Highlighted Reports
MedSun: Newsletter #34, March 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 December 1 through December 31. 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.


GASTROENTEROLOGY/UROLOGY

Device:Tubing, Insufflation, Heated
Manufacturer: Stryker Endoscopy
Brand: Pneumo Sure
Model #: REF 620-040-690
Lot #: 060308D

Problem:

OR staff report that the insufflator blew apart where the device screws into the port at the machine side. The connection that goes into the insufflation machine itself literally blew apart with force. Staff report that this has happened several times in the recent past and that they have been reporting this and each event to the rep. Patient and staff were not harmed.

See picture of damaged insufflator.

photo image of damaged insufflator

Device:Bag, Foley
Manufacturer: C.R. Bard
Model #: 153202

Problem:

Bard Latex-Free 200ml urine meter with bag and Bard EZ-Lok Sampling Port, Ref#153202, and lot number unknown had to be changed by RN twice in twenty-four hours because the plastic piece that dumps urine from the tubing into the urometer kept breaking. This causes urine to go directly into the drainage bag without first flowing into the urometer. Urine outputs then becomes inaccurate for the hour. After talking with other RN's, we discovered that this had been happening frequently with other patients, requiring that they also have a foley system change. BioMed opened new Bard urine meter with lot number NGSK0339 and discovered the same issue. The bent plastic piece had gone into the meter twice, and it fell off of the drain tube easily as if it was not glued on at all.
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Manufacturer response for Urine Meter, (brand not provided)
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Left a voicemail, but have not heard back yet.

ANESTHESIOLOGY

Device:Tube, Tracheostomy
Manufacturer: Cook, Inc.
Brand: Blue Rhino Tracheostomy Kit
Other #: 0882002231

Problem:

The tracheostomy tube at the point where the inner cannula fits in broke three days after insertion of the device. The trach was replaced without complications. The trach was replaced without complications. The exact lot number is not known, but the following four lot numbers were present in the facility at the time of the event (2097034, 2103336, 2155476 and 2072520).
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Manufacturer response for 8 PERC Shiley Trach, Shiley
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Manufacturer representative came to facility to evaluate device. There is not a definitive answer as to why this occurred at this point in time. A similar incident occurred in close proximity to this event involving an 8 DCT Shiley Trach that is part of the Blue Rhino kit (Cook product).

Device:Ventilator
Manufacturer: Covidien Nellcor
Brand: Nellcor
Model #: 840

Problem:

Nellcor 840 ventilator alarm sounded and panel screen went black. Patient was immediately manually ventilated. The ventilator was turned off then back on but the panel screen remained black but all level alarms and lights remained on. The ventilator was exchanged for another ventilator and taken out of service. BioMed reported the cause of the ventilator failure was due to a CPU failure.

Device:Tube, Tracheostomy
Manufacturer: Cook Medical
Brand: Blue Rhino Kit
Cat #: 8DCT
Other #: 0807002123

Problem:

The white tip on the trach was found broken causing the inner cannula to not stay in place. The trach had been placed one day prior to this occurring. The trach was replaced without complication. This trach is a component of the Cook Blue Rhino Kit. A similar incident occurred a few days later involving a 8PERC Shiley trach. The exact lot number is not known, however, these two lot numbers were in the facility at the time of this incident (0808001639 and 0801000384).
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Manufacturer response for 8DCT Shiley Trach, Shiley Trach
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The manufacturer rep came to the facility and evaluated incident, a similar incident occurred a few days later involving a Shiley 8PERC trach. There is no known cause at this point in time.

Device 1:

Device:Anesthesia Machines
Manufacturer: GE Healthcare
Brand: Aisys Carestation
Model #: S5 AISYS

Device 2:

Device:Anesthesia Machines
Manufacturer: GE Healthcare
Brand: Aisys Carestation
Model #: S5 AISYS

Device 3:

Device:Anesthesia Machines
Manufacturer: GE Healthcare
Brand: Aisys Carestation
Model #: S5 AISYS

Device 4:

Device:Anesthesia Machines
Manufacturer: GE Healthcare
Brand: Aisys Carestation
Model #: S5 AISYS

Problem:

During a scheduled Preventive Maintenance inspection, it was noticed that there was rust on the Rod of the Bag/Vent Switch assembly. The assembly was replaced with a new part.
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Manufacturer response for Anesthesia Machines, Anesthesia Machines
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GE acknowledges that there is a problem, and are in the process of sending us an official letter, after their analysis and investigation is complete. The presence of Chloride in their manufacturing process, either during machining or cutting is contaminating the parts causing them to rust. They initially were using stainless steel grade 303 and switched to stainless steel grade 313.

Device:Ventilator
Manufacturer: Drager Medical
Brand: Drager Evita Xl
Model #: Evita XL

Problem:

There was a power surge and after the surge a loud high pitched squeal was heard. The monitor on the ventilator went black and did not work. The room smelled smoky, but no smoke was witnessed. The monitor was also hot to touch. Patient was bagged and a new ventilator was placed on the patient.
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Manufacturer response for Ventilator, Drager Evita XL
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Nothing as yet


GENERAL AND PLASTIC SURGERY

Device:Headrest, Or
Manufacturer: Orthopedic Systems, Inc.
Brand: Gentletouch 7" Headrest Pillow With Right Intubation Slot
Model #: 1937

Problem:

A patient underwent a cervical lymph node biopsy. She was in a prone position with her face in a foam headrest. The procedure was done under monitored anesthesia care. A flash fire occurred.

Unbeknownst to the healthcare provider team, the headrest device may act like a sponge to absorb and trap oxygen. It appears to have acted as a fuel source in a fire triangle.

Device 1:

Device:Cable, Reusable, Harmonic Shears
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Harmonic Ace
Lot #: 22080116
Cat #: E9F20J002

Device 2:

Device:Cable, Reusable, Harmonic Shears
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Harmonic Ace
Lot #: 22080033
Cat #: E9F20J029

Device 3:

Device:Harmonic Shears
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Harmonic Ace
Lot #: E4M36M
Cat #: ACE36E

Device 4:

Device:Harmonic Shears
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Harmonic Ace
Lot #: E4M73E
Cat #: ACE23E

Problem:

Harmonic Cord and open handpiece kept cutting off while cutting out the gallbladder. Handpiece and cord did not start doing this until after they cleaned the tip of the handpiece off. Kept giving Error code 5 "instrument". Changed handpiece and cord. It worked fine for a few minutes, then error code 5 and the code for handpiece temperature kept coming up.

Ethicon sales Representative tested the devices, along with the technical support people at Ethicon Endo-Surgery that were called on the phone. The actual same devices were used to perform this test, Problem could not be duplicated.

Ethicon was able to verify the errors stored in memory.
1- Error 1 is due to tissue stuck on the tip of the device.
2- Error 5 is a connection loose error between the handpiece single-use device and the cable.
3- The two cables were verified and checked, one had been used around 27 times and the other was used 15 times. Per manufacturer's guidelines, these cables should last well over 100 times.

The unit was returned back to service. The disposables will be shipped back to Ethicon Endo-Surgery Company, for further evaluation.

Device:Stapler, Linear Cutter, Surgical
Manufacturer: Ethicon Endo-Surgery, Inc
Brand: Endopath 45
Lot #: E4LL1G
Cat #: ETS45

Problem:

The vascular endo GIA stapler was inserted through one of the previous ports and placed across the superior segmental branch and fired. Upon removal of the stapler, the proximal staple line was noted to be incomplete and significant bleeding occurred. There was significant blood loss; however the procedure was completed without further complication. This patient did receive Hespan and 3 units of RBCs intraop. Patient was discharged home 10 days post op. The blood loss did not appear to impact the length of stay as patient had other some issues with a chest tube that had some increased drainage, but this resolved by discharge.


GENERAL HOSPITAL

Device:Tubing, Iv
Manufacturer: Cardinal Health Medical Products & Services
Brand: Smartsite Infusion Set
Cat #: 2420-0007

Problem:

Medication found dripping on the floor from IV tubing. The tubing had a hole found in the region right below the blue top piece that sits in the actual pump. The tubing was replaced, there was no patient harm.

Device 1:

Device:Bed, Ac-powered Adjustable Hospital
Manufacturer: Stryker Medical
Brand: Bed
Model #: 3000

Device 2:

Device:Nurse Call System
Manufacturer: Hill-Rom Company, Inc.
Brand: Nurse Call Module
Model #: M52

Problem:

The patient was trying to move in the bed and lost her balance and slid out onto the floor. The nurse call alarm did not work and the patient was heard calling from the room. The patient had removed the non-skid socks earlier. RRT trauma and MD was called and no injuries were noted. The bed was checked by Biomed and this bed cannot be connected to the Hill-Rom nurse call system that is used on this floor, because of the type of communication cable connected to the bed. The bed was not connected to the nurse call system which would have alarmed through the nurse call system to notify the clinical staff that a fall had occurred. The bed and nurse call tested fine.

Device:Bed, Ac-powered Adjustable Hospital
Manufacturer: Stryker Medical
Brand: Stryker Zoom Bed

Problem:

Stryker beds were found to have an unstable weld along the frame. There was no event with a patient. Twenty-one beds were examined and all have this unstable frame.

Device:Infusion Pump
Manufacturer: B. Braun Medical, Inc.
Brand: Outlook 100
Model #: 13215

Problem:

This report is a continuation of several reports previously filed. Our facility had been having ongoing issues with our B. Braun Outlook 100 pumps losing their drug libraries. This causes our RN's to resort to manual programming of rates, etc. We had reported a total of 379 events (there are a total 440 pumps total at our facility). We were initially told it was a battery problem by B. Braun. Then, we were told it was a software glitch. B. Braun came to our facility in mid-October to upgrade all of our pumps to a newer version of software. We were optimistic this upgrade had fixed the problem. Unfortunately, it was reported this morning that we have had 7 pumps lose their drug libraries so far this week. We will be creating a tool to keep track of how many times this happens, or if there are any repeat offenders, etc. There have been no impacts on patients at this time. The pumps were removed from service, and sent to our Clinical Engineering department for reloading of software. I did confirm that the 7 pumps had all received the recent software upgrade.

Device:Incubator, Infant
Manufacturer: Draeger Medical
Brand: Caleo
Model #: Caleo

Problem:

During the annual preventive maintenance procedure the Biomed Department discovered an issue with the manufacturer's procedure for calibrating the oxygen; it is not accurate and the unit does not respond in accordance with the manufacturer's documentation on the testing. We could not tell if the units passed the oxygen calibration or not. That made us uneasy so we went to their technical support for help. Until several discussions with technical support and the local service representative, Drager was not convinced there was an issue. Now that their service rep is involved they are finally convinced they may have a software issue with the oxygen calibration required by their software annually, and also in their service manual.

Device:Wound Care Mattress
Manufacturer: Kinetic Concepts, Inc.
Brand: 1st Step Select
Model #: 40525C

Problem:

Reporter was informed in the morning that there had been a burn incident last week involving this unit, and to go check it out. Found that unit was still in use on patient. Warmer was in off position and filter was not clogged to cause over heating of unit. Hoses at unit outlet were luke-warm and routed back around to the unit.

Met with Risk Mgr. Incident involved hoses on top of the mattress overlay which touched patient’s foot and caused a 1st degree blister burn.

They are to do an internal Root cause investigation and hold meeting to report findings. Met with Root cause committee and found that staff incorrectly used equipment, reporting process was not correct, and suspected equipment was not removed. Discussed corrective actions and remedies for Policies and Procedures.

The Staff had incorrectly routed the hoses on top of the foot board instead of around the end and bottom of the foot board, thus causing the hoses to be able to come into contact with the patient’s foot.

Once I was notified, I pulled the unit and ran the unit the way it was set at that time. Found the temperature to be at 103 degrees.
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Manufacturer response for Wound care Mattress, 1st Step Select
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Has never been heard of before. That it is unlikely to be attributive to the equipment in question.


MICROBIOLOGY

Device:Microbiology Culture Media
Manufacturer: Becton Dickinson
Brand: Thioglycollate Vitamin KAnd Hemin
Lot #: 8164953
Other #: product # 221788

Problem:

Gram stain results yielded gram positive beaded organisms on multiple specimens which were grounded using Thioglycollate. No organisms were seen when the same specimens were tested again without using Thioglycollate. The media was found to have high counts of nonviable organisms.
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Manufacturer response for Microbiology Culture Media, Thioglycollate Vitamin K and Hemin
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The response was that a Gram stain by itself can neither rule in or out infection since artifacts and non-viables may be present in the transport media. Most liquid media will have some level of microorganisms present in the product.

The batch history record was reviewed and was found to be satisfactory. There was no evidence of contamination in the retention sample. There was no evidence of contamination in the return sample.


CARDIOVASCULAR

Device 1:

Device:X-ray System, Cath/angio
Manufacturer: Siemens Medical Solutions USA, Inc.
Brand: Axiom Artis

Device 2:

Device:Information Management System, Cardiovascular
Manufacturer: McKesson Information Solutions LLC
Brand: Horizon Cardiology

Problem:

Images from the Siemens Axiom Artis system are supposed to be archived automatically by the McKesson Horizon Cardiology Information system. Sometimes this does not happen. Departmental policy is that at the end of each case the monitoring tech is supposed to verify that the images have transferred over. Once the transfer and archiving is verified, the images can be deleted from the Siemens system.

In this case the team member noted that the images were missing, but didn't attempt to archive them. The team member then accidentally deleted the images from Siemens. Once deleted, these images can't be recovered. The cath procedure was re-done.

Device:Vascular Closure Device
Manufacturer: AccessClosure, Inc.
Brand: Mynx
Lot #: F0824904

Problem:

As the physician was attempting to deploy the MYNX device, the balloon expanded but the physician was unable to withdraw the catheter to expose the sealant. After the MYNX was passed off the sterile field, the physician attempted to pull the catheter up, but was unable to do so. Blood loss during the procedure was within normal limits (50-100cc) and a total of 50 cc of radiopaque was used during the procedure. The patient did have a palpable popliteal pulse or the right side post procedure and was transported to recovery in stable condition. Physician stated one of every two MYNX devices used are defective.

Device:Warming Cabinet
Manufacturer: Pedigo
Brand: Pedigo
Model #: P-2050

Problem:

Early this morning, a blanket warmer overheated (it was set to run at 160F). The blankets inside started to smolder and Plant Operations was called because of the odor. Apparently there was not enough smoke to trigger a smoke alarm. They removed power and then removed the warmer to an outdoor location to minimize the odor in the area. A plant operation's technician opened the door and the blankets flashed into flames. They quickly put out the flames and the fire department was not notified. The investigation into the cause of the fire leads us to believe that the blanket warmer was overfilled, thereby blocking the unit’s temperature sensor.

In talking with the manufacturer, we were informed that a new base was available for the unit. The new base reduces the likelihood of blankets overheating because it allows for extra distance between the bottom of the cabinet and the heating element. The manufacturer also recommended no more than 90 blankets be placed in the unit, and that the blankets should be rotated. Loading blankets at the top and removing from the bottom. This would allow the top blankets more time to warm and keep blankets on the bottom from drying out.

Device:Graft, Vascular
Manufacturer: Intervascular, SAS
Brand: Intergard Knitted Polyester
Model #: IGK0008-20
Lot #: 08F12

Problem:

Patient had 25-50% survivability prior to procedure due to extreme poor health. OR Procedure ECMO Insertion with cannulation by Cardiac Surgeon. Femoral graft attempted but there was severe bleeding (18 units in 1 hr at body of graft not anastomosis). A different graft was then placed in axillary artery with coagulopathy. Surgeon states used this graft for 2 years and that this one was defective. It is not clear what led to the massive bleeding but considering the amount of bleeding that occurred, there is legitimate suspicion that the weave might have been loose.

Device 1:

Device:System, Ecg Analysis
Manufacturer: GE Medical Systems
Brand: Case P2 Ekg Stress System
Model #: CASE P2
Other #: AS06571

Device 2:

Device:Treadmill
Manufacturer: GE Medical Systems Information Technologies
Brand: T2100
Model #: T2100
Other #: AS06574

Problem:

The patient was in the midst of a sestamibi treadmill stress test. During the test the patient had issues with frequent ectopy that were being closely monitored. When the patient got close to peak exercise, the monitoring system and treadmill froze, losing the ability to monitor this patient at a time when he was experiencing significant ectopy. Though the patient did not fall when the treadmill belt froze, we are concerned this could happen should this problem recur. We have had one prior occurrence of this problem in the past.


RADIOLOGY

Device:X-ray Unit, Mini C-arm, Portable
Manufacturer: GE OEC Medical Systems
Brand: Mini View
Model #: 6800

Problem:

Mini C-arm malfunctioned during a case; unable to shoot live films. Field Service Engineer replaced defective monitor. The monitor in this C-arm had also been replaced approximately one year earlier by the company. I talked to the GE Field Service Engineer briefly and he mentioned it seemed that those particular monitors were failing more often than he expected they should. He did not indicate that GE/OEC had a known problem with these monitors.

Device:X-ray Unit, C-arm, Portable
Manufacturer: Philips Medical Systems
Brand: Bv Pulsera
Model #: BV Pulsera

Problem:

In the OR the C-arm would not work. No X-ray and display has message "M379 Battery overcharge has enabled itself". Display also says "reset" next to one of the buttons. Pressed reset, C-arm resets and now can make X-rays. Looked for error message in manual, unable to locate it. Spoke with Philips service rep - he was unable to find info on the message and said to ignore it if it doesn't come back. Rebooted unit and message came back.

In a follow-up message, Philips states "Error indicates monthly battery deep cycle is running or needs to run, should clear after reset. Ok to use C-arm". Checked C-arm the next morning, re-booted unit and still getting M379 error. Philips service was called in to resolve the issue. Found out that setting the date forward 2 months and rebooting the unit will clear the error. Although M379 error is a known issue, it rarely occurs. The unit can be safely used until the error is cleared.

Device 1:

Device:Linear Accelerator
Manufacturer: Varian Medical Systems, Inc.
Brand: Clinac Linear Accelerator 2100 Ex

Problem:

Machine had been serviced several days before event. The physicist performed an IMRT (intensity modulated radiation therapy) quality assurance after service left. Quality assurance on the machine was not completed until he could review the plan the next day with the dosimetrist. After much consideration during the night, he called the next morning and requested that the dosimetrist monitor the first treatment of the day. The treatment was aborted on the first treatment field when MLC leaves did not move according to the patient's plan. Other treatments were simulated on the machine and nonstandard performance was again noted. The equipment was removed from service until vendor service was completed. Physicist performed checks on the machine and all IMRT/Forward Plans before resuming treatments. The machine was down two days.

Final response was not received from the manufacturer until several months later and it included the following information: The failure of a signal that communicates between the MLC and the Beam Gating PCB allowed the Beam to continue while the Step and Shoot field was changing from one field to another/broken or defective contact. In considering the worst case clinical scenario, it is assumed that only one field would receive treatment in this manner before a clinical user would notice that a beam hold is not asserted when the MLC leaves are moving. Step and Shoot treatments are typically the only type dynamic modality delivered at a site, and clinical users are accustomed to hearing the change of the audible beam tone from on to off when the beam hold is asserted: the failure of this change in tone would be apparent. Severity Rationale: Portions of critical structures may receive some dose while the expectation is that the beam has been held (turned off temporarily) to prevent dose from being delivered to critical structures. The planned dose targets would receive slightly lower dose, equal to the dose that had been incorrectly delivered during the prior step segment that should have been delivered during the shoot segment. Probability of harm rationale: the user can hear the Beam On Tone relevant to radiation being gated on and off. The presence and absence of the Beam On tone during high repetition rates is highly detectable. All users, typically a team, would have to not notice this situation. It will be obvious to those monitoring the treatment to notice the beam control was not working correctly due to their familiarity of this treatment type.


CLINICAL CHEMISTRY

Device 1:

Device:Analyzer, Chemistry
Manufacturer: Siemens Medical Solutions Diagnostics
Brand: Immulite 2000
Model #: Immulite 2000

Problem:

After being notified by an Endocrinologist that one of their patients had "unusual" results for Free T4 and TSH, we repeated the tests on the original sample in question the next day and found that the originally reported results were incorrect. The physician was notified of the corrected results. During further investigation we found nothing unusual about the samples. There were no related error messages on the Immulite 2000 instrument and no noticeable differences with anything at the time of repeating the tests. The instrument manufacturer's technical support was called the same day, but no immediate cause for the error was found. Technical support downloaded information from our instrument and told us that they would look into the matter. Two days later the technical service engineer relayed to the physician that there were numerous error messages contained in a log file that we should have been alerted to but were not. The engineer also found several parts that needed to be replaced and could have produced the erroneous results. These parts were replaced and additional quality control checks were performed. We are aware of only one patient that had unnecessary follow-up procedures started due to initial incorrect results.


OBSTETRICS/GYNECOLOGY

Device:Table, Obstetrical, Ac-powered
Manufacturer: BERCHTOLD Corporation
Brand: Operon D850 Multi-specialty Surgical Table
Model #: D850

Problem:

A gyn oncology fellow was trying to remove the leg portion of the bed to enable positioning pt. into lithotomy. The button that needs to be pressed to release the bed part was difficult to move, stuck, and not budging. As Doctor pressed the button, his finger got stuck in the metal latch under the gas cylinder of the bed piece.
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Manufacturer response for Multi-specialty surgical table, Multi-specialty surgical table
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Investigating. Checked out the table and found that when the doctor removed the head section that his right hand was under the gas cylinder. The lever must have been bumped causing the cylinder to release and pinch his fingers.


ORTHOPEDICS

Device:Implant, Acetabular Cup, Total Hip Replacement
Manufacturer: Zimmer, Inc.
Brand: Durom
Model #: 0100214150
Lot #: 2424625

Problem:

Patient admitted for revision right total hip replacement due to failed acetabular component. Indications: Patient clinical evidence for persisting weight bearing pain, right hip consistent with acetabular component loosening. Preoperative x-rays were satisfactory. Clinical experience indicated a strong suspicion of a microscopically loose acetabular component. There was no evidence of infection preoperatively. Findings: Consistent with microscopic loosening of a Durom 50-mm acetabular component metal on metal construct with a 44-mm inner diameter and a corresponding 44-mm diameter metallic head. No evidence of infection. Intraoperative gram stain negative for organisms or significant white cell count. She had a Durom system implant for treatment of osteoarthritis of her right hip. Her hip "never really got better." It became noticeably worse 2 months following surgery. She was having continued discomfort particularly navigating stairs. Eight weeks after surgery, she was still using crutches. X-rays at that time showed no change in the position of the construct including the cup. There were no loosenings noted.

Recall online available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=72743




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