lot #: 5015401

Problem:
Patient was brought to Cath Lab dependent on pacing, for placement of a semi-permanent pacer for complete heart block. Right ventricular (RV) pacing lead (Medtronic Novus) was placed in the RV apex. Pacing threshold through analyzer was less than 1v at 0.4 ms. Lead was attached to the Medtronic cable to the pacing box, but no capture, no spikes. Second pacing box was tried, no capture, no spikes. Medtronic cable was replaced with a second Medtronic cable, again with no capture and no spikes. A third Medtronic cable was then opened and attached, which worked. Nothing different was done when attaching the third cable than when attaching the previous two. After these events a similar sequence of events with another patient was described anecdotally, however at this time we do not have specifics on the second case.


Device:
Type: Cardiovascular Procedure Kit
Manufacturer: Navilyst Medical, Inc.
Brand: Namic Left Heart Kit
Model#: 197002002
Lot #: GFWB1443
Other #: Product packed inside L Heart Kit

Problem:
At the end of the case the guidewire was being wiped with a sponge moistened with heparinized saline. When the sponge was observed after wiping the guidewire, a green colored residue was noted on the sponge. The process of wiping the guidewire with a sponge was repeated and more green colored residue was observed on the sponge. The guidewire and sponges were saved. Packaging for this guidewire was not saved. Customer Service at the company was notified and guidewire/sponges will be returned to the company for investigation.


Device:
Type: Cardiovascular Procedure Kit
Manufacturer: Navilyst Medical Inc
Brand: Namic Left Heart Kit
Lot #: GFWB1443
Cat #: 19700202

Problem:
A staff member opened a left heart kit and opened the packaging and used a 3 mm J angiographic guidewire, Navilyst brand. When wiping the guidewire with a 4x4 that was moistened with heparinized saline, a green colored film was noted on the 4x4. The guidewire was looked at closely and staff noted that the guidewire appeared green in color. Customer Service at Navilyst was contacted and this report was added to the previous report. The guidewire and 4x4 will be sent to Navilyst for further inspection.


Device:
Type: Catheter, Continuous Flush
Manufacturer: Micro Therapeutics, Inc. Dba Ev3 Neurovascular
Brand: Marathon
Model#: 105-5055
Cat #: 105-5055

Problem:
Patient with a complicated history including a ruptured posterior fossa arteriovenous malformation status post (s/p) posterior fossa craniotomy and intraparyenchymal hemorrhage evacuation. Eleven days earlier the patient went to the for an endovascular treatment of an arteriovenous malfunction (AVM). Per dictation, " ...following termination of the Onynx-18 infusion, the physicians prepared to withdraw the microcatheter from the patient. Using gentle traction, while aspirating on the catheter, physician attempted to withdraw the microcatheter from the patient. As they exerted additional force on the microcatheter, the superior cerebellar artery appeared to deflect from its baseline position. Under constant fluoroscopic guidance, traction was maintained on the microcatheter. It was then noted that there was a sudden decrease in tension of the microcatheter, which had fractured in the proximal vertebral artery. The proximal portion of the microcatheter was thus free and removed from the patient. The retained portion of the microcatheter remained in place in the left superior cerebellar artery, adherent to the Onyx. The 6-French groin sheath was left in place with the plan for future intra-operative angiogram."


Device:
Type: Catheter, Intra-aortic Balloon
Manufacturer: Datascope Corp.
Brand: Sensation
Model#: Sensation
Cat #: 0684-00-0469-01

Problem:
Surgeon inserted the IAB catheter with some difficulty. When Respiratory Therapy hooked the device up to the monitoring console no readings were obtained and the device would not calibrate. Fluoroscopy was used to assist in visualizing the placement. This did not yield satisfactory results and the catheter was removed from the patient. No visible signs of damage to the catheter were noted post removal.


Device:
Type: Catheter, Intra-aortic Balloon
Manufacturer: Arrow International, Inc.
Brand: Ultraflex
Model#: IAB-06840-U
Lot #: KF2032806
Cat #: IAB-06840-U

Problem:
The intra-aortic balloon catheter (IAB) ruptured when initial gas filling was occurring. A visual of red foamy substance in the gas port on the balloon was noted. The defective IAB and sheath removed as one unit. New sheath and IAB were inserted after the defective IAB and sheath were removed. Unable to remove the ruptured balloon out of the sheath so the whole unit was removed altogether.


Device:
Type: Device, Percutaneous Retrieval
Manufacturer: Cook Medical
Brand: Günther Tulip
Model#: GTRS-200-RB
Lot #: 3098415
Cat #: G13287

Problem:
Doctor was doing a vena cava filter removal. The end of the retrieval device broke off which is the wire. The wire is in the filter. Doctor could not retrieve the filter or wire. The package and the rest of the retrieval device were given to the Supervisor.


Device:
Type: Snare, Percutaneous Retrieval
Manufacturer: ev3
Brand: Amplatz Gooseneck
Model#: GN2500
Lot #: 9557678

Problem:
Patient undergoing Mediport revision in Interventional Radiology. During the procedure when inserting the Amplatz microwire snare, it was noted that the radiopaque marker at the tip of the wire was no longer seen by fluoroscopy. The wire tip was identified in the right atrium then right ventricle and will likely lodge in the patient's lung.
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Manufacturer response for Goose neck snare, 6.0 Fr Snare Catheter 120cm x 25cm x 102cm (per site reporter)
======================
Not known at this time.


Device:
Type: System, Laser, Transmyocardial Revascularization
Manufacturer: Cardiogenesis Corporation
Brand: Sologrip Iii
Lot #: TA-03733
Other #: 705-37020

Problem:
Physician using Cardiogenesis Sologrip III Handpiece Delivery System. Wire adjacent to handle burned two holes in physician's gown at his chest area. Substituted device with another Cardiogenesis Sologrip III Handpiece. Procedure completed without further incidence. No untoward patient effects. Physician not injured. The calibration for this device is 47%.


Device:
Type: Transducer, Blood-pressure, Extravascular
Manufacturer: ICU Medical, Inc
Brand: Neonatal Disposable Transducer Kit
Cat #: 42634-05

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Problem:
While performing hourly patient temperature/assessment at 0200, RN noticed blood backing up from blue lumen of UVC (umbilical vessel catheter) into tubing. RN assessed all parts of the line to make sure that all connections were tight, when RN noticed TPN/lipids leaking from where the stopcock met the transducer. RN changed the stopcock that immediately preceded the transducer thinking that the stopcock had a crack. RN then flushed the line to find that the IV fluid was still leaking from where the stopcock and transducer met. RN changed the entire transducer line and the problem was resolved.
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Manufacturer response for IV Kit, Transpac IV Monitoring Kit Neonatal, 12", 3 Stopcocks, Disposable Transducer, 30 Ml Squeeze Flush (per site reporter)
======================
awaiting response


Device:
Type: Tubing Set, Contrast Injection
Manufacturer: Medrad, Inc.
Brand: Avanta Fluid Management System
Model#: AVA 500 MPAT
Lot #: 113801

Problem:
During set up of the multi-patient disposable set for the Medrad injector, the vent cap fell off, which could have caused the contrast to leak had it happened during a case. Unit was taken down and a new one from the same lot was used and worked fine.


EAR, NOSE, & THROAT

Device:
Type: System, Vocal Cord Medialization
Manufacturer: Bioform Medical Inc.
Brand: Radiesse Injection Needle
Lot #: LOG247665
Cat #: 8044MO

Problem:
Physician was attempting to inject and medialize the true vocal cords. The injection needle malfunctioned/became clogged and was not useable.

GASTROENTEROLOGY & UROLOGY

Device 1:
Type: Light Cable
Manufacturer: Lumitex Medical Devices, Inc.
Brand: Light Mat Ultra-thin Flexible
Lot #: I01802
Other #: Ref# UA2550

Device 2:
Type: Light Sources, Xenon
Manufacturer: Integra LifeSciences Corp.
Brand: Luxtex Mlx
Model#: MLX

Problem:
During a surgical procedure a surgical illuminator was connected to a Luxtex light source. The surgical illuminator was a Light Mat, mfg, LumitexMD Inc. Ref# UA2550 Lot# I01802. The circulating nurse noticed an electrical burning smell that continued to get worse. She discovered the cord from the surgical illuminator was smoking. She went to remove the cord and as she grabbed the cord to remove it from the light source, she burned her fingers. The metal connection of the surgical illuminator was very hot.
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Manufacturer response for Light Sources, Xenon, Luxtex MLX (per site reporter)
======================
They told us we are not using their illuminator so it is our problem.


Device:
Type: Ng Feeding Tube
Manufacturer: Neomed
Brand: Tube, Feeding, Neomed
Model#: FTL8.0S-EO
Lot #: 20111104

Problem:
During a routine x-ray viewing that the nasogastric (NG) feeding tubes were not showing up on the X-rays. Hospital contacted Neomed at the time and Neomed indicated they had heard of the issue from another institution. They asked facility to remove several lot numbers from use. Facility removed all lots and was sent new materials. However, as of yesterday, there are still issues viewing the radio opaque stripe on the x-ray film.


Device:
Type: Suturing Device
Manufacturer: Covidien, Formerly US Surgical, A Division of Tyco Healthcare
Brand: Endo Stitch
Model#: 173016
Lot #: N9A64
Cat #: 173016

Problem:
Endo Stitch was being used during a Laparoscopic Hysterectomy. During the cuff closure, an Endo Stitch needle was lost during removal at the trocar and had obviously become detached from the instrument. Needle was not located during search of abdomen or external sterile field. Staff had concerns that the needle would not show on an X-ray due to the size of the needle.


Device:
Type: Tube, Feeding, Syringe
Manufacturer: Ameritus Medical Products
Brand: Syringe, Ameritus, Oral, Enteral
Model#: AEG30-KMS 30 ml
Lot #: 20120210 201501

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Problem:
A new enteral Ameritus feeding tubing system was put in place in the NICU. The tubing was attached to the syringe securely and attached to connecting tubing and the feeding was started. However, feeding was noted to have leaked out of an apparent hole or crack in the syringe. After investigating, the nurse noticed that there was a leak in the feeding syringe. The nurse felt a rough edge on the rim of the syringe where the (male) pointed infusion hole lies. There may have also been a pin hole or crack in the syringe, but it could not be clearly seen. The male female connection from the syringe to the feeding tubing was secure and not backing out through the connection as if it was blocked. In fact, the feeding tubing was flushed without difficulty. Again, it appeared to be a problem with the actual syringe leaking. As a result, a new syringe and extension set was hung and infused without difficulty. There was no harm to the patient.


GENERAL & PLASTIC SURGERY

Device:
Type: Clip Applier
Manufacturer: Covidien
Brand: Endo Clip Auto Suture Clip Applier
Model#: REF 176620
Lot #: N1H0889X

Problem:
During a laparoscopic lobectomy, a 5mm endoclip clip applier made by Covidien with reference #176620, and lot# N1H0889X was used. The clip applier was placed on a larger artery, which fed the lobe of the lung which was being removed. The clip from the clip applier dislodged from the applier halfway. The clip clamped on the artery but would not completely come free from the applier.


Device:
Type: Sealing Device
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Enseal Trio
Model#: ETRIO335H
Lot #: H43Z60E
Cat #: ETRIO335H

Problem:
During the procedure, the surgeon noted that after he deployed the EnSeal, the blade between the jaws snapped. The surgeon noted that there were dense adhesion's midline; however it is unknown whether this contributed to the device breaking. A new device was obtained and utilized without incident. It is unknown whether the new device was of the same, or a different, lot. There were no adverse effects to the patient.


Device:
Type: Sealing Device
Manufacturer: Covidien, Formerly Valleylab, A Division of Tyco Healthcare
Brand: Ligasure Atlas
Model#: LS1037
Lot #: SIC0019X
Cat #: LS1037

Problem:
LigaSure device was being used when the unit's jaw would close, but the unit would not cauterize. Unit was functioning normally outside of patient's body. A new LigaSure was opened and functioned as designed by the manufacturer.


Device:
Type: Sponge, Gauze
Manufacturer: Medline Industries, Inc.
Brand: Medline Accu-sort Gauze Sponge Usp Type Vii Gauze
Other #: Reorder NON21428

Problem:
There has been a packaging change for the Medline gauze sponge Type VII (4X4) from a soft container to a hard container (see pictures). This packaging change is similar to the packaging of the Raytec safety sponge from another manufacturer. The Medline is not radiopaque and the Raytec sponge is radiopaque. Staff could inadvertently utilize the wrong sponge when radiopaque is needed. Health professional comment: The non-radiopaque sponge material packaging is now similar to the radiopaque sponge packaging. If the two products are mixed up on the sterile field we could have a non-counted sponge used in a wound and perhaps left behind because it is a dressing material, not counted and it does not have a radiopaque strip on it for easy identification in a post-op x-ray.
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Manufacturer response for gauze sponge, Medline Accu-Sort gauze sponge USP Type VII Gauze (per site reporter)
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No response from manufacturer.

See device images:

Top View of the Medline Gauze sponge package label as compared to the Raytec safety sponge from another manufacturer.  Medline Gauze sponge package label is on the left side; the other manufacturer's sponge package label is on the right side.

Angled View of the Medline Gauze sponge package as compared to the Raytec safety sponge from another manufacturer.  Medline sponge package is on the left side; the other manufacturer's sponge package is on the right side.  Both packages are similarly designed in appearance and in size - both are white plastic containers.

Side View of the Medline Gauze sponge package as compared to the Raytec safety sponge from another manufacturer.  Medline sponge package is on the left side; the other manufacturer's sponge package is on the right side.  Both packages are similarly designed in appearance and in size - both are white plastic containers.


Device:
Type: Stapler, Reload, Surgical
Manufacturer: Covidien, Formerly US Surgical, A Division of Tyco Healthcare
Brand: Endo Gia Universal Roticulator
Model#: 030450
Lot #: N0H0131
Cat #: 030450

Problem:
The surgeon was performing a chest exploration. During the procedure, he was able to confirm the need for a lobectomy. He was using staples for dissection and separation of vasculature. Several loads were used during the procedure. However, while he was using the gun on the pulmonary artery, the surgeon reports the gun misfired. The surgeon discovered the misfire when he was pulling the gun back and the pulmonary artery tore. The patient lost a significant amount of blood and became hypotensive. The artery was repaired, and the patient was transferred to the ICU for recovery.


GENERAL HOSPITAL

Device:
Type: Catheter, Intravascular
Manufacturer: Teleflex Inc,
Brand: Arrowgard Blue Plus Quad-lumen Cvc
Model#: AK-45854-SK
Lot #: RF1117405 120711 1154
Cat #: AK-45854-SK

Problem:
Physician was placing central line. After placing the line it was noticed that one of the ports was leaking. It was the white proximal port below the hub. The port was clamped and labeled not to use and was saved once the device was discontinued.


Device:
Type: Catheter, Intravascular
Manufacturer: Becton Dickinson
Brand: Saf-t-intima
Lot #: 2060135
Cat #: 383323

Problem:
While the nurse attempted IV insertion with BD Intima catheter, the safety did not engage and the needle came out disconnected from the catheter. Blood flowed from the catheter.


Device:
Type: Catheter, Picc
Manufacturer: Bard Access Systems, Inc.
Brand: Groshong Picc
Model#: 7717307
Lot #: REVK1172

Problem:
Called to evaluate patient's PICC for Alteplase administration due to sluggish flush and absent blood return. The nurse reported that the PICU nurse had reported lack of blood return on transfer two days prior, but no action had been taken. On my assessment, I was unable to flush the catheter at all, but was able to obtain blood return. I spoke with Physician who recommended hub replacement, stating that he has had multiple instances (>10) of 3 Fr PICC's that will not flush, but aspiration is possible. Replacement of the hub restores patency. Another nurse also experienced this and has contacted the manufacturer. Awaiting feedback once details are sent. Two hubs have been saved for return to Bard.


Device:
Type: Set, Blood Transfusion
Manufacturer: B.Braun
Brand: Infusomat Space Pump Y-type Blood Set
Cat #: 490043

Problem:
The nurse reported that a B.Braun Infusomat space pump Y-type blood set leaked above the drip chamber where the two tubings meet. The nurse was priming the tubing with normal saline for blood transfusion when she noticed that fluid was leaking just above the drip chamber. The tubing was sequestered and given to the Risk Manager. Unfortunately, the packaging was not saved.


NEUROLOGY

Device:
Type: Shunt, Central Nervous System
Manufacturer: Integra Lifesciences Corporation
Brand: Accudrain
Cat #: INS-8400

Problem:
The patient had a PICC line and an EVD (external ventricular drain) line in place. The patient was in the MRI suite for an exam with contrast. The Radiology tech intended to inject the contrast dye into the PICC line. Instead, the tech accessed the EVD port and injected the dye into the EVD system. The EVD system was set up to drainage. Contrast dye was inadvertently injected into both the brain and the drainage bag. The event was discovered immediately. The physician was notified. MRI images indicate that some dye was present in the brain ventricles. The patient was monitored closely and had no adverse reactions. The plan of care did not change and there was no patient harm.

This event is an unintended Luer misconnection. The tubing on the EVD system near the port is clearly marked and highlighted yellow to bring attention to the port and its intended use. However, the syringe Luer has no engineered properties that physically prevent the Luer connection. In this case, the radiology tech did not trace the line to its origin. Because the patient was on the MRI table, all lines, both the PICC line and the EVD line, were positioned up toward the patient's head. The injection ports on the PICC line are visually similar to the port on the EVD system except that the EVD system has bright yellow marking on the tubing leading up to and coming away from the EVD port.

All staff involved in this event is experienced in performing an MRI with contrast. It is more common to have a patient with an IV line or PICC line in the radiology department than it is to have a patient with an EVD. There was a false sense of reassurance that the port was correct. We have changed our practice to require all techs to trace the line to its source of origin before injecting dye. We have not had an event like this in the past.


ORTHOPEDIC

Device:
Type: Drill Bit
Manufacturer: Arthrex, Inc.
Lot #: 466474A
Cat #: AR-1360B-CP

Problem:
Surgeon was using drill bit that was labeled at 6cm intending to drill a hole in that diameter. The hole appeared bigger and the 6cm screw would not fit. The drill bit was measured and was actually 9cm. Surgeon proceeded to use screw to fit the 9cm hole.


Device:
Type: Spinal Vertebral Body
Manufacturer: NuVasive, Inc.
Brand: Cordent Xl
Lot #: 6908850

Problem:
The cage was to be implanted in spine post spinal tumor removal. Two cages broke during implantation. One cage retrieved entirely but in two pieces; the second cage retrieved in multiple pieces with one piece irretrievable and remaining in patient. Third cage (from different vendor) implanted.


RADIOLOGY

Device 1:
Type: Mri Scanner
Manufacturer: GE Healthcare
Brand: Signa Hdxt
Model#: Signa HDxt 1.5T
Cat #: 2416758
Other #: last upgrade Sept-Nov/2011

Device 2:
Type: Electrode, Ecg, Mri
Manufacturer: Covidien, Formerly Ludlow, A Division of Tyco Healthcare
Brand: Medi-trace
Model#: 850 Series
Lot #: 026718
Cat #: 22853
Other #: 900400 (Medi-Trace)

Device 3:
Type: Monitor, Physiological, Mri
Manufacturer: MedRad, Inc.
Brand: Veris
Other #: 10434

Problem:
Patient had outpatient MRI and was discharged. Patient returned as an inpatient 7 days later. Burns were reported by the patient at that time. Burns were on chest in areas where electrodes were applied.
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Manufacturer response for MRI Scanner, Signa HDxt (per site reporter)
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On site evaluation of equipment by GE. GE reports no problems when doing test and calibrations.
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Manufacturer response for Monitor, Physiological, MRI, Veris (per site reporter)
======================
An investigation questionnaire was completed. Follow up recommendations were received.
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Manufacturer response for Electrodes, ECG, MRI (per site reporter)
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Manufacturer requested sample product from the same lot numbers to be returned to them for evaluation.

Device:
Type: Dosimeter, Radiation, Diode Detector
Manufacturer: Sun Nuclear Corporation
Brand: Qed
Model#: QED Scatter 11300-2
Problem:
Upon removal of dosing diodes from patient's skin, a blister were noted at the site of one of the diodes.

Device:
Type: Mri Scanner
Manufacturer: GE Healthcare
Brand: Signa Hdxt
Model#: 2416758
Other #: last upgrade Sept-Nov 2011

Problem:
Patient was receiving MRI of shoulder. Shoulder coil was in use. Patient was unable to be still for duration of procedure. Procedure time was lengthened as a result. Patient began to complain of a burning sensation in shoulder area. Procedure was terminated at that time.

Onsite evaluation of equipment by GE - GE reports no problems when doing testing and calibrations. Unable to reproduce effects. On site visit by applications person helpful in identifying possible related causes.


Device 1:
Type: X-ray Shield, Protective, Personal
Manufacturer: RF Design, Inc.
Brand: Rf Design
Model#: VS11702
Cat #: VS11702
Other #: 0407113

Device 2:
Type: X-ray Shield, Protective, Personal
Manufacturer: RF Design, Inc.
Brand: Rf Design
Model#: VS11701
Cat #: VS11701
Other #: 0407114

Device 3:
Type: X-ray Shield, Protective, Personal
Manufacturer: RF Design, Inc.
Brand: Rf Design
Model#: VS11701
Cat #: VS11701
Other #: 0407112

Device 4:
Type: X-ray Shield, Protective, Personal
Manufacturer: RF Design, Inc.
Brand: Rf Design
Model#: EB601
Cat #: EB601
Other #: 0801111

Problem:
During scheduled annual maintenance (done one month earlier than scheduled) on lead aprons/vests, four lead aprons/vests were found to have significant damage. All four of the aprons were less than one year old. Both the tech and the vendor reported said that in over twenty years they have never seen damage like this before. There were multiple gaping tears in odd places (i.e. thyroid & groin area). The users of the lead aprons/vests cared for them per manufacturer instructions. Each of the four aprons/vests has a different number based on color and size. Our Radiation Safety Officer will be conducting dosimetry radiation badge reviews for each person involved. The lead aprons/vests were returned to the vendor for evaluation and have since been replaced. Of note: Older apron/vests have not shown this level of damage.

The on-site rep indicated that he had not seen damage such as this before and replaced all four lead devices.

Device:
Type: X-ray System, Cath/angio
Manufacturer: Philips Medical Systems
Brand: Allura Fd 20
Model#: Allura FD 20

Problem:
Poor image quality: Bolus chase/run-off images are poor. Unable to subtract bowel during abdomen/pelvis imaging. Images being transferred to PACS become very dark and unreadable.

Manufacturer has spent multiple hours with multiple technicians and specialists to resolve the issue. As of mid-April, 2012 the issue continues to be unresolved.


Device 1:
Type: X-ray System, Radiographic
Manufacturer: GE Medical Systems, LLC
Brand: Ge Revolution Xq/i With Cotello

Device 2:
Type: X-ray System, Radiographic
Manufacturer: GE Medical Systems, LLC
Brand: Ge Revolution Xr/d With Cotello

Problem:
The GE XQ/i and XR/d X-ray units are capable of dual-energy subtraction chest radiography (DES). The time necessary to perform the image processing for DES was long. In order to accelerate the speed at which the system processes DES images, GE retrofit the XQ/i and XR/d systems with a second, external computer called the "Cotello." The addition of the Cotello processor successfully accelerated the speed at which DES images could be generated. However, we recently discovered that the Cotello hampers the system for correctly processing radiographs produced with fixed radiographic technique, where the user specifies the mAs. Pediatric chest radiographs and other routine radiographic procedures are performed using fixed radiographic techniques. Any radiographs obtained using an XQ/i or XR/d system when using a fixed radiographic technique produce images that are very poor quality. Because of poor image quality, these images may not be usable for diagnostic purposes. This could result in the patient having to repeat the examination, which leads to increased radiation exposure dose(s) to the patient.
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Lollipop Icon

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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