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U.S. Department of Health and Human Services

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


Device:
Type: Coronary Drug-eluting Stent
Manufacturer: MEDTRONIC, INC
Brand: Rx Bms Integrity
Lot #: 10 0006944650
Cat #: INT 30030UX

Problem:
Patient was in the cath lab for an emergency cath and stent placement. A bare metal stent was intended to be placed, but a drug eluding stent was pulled from the shelf. The packages are very similar in marking and color and can be difficult to distinguish from one another during an emergent procedure.

Device:
Type: Electrocardiograph, Cable
Manufacturer: Spacelabs Healthcare, Inc.
Brand: Trulink
Lot #: 2130715016

Problem:
Biomed found an ECG cable that was not standard to all other cables throughout the hospital. In this cable, we noted that the colors for ECG leads were not in a standard format and that it translated into waveforms that would be incorrect. Further, we believe this is isolated to one specific lot number, but we must at this point ask all our users of Spacelabs to review the color pattern of ECG leads on the trunk cable. We have referenced users to locate the brown dot on the cable, but also know that the black and red dots are wrong on the incorrect cable. We've asked our users to please be on the lookout for these cables and alert Biomed upon finding any that are wrong.

Device:
Type: Catheter
Manufacturer: Kimberly-Clark Corp.
Brand: Kim
Model#: 210
Lot #: m3357T501
Other #: Bar code # 010609038001418

Problem:
During a family meeting it was brought to the team's attention that the patient's father was concerned about the length (marking on suction catheter) that staff were suctioning the patient. He was admitted for a tracheostomy and teaching. He was using an in line suction catheter and in report from PICU, he was to be suctioned to the double yellow line on the catheter. On this date it was noted that the patient had an endotracheal closed suction system in place, not a trach closed suction system. Therefore the length of the tube was longer and the patient was being suctioned to a much deeper length with an endotracheal catheter than the tracheostomy catheter. Once in place there is no way to tell which catheter is being used. There should be a way to tell directly on the catheter if it is for a trach or endotracheal tube.


Device:
Type: Catheter, Intravascular, Diagnostic
Manufacturer: Angiodynamics, Inc.
Brand: Soft-vu Omni Flush
Lot #: 610971
Cat #: 10732203
Other #: Non-braided Angiographic Catheter 5 F, 65cm

Problem:
The catheter was under pressure from a power injector during the procedure and was already in place in the patient. A power injector was in use to insert contrast: flow rate of 8cc/24cc and pressure was 700psi. The catheter hub detached from the catheter and contrast and blood were ejected into the work space, including onto staff. The patient was unharmed, though there was minor delay while a new catheter was placed. Several staff members were splashed with one minor injury. There is no known pathogen exposure to date. Catheter was rated for a flow rate of 27cc and pressure of 1050psi.

Device:
Type: Gas-machine, Anesthesia
Manufacturer: GE - Datex Ohmeda Inc.
Brand: Aisys
Model#: AISYS

Problem:
Complete failure of anesthesia machine. The failure occurred following induction and approximately 10-minutes into the anesthetic delivery of the second case of the day. No problems were noted during the 1st case, where the same machine was used. The patient was on mechanical ventilation and normal machine operation was noted. The circuit was then disconnected so that the patient could be turned to be prone. The circuit was reconnected and the ventilation selector switch was turned to manual. The selector switch was then turned back to ventilation mode, which is when the problem occurred. During this transition, the following failure conditions occurred: 1. Machine ventilator display went blank. 2. High pitched noise from the anesthesia machine. 3. Bellows were up, but not moving. 3. O2 flush was pressed, but there were no signs of it working (manual bag or bellows) were not filling and there was no "whooshing" sound signifying any gas flow. Others came in and cycled the power on the machine, but operation was not restored. The AC power indicator was noted to be lit.
Device passed pre-use check.


Device:
Type: Heater, Breathing System W/wo Controller (Not Humidifier Or Nebulizer)
Manufacturer: Fisher & Paykel Healthcare LTD
Brand: Evaqua
Cat #: RT235
Problem:
RN Safety Report:
Situation: At 0100 care time air found to be leaking around ventilator tubing, no vent alarms, PT getting tidal volumes without increasing peak pressures.
Background: EGA 26 week on vent support.
Action: RT called to bedside, vent circuit changed, PT provided PPV with Neotee during change over.
Response: Tubing saved for RT.
RN: When repositioning infant steady stream of air felt flowing from vent tubing close to Y connector. The vent was not alarming. Pt getting adequate tidal volumes with pressures of 15-18 which was consistent with earlier in shift. Leak registered at 15-25%. Vent circuit changed and leak consistent. No change to baby's breath sounds, work of breathing pressure demands to meet tidal volumes and O2 reads stable throughout.
Respiratory Therapist(RT): Vent circuit tubing audibly leaking, no alarms, patient's tidal volume remained within normal limits, no increase in peak pressure noted. Circuit tubing changed out while baby was neopuffed. Hole in tubing found near inspiratory connection. RT also stated it could have been caused by the vent being too close to the isolette. There was a note placed on the circuit tubing that was removed that said "hole discovered on exhalation side where the tape was placed."


Device:
Type: Instrument, Biopsy
Manufacturer: ARGON MEDICAL DEVICES INC.
Brand: Biopince
Model#: 360-1080-01
Lot #: 11072208
Cat #: 360-1080-01

Problem:
During a radiology special procedures case, the physician attempted to retrieve a tissue biopsy sample using a full core biopsy instrument. After extracting the biopsy instrument and trying to place specimen into container physician noted that no sample was present. Physician reinserted biopsy needle and tried a second retrieval and was unable to extract a specimen. Physician asked for a new needle and finally retrieved a specimen for testing. This model instrument was reported in previous events to the FDA.

Device:
Type: Laser Surgical Instrument
Manufacturer: Dornier MedTech America. Inc.
Brand: Olympus Rfid Laser Fibers
Lot #: F1714S
Cat #: HLFD0270C

Problem:
The laser tip broke off 3 inches from the end causes damage to our cysto scopes. The intended procedure was completed by using a laser fiber from the same company just a different lot number.
======================
Manufacturer response for holmium laser tip, Olympus (per site reporter)
======================
they planned to pull all the RFID Holmium -lightguide laser with the lot #, do to their faulty fires.


Device:
Type: Monitor, Physiological, Patient(Without Arrhythmia Detection Or Alarms)
Manufacturer: Stanley Security Solutions, Inc
Brand: Hugs Infant Protection
Lot #: 400082
Cat #: 806A2001

Problem:
Per Nurse Coordinator on pediatrics:
1. When you put the strap through the Hugs Tag, the strap curls and pulls apart.
2. An RN pulled the strap out of a Hugs tag and the alarm should have gone off and it didn't.
3. There were multiple patients that this happened to. Also there were some from devices in this box of straps that worked fine.

The Unit has been using another box of straps with the same number that is stamped on the end of the box for two days and have had no isses. This issues have happened with multiple staff members. Customer Service contacted and said I could not send it back.

======================
Manufacturer response for Infant Security Strap for the Hugs Tags, Hugs Infant Protection (per site reporter)
======================
I had to leave a message with QA

Device:
Type: Oximeter
Manufacturer: Covidien
Brand: Nellcor Max-fast
Cat #: MAXFAST

Problem:
Patient had Nellcor Maxfast SPO2 monitor applied to forehead post surgical procedure. Upon removal of the device from the patient's forehead, the patient reported that a layer of skin came off with the device resulting in a skin tear in the middle of the forehead. After the patient was discharged from the facility, the patient called back to report they did seek treatment for the skin tear.
Manufacturer response for SPO2 Sensor, Nellcor Maxfast (per site reporter)
======================
The manufacturer rep reported there are several layers of adhesive on this device so that the device can be moved around over and over again. The manufacturer has asked the facility several questions regarding the event and has offered staff education. Additional information will be shared with FDA upon receipt.

Device:
Type: Sterilization Indicator
Manufacturer: 3M
Brand: 3m Comply Steam Indicator Tape
Other #: 3M Health Care D-41453

Problem:
Exposure Monitoring product (used for at least past six years at this hospital with no problems) has been noted in past six months to fade away, become pale or completely disappear resulting in question-of-sterility of surgical packets that have gone through sterilization process. Loss of visual indicator stripes causes surgical team to reject packets in OR, requiring 2nd flash-sterilization of set-up trays. Team has reviewed locations of trays, storing of trays and other possible variables.

======================
Manufacturer response for Sterilization Indicator, 3M COMPLY Steam Indicator Tape (per site reporter)
======================
Initial contact with 3M: Complaint line said "they've heard about this and are taking complaint information" but there was no recall, device notification etc. Our hospital facillities engineer contacted them wondering about correlation between new light bulbs installed recently in OR to LED & LCD bulbs "no UV rays" with those bulbs.

Device:
Type: System, Thermal Regulating
Manufacturer: 3M HEALTH CARE
Brand: Bair Hugger
Model#: 42268
Lot #: xv10184
Cat #: 42268

Problem:
The film on the Bair Hugger blanket is sticking together, making it impossible to open up without tearing.

Manufacturer response for Warming blanket, Bair Hugger (per site reporter)
======================
Sales rep came in, met with the department that is having the problems. She shipped back 20 samples for QA

Device:
Type: System, Surgical, Computer Controlled Instrument
Manufacturer: Intuitive Surgical, Inc.
Brand: Davinci
Model#: Ver-13
Lot #: S1013121365
Cat #: 428088

Problem:
The patient was undergoing a single site robotic total abdominal hysterectomy with bilateral salpingo-oopherectomy (TAH-BSO) and cystoscopy. The surgeon was using a single site curved needle driver to complete the suturing at the end of the case, when the head of the needle driver broke off into the patient. The surgeon had to locate and remove several loose pieces from the patient, prolonging time under anesthesia. The side of the driver tip, which is made of hard plastic, appears to have broken off. It is also unclear whether a small piece of gray material that holds the driver hinge in place was missing on this needle driver. It was not found in the patient or in the material returned to us from the operating room. We think it may not have been placed on the hinge during manufacturing, thus allowing the driver to fall apart and break under tension. We have photos for review of the driver we recovered and a new driver we pulled apart.

Device:
Type: System, Surgical, Computer Controlled Instrument
Manufacturer: Intuitive Surgical, Inc.
Brand: Endowrist One Vessel Sealer
Lot #: S10140106
Cat #: 410322

Problem:
During DaVinci procedure, blade of vessel sealer became exposed. Blade was straight out between jaws of vessel sealer. Instrument removed and replaced with new instrument. No harm to patient.


Device:
Type: Tube, Feeding
Manufacturer: Corpak MedSystems
Brand: Corflo Ultra Lite Nasogastric Feeding Tubes With Anti-clog Feeding Port
Lot #: 67758
Cat #: 20-9366
Other #: H8922093660H

Problem:
Patient under anesthesia intubated, RN placing a feeding tube to give 60mls water per Neuroblastoma protocol. 6 Fr feeding tube was placed, proper placement verified with aspiration of gastric contents, Ph test confirmed proper placement. As RN began giving water she noticed water began pooling approximately 1 inch from patient's left nare. RN dried the area, began giving more water and could see the water spewing from a hole at approximately the 45cm mark. The feeding tube was at 44cm at the left nare. Due to the leak, the RN had to remove this feeding tube and place a second one. This hole must have been present when the device was in the packaging. Packaging was intact. It was simply taken out of the packaging, the tip was lubricated, and the patient was measured and the feeding tube inserted without difficulty. No one had manipulated or removed and replaced the guide wire. Another device obtained and placed. Patient had to undergo a second tube placement because the first tube was faulty.

Device:
Type: Wire, Guide, Catheter
Manufacturer: Boston Scientific Coronary Division
Brand: Choice Pt 1. 014x300cm
Model#: H74912155011
Lot #: 17200347
Cat #: (not provided)
Other #: (not provided)

Problem:
Approximately three hours into the PTCA and stenting of the LAD, the physician states in his procedural report that just prior to removing the guiding catheter in question, the Interventionalist noted that a 2-cm segment of the previously removed PTCA wire in the ascending aorta, which gradually entered the descending aorta and eventually migrated into the distal left SFA. The fractured wire tip was removed with a 4.0-8.0 snare catheter. On retrieval it appeared that the wire did not actually fracture but was acutally the hydrophilic coding itself.

Device:
Type: Set, Administration, Intravascular
Manufacturer: B Braun Medical Inc.
Brand: Caresite Luer Access Device
Cat #: 415122

Problem:
Recently, the hospital changed over to the B Braun Caresite luer access device. There has been several instances where the blood had backed up into the tubing once the IV fluids ran out. This access device has a backflow valve and there is a question as to whether or not it is functioning properly.

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All Actions to Date

TitleDate
Highlighted ReportsOctober 2014
Highlighted ReportsSeptember 2014
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
Highlighted ReportsMarch 2013
Highlighted ReportsFebruary 2013
Highlighted ReportsJanuary 2013
Highlighted ReportsDecember 2012
Highlighted ReportsNovember 2012
Highlighted ReportsOctober 2012
Highlighted ReportsSeptember 2012
Highlighted ReportsAugust 2012
Highlighted ReportsJuly 2012
Highlighted ReportsJune 2012
Highlighted ReportsMay 2012
Highlighted ReportsApril 2012
Highlighted ReportsMarch 2012
Highlighted ReportsFebruary 2012
Highlighted ReportsJanuary 2012
Highlighted ReportsDecember 2011
Highlighted ReportsNovember 2011
Highlighted ReportsOctober 2011
Highlighted ReportsSeptember 2011
Highlighted ReportsAugust 2011
Highlighted ReportsJuly 2011
Highlighted ReportsJune 2011
Highlighted ReportsMay 2011
Highlighted ReportsApril 2011
Highlighted ReportsMarch 2011
Highlighted ReportsFebruary 2011
Highlighted ReportsJanuary 2011
Highlighted ReportsDecember 2010
Highlighted ReportsNovember 2010
Highlighted ReportsOctober 2010
Highlighted ReportsSeptember 2010
Highlighted ReportsAugust 2010
Highlighted ReportsJuly 2010
Highlighted ReportsJune 2010
Highlighted ReportsMay 2010
Highlighted ReportsApril 2010
Highlighted ReportsMarch 2010
Highlighted ReportsFebruary 2010
Highlighted ReportsJanuary 2010
Highlighted ReportsDecember 2009
Highlighted ReportsNovember 2009
Highlighted ReportsOctober 2009
Highlighted ReportsSeptember 2009
Highlighted ReportsAugust 2009
Highlighted ReportsJuly 2009
Highlighted ReportsJune 2009
Highlighted ReportsMay 2009
Highlighted ReportsApril 2009
Highlighted ReportsMarch 2009
Highlighted ReportsFebruary 2009
Highlighted ReportsJanuary 2009
Highlighted ReportsDecember 2008
Highlighted ReportsNovember 2008
Highlighted ReportsOctober 2008
Highlighted ReportsSeptember 2008
Highlighted ReportsAugust 2008
Highlighted ReportsJuly 2008
Highlighted ReportsJune 2008
Highlighted ReportsMay 2008
Highlighted ReportsApril 2008
Highlighted ReportsMarch 2008
Highlighted ReportsFebruary 2008
Highlighted ReportsJanuary 2008
Highlighted ReportsDecember 2007
Highlighted ReportsNovember 2007
Highlighted ReportsSeptember 2007

Updated October 30, 2014

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