Highlighted Reports
MedSun: Newsletter #83, April 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 March 2013. All other reports can be searched under the ‘MedSun reports’ menu pane.


Device:
Type: Anesthesia Conduction Kit
Manufacturer: B. Braun Medical, Inc.
Brand: Perifix Fx Continuous Epidural Catheter
Model#: 2014-05
Lot #: 61287412
Cat #: 332097
Other #: CE 17TKFCS

Problem:
Staff noticed that the ink markings were coming off the epidural catheters. The concern was reported to the manufacturer and Braun representatives said that the ink is bio-compatible and that it is more of a quality issue. Staff saved 3 catheters but said they noticed this was happening on many other catheters from 3 separate batch numbers. Product 332097 3 batches had issue 0061287412---0061287476-----0061242123.


Device:
Type: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Manufacturer: Medtronic, Inc
Brand: Artic Front Advance
Model#: 2AF284
Lot #: 29298

Problem:
During the ablation procedure, the steering cable within the catheter snapped allowing for only one-sided catheter flexion.


Device:
Type: Device, Hemostasis, Vascular
Manufacturer: Access Closure Inc
Brand: Mynxgrip Vascular Closure Device
Model#: 8013131130F1233304LK
Lot #: F1233304
Cat #: MX6721
Other #: 6F/7F

Problem:
Patient with ulcerations and peripheral vascular disease underwent lower extremity angiography and stenting. At end the case a Mynx closure devise deployed. However hematoma developed. Manual compression x 1 hour. 2nd procedure required with stenting. Pseudoaneurysm noted. 2nd closure device successfully deployed.


Device:
Type: Instrument, Biopsy
Manufacturer: HS Medical Inc.
Brand: Trapsystem Needle And Trap
Lot #: W1301123
Cat #: 3403904
Other #: Bone Marrow Biopsy Needle and Trap System

Problem:
Facility has used the same needles for many years. Staff noted that the cannula top had changed colors at which time they noted the specimen was "not being locked into the needle" and they were losing the specimens, requiring another stick for the patient.


Device:
Type: Monitor, Physiologic
Manufacturer: Philips Medical Systems
Brand: Intellivue
Lot #: MP50
Other #: CN 1040687

Problem:
NICU patient was on a monitor. Monitor alarmed and nurse hit silence button, expecting the alarm to sound again in a minute if the situation did not correct, which is how they were trained it would respond. Baby's O2 sat stayed down and alarm did not sound. Two minutes later nurse noted baby to be blue, O2 sat at 40. Baby bagged, O2 sat up, baby recovered; long term not known if there will be any impact. Monitor sequestered. After second monitor event a couple of days later, all unit monitor settings reviewed- found to have been set to silence once and not re-sound/re-alarm, although the training of the unit staff and managers was that the alarm would be triggered again after 1 minute, and other monitors in the hospital are configured that way. After desatting issues discovered, nursing staff spoke with Philips who said that the monitors should never have been set up that way and the person who configured the monitors is no longer with the company. Philips sent in a technician to re-configure all NICU monitors on so that if an alarm sounds and is silenced, it alarms again in 1 minute.

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Manufacturer response for Monitor, Intellivue MP50 (per site reporter)
======================
Technician out to reconfigure all monitors


Device:
Type: Pump, Infusion, Pca
Manufacturer: Hospira, Inc.
Brand: Lifecare
Model#: 20709

Problem:
We are continuing to see a problem with the use of the slide clamp with this device. The slide clamp is used to reduce the potential for syringe manipulation and to administer other medications through the IV line. Hospira has received reports of improper use of slide clamp and issued a device correction notice in August, 2012 and an updated device correction notice in February, 2013. Despite these, problems with the device continue to occur. Failure to close clamp can result in over delivery of narcotic meds. Staff closes the clamp to change the syringe or give another medication in the IV line. Staff must rely on memory to re-open the clamp. When the clamp remains closed, the patient can press the PCA button to request a dose, but it is not delivered. Likewise, if the PCA is set on a continuous infusion mode, the medication will not be delivered if the clamp is closed. The PCA pump does not alarm there is an occlusion. When the clamp is opened, the medication from the PCA syringe then squirts out; therefore, it is possible that the patient could receive an unintended bolus of narcotic medication. This device is used across patient populations including children and adults. In addition to PCA intravenous narcotic delivery, this machine also can deliver narcotics to the epidural space. A bolus of narcotic medication in the epidural space as well as intravenously could have serious adverse effects on a patient. We have not had any patient harm with this device. We have notified the manufacturer and have been told that there are ongoing issues with the device. This report represents all devices at our facility: there are over 100 such pumps.

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Manufacturer response for PCA Pump, LifeCare PCA (per site reporter)
======================
Ongoing issues with Hospira PCA Pumps. Manufacturer is aware.


Device:
Type: Respirator, Surgical
Manufacturer: 3M Health Care
Brand: 3m Particulate Respirator And Surgical Mask
Model#: 1860
Lot #: B13028
Cat #: 1860

Problem:
Several clinicians noted that when they tried to place their fitted N95 Surgical masks they found that the mask had a loose fit around the outer perimeter and nose section of the mask. All clinicians had been specially fitted for the N95 mask. Central supply received complaints from several users of the mask. Manufacturer notified and confirmed that the newest lot number was incorrectly sized and out of specification. All masks with affected lot number removed from inventory. These masks are used in high risk areas and isolation rooms.

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Manufacturer response for Health Care Particulate Respirator and Surgical Mask, N95 (per site reporter)
======================
Manufacturer removed affected lot number and will follow up with our Materials group.


Device:
Type: Syringe, Piston
Manufacturer: BECTON DICKINSON
Brand: Luer-lok
Model#: 302832
Lot #: 3015256
Cat #: 302832

Problem:
An anesthesia nurse prepared a 30cc syringe of propofol when she noticed that the stopper smudged the interior of the barrel as the medication was drawn. The nurse was concerned there may be particulates in the medication from the stopper smudging so the propofol was disposed of and syringe returned to Materials. No other syringes were affected. No patient was harmed. Staff do not know why this occurred. This syringe product is routinely used to draw up many different kinds of medication and fluid; this facility has not had this experience with this syringe in the past. The syringe was dry and did not appear to have a defect prior to drawing up the medication.


Device:
Type: System, X-ray, Mobile
Manufacturer: Carestream Health, Inc.
Brand: Drx-revolution

Problem:
Around 0330 a Retrograde Urethrogram was performed by Dr. A image was obtained per protocol during injection of contrast. The digital portable unit #3 was used. Dr. viewed the image prior to reprocessing. At that point the image became non-diagnostic. Dr. was satisfied with the image and continued patient care. Neither of the doctors wanted a repeat exam. I later notified the doctors that the image was unrecoverable.

Radiology Supervisor spoke with Carestream Service Engineer who stated that they identified the software malfunction and will be applying a software patch to correct the issue.


Device:
Type: Ventilator, Continuous, Facility Use
Manufacturer: DRAGER MEDICAL INC
Brand: Evita Infinity
Model#: EVITA INFINITY V500

Problem:
Respiratory Tech reported fluctuation percent leak on vent, high peak pressures. Vent affecting patient care. Vent was changed out, given to hospital Biomed. Biomed determined that the vent was overventilating the patient based on a perceived leak in the patient circuit and the ventilator was attempting to compensate for it. There was no leak in the patient circuit but possible issues with the expiratory flow sensor. No direct patient harm but care of the patient was being changed based on the information provided to the Respiratory Tech by the ventilator.


Device:
Type: Ventricular (Assist) Bypass
Manufacturer: Berlin Heart, Inc.
Brand: Berlin Heart Excor
Model#: 25 ml Berlin heart Blood pump
Lot #: 1220384
Other #: Left Ventricular Assist Device


Problem:
At mid-morning, the blood pump (#1) emptying appeared to be brisked with about 50% ejection, but appeared to halt mid-cycle. The blood pump was changed at the bedside approximately nine (9) hours later after numerous attempts of troubleshooting the device, which included switching the Ikus console, changing console settings , and redressing the VAD site. The blood pump (#2) showed good filling and emptying.


Device:
Type: Instrument, Ent, Balloon Sinuplasty
Manufacturer: Acclarent, Inc.
Brand: Relieva Spin
Lot #: 130108A-CM
Cat #: RS0616M

Problem:
Surgeon working on Sinuplasty procedure and balloon popped.
Device not used on patient / was being tested prior to use. Device malfunctioned, removed from field. No harm to patient. Opened a new product, procedure went well.


Device:
Type: System, Dialysis, Crrt
Manufacturer: GAMBRO RENAL PRODUCTS INCORPORATED
Brand: Prismaflex
Model#: PRISMAFLEX

Problem:
Patient on CRRT, restarted post-op. Time was noted to be incorrect on machine. When RN went to change time, the date defaulted to January 1, 2003. At this point there were no hourly outputs, or variables noted on the machine. Dialysis and SICU were promptly called, and said that this was a known error that BioMed had fixed. BioMed at bedside to assess machine. Blood returned to patient and machine tagged for BioMed.


Device:
Type: System, Hemodialysis, Crrt
Manufacturer: Gambro Renal Products Inc.
Brand: Prismaflex
Model#: Prismaflex

Problem:
Suddenly the CRRT machine alarmed and stopped running. The error message read "Malfunction: memory error." When I examined alarms it listed Error Code 4. Due to: set value incongruence with protective slave and task. The malfunction error also read Malfunction: voltage out of range, memory error.


Device:
Type: Electrosurgical, Ball Electrode Tip
Manufacturer: Covidien, formerly Valleylab, a division of Tyco Healthcare
Lot #: 0113AX
Cat #: E1564

Problem:
ESU in use for LEEP treatment but on changing ESU tip to ball tip lot number 0113AX the ESU did not function. Exchanged tip to another ball tip from the same lot number. No change - ESU did not work. cChanged back to a blade type ESU tip and it worked. We obtained a ball tip that had a different lot number and it worked - we were able to continue the case to completion without complication. All ball tips with this lot number were removed from service.


Device:
Type: Trocar
Manufacturer: SurgiQuest, Inc.
Brand: Airseal
Model#: 101142
Cat #: iAS12-150
Other #: 12mm L150MM

Problem:
Robotic procedure can allow the trocar to become dislodged and insufflation of CO2 to be pressurized into the subcutaneous tisssue. Despite 6 weeks education of team no one seemed to know that the sensor line had to be past the peritoneum to activate the high pressure sensitivity alarm and therefore the CO2 was pressurized into the subcutaneous tissue. Patient had to be kept intubated 3 days until this could resolve.


Device:
Type: Incubator, Neonatal Transport, Battery Pack
Manufacturer: Lammers Medical Technology America, Inc.
Brand: Lmt Nomag Pp
Model#: LMT nomag PP
Cat #: 0800102-B

Problem:
It was observed by users that water from the incubator's humidifier bottle drips through the unit's bottom chassis and directly onto its AC plug and the outlet of the unit's power pack. The dripping water is unavoidable and happens when installing or especially removing the humidifier bottle in its receptacle. The incubator's bottom chassis plate is perforated, and below it in the transport frame is the large box holding batteries and circuitry to generate 120 volts AC during transport. The humidifier bottle is almost directly above the plug and outlet of the battery pack. Water from the bottle pours through the chassis plate and onto the top of the battery box where some pours over the edge directly into the 120-volt AC outlet, or water may drip directly onto the AC plug if the incubator is shifted slightly from its intended position. (Prominent arrow labels show intended position, but it is easy to shift a few inches from that.) Some form of canopy or other protection is needed to keep the dripping water away from the 120-volt plug and outlet on the battery box.


Device:
Type: Incubator, Neonatal Transport, Mri Compatible
Manufacturer: Lammers Medical Technology America, Inc.
Brand: Lmt Nomag Ic 3. 0
Model#: LMT nomag IC 3.0
Cat #: 0100022-C

Problem:
It was observed by users that water from the incubator's humidifier bottle drips through the unit's bottom chassis and directly onto its AC plug and the outlet of the unit's power pack. The dripping water is unavoidable and happens when installing or especially removing the humidifier bottle in its receptacle. The incubator's bottom chassis plate is perforated, and below it in the transport frame is the large box holding batteries and circuitry to generate 120 volts AC during transport. The humidifier bottle is almost directly above the plug and outlet of the battery pack. Water from the bottle pours through the chassis plate and onto the top of the battery box where some pours over the edge directly into the 120-volt AC outlet, or water may drip directly onto the AC plug if the incubator is shifted slightly from its intended position. (Prominent arrow labels show intended position, but it is easy to shift a few inches from that.) Some form of canopy or other protection is needed to keep the dripping water away from the 120-volt plug and outlet on the battery box.


Device:
Type: Incubator, Neonatal Transport, Trolley
Manufacturer: Lammers Medical Technology America, Inc.
Brand: Lmt Nomag Tr
Model#: LMT nomag TR
Cat #: 0600047-B

Problem:
It was observed by users that water from the incubator's humidifier bottle drips through the unit's bottom chassis and directly onto its AC plug and the outlet of the unit's power pack. The dripping water is unavoidable and happens when installing or especially removing the humidifier bottle in its receptacle. The incubator's bottom chassis plate is perforated, and below it in the transport frame is the large box holding batteries and circuitry to generate 120 volts AC during transport. The humidifier bottle is almost directly above the plug and outlet of the battery pack. Water from the bottle pours through the chassis plate and onto the top of the battery box where some pours over the edge directly into the 120-volt AC outlet, or water may drip directly onto the AC plug if the incubator is shifted slightly from its intended position. (Prominent arrow labels show intended position, but it is easy to shift a few inches from that.) Some form of canopy or other protection is needed to keep the dripping water away from the 120-volt plug and outlet on the battery box.


Device:
Type: Pump, Infusion, Enteral
Manufacturer: Nestle HealthCare Nutrition, Inc.
Brand: Compat
Model#: 199235
Cat #: 199235
Other #: multiple S/N's

Problem:
Loose set screws on a significant number of newly acquired Nestle COMPAT Feeding Pump Peristaltic rotor head assemblies:

There were 192 pumps acquired for deployment at hospitals within our Healthcare System: Of 140 units at Facility 1, all 140 there required at least an 1/8 inch turn to tighten the pump head, 3 units were completely off and 14 units required more than a 1/8 inch turn to tighten. All 22 units at Facility 2 required at least an 1/8 inch turn on the set screw. 6 Units at Facility 3 required at least an 1/8 inch turn on the set screw. 7 out of 8 units at Facility 4 required at least an 1/8 inch turn on the set screw. One unit there was cracked – the screw was over tightened. Facility 5 has Duo-Flo those were checked. At Facility 6, 6 out of 8 units required at least an 1/8 inch turn on the set screw and at Facility 7, 3 out of 4 units required at least an 1/8 inch turn on the set screw.

Nestle reps, were unable to provide values for set screw torque. Also noted: there was no lock-tight type material found in use on the set screw. None has been added at this time. We are also waiting for scheduled maintenance information to be provided.


Device:
Type: Pump, Infusion, Syringe
Manufacturer: Smiths Medical ASD, Inc.
Brand: Medfusion
Model#: 3500

Problem:
The part (P/N G6000737) for the top case of the Medfusion syringe pump Model 3500 is constantly cracking in the same spot on all the syringe pumps. The spot is right where the tubing goes towards the patient on the right of the pump. Every time we do a yearly check we are replacing at least 70 percent of the cases because of the cracks in the plastic and this spot is highly likely to be the problem area. This problem was even found on brand new parts. Awaiting replacements for those parts.

We believe that fluids (human and/or cleaning sprays) can get inside, and it is a place that harbors bacteria, grime, and foreign items because it cannot be cleaned as efficiently as a smooth surface. Another reason is that the cracked case can cause injury to the operator because of the rough edges. This is causing premature failures of components inside, an increase in infections, and injuries to staff and/or patients.


Device:
Type: Sterilizer, Chemical
Manufacturer: Advanced Sterilization Products
Brand: Sterrad 200
Model#: 200

Problem:
One of the hospitals in our system received an Alert Urgent letter from ASP on in January of 2012 stating the vacuum pump can cause an increased level of Hydrogen Peroxide. I have called 5 times in the past year to get the Alert addressed and I have to go through Stericycle for the Alert process. Each time I called I got a different answer: you have the wrong letter, your company is not in the system, what letter are you talking about, you have not sent in the attached postcard. Then each time, a few days later, I would get another letter through UPS. The company has been out here to perform a PM but did nothing to the vacuum pump. So last week I called again actually to ASP and scheduled a service to replace the vacuum pump. No response since. It has been one year since the initial letter and not resolved.


Device:
Type: Cane, Safety Walk
Manufacturer: Invacare Corporation
Model#: 40918

Problem:
Patient called stating the cane collapsed on her when she was walking on her porch. This caused the patient to injure her knee and break a couple of her false teeth. Patient requested call back. MedEquip was notified of situation and is trying to make contact with patient for follow-up. Patient's cane #40918 was recalled and Invacare mailed a new cane to patient's home address. It is unknown at this time if the cane was the replacement cane that Invacare sent or the recalled cane that was dispensed in June 2012. Patient also received an HD cane in June 2009.


Device:
Type: Shield, Eye, Radiological
Manufacturer: Radiation Product Design, Inc.
Brand: Tungsten
Cat #: 936-596
Other #: 3mm Eye Shield

Problem:
Patient with mycosis fungoides lymphoma and right eye ectropian, had bilateral Tungsten 3mm shields placed in his eyes to protect his eyes from radiation treatment. Tobradex ointment was placed in both shields prior to insertion in the eyes. The patient sustained a right eye corneal abrasion (left eye was fine). After the fact, the staff examined the shield and noted that the shield to the right eye might not have been smooth. They were able to feel, but not see a nick in the shield.



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