Highlighted Reports
MedSun: Newsletter #17, September 2007

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 June 1 through June 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.

Device: Laryngoscope, Bullard Catalog# LARS-A
Manfacturer: ACMI Corporation
Problem: A trauma patient complained of a sore throat after a nasal fracture reduction procedure. Examination of the patient revealed that a plastic laryngoscope blade extender tip had been left in the patient when the laryngoscope was removed. Examination of the laryngoscope revealed that the plastic extender can be difficult to attach, and, if not properly attached, can unintentionally become disconnected from the device.

Device: Automated External Defibrillator, Powerheart AED Model# 9300E-001
Manfacturer: Cardiac Science Corporation
Problem: The first responders (Police) received a 911 call regarding a person who was having cardiac arrest. Having arrived at the scene prior to the paramedics, the first responders attached their automated external defibrillator (AED) to the patient. The responder opened the lid, which turns the AED on and readies it for use. The “Rescue Ready” light was green, which indicates that the AED is in working order. The electrodes were placed on the patient and the voice/text prompted them “Do Not Touch Patient. Analyzing Rhythm. ” Normally, the next phrase is “Shock Advised. Charging. Stand Clear. ” However, instead, the message that was given was, “Service Required.” (The printout from the AED shows that the patient was in ventricular fibrillation prior to the “Service Required” statement. At this point, the ambulance crew had arrived, and the lid of the nonfunctioning AED was closed, and the paramedics attached their AED. The patient received one shock, was converted to sinus tachycardia, and was transported to the hospital. The patient remains hospitalized at this time. The outside agency (owners of the malfunctioning AED) requested that this reporter complete the MedWatch report. Cardiac Science was notified of this occurrence by the outside agency and its response was to send the AED to the company for evaluation. The outside agency will send Cardiac Science the AED and has requested that the findings of the evaluation be sent to the agency.

Device: Warming System, Blanket,
Level 1 EQ Equator 5000 Convective Warmer Model# EQ 5000
Manfacturer: Smith’s Medical
Problem: The EQ 5000 convective blanket warmer was in use when a burning odor was noted by staff members, followed by a cloud of smoke. The unit was turned off and removed from the surgical room. Upon inspection, the Biomedical Department staff noted that the filter did not contain a gasket, an omission which allowed the plastic filter case to be in direct contact with the heater element, therefore causing it to melt. Later, in a discussion with the manufacturer, staffed learned that the filter parts ordering process requires that the two parts (gasket and filter) be ordered separately for replacement of the filter assembly. These parts have to be assembled together, prior to installation. We suggested to Smiths Medical that the filter be sold as one assembly, which would eliminate any chance of having the filter installed without a gasket and prevent any similar incidents in the future. This issue was discussed in detail with the Smiths Medical Product Manager. As a result, we were provided with a new operator manual, which contains more detailed information on the filter replacement than did the old manual we were using for this device. In addition, we were assured that in the future the device will be sold with the gasket and filter already assembled.

Device: Warmer, Patient,
Bair Hugger Model# 500/OR
Manfacturer: Arizant Healthcare Inc.
Problem: The Bair Hugger was applied for AAA (abdominal aortic aneurysm) surgery. Two hours into the procedure bleeding was noted, and the patient’s temperature was 32.4. The Bair Hugger was found to be providing room-temperature (cool) air.

Device: Central Venous Catheter, Cordis Introducer Model# SSS 8.5 Fr 7007BF85 SSS 7008BF09 9 Fr
Manfacturer: Edwards Lifesciences
Problem: There are multiple concerns with the Edwards central line kits, particularly with the Cordis (9 Fr introducer). They include: (1) the long needle used to puncture the vein is extremely flimsy and frequently bends or breaks when trying to get it under a patient with a thick clavicle; (2) the catheter does not directly interface with the transvenous pacing wires made by the same manufacturer; and (3) the introducer catheter itself is extremely flimsy and prone to kinking and shearing of the tip when the needle is reinserted.

Device: Gastroscope, GIF Model# Q180
Manfacturer: Olympus America Inc., Diagnostics Systems Group
Problem: While performing an EGD (esophagogastroduodenoscopy) on a patient, the doctor commented that there appeared to be a small, black, round object in the patient. He noticed the black object after the biopsy forceps were passed with the scope. He continued to take the biopsy bite, retrieve the specimen, and complete the procedure. The black object was identified as the distal tip ring of the scope. The physician said the ring would come out when the patient had a bowel movement. The scope was given to the endoscopy technician, who sent it away for repair. The scope is routinely hand-cleaned, put through a leak test, run through a sterilization processor, and hung to dry before being used again. It is used between one and three times per day. The distal tip ring is not removed during the cleaning process.

Device: Stone Extractor, Tipless, Nitinol Model# NTSED-024115-UD Lot# U1557727
Manfacturer: Cook Urological Incorporated
Problem: We returned two stone extractors to the manufacturer for evaluation after experiencing difficulty during two different procedures. In both cases, surgeons were unable to get the extractor to close. Cook representatives responded that inadequate adhesion was a potential cause for this failure, and they are investigating the issue further.

Device: Gastric Band, Adjustable, BioEnterics LAP-BAND Catalog# B-2220, Size – 10 cm
Manfacturer: INAMED,
A Subsidiary of Allergan, Inc.
Problem: The LAP-BAND was placed last year. Initially, the band was effective, and the patient was demonstrating good weight loss. Recently, the fluid in the LAP-BAND system has been slowly leaking from somewhere in the system, with no liquid in the band on rechecks. The physician felt the likely site of leaking was at the port. The patient was taken to the operating room for replacement. Upon mobilizing the port from its facial attachment, it was brought up into the wound. A clamp was used to clamp the tubing distal to the port; then, using a huber needle, the port was accessed and saline was injected. A leak was immediately identified in the port at the junction between the rubber dome and the white plastic portion of the port. It appeared that the port was leaking in this location. No other areas of leakage were identified. The port was removed and replaced with a new port. The new port was then accessed with a huber needle, saline was injected, and it was determined that the port was watertight and holding the fluid with no problems.

Device: Sponge Counter, Electronic Safety-Sponge System Model# N10410
Other Device # Software Version
Manfacturer: SurgiCount Medical, Inc.
Problem: We have had numerous problems with the SurgiCount sponge counters. In this particular incident, staff reported that the screen "froze and became scrambled." Upon rebooting the device, the count and report for this case were lost. A staff member was able to continue the case using a manual count. The most common problems with this device have been that the display freezes and becomes unresponsive to all controls. In most cases, the device can be rebooted to solve the problem. In some cases, staff members reported the count in the device indicated an inaccurate sponge count, which suggested that sponges were never used during the case. A manual count is always maintained as a backup, regardless of whether a sponge counter is used, due to the unreliability of devices; the discrepancies oftentimes result in more work for staff members. We have had at least 21 separate cases of device malfunction, which have ranged from freezing during use, to not scanning appropriately, to screens’ becoming unreadable or scrambled, to fields’ overlapping. These problems have resulted in delays during surgery and questionable/inaccurate sponge counts. The manufacturer representatives stated that they were working on new software for this device, and that the new version is scheduled to be released sometime later this month. Some devices have been sent back to the manufacturer, but mostly for repair of mechanical damage. The software glitches seem to be transient and can usually be resolved by rebooting the system.

Device: Table, Surgical, ALPHASTAR
Manfacturer: MAQUET, Inc.
Problem: The head of the bed was pushed in prior to the patient's arrival in the operating room. Upon turning the bed for positioning, a staff member pulled and turned the head of the bed. The head of the bed came out of the bed, and the patient's head hyperextended and flexed forward. A cervical collar was placed on the patient. Portable X-rays were taken of the patient's neck. This table uses a hand-operated crank to lock the head into position. If the handle is not cranked hard enough, the locking mechanisms may not be safely initiated. However, locking/tightening of the head may be difficult for some individuals who are less physically strong. Due to the fact that this is a repeated problem in our facility, other types of beds are being considered for purchase.

Device(s): Dissector System,SPACEMAKER PLUS Lot# U7C38 Catalog# (01)00613830153992 Other Device# (17)090331 (10)U7C38; Trocar, PediPort Lot# P4J1118 and P7A015 Catalog# (01)00613830124794 Other Device# (17)120131 and (17)090930
Manfacturer: United States Surgical Corporation
Problem: The patient was scheduled for a bilateral laparoscopic inguinal herniorrhaphy. A SPACEMAKER PLUS was being used. The balloon on the SPACEMAKER PLUS broke while the trocar was being pulled out. Also, the PediPort from the laparoscopic herniorrhaphy pack would not open. The surgeon states that the PediPorts will not open and that he has had at least 10 of these ports fail in a similar way. All three ports that he tried on this patient failed. He states that he will not use this port again.

Device: Analyzer, Chemistry, Bayer ADVIA Centaur Immunoassay System
Manfacturer: Siemens Medical Solutions Diagnostics
Problem: There have been six reports of incorrect troponin values released. The incorrect values were obtained using the same chemistry analyzer. (1) Troponin imprecision on the Bayer Centaur resulted in reporting of an incorrect troponin value of 0.07 ng/ml. The repeat on another analyzer was 0.03 ng/ml. (2) Troponin imprecision on the Bayer Centaur resulted in reporting of incorrect troponin values of 0.08 ng/ml and 0.39 ng/ml. The repeat on another analyzer was 0.02 ng/ml. (3) Troponin imprecision on the Bayer Centaur resulted in reporting of an incorrect troponin value of 0.08 ng/ml. The repeat on another analyzer was 0.02 ng/ml. (4) Troponin imprecision on the Bayer Centaur resulted in reporting of an incorrect troponin value of 0.30 ng/ml. The repeat on another analyzer was 0.13. ng/ml. (5) Troponin imprecision on the Bayer Centaur resulted in reporting of an incorrect troponin value of 0.15 ng/ml. The repeat on another analyzer was 0.09 ng/ml. (6) Troponin imprecision on the Bayer Centaur resulted in reporting of incorrect troponin values of 0.028 ng/ml and 0.09 ng/ml. The repeat on another analyzer was <0.02 ng/ml. In all six cases, the corrected report was called to the RN. The results were corrected in the computer, with a note of explanation. There was no patient intervention based on the incorrect laboratory results. The company was called, and service representatives came to fix the problem. They think that air was trapped in the lines after the daily cleaning. We do not know how that occurred or how to prevent it in the future. The quality control for the troponins worked, and the technician had no reason to doubt the operation of the instrument for the troponin assay.

Device: Sweat Collection System, Macroduct Model# 3700
Manfacturer: Wescor, Inc.
Problem: The patient is a newborn who was seen for a sweat chloride test. The patient sustained an injury to his arm where the pilogel disc/electrode was placed to perform the test; however, the cause is unknown. This reaction was discovered after the 5-minute sweat stimulation was completed and the pilogel disc was removed. The patient was evaluated in the Emergency Department. It was noted that the patient had a 2–3 mm lesion that was dark in color and appeared to be consistent with a burn. The Macroduct system was evaluated by the Biomedical Department and determined to operate as designed.

Device: Glucose Test Strips, MediSense Precision PCx
Manfacturer: Abbott Laboratories Diagnostic Division
Problem: The facility had used MediSense Precision PCx strips for point-of-care glucose testing for many years. The Neonatal Intensive Care Unit (NICU) was plagued with requests from the term Nurseries and Labor and Delivery to retest infants' blood sugars using our i-STAT device. The i-STAT results were almost always significantly higher than the PCx readings. In April 2007, we began using MediSense Precision PCx Plus strips (AKA: Gold strips). The result was an approximate 75 percent drop in the number of i-STAT tests being done in the NICU!

Device: Head Rest, Cranial Support, Mayfield Modified Skull Clamp With Skull Pins
Manfacturer: Integra LifeSciences Corporation
Problem: During the preparation stage, the patient was placed in the Mayfield head holder by the neurosurgical resident. The left-sided pin was tightened to a torque of 60 pounds, which is standard. The patient was being positioned by the resident and the physician assistant; the pin slipped and a 1.5 cm laceration of the scalp resulted on the left temporal region. The resident sutured the laceration, and notifications were sent out. The C-clamp and pins for the Mayfield were replaced with another set. The C-clamp and pins were segregated. This was a loaner set, in which the torque screws were located on the two pin holders as well as on the left side of the C-clamp. The neurological director requested that an extra staff member be available at the head of the table with the anesthesiologist to prevent this event from reoccurring.

Device(s): Pump, Arthroscopic, Continuous Wave III Model# AR-6475; Tubing, Arthroscopic Pump
Model# AR-6410
Manfacturer: Arthrex Arthroscopy Instruments, Inc.
Problem: During a right-knee arthroscopy, the Arthrex water pump began alarming "Pressure Fault." The circulating nurse stopped the pump and began looking at the troubleshooting procedure. The nurse looked at the fluid and it was adequate; she then took off the suction tubing from the canister and tried to restart the pump. The pump spun very fast and again stated "Pressure Fault." The nurse then reconnected the suction because fluid was coming out of the knee from the field. All the clamps along the tubing were checked and all were found to be open. The pump was restarted, and again it spun very fast. The pump was stopped again. At this point, the surgeon stated that the patient's thigh was very hard, and that he was having difficulty bending the knee. The scope was removed from the knee, and the tourniquet was released after being inflated for only 24 minutes. The surgeon then applied pressure to try to reduce the swelling. The nurse continued to troubleshoot the pump by requesting a new Arthrex pump. The tubing was changed over to the new machine and restarted. After 1 minute, the same "Pressure Fault" error occurred; this time, however, the scope was not in the knee. The tubing was changed and the pump was restarted. Everything seemed to check out and work correctly, and the case was completed. Unfortunately, the original tubing used was discarded after the case was finished. This is at least the third time a problem of this nature has occurred at our facility. This system requires that the exact setup steps be followed precisely in the correct order for the pump to function properly. If the balloon inside the cylinder is inadvertently collapsed, pressure changes will not be correctly detected. The balloon may become collapsed by leaving the tubing clamps on when starting the pump, or by spiking the fluid bags before inserting the disposable pressure-sensing components. If the tubing is disconnected and then reconnected, or if the same tubing is used on a different machine, this will not repair the pressure calibration problem.

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