Highlighted Reports
MedSun: Newsletter #45, February 2010

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 November 1 through November 30. 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.


GENERAL HOSPITAL

Device:

Type: Bed, Hospital, Bariatric
Manufacturer: SizeWise Rentals, LLC
Brand: Lowboy (35" Wide)
Model #: 33060050

Problem:
As a nurse started to raise a SizeWise LowBoy bed from its lowest position, smoke started to come from the AC receptacle where the bed's power cord was plugged in. The power cord was unplugged (by pulling on the cord) leaving the bed (and patient) in a lower position than desired. Patient was moved to another bed and to another room.

Manufacturer response (as per reporter) for Hospital bed, LowBoy (35" wide)

I informed our rental rep (we only rent these beds when needed), and the rental company, of the event and of the problems other manufacturers have had with this same type of power cord plug.

See device images:

The face of the power cord plug of a SizeWise LowBoy Bed, left picture, has been blackened by excessive heat in the vicinity of the ‘hot blade’.  The heat softened the plug material so that some got onto the receptacle, left slot of middle picture, and, when the plug was pulled out by the cord, the blade (not shown) stayed in the receptacle.  The plug was plugged into the lowest receptacle of the raceway to the right of the bed, right picture.  There was no other damage to the bed or the cord.

These are a profile and end-on view of a clear power cord plug that the type that became charred and softened.  In the picture at left, above, and inset one can see that the wire is crimped to the blade.  In the picture at right, one can see the shape of the internal mount for the prongs and this printing ‘MADE IN USA,’ ‘Electri-Cord,’ ‘Westfield, PA,’ the CSA symbol and ‘5-15P’.


Device:

Type: Bassinet, Infant
Manufacturer: Nemschoff
Brand: Newborn Bassinets

Problem:
Since early winter this year, we have had problems with our newborn bassinets cracking, breaking, and developing holes in the corners. Drawers/doors swing open and won't stay closed, carts hard to push, wheels don't roll smoothly. Plexiglas piece along the top of the bassinets were all replaced by the company approximately four months ago. Currently have 11 bassinets not usable. Have pictures of problems I can send.

Manufacturer response (as per reporter) for Bassinets that fit into wooden carts, Newborn bassinets: Initially the company stated that the carts/bassinets were not being handled correctly. Plexiglas parts were replaced and they are all breaking/cracking again. Representative came again and took pictures and I took pictures. We asked if any other facility was having a problem.

See device images:

Bassinet 1

Bassinet 2

Bassinet 3

Bassinet 4

Bassinet 5


Device:

Type: Cover, Skin Temperature Probe
Manufacturer: Coviden Kendall
Brand: Neonatal/pediatric Temperature Cover
Cat #: MI30002

Problem:
Noted area of skin breakdown directly under temperature probe cover on infant's right side of back. Area measured approx 2.5cm X 3cm. Area appeared excoriated almost like a burn, with discolored drainage formed on top of wound. The burn probably was a second degree burn. The nurse did not report any damage to the pad.

See device images

Skin Temperature Probe 1

Skin Temperature Probe 2

Skin Temperature Probe 3


Device:

Type: Indicator, Sterilizer, Biologic And Condition
Manufacturer: Getinge
Brand: Biosign Ssi
Model #: 61301605372
Lot #: 2417C

Problem:
Purple indicators did not completely turn to green.

Manufacturer response (as per reporter) for Biosign SSI test pack, SSI test pack

Phone call placed to Rep


Device:

Type: Pump, Infusion, Implanted, Programmable
Manufacturer: Medtronic Neuromodulation
Brand: Synchromed Ii
Model #: 8637-20

Problem:
Medtronic pain pump failed, it was replaced along with a new catheter.

Comment from FDA: Please see recall on this product online available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=83826


Device:

Type: Iv Tubing
Manufacturer: B. Braun Medical, Inc.
Brand: Ultrasite Iv Set For Outlook Safety Infusion System
Model #: 375196
Cat #: US3140

Problem:
We experienced two episodes with defective Braun primary IV tubing today in the ICU. The first episode involved the injection port on the primary infusion line closest to the patient. The port was leaking out a significant amount of blood on a critically ill patient. The port was used for injection prior to finding the leak.

The second episode was similar, but involved a different patient and the injection port immediately after the pump. Again, the patient was bleeding back and out of that port with a significant amount of blood collected on the floor. Another nurse reported the same type of defect on an IV tubing last week. She saw that the blue stopper did not pop back up after injection.


Device:

Type: Infusion Pump
Manufacturer: Sigma International
Brand: Spectrum

Problem:
IV tubing was inadvertently loaded backwards in the infusion pump which could have resulted in medication not being administered and patient's blood being drawn back into the IV line. Because of complex conversion process at our facility to the new infusion pumps, we requested manufacturer to wait until the install was completed before discussing this issue with us. The Manufacturer responded with additional training when the misloaded tubing was discovered.

We feel that the design of pump channel and/or IV tubing loading process allows a clinician to easily misload IV tubing if the clamp slides too far down the tubing (away from the first access port). The loop caused by this positioning of the clamp (which is also the key to open the pump door) made it difficult to determine which tube was the distal end of the tube.

We attempted various ways to misload the tubing in a way that will "trick" the pump into working, and found two ways to do this easily. The pump design relies on its labeling as well as the nurse remembering to trace the IV line from the bag to the patient on every load. There does not seem to be any safe guard against this human factor in the design of the pump. However, the pump does alarm with an “occlusion” if it is started with misloaded tubing, but there is nothing to prevent the tubing misload from happening in the first place.

See device images

Shows how the tubing can easily be looped around the BLUE CLAMP DOORKEY

Shows how the pump looks if the tubing is loaded backwards

Correct way to load the tubing


Device:

Type: Iv Tubing Set
Manufacturer: B. Braun Medical, Inc.
Brand: Ultrasite Iv Set For Outlook Safety Infusion System
Cat #: 3751196
Other #: US3140

Problem:
The patient had IV fluid being infused by a B. Braun Outlook 100 infusion pump. The nurse noticed something dripping in the area of the IV tubing. Upon further assessment she noticed that the NSS was dripping out of the tubing proximal to the patient, past the IV pump. The inner blue portion of the ultrasite valve was depressed within the white plastic exterior and it did not recoil. The fluid was dripping out of the ultrasite valve and air was being drawn into the tubing. The air was noticed before it reached the patient and no harm occurred to the patient.

The only explanation the nurse had for the failure is that a syringe may have been connected to the port to deliver medication, and when it was removed, the plunger did not return to the closed position. However, that has not been verified.

Manufacturer response (as per reporter) for IV tubing Set, Ultrasite IV set for Outlook Safety Infusion System:

They requested the tubing set so that they can evaluate it. The sales representative stated that this not a common problem and he has not experienced this problem.

See device images
BBraun 1

BBraun 2


GENERAL & PLASTIC SURGERY

Device:

Type: Cautery Device, Thermal, Disposable, Battery Powered
Manufacturer: Bovie Medical Corporation
Model #: AA01
Lot #: 0709A

Problem:
Patient's eyelashes flamed as surgeon cauterized incision(in the eyelash area). Sponge laid on flame to extinguish. Eyelashes stopped burning, but the sponge then ignited, but was put out. There was a plastic corneal protector in place during episode.


Device:

Type: Endoscopic Vein Harvesting Kit
Manufacturer: Sorin Group USA Inc.
Model #: KTV15
Lot #: 0921500032

Problem:
Two bipolar devices broke while being used in the patient's leg. All pieces were removed. The piece is the clear portion that was under the black cap. There was no patient injury.

Manufacturer response (as per reporter) for Bipolar Device, Endoscopic Vein Harvesting Kit

As of this week the manufacturer has offered replacement lots.

Comment From FDA: Please see recall online available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87081

Device:

Type: Cryotherapy System
Manufacturer: COOPERSURGICAL, INC.
Brand: Leisegang
Model #: LM-900

Problem:
Patient came for cryotherapy of cervix. As procedure ended, cryotherapy spurted to the right side of the patient's vagina. Subsequently, she presented with swelling and pain on the right side of her vagina. She has a healing area on her right labia minora that is being treated with premarin cream. The equipment was evaluated by manufacturer and an O-ring was replaced to prevent future occurrence. Failure of the o-ring caused liquid nitrogen to be ejected from device.

Device:

Type: Implant, Vaginal
Manufacturer: Boston Scientific
Brand: Uphold
Model #: UPN M0068317080
Lot #: OML 9092205

Problem:
Bullet on Capio Suture broke off on an Uphold Vaginal Implant, with mesh leg fixation, Boston Scientific. We were unable to use the implant due to broken suture. No patient harm. Broken piece attached to package, will be returned to company for evaluation.


Device:

Type: Table, Operating Room
Manufacturer: STERIS CORPORATION
Brand: Steris
Model #: 3080SP

Problem:
During transfer of the patient from the stretcher to the Operating Room table (which was in the locked position), the bed moved away at the foot of the bed causing the patient to slip between the OR table and the stretcher. The OR team lowered the patient to the floor, however, the patient hit her head on the OR table during the decent, resulting in a small laceration to the head. CT scan of the head and sacrum were negative for any acute injury. This event did not extend the patient's length of stay.


Device:

Type: Saw, Sternal
Manufacturer: STRYKER INSTRUMENTS
Brand: Stryker
Other #: Pack # EHD Sternal Saw

Problem:
After cutting the patient's sternum with the regular Stryker saw, the surgeon noted that there was oil in the patient's wound. The saw was passed off the sterile field immediately. The sternum was irrigated with warm lactated ringers solution and Ancef by the surgeon. It was found that after maintenance of the saw was completed by Stryker, the hand piece was not resealed appropriately to prevent lubrication from leaking from the hand piece.


Device:

Type: Handpiece, Esu, Tissue Sealing
Manufacturer: Valley Lab, Tyco Healthcare Group
Brand: Ligasure Impact
Model #: LF4200
Lot #: 166603
Cat #: 20667085011693
Other #: 317000917

Problem:
During the procedure, the product failed to open while in use. Jaws of product on tissue without incidence. Surgeon was unable to open handle and continue use of the product. No harm to patient.


Device:

Type: Laser Fiber
Manufacturer: Vascular Solutions, Inc.
Brand: Vari-lase
Lot #: 546508
Cat #: ref #7112
Other #: Vari-lase Standard Kit 45 FR 45 CM Sheath

Problem:
Patient admitted to Outpatient Surgery Center for right anterior lateral greater saphenous vein endovenous laser ablation with multiple stab phlebectomies. Vari-Lase laser was used. A Vari-Lase standard kit, 4fr, 45 cm sheath was opened per physician's request.

Sheath was placed. Laser fiber was advanced through the sheath. Click/lock method was used to hold the laser fiber in the sheath, although I (the surgeon) felt that the lock mechanism was a bit loose. I started the laser and pulled back the sheath and fiber together, burning 100 Joules per centimeter, total length of 16 cm. When I pulled the laser fiber out through the skin incision, the laser fiber was flush with the sheath rather than protruding 2 cm as is standard. The tip of the sheath was singed and, while I do not think that any part of the sheath was burned into the anterior lateral GSV, I cannot be completely sure that there are no residual burned pieces of plastic sheath within the patient. I looked to the click/lock mechanism which holds the laser fiber stationary within the sheath and the mechanism had come undone and the laser fiber was moving freely within the sheath. I had the sheath and laser fiber saved for further evaluation.

RN circulator in the room called the vascular lab at the request of Dr. for nurse to bring another ultrasound machine to the room. Ultrasound was performed and no pieces of plastic were noted by either nurse or Dr. The patient remained stable during the procedure. After the procedure the patient's husband was brought to the conference room by Dr. and RN was also present for the conversation while Dr. explained the incident to the husband. It was also explained to the patient. Dr. told the patient and husband potential complications to be aware of.


Device:

Type: Laparoscope Camera & Light Cord
Manufacturer: Unknown
Brand: Unknown

Problem:
Starting a Laparoscopic Operative case using a camera and scope, the light cord to the scope was thrown off the foot of the table to be plugged into the light source box. Light source was plugged in, and not put on standby, leaving the light source just sitting on the field. The light source got hot and caught my gown. I looked down and saw smoke coming from my gown, which I immediately removed and noticed that the fire had gone through the gown and on to my scrubs. It burned a hole through the gown and scrubs. I removed the gown and stopped the burning before it hit my skin. I was not burned. The drapes where not damaged and patient was not hurt in any way.


CARDIOVASCULAR


Device 1:

Type: Catheter, Central Venous
Manufacturer: Cook Medical, Inc.
Brand: Spectrum Glide

Device 2:

Type: Catheter, Central Venous
Manufacturer: Cook Medical, Inc.
Brand: Spectrum Glide
Cat #: G49804

Device 3:

Type: Catheter, Central Venous
Manufacturer: Cook Medical, Inc.
Brand: Spectrum Glide
Cat #: G50821

Device 4:

Type: Catheter, Central Venous
Manufacturer: Cook Medical, Inc.
Brand: Spectrum Glide
Cat #: G50822

Problem:
Multiple reports involving multiple patients and practitioners regarding Cook triple lumen catheters clotting either during insertion or shortly thereafter. Involves one (1) to three (3) ports of the catheters. In comparison w/ three other catheter manufacturers, Cook catheters clotted 50% of the time while other catheters clotted 25% or less, and others had no problems on insertion. No change in physician techniques noted. Issue occurs in multiple patient care units; mostly ICUs where the majority of central lines are used.


Device:

Type: Defibrillator, External
Manufacturer: Philips Medical Systems
Brand: Heartstart Xl
Model #: M4735A
Cat #: M4735A

Problem:
Atrial fibrillation was sustained and required repeated cardioversions. A 200J biphasic shock did not correct the atrial fibrillation with 4 attempts. Pads were reapplied on the anterior chest with "physician pushing on pads" and 200J biphasic shock was successful in returning sinus rhythm. Note: This area is trying to get new defibrillators that are >300J and we are questioning the clinical justifications as there are mixed messages about the effectiveness.

Comment from FDA: Please see the communications, “Energy Levels in External Biphasic Defibrillators: Initial Communication,” online available: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm189259.htm and The Patient Safety News story, “Energy Levels in External Biphasic Defibrillators” online available: http://www.accessdata.fda.gov/psn/transcript.cfm?show=94#7.


Device:

Type: Laser, Endovenous Device
Manufacturer: InaVein, LLC
Brand: Trivex
Model #: InaVein TRIVEX System

Problem:
Patient was scheduled for a left saphenous vein right femoral artery with Trivex, prone and supine. The Trivex machine worked perfectly for the first half of the case while the pt was in the prone position. The patient was turned, and proceeded on with the supine portion of the case. The Trivex was working well for about 20 mins or so and then the resector portion stopped working. At this time, the resector was re-examined. The resector handpiece was taken apart and the non-disposable portion has a wheel that spins to turn the blade on the disposable resector. The wheel was not spinning. The Trivex machine was turned off and on several times. The handpieces were plugged and unplugged. At this point the lights on the machine (that are supposed to be green) have turned orange and will not turn back to green. Biomed and charge nurse were notified. Biomed tech came to the OR to inspect the machine. She did all the things that we did as well. We also opened a new disposable and non-disposable handpiece resector. These changes did not help. Tech left the room to read the manual on the Trivex. She came back and stated that from our description, the responses from the machine and from the manual that it appeared to be a motherboard failure. Surgeon finished the rest of the case with stab phlebectomies. No immediate harm came to the pt from the machine not working.


Device:
Type: Catheter, Atherectomy, Peripheral Artery
Manufacturer: Pathway Medical Technologies, Inc.
Brand: Jetstream G2 Nxt
Model #: PV20300
Lot #: 090805
Other #: Jetstream G2 NXT 2 1/3.0mm Atherectomy Catheter

Problem:
Patient in Cath Lab for atherectomy of his leg vein. Patient suffers from claudification of that extremity. Cardiologist was performing procedure using a Jetstream G2 catheter to remove part of the tissue when it stopped working. Per the MD, the device "froze up". The catheter was removed by the MD, inspected and then re-inserted to use again. However, the catheter did not function as the MD wanted it to so the decision was made, by the MD, to switch modes and perform an angioplasty instead. Procedure was finished and patient sent to CVCU for recovery. No injury or harm to patient but MD did perform alternative procedure to remedy patient's problem.

Device:

Type: System, Thermal Regulating
Manufacturer: MEDIVANCE, INC
Brand: Arctic Sun
Model #: 2000
Cat #: 2000-02 or 2000-02L

Problem:
Patient had been on Arctic Sun external cooling for management of neurogenic fevers for 6 days. When pt was turned on the evening of the 6th day, RN found a large blister on back and thighs where the cooling pads had been applied. Two days later the injury was described as frostbite and may be full thickness. Follow-up treatment with silvadene and debrided a few days later. Clinicians are treating it like a burn.

Pads used with the Arctic Sun Cooling Device were product # 317-00 Universal Lot# K9E1804
product # 317-09 Large Lot# K9K0502
Pads were discarded at time of incident.


RADIOLOGY


Device:

Type: Mri, 3t
Manufacturer: Siemens Medical Solutions USA, Inc.
Brand: Verio
Other #: Body Array Coil 3T magnet

Problem:
Patient has 2 screws in her right calcaneus. During the exam the patient was repositioned several times, due to patient complaining that her heel was burning. The exam was stopped.


Device:

Type: Mri, 3t
Manufacturer: Siemens Medical Solutions USA, Inc.
Brand: Verio
Other #: Body Array Coil 3T magnet

Problem:
Patient came to MRI for a brain MRI with and without contrast. Patient had a known fusion at C6-C7. After the scout was done and 1 set of images was done -totaling 2 minutes- the patient stated that her hair felt hot. Tech checked her hair and it did feel abnormally warm to touch. Radiologist examined patient, waited until her hair cooled down, then attempted to proceed with the MRI. The exam was started, again the patient felt hot, and the exam was aborted. Patient stated that her scalp hurt, felt like a sunburn.

Device:

Type: Mri, 3t
Manufacturer: Siemens Medical Solutions USA, Inc.
Brand: Verio
Other #: Body Array Coil 3T magnet

Problem:
Patient sent to MRI for a scan; did not notify the providers that she had a previous surgery or that she had an implanted rod in her spine. During the scan, the patient complained that her back was hot. The MRI was aborted.

Device:

Type: Brachytherapy, Hdr Afterloader
Manufacturer: Varian Medical Systems, Inc.
Brand: GammaMedPlus
Model #: GammaMedPlus

Problem:
A biohazard leak is believed to have been incompletely decontaminated.
This patient was treated with a Miami applicator with a condom over it. There were no signs of a breach of the closed system for this patient.
On the day of the procedure, the patient (index patient) was treated with the HDR (high dose rate) unit. During setup for the procedure, a stopper was removed from part of the equipment because it did not fit well. After the procedure, inspection of the transfer tubes found biological fluid in the specimen.

The vendor, was contacted at the time and came on-site to decontaminate the equipment. The service engineer used the physics QA (or transfer) tube to remove the contaminated wire.

Approximately 2 weeks later, a different Varian engineer came on-site for routine maintenance. Upon discussion and inspection, it was determined that unit should be considered contaminated because the Physics QA (or transfer) tube was used during the decontamination process, thus contaminating that tube. That tube had continued to be used prior to subsequent further decontamination, therefore all parts of the unit that have been in contact with the wire and all related equipment are being treated as contaminated.

All of these involved patients were treated with this closed system.

The vendor is replacing the necessary equipment so that there is no risk for future patients.


GASTROENTEROLOGY & UROLOGY

Device:

Type: Dialysis Machine
Manufacturer: Fresenius Medical Care North America
Model #: 2008K

Problem:
The Fresenius hemodialysis machines AC power cord with the black plastic bridge, which is manufactured by a power cord manufacturing company exhibited charring at the neutral wire in the molded clear colored plug.

See device image

Dialysis K Power Cord


Device:

Type: Dual lumen catheter
Manufacturer: Covidien Kendall
Brand: DL Mahurkar Dialysis Catheter
Cat #: 8813793009

Problem:
A patient was undergoing a stem cell collection through a right internal jugular DL Mahurkar catheter. It was noted that there was a pin hole leak in the plastic tip of the blue lumen of the (11.5F/16 cm DL Mahurkar Dialysis catheter) catheter. The catheter was pulled. The patient had enough stem cells collected from a prior day and the catheter was no longer needed. In addition a similar occurrence with another patient happened about a month earlier to this reported event where a pin hole was noted in the same catheter. This occurred with a different size catheter (11.5F/19.5cm DL Mahurkar Dialysis Catheter). The pin hole was also noted in the plastic tip of the blue lumen while the patient was undergoing stem cell collection. This patient returned to interventional radiology to have another catheter inserted and the stem cell collection procedure was resumed the following day.

See device image

Dual Lumen Catheter Pin Hole Leak


Device:

Type: Hemodialysis, Continuous Renal Replacement Therapy
Manufacturer: Gambro Renal Products, Inc.
Brand: Prismaflex
Model #: Prismaflex

Problem:
There was a malfunction of the Prismaflex. The machine was restarted twice. Reviewed alarms and took steps per rep's guidance through Gambro's help line to resolve. Staff unable to clear alarm that pre-blood pump scale component was missing. The machine was running with yellow light. Gambro’s recommendation was to end treatment, flush blood back to patient, and disconnect due to machine malfunction of scale. A different machine was acquired and now running without difficulty.


Device:

Type: Hemodialysis, Continuous Renal Replacement Therapy
Manufacturer: Gambro Renal Products, Inc
Brand: Prismaflex
Model #: Prismaflex

Problem:
Prismaflex continuous renal replacement therapy machine lost memory for one hour's worth of fluid totals and the recorded patient weight. The next two hours the machine took off more fluid than it should have without any alarm sounding. The Prismaflex support line was called and machine was taken out of service. A new machine was set up. This delay caused a roughly three and one-half hour lapse of therapy and resulted in the patient requiring an increase in pressor therapy.


Device 1:

Type: Hemodialysis, Continuous Renal Replacement Therapy
Manufacturer: Gambro Renal Products, Inc.
Brand: Prismaflex
Model #: Prismaflex

Device 2:

Type: Hemodialysis, Continuous Renal Replacement Therapy
Manufacturer: Gambro Renal Products, Inc.
Brand: Prismaflex
Model #: Prismaflex

Problem:
Continuous renal replacement therapy (CRRT) machine in use when filter clotted off. A new system initiated, and "Air in Line" alarm received without a way to clear. New CRRT machine attained, when turned on was "stuck" in the reprime screen. Device turned off and then back on; same screen appeared. This step repeated with same result. Dialysis called, and was instructed to turn off again and restart. The screen did not change. Dialysis notified and told to get a new machine. Attained new machine, and started priming. During prime test machine failed at 2nd bar multiple times. Dialysis called and new machine delivered pre-primed. Previous two machines placed in dirty utility room with signs placed on the machines with descriptors of problems. Devices transported to BioMed a few days later.

Device:

Type: Hemodialysis, Continuous Renal Replacement Therapy Tubing
Manufacturer: Gambro Renal Products, Inc.
Brand: Prismaflex Hf 1400 Circuit
Lot #: 8399040
Cat #: Prismaflex HF 1400 circuit

Problem:
Prismaflex circuit changed on evening shift due to 96 hour limit. New circuit had to be replaced at midnight due to inability to recover from pressure alarms.

This circuit started without incident. An extra manual prime was done. Large amount of foam developed in the deaeration chamber, which was removed multiple times with syringe. The foam continuously reaccumulated, and it appeared to be from the purple line initially where it enters the deaeration chamber. It was later noted that small bubbles were at the top of the filter in the blood line when the blood was being returned. All connections were checked and double checked. Attempted to change the rate of the post replacement fluid. This did not change the rate of foam accumulation. A new circuit was then started with a full re-prime of the circuit. There were no issues with this circuit.


Device:

Type: Hemodialysis, Continuous Renal Replacement Therapy
Manufacturer: Gambro Renal Products, Inc.
Brand: Prismaflex
Model #: Prismaflex

Problem:
Continuous renal replacement therapy (CRRT) hemofilter Memory error Code 6 alarm when attempting to adjust fluid removal rate. Self test alarmed. When self test completed patient fluid removal remained highlighted. However, at first attempt to continue to adjust fluid level, memory error 6 alarmed. Attempted to turn off/on and unplug filter, but filter still clotted. Staff unable to return blood to patient. Surgical Critical Care notified . A new filter obtained and CRRT resumed.

Device:

Type: Hemodialysis, Continuous Renal Replacement Therapy
Manufacturer: Gambro Renal Products, Inc.
Brand: Prismaflex
Model #: Prismaflex

Problem:
Prisma citrate bags were bone dry. The system did not alarm. The system took in air, and machine stated "system failure in need of maintenance"...enough air was in line that machine shut down.

The PrismaFlex dialysis machine went down and this could have been a potential disaster. Risk Management was made aware. The machine continued to infuse air, the alarm did not go off, and the message came up for "System failure". The citrate bag line sucked in air--there was so much air that they could not recirculate blood.

I inquired on the patient status and was informed that this has happened to this patient with this machine before. She can be off dialysis for a short time.

This machine goes down after 18-30 hours for this patient. Earlier in the day they had a back up machine, but that was used for another patient and the hospital does not have any other machines available.

Device:
Type: Electrode, Esu, Hook
Manufacturer: Richard Wolf Medical Instruments
Brand: Hook Electrode
Lot #: 732081

Problem:
During cystoscopy and incision of ureterocele the insulation on the sheath slipped off and slid over the tip of the catheter exposing the back part of the electrode.

There was no patient injury. Procedure was completed before sheath moved. It is a single use device. The power setting point was 10 of cut and 0 of coag.

Device was returned to the MFR.

Manufacturer response (as per reporter) for Hook Electrode, Hook Electrode

They will investigate the issue.


Device:

Type: Bag, Hemodialysis, Continuous Renal Replacement Therapy
Manufacturer: Gambro Renal Products, Inc.
Lot #: 0921
Cat #: 6033765

Problem:
Urine collection bag split a hole in the middle and dumped nine liters of urine on the floor. Patient's daughter stated that this happened two other times over the weekend. The alarm to change the bag had just went off and the bedside RN was getting ready to do so when the bag exploded.


Device:

Type: Basket, Mechanical Lithotriptor, Stone Retrieval
Manufacturer: Olympus America
Brand: Lithocrush VMechanical Lithotriptor
Model #: BML-V442QR-30
Lot #: #93K

Problem:
The stone was captured in the basket. The handle was turned on to engage and crush the stone. The handle was turned and met with resistance. Upon further turning of the handle there was a loud snapping sound, where upon it was discovered that the rod that manipulated the basket had broken distally near the handle. There were several attempts to disengage the stone. When that could not be accomplished, the sheath was removed leaving only the wires from the basket within the patient. The physician then attempted to push the wires forward to release the stone. The doctor attempted to pull the stone intact, but could not perform this due to the resistance of the impacted stone. It was then decided to withdraw the scope and consult a surgeon to remove the stone and basket via surgery. The broken instrument was put into a bag without reprocessing.


ORTHOPEDIC

Device:

Type: Ronguer, Disk
Manufacturer: Codman
Brand: Peapod
Cat #: 53-1255

Problem:
During a laminectomy, a pituitary ronguer was used but fell apart with use, due to the screw falling out. Screw not found in wound. X-ray confirmed.


CLINICAL CHEMISTRY

Device:

Type: Glucose Testing Strips
Manufacturer: Abbott Diabetic Care Inc.
Brand: Abbott Precision Pcx-plus
Lot #: 6CVK5G
Cat #: 80063-02

Problem:
Discovered our point of care glucose testing was varying by as much as 50% with our venous blood glucose testing. We did a study and proved with data that we had an average of 13% of our glucoses that varied by >20% between our point of care testing and venous testing. We then switched glucose testing strip lots and our variance was within expected variance <20%.


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