Highlighted Reports
MedSun: Newsletter #87, August 2013

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 2013. All other reports can be searched under the ‘MedSun reports’ menu pane.

Device:
Type: Binder, Abdominal
Manufacturer: DeRoyal Industries, Inc.
Brand: Abdominal Binder
Model#: (not provided)
Lot #: 31735501
Cat #: A131067
Other #: (not provided)

Problem:
Per Mother Baby nurse: "Velcro binder causing itchy red flattish rash where binder covered on abdomen". Rash was nonraised. Binder was removed and replaced with soft stretchy binder (different product). This facility has had more than 9 similar events with this product in the last 5 months. Product states latex free. The facility reports this type of reaction has been seen in patients with C-sections as well as vaginal deliveries; thus, staff does not believe that there is a reaction to the skin prep used for C-section deliveries because the prep is not used in a vaginal delivery. Also, staff has stated in previous incidents that the rash occurs on areas which does not have the skin prep but does have contact with the binder. Patients with and without known allergies have been affected. The manufacturer has been notified. They are unaware of any other complaints like this.
We checked with our surgical unit because they use quite a few abdominal binders and they have not heard of any concerns regarding rash. Patients in the surgical unit would have similar use of this device. Also, there are patients in the surgical unit both who have and who have not had exposure to the same brand of skin prep as the patients on the other nursing unit. The storage procedure/process for both nursing units is identical: storage and transportation of the devices are not believed to be contributing factors in these events.

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Manufacturer response for Medium/Large abdominal binder, (brand not provided) (per site reporter)
======================
Spoke with DeRoyal rep. They plan to send shipping label for product return.

Below is an email from DeRoyal Senior Area Manager that was sent to the Manager of Materials Management:

"I have people checking into any problems with these ab binders. But as of now I have heard of no problems at other accounts using these two products. They are used at (xxx), (xx) and (x) hospital.
That being said if you would like to try a different binder that is still on contract I would try.
13661056 9in s/m
13662067 9in m/l
O&M may have these in stock since they are used in some (hospital) accounts. If not we can drop ship them for O&M.
Hope this helps.

DeRoyal Orthopedics
Senior Area Manager"


Device:
Type: Immunoassay Analyzer
Manufacturer: Beckman Coulter
Brand: Access 2
Model#: Access 2
Lot #: (not provided)
Cat #: (not provided)
Other #: Asset Tag # 07917

Problem:
The analyzer developed a crimp in the line from the buffer/buffer unit to the main unit of the Access 2 analyzer at the point where all the tubing from the buffer/substrate module enters the main module of the unit. The problem became progressively worse as the tubing became more crimped and there was no buffer solution coming through the line at all. Only at this point did the analyzer stop producing results, and only then did the analyzer produce multiple error messages that could be seen on screen. However, just prior to this, the analyzer was able to pipette sample and dispense substrate and reagent. Testing and results continued even though there was little or no buffer being dispensed. Without the correct amount of buffer, the system is unable to clean the main pipettor and probes, and remove unbound material during test processing. This issue became progressively worse causing increasingly elevated/abnormal results that were erroneous.

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Manufacturer response for Immunoassay analyzer, Access 2 (per site reporter)
======================
Pending-Under Investigation



Device:

Type: Neurological Tray
Manufacturer: CareFusion
Brand: Manometer
Model#: 4330
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
During OR setup and product inspection it was noted that there was a small hair noted to be inside the package. The instrument was not used and there was no patient in the room.


Device:
Type: Tube, Tracheal/bronchial, Differential Ventilation (W/wo Connector)
Manufacturer: Teleflex Medical
Brand: Hudon Rci/sheridan
Model#: (not provided)
Lot #: 01H1200 518
Cat #: 5-10405
Other #: ID:2.5, OD: 3.6, Uncuffed 2.5 ETT


Problem:
This device provides an airway to critically ill extremely low birth weight premature newborns. The product attaches to a mechanical ventilator to provide 02 & life support. In the last 6 months, we have had a total of 5 issues with this device. A previous device report was submitted. At the time of the previous report, the suspected device lot numbers were removed from our facility's shelves. The manufacturer sent replacement product, but it was from the same lot number. The problem continues despite this effort.

When attempting to pass a 6 Fr. Suction catheter tube down the ETT, it was not able to pass the end of the tracheal tube. It felt as if the ETT was pinched at the end, resulting in occlusion. Different suction tubes were used to assure that it was not the suction tubing, and the same thing occurred. The neonates involved demonstrated an increased need in F102 requirements. The neonates needed to be reintubated, therefore putting the babies through an unnecessary additional procedure & possible delays in treatment. There are no patient factors attributed to these events.

The staff were able to duplicate this type of problem outside of the patient with the same result. The suction catheter would not pass through the ETT for this lot number. Staff reported that the sensation of feeling the ETT was pinched was the same when the device was in a patient as when it was not.

The nurse manager has been in close contact with the Manufacturer regarding this problem. Manufacturer rep told the nurse manager that they have had this same problem with this device at another facility. Our facility has pulled all of this manufacturer's product off of our shelves again.

======================
Manufacturer response for Hudson RCI/Sheridan Uncuffed 2.5 ETT, Hudson RCI/Sheridan Uncuffed 2.5 ETT (per site reporter)
======================
Teleflex Medical was contacted several months ago and informed that there was problems with the device.



Device:
Type: Tube, Tracheal/bronchial, Differential Ventilation (W/wo Connector)
Manufacturer: Teleflex Medical
Brand: Hudon Rci/sheridan
Model#: (not provided)
Lot #: 01H1200 518
Cat #: 5-10405
Other #: ID:2.5, OD: 3.6, Uncuffed 2.5 ETT

Problem:
This device provides an airway to critically ill extremely low birth weight premature newborns. The product attaches to a mechanical ventilator to provide 02 & life support. In the last 6 months, we have had a total of 5 issues with this device. A previous device report was submitted. At the time of the previous report, the suspected device lot numbers were removed from our facility's shelves. The manufacturer sent replacement product, but it was from the same lot number. The problem continues despite this effort.

When attempting to pass a 6 Fr. Suction catheter tube down the ETT, it was not able to pass the end of the tracheal tube. It felt as if the ETT was pinched at the end, resulting in occlusion. Different suction tubes were used to assure that it was not the suction tubing, and the same thing occurred. The neonates involved demonstrated an increased need in F102 requirements. The neonates needed to be reintubated, therefore putting the babies through an unnecessary additional procedure & possible delays in treatment. There are no patient factors attributed to these events.

The staff were able to duplicate this type of problem outside of the patient with the same result. The suction catheter would not pass through the ETT for this lot number. Staff reported that the sensation of feeling the ETT was pinched was the same when the device was in a patient as when it was not.

The nurse manager has been in close contact with the Manufacturer regarding this problem. Manufacturer rep told the nurse manager that they have had this same problem with this device at another facility. Our facility has pulled all of this manufacturer's product off of our shelves again.

======================
Manufacturer response for Hudson RCI/Sheridan Uncuffed 2.5 ETT, Hudson RCI/Sheridan Uncuffed 2.5 ETT (per site reporter)
======================
Teleflex Medical was contacted several months ago and informed that there was problems with the device.


Device:
Type: Tube, Tracheal/bronchial, Differential Ventilation (W/wo Connector)
Manufacturer: Teleflex Medical
Brand: Hudon Rci/sheridan
Model#: (not provided)
Lot #: 01H1200 518
Cat #: 5-10405
Other #: ID:2.5, OD: 3.6, Uncuffed 2.5 ETT

Problem:
This device provides an airway to critically ill extremely low birth weight premature newborns. The product attaches to a mechanical ventilator to provide 02 & life support. In the last 6 months, we have had a total of 5 issues with this device. A previous device report was submitted. At the time of the previous report, the suspected device lot numbers were removed from our facility's shelves. The manufacturer sent replacement product, but it was from the same lot number. The problem continues despite this effort.

When attempting to pass a 6 Fr. Suction catheter tube down the ETT, it was not able to pass the end of the tracheal tube. It felt as if the ETT was pinched at the end, resulting in occlusion. Different suction tubes were used to assure that it was not the suction tubing, and the same thing occurred. The neonates involved demonstrated an increased need in F102 requirements. The neonates needed to be reintubated, therefore putting the babies through an unnecessary additional procedure & possible delays in treatment. There are no patient factors attributed to these events.

The staff were able to duplicate this type of problem outside of the patient with the same result. The suction catheter would not pass through the ETT for this lot number. Staff reported that the sensation of feeling the ETT was pinched was the same when the device was in a patient as when it was not.

The nurse manager has been in close contact with the Manufacturer regarding this problem. Manufacturer rep told the nurse manager that they have had this same problem with this device at another facility. Our facility has pulled all of this manufacturer's product off of our shelves again.

======================
Manufacturer response for Hudson RCI/Sheridan Uncuffed 2.5 ETT, Hudson RCI/Sheridan Uncuffed 2.5 ETT (per site reporter)
======================
Teleflex Medical was contacted several months ago and informed that there was problems with the device.


Device:
Type: Tube, Tracheal/bronchial, Differential Ventilation (W/wo Connector)
Manufacturer: Teleflex Medical
Brand: Hudon Rci/sheridan
Model#: (not provided)
Lot #: 01H1200 518
Cat #: 5-10405
Other #: ID:2.5, OD: 3.6, Uncuffed 2.5 ETT

Problem:
This device provides an airway to critically ill extremely low birth weight premature newborns. The product attaches to a mechanical ventilator to provide 02 & life support. In the last 6 months, we have had a total of 5 issues with this device. A previous device report was submitted. At the time of the previous report, the suspected device lot numbers were removed from our facility's shelves. The manufacturer sent replacement product, but it was from the same lot number. The problem continues despite this effort.

When attempting to pass a 6 Fr. Suction catheter tube down the ETT, it was not able to pass the end of the tracheal tube. It felt as if the ETT was pinched at the end, resulting in occlusion. Different suction tubes were used to assure that it was not the suction tubing, and the same thing occurred. The neonates involved demonstrated an increased need in F102 requirements. The neonates needed to be reintubated, therefore putting the babies through an unnecessary additional procedure & possible delays in treatment. There are no patient factors attributed to these events.

The staff were able to duplicate this type of problem outside of the patient with the same result. The suction catheter would not pass through the ETT for this lot number. Staff reported that the sensation of feeling the ETT was pinched was the same when the device was in a patient as when it was not.

The nurse manager has been in close contact with the Manufacturer regarding this problem. Manufacturer rep told the nurse manager that they have had this same problem with this device at another facility. Our facility has pulled all of this manufacturer's product off of our shelves again.

======================
Manufacturer response for Hudson RCI/Sheridan Uncuffed 2.5 ETT, Hudson RCI/Sheridan Uncuffed 2.5 ETT (per site reporter)
======================
Teleflex Medical was contacted several months ago and informed that there was problems with the device.


Device:
Type: Ventilator
Manufacturer: Philips Medical Systems
Brand: Respironics
Model#: Trilogy 202
Lot #: (not provided)
Cat #: 1040007
Other #: 1040007

Problem:
Trilogy 202 ventilators were recently upgraded to 13.0 software. The software contained new ventilator options beneficial to our patients. A software issue regarding the 100% oxygen 2 minute capability has been identified. The user initiates 100% oxygen by pressing the 100% O2 left key. During the 2 minute administration of 100% O2, a Cancel icon will appear within the 100% indicator on the lower left of the screen. The icon will stay on the screen for the 2-minute duration of the flush, and then it should disappear when the flush is complete. Currently, the Cancel icon stays on the screen, even after the flush is complete and the FiO2 is returned to the preset value. The next time someone pushes the 100% O2 left key, the popup prompts/asks the user if they would like to "cancel 100% O2?" instead of the normal message "100% O2?". The user then needs to select the Yes left key to Cancel 100% O2 and then press the 100% O2 left key to administer 100% O2.
Users who may not actually read the prompt believe that they are initiating a new 2-minute oxygen flush, when in fact they have merely canceled the previous one (because the 100% O2 function did not reset itself as it should). Please be aware of this current issue and know that it does not affect the delivery of 100% oxygen or the return to baseline oxygen setting on the first initiation. Subsequent attempts to provide 100% Oxygen will require the user to "cancel 100% O2" initially and then press the 100% flush button (left) again and then confirm by pressing the right (YES) button. A corrective software update will be issued soon.


Device:
Type: Ventilator, Emergency, Powered (Resuscitator)
Manufacturer: Mercury Medical
Brand: Neo Tee Infant T-piece Resuscitator
Model#: (not provided)
Lot #: unknown
Cat #: 10-50811
Other #: (not provided)

Problem:
This Spring, infant in nursery starting having respiratory problems and was in need of immediate resuscitation. Nurse grabbed the Neo Tee device which is a single use device. She opened the package and applied device to baby. The device would not function. A new package was opened and baby was resuscitated. Product failure did delay effective resuscitation however; no harm came to the baby. The malfunctioning device was then inspected. It was found that the manometer mechanism was not aligned properly. This came out of the package that way. If the nipple on the manometer is not mated in the hole and body of the resuscitator properly, oxygen will free flow and the resuscitator will not work properly. It was reported that after inspection of other unopened units one more problem device was found. This was reported to the manufacturer at the time of the event. However this was not reported to our Risk or Clinical Engineering department until recently. Therefore, we do not have a lot number to report. After an investigation was completed by Clinical Engineering it was discovered the manufacturer has not responded back to our facility at this time.


Device:
Type: Cardiac Ablation System
Manufacturer: Atricure, Inc.
Brand: Isolator Synergy Glidepath
Model#: EMR2
Lot #: 41233
Cat #: (not provided)
Other #: (not provided)

Problem:
A Thorascopic maze procedure was being performed to treat patient's recurrent paroxysmal atrial fibrillation following a catheter-based ablation several years ago. Surgeon experienced difficult exposure due to limited deflation of the lung. As surgeon was using the EMR2 clamp, the "rubber attachment" failed and came off of the instrument. The piece was retrieved and removed. Procedure was completed without injury to the patient.



Device:
Type: Electrode, Defibrillation, Single Use
Manufacturer: Vermed
Brand: Vermed
Model#: D309
Lot #: Y120512-04
Cat #: (not provided)
Other #: Adult Radiolucent Electrode (one pair)


Problem:
During an emergency cardiac cath for ST elevation myocardial infarction, the patient experienced VFib arrest. After 3-4 defibrillations at 150 joules, the Vermed defib pads no longer delivered a shock. The staff verified correct pad placement and adherence to patient's skin. The non functioning defibrillator pads were removed and replaced with Philips pads. Additional defibrillations were successful and patient was trasferred to ICU following procedure. Biomed checked all functions of the defibrillator and found no problems.

Device:
Type: Ligator, Esophageal
Manufacturer: Wilson-Cook Medical, Inc.
Brand: Instinct
Model#: INSC-7-230-S
Lot #: W3241176
Cat #: (not provided)
Other #: (not provided)

Problem:
Patient was undergoing removal of a 1.5 cm sessile polyp during colonoscopy. Polyp was mostly removed with hot snare. Cautery was applied to control bleeding and surgeon attempted using the endoclip to close the mucosal defect. As the hemoclip was being released at bleeding site, the release handle was pulled and the wire connected to the hemoclip broke preventing application of the clip. Device was removed and procedure was completed without patient injury.



Device:
Type: Electrosurgical, Vessel Harvesting, Generator
Manufacturer: MAQUET Cardiovascular LLC
Brand: Vasoview Hemopro
Model#: VH-3010
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
After engaging the DC cautery while in the leg during an endoscopic saphenous vein harvest the energy did not dissengage. The audible tone from the power source continued when the button was released and the heating element on the bisector tip began to glow "red hot." The bisector was quickly withdrawn into the harvesting cannula and the power cord was disconnected. There was no injury to the patient. A new Vasoview Hemopro device was opened and the case was completed without incident.

This is the second time this issue has occurred.


Device:
Type: Electrosurgical, Vessel Harvesting, Instrument
Manufacturer: MAQUET Cardiovascular LLC
Brand: Vasoview Hemopro
Model#: (not provided)
Lot #: 250790
Cat #: VH-3000
Other #: (not provided)

Problem:
After engaging the DC cautery while in the leg during an endoscopic saphenous vein harvest the energy did not dissengage. The audible tone from the power source continued when the button was released and the heating element on the bisector tip began to glow "red hot." The bisector was quickly withdrawn into the harvesting cannula and the power cord was disconnected. There was no injury to the patient. A new Vasoview Hemopro device was opened and the case was completed without incident.

This is the second time this issue has occurred.


Device:
Type: Table, Operating Room
Manufacturer: STERIS
Brand: Steris Cmax
Model#: CMAX 100
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
The event occured in the orthopedic Operating Room. The surgeon had finished the operation and they were reversing the anesthesia effects. At this point one of the nurses/techs smelled something burning and realized there was smoke coming from the bottom of the bed. The patient (still intubated - therefore no exposure to the smoke/fumes) was transferred to a stretcher and removed from the room. The OR table was inspected and assessed for potential water damage - water was not found. After inspecting, it was found that the power supply had burned up and so had the internal cables.


Device:
Type: Table, Operating-room
Manufacturer: Steris Corporation
Brand: (not provided)
Model#: 4085
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Steris 4085 OR table started to move during an active surgery case. The remote showed the bed was locked; however, the feet of the table retracted allowing the table to move. Follow up with BioMed technician revealed that this problem had been reported in previous surgeries for all three Steris 4085 beds, but he was unable to recreate until this incident (documentation on file). Review of MedSun Reports shows a similar situation at another facility.
Per mfr's response to hospital: Initial response was that there was nothing wrong with the table however, the technician offered to replace the hydraulic manifold, which was completed the following day. The company would not address the issues with the other two beds as they were out of warranty. Due to the number of recorded events by BioMed related to the feet retracing during active cases on all three Steris 4085 OR tables, Risk Manager felt this was an ongoing, pre-existing issue that should be addressed by Steris due to possible patient and staff safety issues. Risk Manager put in a call to the Regional Steris rep to discuss the case. Steris representative quickly returned the call. After being advised that we do not have confidence that these tables are safe to use, especially after reading the SMDA MedSun report summary related to this same situation, the Steris Rep advised he will be sending technicians to our facility on to review the devices to ensure they are safe to use.


Device:
Type: Syringe, Piston
Manufacturer: BD
Brand: Integra
Model#: (not provided)
Lot #: 0265039
Cat #: 305271
Other #: (not provided)

Problem:
The staff has reported problems with the needle retracting back into the syringe (very difficult to push the button). Most of the time it works well. When looking at these, it was noted that there is an expiration date of 2/13. Spoke with distribution, he said the BD came out with an memo in 2008 and in 2010 saying that the use by date is only for international buyers.
They didn't want packing different for the states and then for abroad. For the states, sterile until open.
This seems strange and confusing for hospitals staff.


Device:
Type: Collection Set, White Blood Cell
Manufacturer: Terumo BCT
Brand: Cobe Spectra
Model#: (not provided)
Lot #: 05V15257
Cat #: 70629
Other #: White Blood Cell Set - Functionally Closed

Problem:
Initiated PBSC (peripheral blood stem cell) collection on the Cobe Spectra using the FC-WBC set. A small amount of blood was noted on the surface of the machine. A pinhole was noted in the tubing set, which the blood was leaking from.

Manufacturer is aware of the event and asked to have the kit returned to the quality assurance division.


Device:
Type: System, Hypothermia, Intravenous
Manufacturer: Zoll Circulation, Inc.
Brand: Alsius Icy
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Patient was admitted after a PEA arrest and an ICY catheter was placed in his groin. After the hypothermia protocol had been completed he continued to receive IV medications through part of the catheter. IV Levophed was found to be infusing through the cooling port instead of the IV port. This is the second occurrence of this happening. Upon examining an IC cathether, the cooling ports and the blue IV port could be mistaken by someone who is color blind or if the area is not well lit. Also, all of the ports (both the cooling and and IV) have a luer lock adaption. If the cooling ports were not luer lock compatible this would be less likely to happen.

This particular catheter was not saved and lot and reference number information is not available.


Device:
Type: Wheelchair, Powered
Manufacturer: Invacare Corporation
Brand: (not provided)
Model#: TDXSP
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Patient was moving the power wheelchair and driving in the forward position. The switch was faulty and caused the patient to move forward and hit a table.

Area rep came in to check the chair and found that it was operating normally. Connections were checked, normal; programming checked, normal and set for a person learning to drive with a ASL Head Array driver control. Batteries checked and were within normal operating condition. Electronic codes reviewed by rep with Invacare technical service department and nothing out of the ordinary was found.



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