Highlighted Reports
MedSun: Newsletter #36, May 2009

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 February 1 through February 28. 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.


Device 1: Needle, Suture
Manufacturer: Arthrex Arthroscopy Instruments, Inc.
Brand: Scorpion -Surefire Needle
Model #: AR-13991N
Lot #: 170421

Device 2: Needle, Suture
Manufacturer: Arthrex Arthroscopy Instruments, Inc.
Brand: Scorpion -Surefire Needle
Model #: AR-13991N
Lot #: 170421

During an arthroscopic rotator cuff repair of the left shoulder, the procedure tips of the scorpion needle (2 pieces) broke off in the shoulder while going through tissue. The tips were both approximately 3.0 mm each. The surgeon was unable to locate them. A post-op x-ray showed both pieces in the shoulder.


Device: Anesthesia Delivery Unit
Manufacturer: GE Healthcare
Brand: S/5 Avance Carestation

During a cardiac procedure on an infant with an interrupted aortic arch defect, the inspired CO2 reading on the anesthesia machine started rising to the mid 30mmHg CO2. The patient was under pressure support ventilation on the anesthesia machine's ventilator. The patient's pCO2 was starting to give readings above 100mmHg and physician was concerned about respiratory acidosis occurring. The Physician then exchanged the ventilator to a stand alone vent and was able to get the inspired CO2 to drop in pressure support ventilation on the exchanged ventilator. Physician noted to Biomedical that elevated inspired CO2 readings were occurring frequently during pressure support ventilation on all the anesthesia machines while ventilating infant patients and neonates.


Device: Dual Port Feeding Tube With Flow-through Stylet
Manufacturer: Covidien Kendall
Brand: Entriflex
Cat #: 8884-721088

ICU RN attempted to place a NG tube, but was not able to pass it past the right or left nares. The charge RN then attempted and easily passed the tube on the right side. Air was auscultated over the stomach and an x-ray was obtained. The x-ray showed a pneumothorax in the right lung. The MD was notified, and ultimately the patient had a chest tube placed to relieve the pneumothorax. This is a new device for our facility. Staff noted that the new device has a weighted tip, which they believe may have contributed to the pneumothorax because they believe the RN had less sense of resistance.

Device: Catheter, Foley
Manufacturer: C.R. Bard
Brand: Bardex
Model #: 165816
Lot #: NGS10155

The balloon failed to deflate completely. The nurse followed standard protocol, which consisted of attaching a syringe and allowing the balloon to deflate. When catheter was removed, the patient complained of pain in the urethra. The nurse observed resistance to removal. Upon removal, nurse observed cuffing of the balloon.

The site has not heard back from sales representative. A message was left two business days ago.
In previous incident, manufacturer had stated that balloon on all silicone catheters tend to have incomplete deflation resulting in cuffing; reportedly silicone does not have the same degree of "memory" that latex balloons have.

Patient had pain during and after removal of catheter.
FDA comment: FDA has received other reports on this issue


Device: Pump, Centrifugal Blood, ECMO
Manufacturer: Medtronic Perfusion Systems
Brand: Bio-pump
Model #: BP50
Lot #: 85185-00

An infant underwent open heart surgery and post operatively was immediately placed on ECMO. Three days later, the patient underwent a circuit change. Approximately 48 hours later, the nurse was cleaning blood off a stop cock near the cone (Bio-Pump) with a saline soaked 4x4. When she wiped blood off the cone from the stop cock, she noted the cone to have fine cracks on it. She notified the MD. The cone started to leak blood. The cone was changed. Baby desaturated during the change. Baby recovered on ECMO and remains on ECMO.

Cracked ECMO Pump

Device: Monitor, Physiological, Wireless
Manufacturer: GE Healthcare
Brand: Dash 4000, Wireless
Model #: Dash 4000 Wireless

Approximately two months ago we began experiencing 'NO-COMM' issues with GE wireless dash 4000 monitors running on an 802.11b network. The main software = 6.4, main boot software = 6.3, Dash boot software = 6.0, ECG SW = 1A, Spo2 = 1599V4.0.0.1. We have been working on a daily basis with GE and our own IS networking team. As many as 50% of the monitors have experienced communications issues. The symptom of 'no-comm' causes the data transfer between the bedside monitor and the nurse’s central station to lose monitoring capabilities as shown at the central station. At that point only the bedside monitor can alarm and display physiological information. The following is a list of troubleshooting already performed:

1) Sent log files to GE for December and January.
2) Opened a GE I-trac to dedicate GE engineers and technicians to this problem.
3) Replaced the central station in attempts to verify a hardware issue.
4) Set up a central station complete with monitors and simulators in a test environment to troubleshoot hardware and IS networking.
5) Sent several more log files to GE from the Grant 6 respiratory dept who have experienced (and made us aware) of a very large number of ‘no-comm’ (No communications) situations that have affected patient care.
6) Received reports from GE engineering who recommended several hardware and networking settings to be verified.
7) Coordinated several teleconferences between GE, Clinical Engineering and IS networking groups.
8) Set up an alternative switch/hardwired network in a test environment to determine if any hardwired communications or data is being affected. No hardwired devices have experienced any issues.
9) Moved 'no-comm' dash monitors to other areas to see if the problem followed them for network vs. monitor troubleshooting.
10) Fully tested the 'no-comm' monitors in a test environment which confirmed the problems.
11) Sent more log files of 'no-comm' monitors as verified in a test environment to GE for analysis.
12) Have now determined that 'no-comm' problem is spread across all wireless dash areas.
13) Have initiated a PO to secure GE engineers to troubleshoot on site networking and wireless dash configurations.

Device 1: Module, Physiological Monitor
Manufacturer: GE Healthcare
Brand: Pdm, Carescape
Model #: PDM, Carescape

Device 2: Monitor, Physiological
Manufacturer: GE Healthcare
Brand: Transport Pro
Model #: Transport Pro

Device 3: Monitor, Physiological
Manufacturer: GE Healthcare
Brand: Solar
Model #: SOLAR 8000I

Pt was admitted to the MICU when several attempts were made to transfer the patient to the solar monitor using the PDM (Tram module) and the bedside PDM docking station. Each attempt was unsuccessful. Additional PDMs were used without success. Biomed found that the Eport (connector on the rear of the PDM module) on the PDMs were bent and the Eport connector on the PDM docking station was also bent therefore the PDM could not connect. This critical pt. had to be monitored with a defibrillator until Biomed got another PDM that did not have a bent Eport and the PDM docking station had to be replaced. Other equipment was used to monitor the pt hemodynamics during the wait for a new PDM and PDM docking station. The Eport connector on the PDM as well as the PDM docking station's Eport connector is a poor design and GE has been made aware via itrack which occurs every time we encounter this problem and notify GE. This is not the first problem we have had with the PDM and the Eport connectors. GE has been replacing all the PDMs with bent or broken Eport connectors, but something rather than just replacing parts must be done about the design of the PDM. We have also noticed this problem with the PDM and PDM docking station on the transport pro monitors.
Manufacturer response for Module, Physiological Monitor, PDM, Tram, Monitor, Physiological Transport Pro and Solar
GE has replied to emails stating that they have forwarded our concerns to their headquarters. A GE nurse has contacted us to find out about the events involving this patient. However we have had no follow up on how GE plans to fix the design on the PDM's Eport/Eport connectors and docking station.

Device: Wall Mount, Physiolgical Monitor
Manufacturer: Philips Medical Systems
Brand: MSeries
Model #: M Series WMM-0001-01B
Newly installed (within the last year) Phillips ECG monitoring mounts are working loose at the joint next to the monitor for horizontal movement.
Manufacturer response for Wall Mount, Physiological Monitor, M Series
They are unaware of this happening elsewhere.

Device 1: Defibrillator, External, Biphasic
Manufacturer: Zoll Medical Corporation
Brand: MSeries

Device 2: Defibrillator, External, Monophasic
Manufacturer: Zoll Medical Corporation
Brand: MSeries
Model #: Type M

Device 3: Magnetic Navigation System
Manufacturer: Stereotaxis, Inc.
Brand: Niobe
Patient was being treated for atrial flutter during an ablation procedure in the Stereotaxis room. The Stereotaxis system was not being used and was in the stowed position. The patient went into atrial fib and required cardioversion. A Zoll biphasic defibrillator was moved closer to the patient, which put it within 6 feet of the stowed Stereotaxis magnet. The defibrillator was displaying an ECG and "sync markers”, showing that it was ready to cardiovert. When the charge button was pressed, it displayed an error code and a “sync error” message. The electrodes were then connected to the second defibrillator (Zoll monophasic) and the charge button was pressed. Again an error message was displayed, reading “defib error”. A third Zoll defibrillator from another area was brought in and, this time, was held in a different location, closer to the patient, by a cath lab staff member. This defibrillator charged and fired normally. Patient was cardioverted. The two defibrillators were tested outside of the room and functioned properly. It is believed that the two defibrillators which were originally used may have been located within the "5 gauss line" of the Stereotaxis magnets (about 6 feet). The location of the defibrillator which later charged and fired properly was further from the magnet (next to the patient, at mid-table).
Manufacturer response for Biphasic defibrilator, (Zoll)
They were not aware of any other events of this type.
Manufacturer response for Monophasic defibrillator, (Zoll)
Not aware of this happening


Device 1: Syringe, 60ml, Luer Lock
Manufacturer: Becton Dickinson

Device 2: Syringe, Catheter Tip, 60ml, Graduated
Manufacturer: Becton Dickinson

Device 3: Catheter, Jejunostomy, Baker
Manufacturer: Bard Access Systems

Device 4: Port, Vascular Access
Manufacturer: Bard Access Systems

Device 5: (Gastroenterology & Urology): Feeding Tube, Gastrostomy
Manufacturer: Kimberly-Clark Corporation

A patient was scheduled for a radiology study to evaluate the reason for a non-functioning jejunostomy. Hypaque (an oral contrast material) was mixed with tap water, placed in a Luer lock syringe and injected into the patient’s Port-a-cath by the rad tech. The radiologist was alerted to the misadministration because no contrast was going through the patient’s J-tube during fluoroscopy. The injection was immediately stopped and the radiologist aspirated the contrast from the Port-a-cath tube until blood appeared (3ml). The line was then flushed with saline.
Two techs were involved in the preparation. The patient handed the tech what he thought was the J-tube. The tech saw that it was a Luer connection and placed the contrast in a Luer syringe for administration. The tech interpreted what he thought was the patient’s tube feeding (but it was actually a lipid infusion) and injected the oral contrast.

This is an unusual exam. One tech was fairly new and hadn’t done this procedure before. The other seasoned tech had done this procedure once before. Another contributing factor was the fact that the patient’s port-a-cath line was routed through a telemetry pouch that was built into the patient’s gown. The line was not traced to the patient’s skin.

Both Luer lock syringes and graduated tip syringes are available in the storage room. Luer lock syringes are necessary for aspirations and IVP studies. The graduated tips are generally used for enteral tube access.

Once the assisting tech saw the port that needed to be accessed, a Luer lock syringe was retrieved and used to draw up the contrast material. The connection was easily made and there was no tactile warning that a connection error had occur.

Normally a syringe with a graduated tip is used for J or G tube access. Luer connecting syringes are used to access NICU enteral tubes. Feeding tubes for NICU patients are manufactured so that a Luer syringe is needed to access the port.

The patient had been immunocompromised due to recent chemotherapy and was on broad spectrum antibiotics prior to this event. 2-3 hours after the event, the patient became hypotensive and was transferred to ICU. Blood cultures have been negative. The patient has been transferred out of ICU and is doing well. No other patient information is known.

Device: Hospital Bed
Manufacturer: Graham-Field Health Products, Inc.
Brand: Whisperlite Ii
Model #: WL0208

Patient's caregiver called to report that the foot of the bed on the right side collapsed while patient was in the bed. Patient was not injured and did not have to seek any medical attention. The Home Medical technician made a home visit to repair the wheel on the bed which appeared to have contributed to the foot section leaning.

Device: Intrathecal Pump
Manufacturer: Medtronic Neuromodulation
Brand: Synchromed-ii
Model #: 8637-40

Pump had motor stall. Telemetry reviewed. Found one stall with a restart then a second stall without a restart. Pt required a new pump to be placed.

Device: Exam Gloves
Manufacturer: Cardinal Health
Brand: Esteem Stretchy Nitrile
Lot #: Thin: 2Y08P002; Norm: 9R08K032
Cat #: 8817N
Other #: (01) 0 0380470 05765 1

The company sent thinner, non chemo-tested and non lab-tested blue gloves in a slightly smaller box with the same product code as a box that contains bona fide chemo-tested and lab-tested gloves. This means that our lab, oncology and pharmacy staff will be using gloves that they think will protect them but may not. At this point, there are not any known exposure incidents to staff or patients.
Manufacturer response for Exam Gloves, Esteem Stretchy Nitrile
Manufacturer's rep acknowledged a manufacturing problem. Our distributor heard about it from us.

Device: Set, Enteral Feeding
Manufacturer: Covidien (Kendall)
Brand: Kendall (E-pump Kangaoo Tubing -1000ml Pump Set W/1000ml Flush Bag)
Lot #: 8319304, 8333307, 8347451
Cat #: 773662

Late last summer, we first reported to Kendall that the tubing was not priming. They said it was an educational issue and did another in-service. Three months went by without complaint, but the same problem was recently reported. Once again reported to Kendall. Lot numbers include: 8319304, 8333307, 8347451, 8326306, 8312293.

Device: Set, Enteral Feeding
Manufacturer: Covidien Kendall
Brand: Kangaroo Feeding Pump Set With Flush Bag
Lot #: 8234160
Cat #: 773662

The feeding line cannot be primed and nursing is having to try many sets before finding one that works. This causes a delay in therapy. The tubing sets are correctly placed on the machine with the rotary valve (aka, anti free flow valve) sitting in a well over the valve shaft, a segment of tubing that wraps around a peristaltic wheel and an identification magnet that sits in another well over a sensor. At the appropriate moment, the pump attempts to turn the rotary valve but it won't turn due to a manufacturing problem so the valve stays in the no flow position. Meanwhile, the valve shaft turns against the nylon teeth of the rotary valve and makes chewing marks on those teeth.

In our discussions with the manufacturer, they told us that a silicone lubricant was not applied to the rotary valve body during assembly. The valves are used by both the 773662 and 774669 (w/ spike instead of flush bag) sets. They sent us some replacement cases free of charge. They worked with the distributor to get affected lots off the distributor's shelves but they didn't issue a formal recall nor inform us exactly which lots were bad.

Device: Iv Tubing
Manufacturer: ALARIS Medical Systems, Inc.
Brand: Smartsite Infusion Set Iv Tubing
Model #: 2420-0007
Other #: 08125224

IV tubing found disconnected from the Y-Site, and was in the patient’s bed. The tubing was infusing hyperalimentation at time of the disconnection. The tubing was intact, and the Y-Site was intact. Disconnection with this type of tubing has occurred approximately 2-3 other times. We were unable to delineate the possible cause, but considering the frequency, the tubing is being questioned. All events involved TPN (total parenteral nutrition).

Device: Iv Tubing
Manufacturer: ALARIS Medical Systems, Inc.
Brand: Smartsite Infusion Set
Model #: 2420-0007
Other #: 08125473

IV tubing was found to be leaking after it was primed and placed in the infusion pump. The tubing was removed from the pump, and a hole in the tubing was noted. The tubing was never connected to the patient, so there was no patient harm.

Device: Tubing, Iv
Manufacturer: ALARIS Medical Systems, Inc.
Brand: Alaris Pump Module Administration Set
Lot #: H370240105001
Cat #: 2401-0500

A new administration set was opened for use. While the tubing was being primed (flush all air out of the tubing with fluid prior to use), it was noted to have debris that looked like pieces of plastic in it. The tubing was never connected to the patient.

Device: Infusion Pump
Manufacturer: ALARIS Medical Systems, Inc.
Brand: Signature Gold
Model #: 7130B

Alaris Pump kept alarming "performing self-checks" with instructions to remove the IV cassette. This happened three times, at which time the Alaris pump was exchanged for a new one. Maintenance IV fluids were infusing at the time the Alaris pump was alarming.


Device 1: Laser, Holmium
Manufacturer: Lumenis, Inc.
Brand: Versapulse Powersuite
Model #: Powersuite-20W

Device 2: Laser Fiber, Reuseable
Manufacturer: Lumenis, Inc.
Brand: Slimline 365 Fiber
Model #: Slimline 365

Patient undergoing extraction of an ureteral stone with holmium laser. During the procedure the laser fiber made an audible "pop" noise and flashed. All staff and the patient were wearing eye protection. There was no evidence of laser contact to skin (of patient or staff). The laser unit and fiber were removed from service and inspected by a biomedical engineer. The laser unit was tested with a test fiber and found to be functioning properly. The blast shield was replaced because it was "damaged." (The blast shield acts as a "fuse" and protects the laser's internal components in the event of a fiber failure.) The laser was placed back in service. The engineer did not inspect the fiber, but it was retained in the event the manufacturer requests to inspect it. The laser fiber is a reusable item. We do keep track of how many times they are used/sterilized. They can be used up to ten times, but usually do not achieve that number. They are inspected and trimmed with a tool after each use.

The fibers can be used up to 10 times. We keep track of the times the fiber has been used/sterilized by marking the container the fiber is sterilized in. We have a cutting/trimming tool for the fibers according to size. The reuseable fibers are discarded for the following reasons:

1. The fiber is trimmed to the point that it's too short to reach from the laser to the sterile field.
2. The fiber has been used 10 times.
3. After each trim, the fiber is checked with an inspection scope to check for damaged fibers. If there are damaged fibers that can't be trimmed, the fiber will be discarded.
4. There is a blast shield on the laser. If this needs to be replaced during a case, the fiber that is being used is discarded because you can't be sure that the fiber has caused this.

Fiber failure can cause injury to staff/patient, but in this case there was no adverse outcome.

Device: Mesh, Hernia
Manufacturer: Davol, Inc. Sub. C.R. Bard, Inc.
Brand: Bard Composix Kugel Hernia Patch Small Oval
Lot #: 43LQD184

Patient had ventral hernia repair with insertion of mesh. Patient had continued tenderness RLQ and bulge. Mesh removed after a few months, with re-repair of ventral hernia and new mesh inserted.

See recall online available at: http://www.fda.gov/cdrh/recalls/recall-122205.html. Also see May’s Medical Device Problem Summary describing adverse events with hernia mesh.

Device: Sternal Saw Hose
Manufacturer: ConMed Linvatec Hall Surgical
Brand: Hall Sternum Saw
Model #: 5052-10

Midline sternotomy was made from the sternal notch to the xiphoid process. Approximately halfway through the sternum with the sternal saw, the pressure line to the sternal saw exploded. Pressure setting for saw was set at 150 psi via nitrous pressure control valve. There was one small piece of rubber on the upper portion of the drapes which was removed and this area was covered with sterile towels just to ensure sterility. In addition, the patient was given 1 g of vancomycin intravenously at this point in time just as a precaution. A new saw was used to finish the sternotomy. Rest of procedure completed without further incidence. Patient was taken from the operating room to the cardiovascular recovery room in stable condition.


Device: Bed, Low Air Loss
Manufacturer: Kinetic Concepts, Inc. (KCI)
Brand: Kinair Medsurg
Model #: KinAir MedSurg
Cat #: 201001W

Rails fully raised. Pt head trapped under upper left side rail and caught between siderail and inflating KinAir MedSurg air mattress. Bed head deck section raised ~10-20 degrees. Pt did not sustain injury.
Manufacturer response for air flotation, low air loss support surface bed, KinAir MedSurg
No response. Have requested entrapment zone testing data from them on this bed. They have not provided.

Device: Specialty Air Bed
Manufacturer: Kinetic Concepts, Inc.
Brand: Kinair

Critically ill patient with multiple skin tears, decubiti (DQ's) on buttocks and coccyx, on KCI specialty air bed Kinair. Bed placed on instaflate and patient turned to side to wash back and place zenaderm on her DQ's. Bed in locked position, however bed was not locked and moved. Patient's leg fell off side of bed and hit lower side rail. Unable to get bed to lock even though the brake was on. More staff called in to help and hold bed while trying to finish getting patient cleaned up. Right leg now has a very deep skin tear to shin, adipose tissue visible, area appears to be developing a bruise on area that hit the side rail. KCI called to have someone come fix the bed. The person who answered the 1-800 number acted like she had never heard of our hospital and informed me she did not have any beds in use at our hospital. Staff called hospital central supply who coordinated via other means to get a KCI rep on-site. From KCI: staff were informed that the wheels have to be in a certain position in order for the bed to lock, and staff was not aware of this. Once the KCI rep informed staff of this, they were able to get the bed to lock. This is not a common bed used in the ICU. The caster wheel on the right side must be parallel to bed frame to lock into position. ICU staff requested an information card be placed on beds for safety reasons. Patient leg required sutures to close open skin tear.
Manufacturer response for Specialty Air Bed, Kinair
KCI rep to arrange to have staff in-serviced ASAP.

Device: Treadmill
Manufacturer: Woodway
Brand: Treadmill
Model #: DESMOM

Patient completed training on the treadmill. The treadmill was switched to the "off" position. Physical Therapist stepped off the treadmill in order to prepare for patient to come off while the patient held onto the rails of the treadmill. At that point, the belt of the treadmill lunged backwards, causing the patient to fall on his buttocks while he still held onto the rails. After initial assessment of pain, at the sacrum, the patient was assisted to a chair for rest.

In our discussions with the manufacturer, they have informed us that there is a modification to stop the belt from 'free-wheeling' when power is off. Our facility was sent parts to install, but it did not fix the unit. We are in the process of coordinating a factory repair.
Device: Cold Therapy Unit
Manufacturer: BREG, Inc.
Brand: Polar Care
Cat #: 04790

The Polar Care unit with the universal pad was placed directly on the patient's skin (right knee) and then wrapped in place with gauze. When the patient complained of pain at the site, the RN removed the dressing and polar care pad and discovered that blisters had formed along the incision line. Three blisters were noted measuring 13cm long x 5cm wide, 3cm x 2cm, and 3cm x 2.5cm. The MD was notified, Polar Care unit discontinued, and non-adhesive gauze dressing applied. Hospitalization was not extended. Pt's skin is dry and fragile. No lotion was on the pt's skin--polar care unit was applied directly to the skin without a barrier in place. The device insert and the device itself are clearly marked to indicate that a barrier should be used. The cooling unit as well as the pad both contain warnings to use a barrier with the device.

Device: Heat Pack
Manufacturer: Hospital Marketing Services Co., Inc
Brand: Novaplus Instant Warm Pack
Cat #: V6001-043

Patient reported to RN that she was burned from the warm pack that was placed on her left arm prior to an IV start. RN noted the area was red with slight elevation, but no blistering. Patient complained of discomfort. MD notified--no change in management plan. No medications required to treat reddened area. RN noted that the warm pack had been applied directly to the skin and that the hot pack cover had not been applied.

This heat pack is a relatively new product to our facility. The previous product did not require a cover or sleeve--this new product does. Staff applied the heat pack without the sleeve, although the packaging clearly indicates that a towel or soft cover should be wrapped around the heat pack before application.


Device: Shunt, Central Nervous System and Components
Manufacturer: Medtronic Neurosurgery
Brand: Ventricular Shunt Catheter
Lot #: A77305
Cat #: 27782

The patient was admitted to the O.R. with a shunt malfunction. A 5 cm shunt catheter was found to be disconnected from the shunt catheter base. The base was removed, but the catheter was disconnected in the brain.

On the ultrasound, the catheter could be seen; it was about 1 cm into the brain. Clinician followed the previous track and looked down carefully to the hole, but could not find any evidence of the shunt, could not palpate the shunt. Therefore, the search for the catheter was abandoned.

Our facility has identified 7 cases, to date, of this unusual mode of failure. Our site has switched to a line of ventricular shunts that do not have the BioGlide coating (we are concerned that the BioGlide coating on these ventricular shunts may compromise the bonding between device components, thus causing the disconnection).

In our discussions with the manufacturer, our site learned that Medtronic has issued a voluntary recall on the Bioglide Ventricular shunt catheter product # 27782.

See recalls online available: http://www.fda.gov/cdrh/recalls/recall-021209.html and at: http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1238091091955&lang=en_US

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