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MedSun: Highlighted MedSun Reports

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Highlighted MedSun Reports

Here you will find a small sample of the hundreds of important reports MedSun receives per month. This sample is selected based on completeness of report and perceived level of interest to the clinical community. To view all reports received in the past 30 days, see the bottom of this month’s Newsletter, and for a complete search of all MedSun reports, see the MedSun Reports page.

Highlighted MedSun Reports

Highlighted Reports

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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 July 2014. All other reports can be searched under the ‘MedSun reports’ menu pane.

Device:
Type: Catheter Introducer Kit
Manufacturer: Teleflex Inc.
Brand: Arrow Mac Two-lumen Central Venous Access Kit
Model#: CDC-11241-1A
Lot #: 23F14A1091

Problem:
The physician was getting ready to place a central line into the patient. As he was setting up his 9Fr MAC Catheter Kit, he noticed the end of the dilator was serrated and broken. The defect was visually evident prior to use and upon opening the kit. He brought the problem to the attention of the anesthesiologist and anesthesia technician, who both agreed that the device was improperly manufactured. The altered dilator was disposed of and a new kit was opened and inspected before proceeding with the case. There were no issues with the second kit.


Device 1:
Type: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Manufacturer: Argon Medical Devices Inc.
Brand: L-cath Picc Kit
Lot #: 11061080
Cat #: 384061

Device 2:
Type: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Manufacturer: Argon Medical Devices Inc.
Brand: L-cath Picc Kit
Cat #: 384061


Device: 3
Type: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Manufacturer: Argon Medical Devices Inc.
Brand: L-cath Picc Kit
Cat #: 384061


Problem:
PICC was placed in very premature infant. Once the picc was placed, the needle was withdrawn and attempted to peel away. The needle did not peel away correctly and forceps had to be used to break the remaining needle away to save the picc. The problem is with the splittable needle in the L-Cath PICC kit. The needles are designed to split apart, but they are not. If unable to split, the staff have to attempt a work-around or the line would need to be removed and replaced. The patient population that these devices are used on are not stable: subjecting the patient to another line insertion attempt increases risk to the patient. These patients also have limited vascular access points.

This facility has had similar events on other patients with this product. Staff inserting these lines are very familiar with the product & have extra training in the insertion of the line. There has been approximately one or more similar events per month with this device over the last several months. The manufacturer has been notified and product has been returned to them for testing. The cause of the problem remains unknown. Staff are following the manufacturer's instructions for use of this product.



Device:
Type: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Manufacturer: BECTON DICKINSON & CO
Brand: Bd Insyte Autoguard Shielded Iv Catheter
Model#: 381434
Lot #: 4042741
Cat #: 381434

Problem:
Needle of IV catheter did not completely retract after pressing the push button shielding mechanism. There was approximately 1/4" of needle exposed beyond the tip of the safety barrel. This exposed portion of the needle caused user to sustain a needle stick. Medical intervention for healthcare provider required. Patient needed another IV start.


Device:
Type: Detector And Alarm, Arrhythmia
Manufacturer: Spacelabs Healthcare, Inc.
Brand: Spacelabs Ultraview Sl Command Module
Model#: 91496-1bdhnrs

Problem:
Space lab monitor would not read oxygen saturation level despite new probe being applied. The channel was changed out and immediately we were able to read oxygen saturation.


Device:
Type: Gas-machine, Anesthesia
Manufacturer: Datex Ohmeda
Brand: Ge Aestiva/5
Model#: 7900 CON

Problem:
The anesthesia machine initially seemed as though there was a leak which produced inadequate tidal volume. CRNA stated she turned the flows up to compensate for this leak and the end expiratory pressures began climbing. Upon further exam the vent pressures were also climbing. The patient was removed from the vent and was hand ventilated via an ambu bag for the remainder of the case. The patient was also placed on a Propofol infusion during this time. The machine was tagged and the room was also tagged as being out of service. No previous indications that there was a problem with the machine. Device passed all checks prior to procedure start.


Device 1:
Type: Infusion Pump
Manufacturer: Baxter Healthcare Corp
Brand: Spectrum Sigma
Model#: 35700

Device 2:
Type: Infusion Pump
Manufacturer: Baxter Healthcare Corp
Brand: Spectrum Sigma
Model#: 35700

Device 3:
Type: Infusion Pump
Manufacturer: Baxter Healthcare Corp
Brand: Sigma Spectrum
Model#: 35700

Device 4:
Type: Infusion Pump
Manufacturer: Baxter Healthcare Corp
Brand: Sigma Spectrum
Model#: 35700

Device 5:
Type: Infusion Pump
Manufacturer: Baxter Healthcare Corp
Brand: Sigma Spectrum
Model#: 35700

Problem:
Upon hanging new bag of TPN for a TPN dependent patient, Sigma pump was reading "air in line" when there was no air in the line. The line was rep rimed and pump was still reading air in line. RN changed the line to 4 other Sigma pumps in the room. All pumps were reading air in line when no air was in line. Charge RN to bedside to try to resolve problem and had the same problem with all the pumps reading air in line. As a result, the patient's blood sugar level dropped. Found new pump that was not reading air in line and RN was able to begin infusing TPN.

This facility has had multiple similar events with this pump. The facility has been working with the manufacturer directly for almost a year but the problems continue on a regular and consistent basis and across multiple nursing units. Initial and additional education has been provided to staff. Extra resources, including a clinical staff member, have been added in an effort to address the issue, but the problems continue. The facility is concerned regarding the delay in therapy, which sometimes has resulted in the need for additional medical care for the patient. Patients and staff have verbalized frustration with the pump (patients are upset that the pump alarms frequently and staff are concerned that they are unable to distinguish between a critical alarm and a non-emergency alarm because the alarm tones are identical).


Device:
Type: Infusion Pump
Manufacturer: Baxter Healthcare Corp.
Brand: Sigma Spectrum
Model#: 35700
Cat #: 35700

Problem:
Medication added to pump and alert for "Battery" sounded. No prior warning or indication that battery was low. IV pump had been functioning fully and without issues prior to the staff member adding a medication to the pump. Unable to resolve battery alarm. Another pump was obtained. Patient experienced delay in care until IV pumps were switched out.

This facility is experiencing multiple similar issues with this device. The battery life does not last the expected amount of time, regardless of whether the pump is plugged in and indicating fully charged. All of the pumps at our facility are affected (estimate >1,000). There is no warning or pattern to when the battery on the pumps will shut down. When the battery shuts down, the staff are unable to get the pump started back up and a new pump has to be used. This facility has been in contact with the manufacturer multiple times over the last several months. There is currently no solution to the problem that has worked. The malfunctioning batteries have been exchanged with new batteries, but the new batteries are having the same issues.


Device:
Type: Infusion Pump
Manufacturer: Carefusion
Brand: Alaris
Other #: 13752865 and 13836709

Problem:
The patient was on an Epinephrine infusion. While the nurse was programing high volume pump, message came across brain of system error and the entire brain and channels shut down. Epinephrine syringe was quickly changed to a separate brain and restarted however in the process the patient received a bolus and her blood pressure increased to 310/160. The bedside physician paused the infusion until the patient's blood pressure was back to a normal range for her and then restarted.


Device:
Type: Needle, Catheter
Manufacturer: CARE FUSION 303, INC.
Brand: Thoracentesis Paracentesis Tray With Catheter
Lot #: 0000634460
Cat #: DBTPT1000

Problem:
A drainage bag contained in the thoracentesis kit was missing a connection point to attach to tubing. A second kit was obtained and required pieces were all present. No harm to patient.

======================
Manufacturer response for Thoracentesis kit, Thoracentesis (per site reporter)
======================
We are waiting for a response back.


Device:
Type: Oximeter
Manufacturer: Covidien
Brand: Nellcor Neoatal-adult Spo2 Sensor
Lot #: 141290181XN
Cat #: MAXN

Problem:
The bandaid elastic piece of the probe attached to the white cable has slid off the cable exposing the wires underneath leaving a potential for them to be broken or cut and thus causing an electrical safety issue for the patient and the staff. Staff say this cannot be explained with the normal rotation of site that happens per shift as per manufacturer's recommendation. We just started using these probes about 3 weeks ago and now have at least 10 documented occurrences in the last week, but verbal reports from staff indicate that the issue was noted about 3 weeks ago but not documented. Probes are currently changed prn per manufacturer's recommendation.


Device 1:
Type: Piston Syringe
Manufacturer: Ozburn-Hessey Logistics
Brand: Medichoice Toomey Piston Syringe
Lot #: 1308ak09a

Device 2:
Type: Piston Syringe
Manufacturer: Ozburn-Hessey Logistics
Brand: Medichoice Toomey Piston Syringe
Lot #: 1308ak09a

Device 3:
Type: Piston Syringe
Manufacturer: Ozburn-Hessey Logistics
Brand: Medichoice Toomey Piston Syringe
Lot #: 1308ak09a

Device 4:
Type: Piston Syringe
Manufacturer: Ozburn-Hessey Logistics
Brand: Medichoice Toomey Piston Syringe
Lot #: 1308ak09a

Device 5:
Type: Piston Syringe
Manufacturer: Ozburn-Hessey Logistics
Brand: Medichoice Toomey Piston Syringe
Model#: (not provided)
Lot #: 1308ak09a

Problem:
Attempting to open a toomey/piston syringe for scrub nurse and noticed a hole in the packaging. Went back to supply to get another sterile syringe and found four more of the same syringes with the same hole or defect in the package near the plunger area. There was also a distinct difference in the tactile feeling of the plastic; it was not uniform and was thinner, creating balloon effect where the defects were found. Device located that did not have defective product for use in patient's surgery. Delay while obtaining equipment without hole in packaging.


Device:
Type: Probe, Lachrymal
Manufacturer: BAUSCH & LOMB, INC
Brand: Storz Benger Probe Hook
Model#: E4222
Cat #: E4222

Problem:
During TDP (Tear Duct Probe) procedure, physician informed circulator that crochet hook in the set broke at the tip and was inside the patient's nose. After several attempts, the objects was found and removed. A follow-up X-Ray was performed.

This is the second event reported with this medical device at this facility within approximately 5 months. Staff/physicians do not know what is causing the events to occur. The manufacturer has been notified and product has been returned.


Device:
Type: Pump, Infusion
Manufacturer: Baxter Healthcare Corp
Brand: Sigma Spectrum
Model#: 35700

Problem:
The IV pump was infusing maintenance IV at the correct rate when the pump operation was verified by the nurse at the 2030 assessment. Upon returning to the patient's room around 2100, the nurse observed the pump to be operating properly. However, around 2200 the nurse found the IV pump to be non-functioning. The pump was off and no alarm had sounded. The pump was removed from service and a new one was used to administer the maintenance IV fluids. The pump was returned to the rental agency with instruction that they send a service report to our Biomedical Engineering Department.


Device:
Type: Pump, Infusion, Tubing
Manufacturer: ZEVEX, Inc.
Brand: Moog Curlin Infusion Administration Set
Model#: 340-4134
Lot #: CF 1403808

Problem:
Nurse noted fluid near IV pump; upon investigation identified that there was a leak in the tubing that was administering Fentanyl to the patient. Tubing removed and replaced. Patient received adequate pain control with new PCA tubing.
Leak occurred at the point just below the yellow slide (piece that goes into the pump) where the size of the tubing changes.


Device 1:
Type: Software
Manufacturer: GE MEDICAL SYSTEMS INFORMATION TECH.
Brand: Centricity Emr 9. 8
Model#: Centricity EMR 9.8 Service Pack 3 Patch 1 (9.8.3_0)

Device 2:
Type: Software
Manufacturer: Medi-Span
Brand: Medi-span Med-file Database 2014. 06

Problem:
GE Healthcare recently updated its drug-drug and drug-disease interaction database in Centricity® to obtain data from Medi-Span's Application Program Interface (API). Prior to the update, GE Centricity® had three levels of interaction severity alerts. Medi-Span's API has five levels of interaction severity alerts. Because GE Healthcare did not have time to enhance their product to handle five severity levels they mapped their three existing levels to the five levels in Medi-Span's API. This mapping strategy is outlined in Table 1.

Medi-Span API Level (new) Medi-Span Legacy Level (and CPS/EMR)
Contraindicated Absolute contraindication
Not recommended Absolute contraindication
Extreme caution Potential contraindication
Use cautiously Potential contraindication
Informational Use with caution
Table 1. Centricity®mapping of Medi-Span's 5 API levels to their 3 existing alert severity levels

This mapping strategy results in an inflated number of alerts categorized as absolute and potential contraindications. Falsely-severe alert warnings result in alert fatigue for prescribers and dilute the importance of clinically significant alerts. Both phenomena may lead to oversight of an important drug-drug or drug-disease interaction and subsequent patient harm.

Several examples of alerts generated in GE Centricity® are available to be sent to the FDA but could not be attached to this report. The sheer number of falsely-severe alerts has become overwhelming for our providers, and our team is unable to simply shut off these alerts. For the safety of our patients, we have been advocating to GE Healthcare that these issues be resolved in a timely manner.


Device:
Type: Transducer, Blood-pressure, Extravascular
Manufacturer: ICU Medical Inc.
Brand: 30 Ml Flush Monitoring Kit #3
Model#: 46010-34
Cat #: 46010-34

Problem:
Previously healthy patient admitted to outside hospital several months ago with multilobar pneumonia. Pt placed on V-V ECMO approximately 4 days after admission to outside facility. Transferred to this facility on ECMO approximately one month later for lung transplant evaluation and has remained on ECMO. Approximately 2 months after transfer to this facility, 2 RNs performing routine q 12 hr flush and zeroing of the ECMO circuit pressure lines. Immediately after zeroing line on venous side of ECMO circuit & releasing pigtail stopcock, ECMO RNs noted air on venous and arterial side of oxygenator of the ECMO circuit. RN immediately clamped the lines. Code Team summoned. Pt bagged and prolonged resuscitation including chest compressions and arrest meds occurred while pt was recannulated and converted to Veno arterial ECMO. Pt remained critical and the next afternoon, after lengthy discussion with MDs, parent requested that we withdraw treatment. Patient expired while surrounded by family. How air got into the circuit is not known at this time. The tubing remained visually intact & did not "fall apart"; however, it is possible that the stopcock and connectors became loose and allowed air to be drawn into the line. There have been no previous issues with the tubing at this facility. The ECMO machine did not alarm: air was detected by the two ECMO RN's before the air reached the ECMO circuit. Both ECMO RN's had received training/education to perform the line flush and are experienced in this procedure.

Preliminary cause of death is ARDS. Autopsy being performed.

Device:
Type: Tube, Endotrachial
Manufacturer: Teleflex Medical
Brand: Rusch 2. 5Mm "slick Set" Uncuffed Ett
Model#: 150025
Lot #: 11KE45
Cat #: 150025
Other #: 2.5 mm

Problem:
RUSCH package labeled as 2.5 ETT. A 3.5 ETT was in the package. Packaging was intact. Discovered prior to use on the patient: no patient harm.


Device:
Type: Tube, Tracheal (W/wo Connector)
Manufacturer: Kimberly Clark Corporation
Brand: Kimvent Mircrocuff Subglottic Suctioning Endotracheal Tubes
Model#: 8.0 mm Adult

Problem:
During initial assessment of patient, pilot balloon was missing from endotracheal tube (ETT). Called night shift RT and RN and was informed RN found pilot balloon in patient's linen and disposed of it. Cuff of ETT was deflated and leak was present at this time. This is a subglottic suction endotracheal tube, with no lot number on the tube. New package was opened and the pilot balloon was tugged on and it separated from the channel on the endotracheal tube more easily than the standard endotracheal tube which caused the pilot balloon to be stretched longer but not separated from the tube.


Device 1:
Type: Tubes, Gastrointestinal (And Accessories)
Manufacturer: Corpak MedSystems
Brand: Farrell Valve System
Model#: 20-4100
Cat #: 20-4100

Device 2:
Type: Tubes, Gastrointestinal (And Accessories)
Manufacturer: Corpak MedSystems
Brand: Farrell Valve System
Model#: 20-4100
Cat #: 20-4100

Device 3:
Type: Tubes, Gastrointestinal (And Accessories)
Manufacturer: Corpak MedSystems
Brand: Farrell Valve System
Model#: 20-4100
Cat #: 20-4100

Device 4:
Type: Tubes, Gastrointestinal (And Accessories)
Manufacturer: Corpak MedSystems
Brand: Farrell Valve System
Model#: 20-4100
Cat #: 20-4100

Device 5:
Type: Tubes, Gastrointestinal (And Accessories)
Manufacturer: Corpak MedSystems
Brand: Farrell Valve System
Model#: 20-4100
Cat #: 20-4100

Problem:
Farrell bag tubing was leaking where the tubing meets the orange hub. Some of the tube feeding had leaked onto the bed (<5ml). Tubing changed.

The NICU has five tubings that have leaked all at the connector site ("orange Christmas tree"). All five will be returned to the manufacturer. Packaging is intact and no visual defects seen prior to leaking.

======================
Manufacturer response for Farrell Valve Enteral Gastric Pressure Relief System, (brand not provided) (per site reporter)
======================
They have asked I return the used bags for investigation.


Device:
Type: Ventilator
Manufacturer: CareFusion
Brand: Avea
Model#: 16448

Problem:
Infant patient with neurologic impairment, a seizure disorder and dysphagia. Viasys Avea Ventilator being used for comprehensive critical care ventilation. Viasys Avea Ventilator screen display froze with red light (status) displayed. Viasys Avea Ventilator not cycling with continuous alarm. Alarm continuous after Viasys Avea Ventilator restarted. Viasys Avea Ventilator removed from patient and replaced with another Viasys Avea Ventilator. Patient unaffected by Viasys Avea Ventilator malfunction.


Device:
Type: Ventricular (Assisst) Bypass
Manufacturer: Thoratec Corp.
Brand: Heartmate Ii Pocket Controller
Model#: 106t62

Problem:
Patient heard an alarm on his pocket controller. He saw a yellow wrench in addition the driveline fault alarm and contact hospital personnel were visible in the display screen. He silenced the alarm and called the LVH VAD emergency line. PA-C responded to the call. After speaking with the patient, she then called the physician and the Thoratec Clinical support to discuss the plan. The patient felt well, all pump parameters were within his normal range. But secondary to the seriousness of the alarm he was brought into the office for evaluation. As there are false positive driveline fault alarms, the standard process is to connect to the system monitor and clear the alarm. Following the Thoratec Corp. algorithm we cleared the alarms but it returned approximately 10 minutes later; we repeated the alarm clearing procedure 2 more times. Each time it returned within 5 to 10 minutes. Again all pump parameters remained within in his normal range. (Speed 8980 to 9000; Flow 4.0 to 4.9; Pump Power 4.9 to 5.4; Pulse index 7.2 to 8.1) He continued to feel well. We manipulated the driveline in an attempt to reproduce an alarm, thus attempting to validate a true driveline fracture. We could not reproduce the alarm. The next step was to replace the controller. Before proceeding to the exchange, waveforms were downloaded and sent to Thoratec Corp. The patient was placed in a bed and his backup controller was used (PC-23645-E) for the exchange. The controller exchange was uneventful. The patient did not experience any symptoms during the exchange. He was given a new controller to be used as backup (PC-23620-E). (Lot # 139065). The patient connected his new backup controller to batteries in order to charge the backup battery housed within the controller. He remained with us for about 30 minutes after the exchange during which time he walked around the area, in addition the driveline was manipulated but the alarm never returned. Prior to leaving the following pump parameters were observed; Speed 8990; Flow 4.9; Pump Power 5.2; Pulse index 7.9. He was therefore allowed to return home.

The equipment was returned to Thoratec Corp. and a replacement was promised.



Device:
Type: Oximeter
Manufacturer: Masimo Corporation
Brand: Lncs Oximetry Sensors

Problem:
Pulse oximeter sensor removed from the dorsum of left foot earlier this year. There were exposed wires noted on the pulse oximeter. A small (2cm) erythematous indentation was noted. There were also exposed wires noted on the device. Physician was notified and site was left open to air.


Device:
Type: Device, Hemostasis, Vascular
Manufacturer: Access Closure, Inc.
Brand: Mynx
Lot #: F1403703
Cat #: MX6721

Problem:
Lead technologist was using the Mynx closure device. When pulling back the sheath, after deploying the mynx plug, there was no white advancing stick present to hold the plug in place while removing the device. The technologist then deflated the device balloon and held manual pressure. There was no harm to the patient in this event.


Device:
Type: Set, Administration, Intravascular
Manufacturer: CareFusion Corporation
Brand: Versasafe Split Septum
Cat #: 2110-0500
Other #: 2120-0500

Problem:
Back up primary tubing required further education on use. Medication going too quickly, but was caught by nursing staff before the patient was effected. The ER experience was that the meds backed up into the primary line. Spoke with distribution and paged director as manager on vacation. Physical examples of tubing brought to each area with paper copy of explanation. Email to be left with each charge nurse with explanation. "Please be aware that our standard Alaris tubing is on backorder and the materials department was able to secure a replacement that is slightly different. Please note the slight changes below:

Please find information on original and sub below:
2120-0500 (GREEN) = ORIGINAL
2110-0500 (RED) = SUB COMING IN ON SATURDAY
Check Valve is missing in sub, but roller clamp is the same. The sub is two inches shorter. THIS MEANS THAT YOU NEED TO CLAMP THE TUBING AT THE TOP WHEN YOU ARE GIVING A SECONDARY MED. PLEASE MAKE SURE STAFF UNDERSTAND THIS.


Device:
Type: Insert, Tubal Occlusion
Manufacturer: Bayer Healthcare
Brand: Essure
Cat #: ESS305

Problem:
After deployment of the coils into the fallopian tube, there was a wire that remained in the uterine cavity and protruded out the cervix. Upon trying to remove the wire, the patient began to have increased bleeding and her abdomen began to distend. The representative from the company was called. Bleeding then obscured the hysteroscopic field. An exploratory laparoscopy was performed to rule out tube rupture or obvious perforation. A Filche clip tubal ligation was performed in order to complete the sterilization. The patient had to be admitted for observation.



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TitleDate
Highlighted ReportsAugust 2014
Highlighted ReportsJuly 2014
Highlighted ReportsJune 2014
Highlighted ReportsMay 2014
Highlighted ReportsApril 2014
Highlighted ReportsMarch 2014
Highlighted ReportsFebruary 2014
Highlighted ReportsJanuary 2014
Highlighted ReportsDecember 2013
Highlighted ReportsNovember 2013
Highlighted ReportsSeptember 2013
Highlighted ReportsAugust 2013
Highlighted ReportsJuly 2013
Highlighted ReportsJune 2013
Highlighted ReportsMay 2013
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Highlighted ReportsJanuary 2013
Highlighted ReportsDecember 2012
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Updated August 29, 2014

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