Highlighted Reports
MedSun: Newsletter #71, April 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 January 1 through January 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.

ANESTHESIOLOGY

Device 1:
Type: Breathing Circuit, Ventilator
Manufacturer: Teleflex Medical
Brand: Hudson Rci
Model#: 780-24
Lot #: 02F1101570

Device 2:
Type: Breathing Circuit, Ventilator
Manufacturer: Teleflex Medical
Brand: Hudson Rci
Model#: 780-24
Lot #: 02H1100392

Device 3:
Type: Breathing Circuit, Ventilator
Manufacturer: Teleflex Medical
Brand: Hudson Rci
Model#: 780-24
Lot #: 02H1102877

Problem:
The ventilator circuits are coming in from the manufacturer with cracks in them, making them unusable. The company was made aware of this problem a month ago and circuits were replaced. We are experiencing this problem again. This defect makes it difficult to set up a ventilator urgently because the circuits will not pass the compliance and leak test on the ventilator. Twice the therapist had to manually ventilate two patients as he went through 5 to 6 circuits and could not get them to pass. Our current solution is to inspect the circuits when we have down time and try to do the circuit compliance then leave the vent in standby mode so it's ready when we need it for a patient. So far, three separate lot numbers are affected: 02F1101570, 02H1100392, and 02H1102877.

Device:
Type: Endotracheal Tube
Manufacturer: NeoTech Products, Inc
Brand: Neobar
Lot #: 21800

Lollipop Icon

Problem:
There have been 5 reported instances of grey NeoBar failure at this hospital in December 2011. All of these issues were with NeoBars from Lot#21800. On 4 separate occasions, the duoderm pad adhesion failed and the bar became disengaged from the adhesive tab. In other words, the adhesive tab adhered to the patient's face, but the grey plastic arm came loose from the adhesive connection, causing problems with the intubation. Four of the incidents occurred to the same patient.

There was no permanent harm to any of the patients, but one patient experienced the following due to the detachment of the neobar "bar": Pt. was coughing and gagging on secretions and ETT and neobar became loose. The RT in room with nurse retaped neobar, but patient was gasping and coughing due to low volumes on vent, so removed ETT and paged anesthesia to reintubate. NICU attending came over to assist, and intubated pt. with 4.0 ETT. Pt was bagged during entire event, no LOC, brady and desat initially, and recovered. The 2nd patient self extubated in one incident, but was discovered and was not harmed.

All NeoBars of that lot number were pulled from stock and replacements have already arrived from the NeoTech plant. According to anecdotal information on a list serve, at least 2 other facilities have reported the same issue. No other problems have been reported with the new lot of gray NeoBars, however, only one has been put to use so far.

It is recommended that this lot number be evaluated for a nationwide recall.
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Manufacturer response for NeoBar ETT (per site reporter)
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They replaced the stock of Lot number's affected with a new lot number.


Device:
Type: Gas Machine, Anesthesia
Manufacturer: GE Healthcare
Brand: Avance S/5

Problem:
The Biomedical Engineering technician discovered that the GE Anesthesia Machine Model: Avance S/5 with software version: 6.20 that was installed December 2010, has a problem with Pressure Ventilation Mode's not defaulting properly. The three modes affected are Pressure Support with Apnea backup mode (PSVPRO), Synchronized Intermittent Mandatory Ventilation (SIMV-PC), and Pressure Control Ventilation (PCV). When using these modes the Peak Inspiratory Pressure, max (Pinsp) does not default back to initial default settings when the case has ended. When selecting a "new case" on the machine the "Pinsp" defaults back to the last case setting and not the original default for this mode. The only way for the "Pinsp" to default back to the default setting is for the clinician to shut the machine completely off and reboot the machine. The Biomedical Engineering technician notified the GE Technical Support line and made them aware of the issue. GE Clinical Support instructed biomedical engineering to call in the GE technical support engineer to evaluate the problem. The problem was replicated by GE technical support but GE Healthcare does not have a fix for the problem at this time. Biomedical Engineering informed the head of anesthesia about the problem. This is one of sixty anesthesia machines at this facility.
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Manufacturer response for Gas Machine, Anesthesia, Avance S/5 (per site reporter)
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Biomedical Engineering notified the GE Technical Support line and made them aware of the issue. GE Clinical Support instructed Biomedical Engineering to call in the GE technical support engineer to evaluate the problem. The problem was replicated by GE technical support, but GE Healthcare does not have a fix for the problem at this time.


Device:
Type: Humidifier, Respiratory Gas
Manufacturer: Allied Healthcare Products
Brand: B&f Medical
Model#: 64377

Problem:
Patient was experiencing flash pulmonary edema and required high flow oxygen, with humidification. Nasal cannula with bubbler humidifier set up. Water was filled to less than the max-fill line. Patient was placed on 13L of O2. There was a small amount of saline noted in tubing initially but quickly resolved with O2 flow. Approximately 5 minutes later, the bedside sitter alerted nursing staff that patient was complaining of choking sensation and there appeared to be water in the tubing flowing into the patient's nasal cannula. RN quickly disconnected the tubing and bubbler and began to suction the patient. Patient did have O2 saturation decline into the 60s for a brief period of time. Fortunately, the patient's O2 sats came back up to the 90s within a few minutes and after the suctioning and Bi-pap being set up.


Device:
Type: Ventilator
Manufacturer: Maquet Critical Care, AB
Brand: Servo I


Problem:
Patient ventilator was found alarming, on arrival into patient's room, staff found vent screen reading Apnea alarm in red, with the Oxygen box, PEEP box, rate box tidal volume box missing. Patient taken off of the vent and hand bagged. Ventilator had no flow coming through the circuit although it was connected to oxygen and air. Changed vent out with same vent settings. Biomed investigated the event logs on the Servoi, downloading them to a service card. Biomed contacted manufacturer regarding the error code. Manufacturer stated that the PC 1771 Board needs to be replaced. Manufacturer rep came in and downloaded the logs and took the faulty board and sent to Maquet HQ's for further investigation.


CARDIOVASCULAR

Device:
Type: Catheter, Percutaneous
Manufacturer: Vascular Solutions
Brand: Guide Liner
Model#: 5571
Lot #: 553043

Problem:
During the procedure, the catheter would NOT pass through the guide catheter. Another guidewire was used. The patient suffered no adverse effects.


Device:
Type: Device, Hemostasis, Vascular
Manufacturer: Access Closure Inc.
Brand: Mynx Cadence
Lot #: F1125203
Cat #: MX5001

Problem:
The doctor was using the Mynx device to gain hemostasis of the femoral artery. When deploying the vascular plug, the device was missing its plug advancer. The piece that was missing was the white shaft that is used to hold the plug on an artery when the balloon and the device is removed. Manual compression was used for 20 minutes to obtain hemostasis. There was no change in the patient's outcome due to the device failure. We have other devices from the same lot, but none of the other devices used have had pieces missing.


Device:
Type: Filter, Intravascular, Cardiovascular
Manufacturer: Cook Medical
Brand: Celect
Model#: IGTCFS-65-FEM-CELECT-PERM
Lot #: E2819480

Problem:
Patient required placement of a vena cava filter due to deep venous thrombosis and recent major hemorrhage from a ruptured aneurysm. A 9 French sheath was placed and using ultrasound to determine placement, the filter was delivered without difficulty. However, when deployment was initiated, the initial feet deployment did not occur. Surgeon was able to capture the filter and remove under fluoro guidance. At the very end of the removal the sheath came off the filter and the filter came through the soft tissue and everted; however, there was no damage to the vein by ultrasound. Procedure was performed again using a Greenfield stainless steel filter.


Device 1:
Type: Hemodynamic Monitor System
Manufacturer: McKesson Israel Ltd.
Brand: Horizon Cardiology Hemo
Other #: V 12.1 Hemo

Device 2:
Type: Hemodynamic Monitor System
Manufacturer: McKesson Israel Ltd.
Brand: Horizon Cardiology Cvis
Other #: V. 12.2 Imaging

Problem:
The McKesson Hemodynamic application experienced issues that prevented the use of the systems. Main three labs inoperable necessitated diverting potential emergencies (ST segment elevation myocardial infarction - STEMI) to another facility thereby potentially delaying care. Fortunately, no patients had to be diverted during the 3 hours software was inoperable. This hospital is a Level 1 trauma and cardiac facility.
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Manufacturer response for Horizon Cardiology Hemo, Imaging App & Hemo App, Horizon Cardiology Hemo, Imaging App & Hemo App (per site reporter)
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McKesson performing root cause analysis of each Hemo station. Lab 1 had a corrupt user profile that prevented the normal account from logging in. Labs 2&3 had corrupt SQL instances on their local databases. Final determination of what caused both corruptions is not complete, but it was determined that the systems had been "hard booted" (pressing power button to restart) many times. This is a known way to cause SQL corruptions. Preventative measures are to configure one PC to be a hot spare. McKesson coming on site to physically rebuild to a baseline "pristine" build. This will remove any residual settings from the devices.

Device:
Type: Lead, Lv/cs
Manufacturer: St. Jude Medical
Brand: Quickflex µ
Model#: 1258T/86CM

Problem:
The patient had a Biventricular (BiV) ICD implanted. Upon ICD evaluation by the St. Jude Medical rep on the following day, the left ventricular (LV)/coronary sinus (CS) lead threshold had increased, requiring further investigation. Upon fluoroscopy, LV/CS lead was noted to have dislodged from the coronary sinus. The patient was scheduled for lead revision the next day. The patient was doing fine after the procedure.
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Manufacturer response for CS/LV lead, SJM Quickflec CS/LV lead (per site reporter)
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none at this time.


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

Problem:
Patient's monitor did not alarm; however, it was noted that the patient had an erratic rhythm, which was obviously not this patient. This has happened multiple times with different patients on this date. Biomed advised and are working on the situation. Apparently this is a widespread issue with the Dash monitors with software version 5.4. Additional fact findings:
1-Rewind back to the original event of last summer. If you analyze the frequency of the QRS's on the graph paper you would come to the conclusion that it is not humanly possible, not even with a pediatric patient. This analysis was confirmed to be correct by GE.

2-The symptoms for these events are consistent with the original event. GE has acknowledged the two issues to be the same. However what appears to be different according to GE is the CPU board manufacturing and revision versions. The original issue was related to CPU boards manufactured between January 2003 and January 2007. These events (seven current ones) occurred with Dash monitors having CPU boards manufactured post January 2007.

3- Problem defined: According to GE this issue is definitely a Dash problem, hardware related. It is not physiological/patient issue. It is caused by high network traffic overheating a component (Ethernet chip) on the CPU board, which in turn causes the waveform to be condensed. The monitor does not alarm when this happens, since processing has already taken place. "Arrhythmia processing" would have seen the correct patient rhythm but somehow was displayed incorrectly by the Dash monitor.

4-One of the challenges relates to the newer CPU board type which do not accept original software version. The latest software version is not the same as older version causing potential for user interface errors.


Device:
Type: Tubing, Contrast Injection
Manufacturer: Medrad, Inc.
Brand: Avanta Fluid Management System
Model#: AVA 500 MPAT
Lot #: 113401

Problem:
Upon refilling the fluid management system with more contrast, the air vent port of the MPAT contrast tubing spike popped off when pulling the spike out of the existing empty bottle of contrast.


Device:
Type: Vascular Closure Device
Manufacturer: Cordis
Brand: Exoseal
Lot #: 15475795
Cat #: EX600

Problem:
According to the operative procedure notes, following injection of contrast into the right groin for possible closure device the arterial sheath was removed and closure device (Exoseal 6FR) was deployed. Seventeen seconds later, the closure device was noted to have failed. Arterial sheath pulled and manual pressure held for 20 seconds. Oozing noted after holding manual pressure; therefore, a Femstop device was applied to site with successful hemostasis. Femstop removed and Opsite dressing and sandbag applied.


GENERAL & PLASTIC SURGERY

Device:
Type: Active Electrode, Esu, W/suction
Manufacturer: Medtronic Advanced Energy LLC
Brand: Peak Plasmablade 3. 0s
Lot #: 47588
Cat #: PS210 - 030S
Other #: P/N LBL-00009 Rev A

Problem:
PlasmaBlade is used in implantation of AICD, revision, or extraction of same. It is knife, electrode (cuts & coagulates) and separate suction portal (which connects to wall suction), in one hand held device. In this case, the suction did not work during the procedure, in that it did not suction the smoke that is created when the PlasmaBlade is cutting. The operative field was obscured. It was changed out for a new unit. I was told by the doctor that this is the second occurrence of this same malfunction. It was not reported to me initially. Now that we have a 2nd malfunction of the same lot number, we have pulled the devices with that number off the shelf and will return the PlasmaBlades to the manufacturer. We submitted this unit to our BioMed Dept. for evaluation. They found that it did not work as intended.
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Manufacturer response for Active Electrode, ESU, w/Suction, Peak PlasmaBlade 3.0S (per site reporter)
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I have spoken with the local sales representative for Medtronic Surgical Technologies, who has taken over Peak Surgical in Palo Alto, CA. He is unaware of any issues with these PlasmaBlades. He will query other institutions that use this product, and get back to me. He believes it may be a matter of practitioner technique. Sales representative update: Meeting with sales representative yesterday. He has queried other institutions, and has not had any negative feedback. He believes that product difficulties are practitioner dependent, and will schedule an in-service for EP Lab staff. The Nurse Manager has agreed to the in-service.


Device 1:
Type: Instrument, Robotic Surgical, Tip Cover Accessory
Manufacturer: Intuitive Surgical, Inc.
Brand: Microtek Da Vinci
Model#: 400180 ver-10
Lot #: C11192

Device 2:
Type: Instrument, Robotic Surgical, Tip Cover Accessory
Manufacturer: Intuitive Surgical, Inc.
Brand: Microtek Da Vinci
Model#: 400180 ver-01
Lot #: c11192

Problem:
During surgery using the laparoscopic Da Vinci, the surgeon noticed arcing from the accessory tip cover that was covering the scissors. Upon closer inspection, small holes were discovered in the cover allowing current to escape. The surgeon voiced concern about an increased risk of an inadvertent burn to surrounding tissues. The same problem has been reported twice within the last week. No patient injury was sustained on either event. Additionally it was noted on both used tips that the ink that is used labeling is flaking off making it illegible.

Device:
Type: System, Surgical, Computer Controlled Instrument
Manufacturer: Intuitive Surgical, Inc.
Brand: Da Vinci
Model#: SS 3000

Problem:
During a transoral robotic-assisted surgical procedure, the robotic monopolar cautery was being used and suddenly a small flame appeared at the surgical site. MD immediately stopped surgery, PA withdrew instrument, and sterile saline was poured into the field extinguishing the flame. It appeared the disposable cautery spatula tip was what had caught on fire as it was burned and a piece fell off - it was removed from mouth. Moistened raytec were in place surrounding the mouth and retractors. Charge nurse and MDA (MD Anesthesiologist) notified. Mouth and throat were examined by surgeon and MDA. No apparent harm to patient. Cautery tip was removed and replaced with a new one. Patient was being ventilated with 100% oxygen prior to incident due to low Sp02 when N2O was used and after incident water was poured into the mouth and throat and a small cuff leak was noticed. Pt stable and case continued without incident after all parties concurred it was safe to continue. Family notified by MD after procedure.

Device:
Type: Suture, Absorbable
Manufacturer: Ethicon, Inc.
Brand: Vicryl
Model#: J232H
Lot #: DC2652
Cat #: J232H

Problem:
Thread frayed while suturing.
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Manufacturer response for Suture, Adsorbable, Vicryl (per site reporter)
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We sent pictures for their review. They will review and get back to us.


Device:
Type: Suture, Absorbable
Manufacturer: Ethicon, Inc.
Brand: Endoknot, Coated Vicryl
Model#: JK10G
Lot #: CBX763
Cat #: JK10G

Problem:
When the OR nurse opened a sealed(brand new)package of Endoknot suture size 0 Coated Vicryl she discovered pin hole/s in the foil packaging and discarded the product inside assuming since there was a hole the suture must not be sterile anymore. The nurse could not figure out how the hole/s were created hence, it was suggested to the staff that when they open the package to inspect for holes before handing the suture to the surgeon. There have been 5 packages discovered with holes. The manufacturer is aware and it was reported by the manufacturer that the hole was tested for leaks. This is their response: A dye penetration test was performed on the suspect areas, and there was no leakage of the dye through the voids, indicating that the barrier had not been compromised. The OR nurse did her own test on 4 different packages and 2 out 4 packages had leaked confirming that the foil packaging are not reliable for sterility especially if the pin holes are not discovered.


GENERAL HOSPITAL

Device 1:
Type: Catheter, Intravascular, Short-term
Manufacturer: Smiths Medical
Brand: Protectiv
Lot #: ST2114652
Other #: 22 G 1inch

Device 2:
Type: Catheter, Intravascular, Short-term
Manufacturer: Smiths Medical
Brand: Protectiv
Lot #: ST2094256
Other #: 22 G 1inch

Problem:
Plastic tips of several 22G catheter IVs are noted to be split when taken out of packaging or are splitting during insertion.

Device:
Type: Catheter, Intravascular, Short-term
Manufacturer: Smiths Medical
Brand: Protectiv

Problem:
Since our facility switched to the Smith Protectiv IV over 1 year ago, we have received over 100 event reports related to its use, such as kinking of the catheter, inability to advance the needle, puncture of the catheter by the needle when removing the cap, burrs noted on the needle, safety feature not engaging needle. The facility has assembled a team to determine root cause of the issues. The manufacturer is also retraining staff.
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Manufacturer response for IV Catheter, Protectiv (per site reporter)
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The manufacturer, Smith Medical, has re-trained staff on use of device.


Device:
Type: Catheter, Intravascular, Short-term
Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.
Brand: Bd Insyte Autoguard
Lot #: 1286765
Cat #: 381423

Problem:
Nurse inserted IV catheter without difficulty, removed needle, and connected catheter to IV tubing. Nurse immediately noticed leaking of the IV fluid at the point where the catheter tip joined the blue Luer connector. The catheter was then removed and a new one inserted, which worked properly.


Device:
Type: Catheter, Intravascular, Short-term
Manufacturer: Smiths Medical
Brand: Protectiv
Model#: 3065
Lot #: ST2127875
Cat #: 3065
Other #: 18G x 1 1/4"

Problem:
An experienced Emergency Department nurse was performing a routine IV start when after the IV was cannulated, the nurse pulled the safe needle retractor out and the nurse got stuck by the exposed needle in the left index finger. The manufacturer was contacted and the device will be picked up by the manufacturer and inspected.


NEUROLOGY

Device:
Type: Chair, Rotary, Vestibular Balance Testing System
Manufacturer: Neuro Kinetics, Inc.
Brand: Neuro Kinetics Barany Chair System
Model#: RCS-365

Problem:
Description of Device:
A vestibular/balance testing rotational chair was purchased in 2007. After installation of the chair, in collaboration with the manufacturer, modifications were made to the software / hardware for an additional clinical testing protocol. The chair came programmed with several protocol options. Newer machines now include hardware that does require the modifications made at this facility as a standard option. Additionally, with manufacturer knowledge, a knee strap was developed which could be secured to the chair. The chair is standard with a four point chest restraint and foot guards. The four point restraint, knee strap and foot guards are utilized to secure a patient in the chair.

Event:
Patient in NeuroKinetics rotational chair for vestibular/balance testing. Staff had secured the four point chest restraint correctly. The knee strap and the foot retention systems were not utilized. During the test the patient slid down in the chair and attempted to remove the four point chest restraint. Patient was choked by the four point upper strap, lost consciousness and was projected to the floor by the spinning motion of the chair. Patient assessed and admitted to the hospital for multiple lacerations, back and rib fractures, pain.

The manufacturer was contacted regarding the event. Internal discussions ensued regarding need for enhanced safety features with auto-stop magnetic sensors if restraint/straps are not secured. The manufacturer is being contacted regarding participation in this type of modification. Manufacturer stated they filed report with FDA.

The manufacturer performed the routine maintenance check on the equipment three days after the event (pre-scheduled). System was in normal working order.


Device:
Type: Device, Neurovascular, Embolization
Manufacturer: Covidien
Brand: Pipeline

Problem:
The first patient died within 24 hours of Pipeline stenting of cerebral aneurysm. Patient had an unexpected and catastrophic intracerebral hemorrhage.

The second patient had cerebral infarcts, thrombosis of Pipeline stent, subarachnoid hemorrhage, neurosurgery and unexpected death after Pipeline stenting procedure.


RADIOLOGY

Device:
Type: System, Ultrasound, Pulse Volume Recorder
Manufacturer: Parks Medical Electronics
Brand: Flo-lab
Model#: 2100SX

Problem:
This was a near miss where the design of the connectors have the potential to cause serious harm to the patient. We had an actual misconnection approximately 1 year ago with this same machine. This was also reported to MedSun.

Patient was undergoing arterial duplex study and within a few minutes of the blood pressure cuff inflating, the patient went into cardiac arrest. Initially staff felt they may have connected the blood pressure cuff to the IV (which is possible) and gave the patient an air embolism. They felt this based on the fact that we did have the situation happen approximately 1 year ago and based on the sequence of events that took place. After a thorough review of the process, we have learned that the misconnection did not occur and rather the patient’s medical condition caused the cardiac arrest. This is a very serious design problem that is going to cause someone to be significantly harmed. For that reason (and we had 1 event and 1 near miss since we have had this machine), we are looking to see if a better product exists on the market to replace this current machine.


Device 1:
Type: X-ray System, Radiographic, Dr
Manufacturer: Philips Medical Systems
Brand: Digital Diagnost
Other #: S/W version 2.1.2 Workspot S/W version 22.6.6

Device 2:
Type: X-ray System, Radiographic, Dr
Manufacturer: Philips Medical Systems
Brand: Digital Diagnost
Other #: S/W version 2.1.2 Workspot S/W version 22.6.6

Problem:
Philips Digital Diagnost Auto-Stitching issues dating back to the date of install (Software version 2.1.2 and Workspot software version 22.6.6):

The hospital purchased and installed 2 Digital Diagnost (DR) X-ray machines from Philips Healthcare in 2011. They are both in the Orthopedic Clinic and at the time of purchase have auto-stitching software package with the version listed above.

During the clinical application training, and many more times up to the date of this report, the department noticed 2 issues. On numerous occasions we have approached Philips with these issues especially the auto-stitching problem:

1. Ghosting: During the acquisition of images for scoliosis patients, two X-rays are taken, one after the other on the same breath hold. The system is supposed to transfer the first image and erase the plate before the second image is acquired. Ghosting occurs when residual image data is not completely removed from the imaging plate before the second one is acquired, leaving part of the initially acquired information on the second image. This causes issues especially for the radiologists and clinicians.

2. Auto-Stitching: The software is supposed to automatically stitch both images to form a single image. The problem with this is that often, there is an overlap of the acquired images during the stitching process leading to distortion of the final image. This image, especially the improper alignment created by the software causes a serious patient safety issue.

We have contacted Philips on these issues and they are aware of the significant impact this can cause to patient safety. There have been communications between the Department of Radiology and Philips without any significant resolution.



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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