Highlighted Reports
MedSun: Newsletter #25, June 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 March 1 through March 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: monitor, physiological
Model# Dash 4000; Dash 3000; Solar 8000i
Manufacturer: GE Medical Systems Information Technologies
Problem: Dash 4000 monitor went blank while in use on patient. Dash 3000 monitor went blank while in use on patient. Solar 8000i monitor also made by GE failed to correctly detect patient's heart rate while in use.

Device: Defibrillator; M Series
Manufacturer: Zoll Medical Corporation
Problem: Patient with a near syncopal episode earlier, but no signs/symptoms at time of paramedic arrival. Pacer pads were placed on the patient, and staff were unable to pace. Patient had all four leads on, and each electrode had full contact with the patient's skin. All wires were properly hooked up to the monitor. All leads were in the appropriate spot/side and all leads (I, II, III, aVF, aVL and aVR) were showing the patient's rhythm on the defibrillator/monitor screen. The pads were also properly placed (anterior/posterior) and attached correctly at each junction. The monitor was put on "pacer" and the spikes that indicate the dialed rate (70) were noted in the monitor and the rate could be modified with the dial. When the mA dial was turned the monitor showed "0" and did not change when the dial was turned either way. The patient's rhythm did not change either and the patient denied feeling the "shocks" from being paced. Patient was transported to hospital as a "Code III" (emergency vs. routine) status due to the staff's concern that the patient's condition could deteriorate and the defibrillator would not work. There was no change in the patient's condition in route to the hospital. The defibrillator was removed from service and sent to Zoll for repair. Zoll reported that device is able to power up on battery and AC. The problem of being unable to adjust the pacer current was verified. The "Control to System Flex Cable" was reseated to remedy the problem condition. Software version 38.80 was installed. The device passed all final system level tests and was recertified to be used clinically.

Device: Lead, ICD; Sprint Quattro
Model# 6947
Manufacturer: Medtronic, Inc.
Problem: During ICD RV lead implant, RV lead became stuck at axillary/subclavian juncture. Medtronic called to assure MD that suture sleeve would not dislodge if lead pulled back. Assured by Medtronic. Physician pulled back lead and sleeve dislodged and lodged in lung tissue. At this time, Medtronic called back and said sleeve could dislodge. It was decided that there would be more harm if we attempted to remove sleeve so it remains lodged in the patient. Patient is aware. No harm to patient at this time.


Device: Hemodialysis Machine; Centry 3, C3+
Manufacturer: Gambro Renal Products, Inc.
Problem: During setup of the pH alarm on the Cobe/Gambro Centry C3+ dialysis machine, the machine alarmed "dialysate pH low." The biomed testing conclusion was that the problem was due to inadequately mixed bicarb solution.

Device: Dialysis Machine; Phoenix
Manufacturer: Gambro Renal Products, Inc.
Problem 1: Dialysis treatment delayed for alarm Concentrate Type Error A pump 40. Found mineral buildup on concentrate line connectors. Operating within manufacturer's guidelines after vinegar rinse.

Problem 2: Machine did not pull target weight and patient remained hypertensive after treatment. Required one dose of sublingual nifedipine.

Problem 3: Three problems at the beginning of the dialysis treatment: High level in UF vessel, # 144 Flow Balance error and #145 UF rate vessel. Treatment was stopped and reinitiated on another machine. No harm to patient.

Problem 4: Machine produced a dialysate flow error message. Operator may not have performed vinegar rinse prior to use.

Device: Catheter, Dilation; XXL
Model# XXL/12-4/5.8/75
Lot# 9794903 or 9794900
Catalog# M001145100
Other Device# 14-510
Manufacturer: Boston Scientific

Device: Stent, Biliary; Wallstent
Lot# 9441404
Catalog# H9654031100
Other Device# 40311
Manufacturer: Boston Scientific

Problem: Attempted placement of superior vena cava stent. The Wallstent was positioned in the SVC and deployed. The balloon was inflated to its rated burst pressure of 8 atmospheres. There was still a waist at the superior margin of the stent therefore the balloon was inflated to 10 atmospheres. As the pressure approached 10 the balloon ruptured. The patient went into full cardiac arrest and could not be resuscitated. Autopsy revealed a hemopericardium (300 cc's of liquid/clotted blood), immediate cause of death: Cardiac Tamponade.

The WALLSTENT Endoscopic Biliary Stent System is indicated for use in the treatment of biliary strictures produced by malignant neoplasms. For more information, visit:


Device: Sterilizer, Scope, Universal Tray; Universal Flexible Processing Tray
Manufacturer: Steris Corporation
Problem: Urgent recall notice received for Steris System 1 processor. The alert necessitates a change in the way the c1160 tray accessory is used with the system 1 sterile processing system. Until further notice you must run a diagnostic after each cycle or you must discontinue use of these trays if this can't be done.

Device: Catheter, IV, Safety; Protectiv Plus; 18g 1-1/4"
Lot# 37H11SD02
Catalog# 3065
Manufacturer: Smiths Medical
Problem: Nurse completed IV catheter insertion. Upon disengaging device from catheter, needle was unable to fully retract and lock inside the protective chamber. Nurse sustained needle stick from dirty needle. When looking at the device, the back portion of the protection chamber is noticeably flattened instead of round. This change in shape prevented the needle from retracting and locking. The plastic material the device is manufactured from is not cracked or broken. It is unknown why the shape of the device is distorted. Smiths Medical was very concerned. After the incident was relayed to the sales rep, it was only about an hour and a half before their QA contacted the site. The QA person responded that she would be filing a report with the FDA. Smiths did ask for the catheter but until all of the testing for nurse's health is complete, we will not release. The rep did come by last week; she did look at the device. It is obvious by looking at the device that something is wrong with it. She saw the defect and commented that she did not know what happened. Smiths is welcome to come in and inspect the device in our lab.

Device: Pump, IV; Medfusion
Manufacturer: Smiths Medical
Problem: Possible underinfusion of IV medication indicated by patient response to drug being infused. Infusion pump was programmed to deliver body weight/concentration mode which is used by anesthesia. Nursing uses volume over time and rate mode, causing confusion to nurse operator and possibly induced programming error.

Device: Tubing, IV; LifeShield PlumSet
Manufacturer: Hospira Global Medical Affairs

Device: Drug Transducer Device, Closed System; PhaSeal
Manufacturer: Carmel Pharma Inc.
Problem: The RN met with resistance when trying to administer Doxorubicin with an attached Phaseal injector luer lock device. There is a question of incompatibility between the Hospira/ICU Medical IV clave and the Phaseal luer lock. Hospira says the clave is not compatible; PhaSeal has represented that it is. Additional problems our hospital has experienced with the PhaSeal:

1) syringe pump with the PhaSeal pieces does not sense or accept any syringes smaller than 20 cc’s which is a problem with the pediatric and neonate population;

2) we have had needle exposures due to incorrect use;

3) in a couple of situations our connector has broken the clave.

The manufacturer is working with the hospital to resolve these issues, some of which are education-related.

Device: Warmer, Infant; Air-Shields Infant Intensive Care System
Model# IICS-90
Manufacturer: Draeger Medical
Problem: Each infant warmer has a double cylinder holder mounted onto each unit. Plastic knobs with threaded screws hold E Oxygen cylinder tanks in place. The plastic knobs stick out, and 2 had become broken just by moving the warmers around in the storage room. When the plastic knob breaks, they break in such a manner that leaves very sharp edges. Two staff members had their fingers sliced by the sharp plastic, and therefore replaced the plastic knobs with different screws made strictly out of metal, with a flat end the user can grip to turn and tighten.

Device: Incubator, Infant; Isolette
Manufacturer: Draeger Medical
Problem: RN found neonate tachycardic, tachypneic and decreased saturations. Both baby and isolette were very warm. Was set on servo control but was found to be on air control, attempt to change but alarmed 'probe malfunction.' Unable to change to servo control. Had to turn bed off to decrease neonate's temp from 101.9. After temp decreased, attempt to turn bed back on was unsuccessful.

Device: Tubing, IV; Mini Loc Safety Infusion Set
Model# 0682234
Lot# asrhs002
Manufacturer: Bard Access Systems
Problem: A total of 5 of these 90 degree angle infusaport access needles broke off from the attached extension set.


Device: Ventilator; Servo I
Manufacturer: Maquet, Inc.
Problem: Servo Ventilator went into Non-Functioning failure mode with screen display saying: technical error 25, 33, etc. Brought unit to Biomed and checked log to confirm errors. Screen shows solid technical error 33 in red. Log shows various technical errors including, technical error 10, 11, 12, 16, 25, 33 and 35. Will place call to Maquet for service. The investigation performed by Maquet shows heavy oxidation and stains from fluids on the PC boards (PC1771, PC1772, PC1781 and PC1784). This was caused by fluid entering the device on several occasions. The source of the fluid and how it entered the device cannot be determined. Alarms were generated by the device during the event. The cause of error codes in the error log are short circuits at several places due to heavy oxidation. No further actions are being taken by Maquet at this time. Based on the above information Maquet considers this complaint closed. Maquet will add the investigation information to their complaint database and will monitor for trends.

Device: Suction, Endotracheal; Ballard Trach Care
Model# 198
Manufacturer: Kimberly-Clark Corporation
Problem: NICU infant was being suctioned by RN. Suction catheter broke off inside of the patient's endotracheal tube. RN had to cut the plastic covering to retrieve the broken catheter from the infant's endotracheal tube.

Device: Suction, Endotracheal; Ballard Trach Care-Y-adapter
Model# 198
Manufacturer: Kimberly-Clark Corporation
Problem: Eight french closed suction system being used to suction the endotracheal tube of an infant in the NICU. The suction control port was compressed to activate the suction, and it stuck in the on position. RN was unable to relieve the suction or disengage the port. Device was removed from the patient and replaced with new device of same type without further incidence.


Device: Razor, Surgical Prep; Shave Prep Comb/Comb
Model# Item 139083
Manufacturer: Covidien Kendall
Problem: The Kendall brand prep razor is a new product at this facility. Many staff members have reported difficulties with safely removing the clear plastic protective caps that cover the razor's edges. There are two arrows embossed on the top of the razor which are located adjacent to the words "Side A", and point downwards to Side A. Two injured staff members explained that they believed the arrows pointed to where on the razor their fingers should be placed in order to remove the protective cover. However, the arrows are in place to indicate which side of the razor is "Side A" of the double-bladed razor edge. Two injuries have resulted so far due to staff members placing their fingers on the blade side of the razor to remove the cover. One staff member received a laceration of the finger that required suturing, while another staff member received an avulsion of a portion of the finger pad. Surgigel was used to repair the avulsion, and both employees missed some of their scheduled shifts because of these injuries. Of note, to safely remove the protective cover, the cover is to be gripped on the short sides of the razor (not "Side A") and pulled upward to remove the cover. Additional educational materials for this product was requested from the manufacturer, however, it has been learned that there are no instructions available on how to safely remove the cover.

(Note from FDA: Good example of Human Factors issues seen with medical devices).

Device: Arm, Robotic Device; da Vinci Robot Endoscopic Instrument Control System
Model# PS2000
Manufacturer: Intuitive Surgical, Inc.
Problem: Physician was using Intuitive da Vinci robot when camera arm stopped working during a case and listed non-recoverable error 23020 fault. Camera arm was replaced next day with a re-manufactured arm and tested by Intuitive engineer. Same arm failed again just prior to the start of next scheduled case. Engineer replaced a second camera arm. As a precaution, two other robotic arms where replaced to match software version of the third.

Manufacturer response for da Vinci Robot Endoscopic Instrument Control System
Manufacturer was sympathetic and regretted circumstances surrounding robot arm failing twice in a row. Manufacturer offered to add hospital to their “customer care plan”, which is designed to increase customer confidence by having service engineer download machine values after each use. In theory, downloaded values will identify issues prior to them happening.


Device: Lens Injector; Monarch IOL Delivery System
Model# SN60WF IOL
Manufacturer: Alcon Laboratories, Inc.
Problem: Ophthalmologist performed two cataract surgeries at one of our sister facilities. Procedure went well until following lens implantation; a small tear was noted at juncture of optic and haptic. Surgeon decided to leave lens implanted as little risk of short or long term vision problem. Both patients remain doing well. Alcon rep was contacted, and investigated immediately. Decision was that injector used did not match the shooter. Surgeons had been unaware of this. Decision to remove purple injectors from ORs across the system was made and accomplished. Educational issue may involve other institutions. Alcon rep informed, and immediately investigated. Findings: No defective device, found mismatch in injector and cartridge. Advised removal of all purple injectors from system. This was done immediately. Appropriate color match replaced.

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