Highlighted Reports
MedSun: Newsletter #23, April 2008

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 January 1 through January 31. 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.

ANESTHESIOLOGY

Device: Blade, Laryngoscope; FiberOptic Light Blade; GreenLine
Manufacturer: Sun Med Healthcare
Problem: The fiber-optic laryngoscopes blades are labeled with small identification markers that look like plastic green dots, and are approximately 1/4 inch in diameter. The green dots, which are located at the back side above the interface with the handle, come loose after sterilization. The loose dots present a patient safety hazard of being swallowed, or otherwise being absorbed into bodily cavities. The hospital received about 100 new fiber-optic laryngoscope blades, and after the first sterilization cycle, it was noticed that loose green dots were present within the sterilization packages. The inventory was removed from service, and the vendor was contacted to immediately replace the defective inventory. Unless users are trained to examine each product for a loose or missing dot defect, it is difficult to detect this problem.

Device: Anesthesia Machine; S/5 Anesthesia Delivery Unit (ADU); Compact Block P/N 8503666
Manufacturer: GE Medical Systems, LLC
Problem: Obese male patient in OR for explorative laparotomy for incarcerated hernia. Rapid Sequence Induction with cricoid pressure planned for patient's morbid obesity and unsure NPO status. Difficulties occurred with laryngoscope, necessitating mask ventilation. Oxygen saturation fell to 88%. Unable to fill bag on machine. Patient was hand bagged and then intubated. Check of machine showed broken connection at seat of CO2 absorber. Machine replaced in room and patient suffered no further problems. Biomed checked out equipment after the event. Problem initially could not be duplicated, but on closer inspection one of 4 plastic latching pins had broken off even though testing did not replicate previous problems.
======================
Manufacturer response for Anesthesia Machine, GE Datex Ohmeda
======================
The GE Datex Ohmeda representative stated that the compact block style we use is obsolete and no longer in production. He also stated that this type of breakage (one plastic pin was broken although problem could not be duplicated) has been noted by other users who autoclave their blocks. Our concern is that there may be other users of this type of compact block that could be at risk. As of the date of this report, current production style compact blocks that use metal pins have been delivered and will be put into service as soon as possible.

Follow-up reveals that the compact block is a part of the anesthesia machine to which the CO2 absorber cannister is attached, and held in place by the latching pins described in the report (One of which broke). In the newer production style compact blocks, the plastic pins opposite the locking / releasing latch have been replaced by a metal pin that extends from one side, through the block to the other side. GE Datex Ohmeda was unable to differentiate the production styles based on the part number alone. Only the metal pin style is available at this time. The company's tech support department was unable to define the changeover more precisely than around November of 2003. The compact blocks are date coded in the format YYYY-WW. The blocks we have with all-plastic tabs are date coded from 1999 and 2002.

Device: Valve, Tracheostomy, Speaking; Shiley Phonate Speaking Valve; catalog #SSVO
Manufacturer: Nellcor
Problem: Pt. had a speaking trach valve in place. Anesthesiologist inflated cuff, therefore, pt. could not exhale (acts as a 1-way valve for speaking when cuff deflated). The device was not labeled as such and physician unfamiliar with valve. Able to get air in lungs, but not exhale. Pt. suffered a cardiac/respiratory arrest and died.

Device: Ventilator; model #840
Manufacturer: Puritan Bennett Corporation
Problem: Pt on ventilator was having difficulty breathing. When Resp therapist attempted to adjust vent parameters, screen went black and high-pitched tone emitted from machine. Pt removed from vent and bagged w/ 100% oxygen. After shutting off vent, restarted with same black screen present. Vent removed and sent to Biomed. Pt placed on new vent. Biomed report: Vendor service requested. Vendor tech reported GUI CPU failure; warranty replacement of GUI keyboard necessary.

Device: Monitor, Module, Anesthesia; S/5, M-PRETN; model #M-PRETN
Manufacturer: GE Medical Systems Information Technologies
Problem: Prior to a surgical procedure and during a patient intubation, the anesthesia machine monitor exhibited a non-invasive blood pressure failure giving a "NIBP Occlusion Fail" error message. Even after replacing (removing and reinserting) the module the error message would not clear unless the monitor power was recycled. Biomedical has sent modules back for repair with this problem only to be returned back to us un-repaired due to "no problem found". Later the same module would fail once again. We have returned up to 6 modules for this exact failure to the manufacturer (MFR). They come back with could not duplicate any of the failures. The modules returned to us with replaced boards would become operational once again. Biomedical has determined that there is an intermittent problem with these modules that can fail at any time and the problem lies in the NBP interface PCB. Biomedical was able to recreate the failure. During calibration of the NIBP module failure mode, biomedical note that transducer B2 would gave a zero reading during a pressure increase on the test bulb. Transducer B1 would track the increase in pressure. Another module would be placed on the same anesthesia machine and a calibration check would show that the good module would have both transducers B1 & B2 track the pressure increase correctly. A similar failure was confirmed by the manufacturer (MFR). The Field Service Report (FSR) and module were sent back for analysis. The MFR could not duplicate the problem on a returned module tested by the Field Service Engineer (FSE), but they still replaced the NIBP interface PCB as a precaution.

Device: Adapter, Hose, Respiratory; catalog #1422; Other device #15 mm I.D./ 22mm O.D.
Manufacturer: Hudson Respiratory Care, Inc.
Device: Nebulizer; Micro Mist; catalog #1883
Manufacturer: Hudson Respiratory CAre, Inc.
Problem: The patient was admitted to the PACU with anesthesia at the bedside. On admission the patient was non-responsive with an oral airway and endotracheal tube (ETT) intact. Breath sounds clear bilaterally. The patient was connected to a monitor with oxygen saturations 88-89 increasing to 92%, respirations deep at 16, EKG with a sinus rhythm , heart rate at 105, BP 107/62. Anesthesia requested breathing treatment. An order was placed and Respiratory Therapist responded within minutes. Oxygen saturation remained at 88-92% with an intermittent waveform. The RT was going to get a ventilator, but stayed by the bedside and the assistant placed the nebulizer for the breathing treatment over the patient's ETT. The patient began coughing and RT stated the patient needed to be placed on a ventilator and went to get it. Within seconds, the patient's cheeks ballooned out and face became cyanotic. The apparatus was removed from the ETT with a "whooshing" sound when disconnected from the ETT. Immediately began bagging the patient with edema increasing in the face, eyes, neck and upper torso. Breath sounds were absent on the right. The EKG was sinus brady with a rate in the 50's. Code Blue called and CPR initiated. Physician at bedside punctured left chest with audible sound of air escaping. Patient transported to OR and expired a couple of days later. Additional device identifiers are not available. The issue is the inner diameter of the adapter allowed it to be attached directly to the end of the ET tube. We have now switched to a larger diameter adapter.

Device: Ventilator; Avea
Manufacturer: Viasys Healthcare Medsystems
Problem: While operating ventilator on batteries, ventilator would go into low battery alarm after very short periods of time despite battery indicators showing fully charged batteries. There were a couple of instances where ventilator failed to switch from external to internal batteries despite indications of fully charged batteries. In all cases, ventilation function stopped and ventilator went into alarm.


GASTROENTEROLOGY/UROLOGY

Device: Kit, Extracorporeal Photopheresis; lot # V744; catalog # XT125
Manufacturer: Therakos, Inc. (A Johnson and Johnson Company)
Problem: At start of Extracorporeal Photopheresis procedure treatment noted leakage in kit at site of inlet tubing connection to centrifuge bowl (connections had appeared secure). Breach of sterility & potential for air being pulled into kit. Contacted Therakos & aborted treatment. Approximately 30 ml blood loss in kit. Patient did not contact nonsterile blood or fluids as none was returned to patient from this kit. Assessed patient & labs & vital signs. Reprimed new kit - no leakage or loose connections noted. Continued with Extracorporeal Photopheresis procedure without problems; patient tolerating well. Returned 3" piece of tubing at leakage site to Therakos after cleaning with bleach solution 1:10. Notified MD.


GENERAL HOSPITAL

Device: Drug transfer device; PhaSeal
Manufacturer: Carmel Pharma Inc
Problem: Upon removing chemo from bag the spike had broken off and taxol spilled into bag and on the portable table. Appropriate spill protocol. New chemo ordered from pharmacy. Pt received treatment with minimal delay.
======================
Manufacturer response for Drug transfer device, PhaSeal
======================
Problem: The spike of the above adapters may fracture when used with a certain combination of drugs and intravenous bags. The manufacturer issued a Technical Bulletin letter. The firm has updated its training procedures for the above product, as well as the product's instructions for use. Health Canada has designated this action Type II Recall. Action Needed: Verify that you have received the Technical Bulletin letter from Carmel Pharma. Identify any affected product in your inventory. Refer to the manufacturer’s letter and updated instructions for use when using the above adapters. For further information, contact Carmel Pharma by telephone.

Device: Traction Assist System; Hill-Rom VersaCare Patient Helper Adapter; catalog #
00-0965-000-00
Manufacturer: Zimmer , Inc.
Problem: Hospital purchased Hill-Rom Versa Care beds for use on a newly opening Trauma Specialty Care Unit. We had a need for traction patient assist brackets for the new beds. (Hill-Rom publishes a document of traction accessories available from other vendors for the Versa Care bed on their website @ hill-rom.com ) We purchased the Zimmer Patient Helper bracket/bar assembly only to find out once they were installed on the beds that there is an inherent safety problem with the bracket set up. This helper bar slides into a tube attached to the head of the bed and is secured by a hand knob at an adjustment clamp, allowing you to vary the height of the bar assembly above the patient. If you attempt to adjust the bar by loosening the hand clamp, and you are not holding onto the bar, it will slam down towards the patient's head. There is a potential for serious injury. The other problem identified; as the bar slams down, the metal on the bar gets shaved, to a point of having very sharp burrs left on the bar. Those burrs could cause cuts to caregiver’s hands or anyone who tries to get the bar off the bed.
======================
Manufacturer response for Traction Patient Assist Bar, Hill-Rom VersaCare Patient Helper Adapter
======================
Initially they indicated there was no type of safety lock or stop available and that when we adjusted the bar we had to hold on to it. Today we had a rep from Zimmer come in to see our concern first hand, we gave him a little demo of the slamming down of the bar on an empty bed, and showed him the shaved metal burrs on the bar afterwards.

Device: tubing, IV, Burette Set; Horizon; various lot #’s; model #375150
Manufacturer: B. Braun Medical, Inc.
Problem: Our facility has recently switched to B Braun's Horizon Pump Burette Set (Buretrol Set). It was noticed on our units that there is a "disc" in this device that is supposed to float on top of the medication and as the medication is delivered to the patient, it floats down and upon completion of delivery closes off the drip. Unfortunately this "disc" was floating down prematurely and closing off medication being delivered before completion. In contacting the company, they advised our staff to "turn the buretrol over if the chip floats to the bottom." Our staff members are not comfortable doing this and are afraid it could lead to safety issues. They feel this suggested fix is a nuisance and may actually cause errors with late infusions if the RN has to repeatedly go in to ensure device is infusing properly. We had previously used a set without a "disc" and will hopefully be switching to B Braun's device which is essentially the same as this minus the "disc." The device packaging of the product with the disc does indicate "re-floating of the disc" and advises how to do so.

Device: bed, hospital; 3002 Secure II
Manufacturer: Stryker Medical
Problem: There has been a chronic problem with bed brakes not working after two to three months. The facility has had numerous discussions with the manufacturer to resolve the problem. Manufacturer has developed several repair kits which have not resolved the problem. Current kit reduces the brakes ability to prevent caster swiveling.

Device: Bed, Patient, Alarm; VersiCare Bed with Prime Air Mattress; model #455
Manufacturer: Hill-Rom Company, Inc.
Problem: The bed scale and bed alarm are coordinated. Staff unfamiliar with how the bed operates, inadvertently "zero" the bed by randomly pushing buttons. When this happens the bed alarm cannot be reactivated until the patient is removed from the bed and the scale is again "zeroed" out. Therefore, those patients’ at risk for falling out of bed do not have the bed alarm protection.

Device: Drape, Slush; lot #0907003; catalog #ORS-320
Manufacturer: OR Solutions, Inc.
Problem: The OR staff were setting up for a CABG. The scrub technician reported that she had a puddle on the floor before she pulled the tables up to the operative field. She questioned the circulator, and both thought that some saline may have been accidentally poured on the floor when the slush machine was initially loaded for the case. However, during the surgery, the scrub technician reported needing more saline to make slush. Otherwise, the surgery itself was uneventful. At the end of the case, as staff were taking the equipment down, staff noted that there was a hole in the drape that lined the slush machine and that saline was standing in the machine. Upon closer examination, there was an area around the disk in the drape that was steadily leaking. Per staff, no instruments are placed in the slush machine. Staff state that it is not possible that an OR instrument or another piece of equipment could have caused or contributed to the hole. No patient or staff were harmed in this event. The rep was notified of the event and has already picked up the device. Staff suspect that the hole was present prior to opening the drape. In reviewing the event, staff are confident that the saline they saw on the floor was a result of the leaking drape and not a spill.
======================
Manufacturer response for Sterile Slush drape, (brand not provided)
======================
The rep was contacted on the day of the event, and came to the hospital to pick up the device.


GENERAL SURGERY

Device: Table, Orthopedic; Pro FX; model # 6850
Manufacturer: Orthopedic Systems, Inc.
Problem: A technician described the problem with our Orthopedics Systems, Inc. (OSI) model ProFX, orthopedic table. The malfunction is an intermittent failure whereby the table will fail to go up or down (change elevation). In order to change the elevation of the table, all 4 brakes must be on. When the brakes are on the brake light indicator should be "on." The problem is that the indicator light is showing the opposite of what is true. In other words, when the brakes are on the indicator light is "off" and when the brakes are off the indicator light is "on." Thus the user, thinking the brakes are properly engaged because the indicator light is "on," is unable to change the elevation of the table as expected. To resolve this problem and change the elevation of the table, the user must either press the override button or perform the additional steps of locking and unlocking the table brakes to get the electronics in sync with the foot brakes. The table will then go up or down properly. This failure is believed to be a result of the electronic safety update performed late last year. There may be a new upgrade available to resolve this newest safety operation issue. This orthopedic table is only 10 months old. Another model, Allegro may also be prone to this failure.


LABORATORY

Device: Monitor, PT/INR; INRatio PT Monitoring System
Manufacturer: HemoSense, Inc.
Problem: The patient has a history of post-op DVT and pulmonary emboli diagnosed five weeks ago after ventral hernia repair. He was treated with IV unfractionated Heparin and Coumadin at that time. He was eventually stabilized on oral Coumadin and was discharged home with instructions to continue with Coumadin 5mg po every night, and to have daily PT/INR levels called to the physician. A day prior to the event, the PT/INR level was obtained per fingerstick, and the level was 1.6. The physician was contacted and he increased the Coumadin dosage to 15mg. The patient had been participating in physical therapy at home. The next day, the patient was noted to have left back pain, and shoulder discomfort along with generalized weakness. He suffered a syncopal episode and was transported to the hospital. His lab results included a hemoglobin (9.1) and hematocrit (27.1). The platelets were 199,000 and the INR was 10.5. The patient was admitted to the ICU and given Vitamin K. There were two separate HemoSense machines that could have been used and both are sequestered and will be analyzed.


NEUROLOGY

Device: Monitor, EEG; model# nEEG
Manufacturer: Nicolet Biomedical
Problem: The NicoletOne nEEG amplifier has an event button for the nurses or family to press when the patient is seizing. Activation of the event button will mark the patient’s record and activate a relay. The relay is used to call the nurse for help by activating the nurse call system. The marking of the record works fine with every button press. The nurse call activation will not work if the button is pressed more than once in a two second period. The button can be repeatedly pressed for long periods of time without triggering a call to the nurse. If the button is pressed just once it works fine. There is a two second delay from when the button is pressed to when the nurse call is activated by the Nicolet relay. This delay may cause the user to press the button again because it appears as though it didn’t work the first time.
======================
Manufacturer response for Long-term EEG monitor, Nicolet Biomedical
======================
They have reproduced the problem. They may try to resolve through changes in the software programming.


MedSun Newsletters are available at www.fda.gov/cdrh/medsun