Highlighted Reports
MedSun: Newsletter #30, November 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 August 1 through August 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: Analyzer, Troponin; Centaur
Lot# TNI reagent lot 027/Calibrator
Manufacturer: Siemens Healthcare Diagnostics
Problem: Our technologist noticed an unusual pattern of results for Troponin for patients from the ED. She called the ED and notified them of her suspicions, and told them she was going to investigate a potential instrument malfunction. She told the ED staff that she would notify them of her investigational outcome. The technologist identified the problem as a depletion of a wash 1 solution that caused the instrument to report falsely elevated Troponin results on three patients. She corrected the instrument issue and reran the patient samples on our other instrument and notified the ED of the corrected results. The technologist reviewed and reran


Device: Defibrillator, External, Biphasic; M Series
Manufacturer: Zoll Medical
Problem: Attempted cardioversion on a patient whose BMI=28.9. The first shock was delivered at 120J biphasic, using externally applied pressure. There was no effect. Attempted again with 200J (the device maximum) using externally applied pressure. The patient remained in Afib. Obtained another manufacturer's 360J biphasic defibrillator and successfully cardioverted from Afib with one shock at 360J. The Zoll M Series device was tested by our Biomedical engineering dept and is working within specification.

Device: Shunt, Carotid; 9 F; Pruitt-Inahara Carotid Shunt (Outlying)
Other device #: REF # 2000-49
Manufacturer: LeMaitre Vascular, Inc.
Device lot #’s PIS1157, PIS1157, PIS1345
Problem: During carotid surgery three Pruitt-Inahara carotid shunts did not function as expected. Either the balloon would not completely inflate or deflate and the third one leaked. There was no impact to the patient at any time. The first shunt (lot #PIS 1157) was found to have the balloon not be completely round and would not deflate on testing. The second shunt (lot# PIS 1345) would not inflate evenly and would not deflate. The third and final shunt (lot # PIS1157) was leaking after it was finally inflated.

Device: Proximal Seal System, Anastomosis; HeartString II
Lot #8030771
Other device #REF HSK-2043
Manufacturer: MAQUET Cardiovascular
Problem: Patient scheduled for CABG x 4 with aortic valve replacement. Part of the procedure involves placement of a coiled suture patch (HeartString II Proximal Seal System) which is placed in the aorta prior to anastomosis. After anastomosis, the Seal System was withdrawn with some difficulty, appeared to get "stuck" and the associated anastomosis appeared disrupted. A second Seal system was deployed without incident and repair of the disrupted sutures was performed. The first Seal System strand was measured and appeared to be approximately 8 mm shorter than the expected standard length. It appeared that the Seal System strand had broken off at some point during withdrawal.

Device: Laser, Cardiac Lead Removal System; LLD #1
Lot # LLD080514B
Catalog #518-018
Manufacturer: Spectranetics

Device: Laser, Cardiac Lead Removal System; LLD E
Lot #LLD080512B
Catalog #518-039
Manufacturer: Spectranetics

Problem: The cardiologist was using Spectranetics laser lead removal equipment LLD#1 and experienced the same problem with the first three devices. Each came apart or broke while in use and were no longer functional as the lock failed to hold together. The doctor also attempted the lead removal with a Spectranetics LLD E laser lead removal device. This device failed to unlock and a small portion of it had to be left in the patient within the lead.

Device: Module, Physiologic, Multi-parameter; Ultraview SL Command Module
Model #91496
Manufacturer: Spacelabs Healthcare
Problem: Patient in PICU went into SVT and required cardioversion. Standard procedure requires staff to utilize a Physio-control LP9 defib with sync cable from our Spacelabs Module. They sync cable connects with the "hi01" output jack from the Spacelabs Module to the LP9 defib patient input connector. Staff were unable to obtain ECG signal through to the LP9 defib via sync cable. The situation was resolved by attaching the defib directly to the patient's chest electrodes.

After the event occurred, an organizational wide review of all other Spacelabs Modules identified a total of nine other modules that showed the same problem. The manufacturer was contacted and a field service tech confirmed that device failure. The manufacturer has requested that all nine modules be shipped to them for further investigation. The manufacturer has also made arrangements to over-night send replacement modules. Of interest, the serial numbers for the failed devices are sequential.

Device: Monitor, ECG; Cardio-respirator
Model #M1094B
Manufacturer: Hewlett-Packard Co.
Problem: The neonate was in the NICU for care and treatment, and receiving multiple treatments. The infant's heart rate was noted to be 37 with O2 sats of 32 without the sounding of any alarms. The Cardio-Respirator monitor alert alarms have the ability to be turned off or down so low that they are unable to be heard. This is not a safe feature and compromises the safety of patients. The next revision of software (C.0) prevents caregivers from turning alarm volume to zero or non-audible. Our facility is in the process of moving from software version B.0 to C.0. The infant was resuscitated and is currently doing fine.

Device: Electrode, Defibrillation; stat-padz
Manufacturer: ZOLL Medical Corporation

Device: Defibrillator
Model #PD 1200
Manufacturer: ZOLL Medical Corporation

Problem: Patient was being defibrillated and spark caused small fire resulting in second degree burns to patient's chest. Oxygen was in use at the time.


Device: Ventilator, Transport; iVent 201
Model #1.4.5 iVent 201
Manufacturer: VersaMed, Inc.
Problem: Transport ventilator was turned on, calibrated and placed on patient. Functioning properly until patient given sedation, and then a red "service alert" alarm flashed. The alarm was silenced and the alarm screen disappeared and the ventilator appeared to function appropriately. Then during transport from PICU to CT scan, the alarm occurred again and the patient began to desaturate. The Fio2 was increased and the saturation improved. In the CT scan room the patient gas source was attached to the wall outlet, and the patient saturation was stable during that time, however the alarm continued intermittently while the ventilator continued to function appropriately. While transporting from CT back to PICU the patient began to desaturate, and when increasing the FIO2 from 40 to 60%, there was no improvement in patient saturation. The patient's saturation was in the mid 80's upon return to the PICU and when placed on another ventilator at a lower FIO2, the saturations were 100%.

The patient had ET CO2 monitoring during the entire transport and this was never compromised, with values maintaining at 38-40%.
The transport ventilator was checked by Clinical Engineering after the event. It was noted that the ventilator does not have a way to display the actual FIO2 values, only the set value. Another problem with the design of the ventilator, is that when a service alert is issued, no details of the problem is given. There is a service code written to the service log, but that information goes away when the ventilator is shut off.

Device: Ventilator, Portable LTV Ventilator
Model #LTV 1000
Manufacturer: Pulmonetic Systems, Inc.
Problem: The patient was placed on a LTV(portable ventilator)for transport to Radiology (power source was the external battery). The ventilator shut itself off. The patient was removed from the ventilator and was manually ventilated with an ambu bag. The ventilator turn itself back on and the alarm LCD window said "RESET." The ventilator appeared to be functioning, but then shut itself off again. The patient was continuously manually ventilated with an ambu bag during transport and was being closely monitored. The patient did not suffer an adverse outcome because of this event. The patient was placed on a new LTV ventilator upon arrival to the Radiology Department. Follow-up: The ventilator was tested by Biomed staff and problem as stated above was repeated approximately eight times while connected to a test lung. This unit was also subject to a manufacturer recall (capacitor) dated 2/22/08 and this facility was still in the process of cycling the affected ventilators one at a time to the manufacturer for the upgrade. This particular ventilator had not been sent in yet for correction. This unit was sent to the manufacturer to address the recall and also to assess the problem that occurred with the ventilator (separate issues). The manufacturer replaced various parts and installed a new battery pack (internal) and the ventilator tested to specifications and was returned to this facility. The ventilator was placed back in service.
Manufacturer response for Portable Ventilator, LTV Ventilator
Unit required repair.

Device: Ventilator; Servo-i
Catalog #06487800
Manufacturer: Maquet, Inc.
Problem: Respiratory therapy set up the NICU ventilator. During the 3 to 7 pm shift an alarm went off; while trouble shooting the reason for the alarm, it was thought that the gray temperature probe wire had a kink in it so it was exchanged. Several hours later, the ventilator alarmed. A second Respiratory Therapist exchanged the entire heater unit. Several hours later, the ventilator alarmed again. A third Respiratory Therapist noted that the inspiratory tube was connected to the expiratory port, and the expiratory tube was connected to the inspiratory port. Because the tubes were connected improperly, the air being inspired was not being heated (wrong tubing was connected) and the temperature of the air was decreasing, causing the alarm. The tubing is able to be connected to either port. There is no color code on the vent to prevent misconnection; there is also no key index on the ventilator or tubing to prevent misconnection. The ventilator would deliver the correct therapy as set on the ventilator; the neonate just would not receive the humidified air.

Device: Ventilator
Model #Servo 300
Manufacturer: Maquet, Inc.
Problem: This is an accumulation of four cases from Respiratory Therapy on the Servo 300 ventilator. Circuit boards numbers 1585 and 1586 burned out when the safety valve opens and the mechanical ventilation is interrupted. On two occasions it was during patient use. Immediate intervention prevented patient injury. There is a very strong burning smell and on two occasions visible smoke occurred during the time of failure.
Manufacturer response for Ventilator, Servo 300
They set up the pick up of the 30 plus units for repair.

Device: Airway, Prongs, CPAP
Manufacturer: Fisher & Paykel Healthcare, Ltd.
Problem: Neonate was extubated from ventilator and placed on long prongs for approximately four hours. Because of patient agitation, the neonate was changed to short prong CPAP (continuous positive airway pressure). Nurse reported bruising of neonate's septum fifteen hours later in care notes and again in shift report. The day shift nurse noted that it was not a bruise, but necrotic tissue found during cares. The CPAP was removed from the neonate, and orders received from MD to change therapy to nasal cannula. Neonatalogist contacted risk on regarding this outcome. Neonate may require some surgery in future to repair depending on healing process. The Respiratory Therapy department has discontinued use of this type of delivery system and will use an alternative.

Device: Airway, Nasal; Robertazzi Nasopharyngeal Airway
Lot #08A03
Catalog #123128
Manufacturer: SunMed Healthcare
Problem: Patient had a latex free #28 nasal trumpet in place. The patient had a large amount of secretions. Patient aspirated trumpet, which was removed with McGill forceps.
Comment from FDA: MedSun has received a similar report discussing nasal airway collapse with the Robertazzi Nasopharyngeal Airway device.


Device: Plaster Casting Bandage; Gypsona
Lot #842338
Catalog #C7045
Other device #30-7367
Manufacturer: BSN Medical
Problem: Opening the Gypsona bandage package causes a cloud of plaster dust in the OR. Surgery used to purchase a similar 4" x 5yd plaster casting bandage made by DeBusk but without warning started receiving the Gypsona product by BSN Medical with the DeBusk product label on the box covering the Gypsona name and product info. The individual product package has just the Gypsona name on it.


Device: Catheter, Brachytherapy; Mammosite Balloon Catheter
Lot #06E09
Other device #06K17 and 07C19
Manufacturer: Cytyc Surgical Services, Inc.
Problem: Two mammosite balloon catheters placed were defective. First placement burst in the night; second placement, three days later deemed to be asymmetrical upon evaluation in Radiation Oncology and had to be removed.

Three lot numbers involved: 06E09, 06K17, 07C19 - 100 cc balloon.

Discussed with patient multiple times; to remove first catheter and place second; then of second defective balloon and removal and plan for external beam treatment instead.

Device: Treatment Planning System, Radiation Oncology; ADAC Pinnacle Treatment Planning system
Manufacturer: Phillips Medical Systems
Problem: The patient was to receive radiation therapy to the tonsils for cancer. The Phillips ADAC Pinnacle Treatment Planning System was used. The system apparently has an automatic default that is not well known. The default occurred without the knowledge of the physician or techs. The patient received radiation to the optic nerves unintentionally for a total of 31 times. The problem was discovered when the patient presented with a rash to an unexpected area.

Device: CT scanner, Radiation Treatment
Manufacturer: TomoTherapy Incorporated
Problem: The patient had previous radiation therapy for anal carcinoma, stage IV when the pelvis and inguinal regions were treated and concurrent chemo was given. That treatment was not completed due to another illness. The patient missed the final seven radiation sessions. She returned to have para-aortic nodes irradiated. She refused additional tattoos at first. It was decided to use the previous pelvic tattoos for centering the patient and one additional abdominal tattoo was placed higher on the abdomen over the para-aortic region. The patient was to receive IMRT treatment to the para-aortic region for a total dose of between 4500 and 5500 cGy. No chemo was used. A CT was done to use in setting up the simulation. Instructions were entered into the software in the Tomo machine for this patient to let the therapist know that the pelvic tattoos were to be used for positioning only and the abdominal tattoo was to be used for therapy. The therapist failed to read the note and the pelvic tattoos were used exclusively leading to the dose going to an area 14 cm below the correct region. Protocol calls for the final approval of the region to receive therapy to be given by the physician and the physicist. In this case the original CT taken to set up the plan and the CT taken by the Tomo were fused as expected but because one of the CT's was presented in an almost clear color, the fusion appeared correct when it was not. The other CT was presented in a light blue. Both the doctor and the physicist believed at the time that the fusion was correct and approved the plan. The patient received six doses in the incorrect area. A therapist then noted what looked like a poor fusion and believed the numbers were incorrect. She had the physicist look at the plan and the error was discovered. The Tomo machine allows the CT is be almost changed to a clear color allowing the viewer to look at it and be able to almost look through it. This removes the effect of contrasting colors which adds to the risk of incorrect fusion. The software had recently been updated on the machine and the only specific training provided by the manufacturer was a CD to be viewed by staff. There was minimal mention of the use of the note function and also the effect of changing colors of the CT's.


Device: Catheter, IV, Safety; Insyte Autoguard
Lot #8066658
Catalog #38144
Manufacturer: BD Infusion Therapy Systems, Inc.
Problem: Multiple reports from maternity nursing unit and anesthesia staff of IV fluid leaking from the same spot, where the cath tubing meets the green hub. All identified as having same lot number. No patient information provided. Lot pulled in all areas.

Device: Lift, Patient; Reliant 450
Manufacturer: Invacare Corporation
Problem: One strap of Mechanical Lift pad slipped off mechanical lift hook as CENA was beginning the lift of the resident. Initial investigation appeared to be human error which led to one on one education with Rehab expert. Seven days earlier an identical occurrence occurred with the Rehab expert who reports that she was positive that the pad loop was secure on the lift but equipment failed when the sling came off the hook as in the first occurrence. Staff called the manufacturer to find out about a sling retrofit hanger upgrade kit. The kit # 1143629 was installed and seems to have solved the problem of the sling coming off of the lift. It was assumed that it was human error by not securing the pad loop on the hook with the first incident until it was repeated with a rehab professional in the second occurrence. Regardless of whether it is human or mechanical error it is a patient safety issue that led to a fractured hip. We are suggesting you consider recalling the old mechanical hanger and replacing with the retrofitted version that prevents the loop from slipping off.

Device: Cabinet, Automatic Medication Dispensing
Manufacturer: McKesson Automation Solutions
Problem: After gaining authorized access to the identified lock-lidded pocket, the security of the other pockets located in that drawer can be easily breached by minimal force using the same method that opened the authorized pocket.
Manufacturer response for Automated Medication Dispensing Cabinet, Automated Medication Dispensing Cabinet
The manufacturers are working diligently to find a solution and may give consideration (safety alert format) to a communication with all users.

Device: Container, Sterilant; Steris 20
Lot #2578B05228 10 03
Catalog #S2000
Manufacturer: STERIS Corporation
Problem: A nurse in our GI suite, while preparing to process an endoscope in the Steris processor, noted an "X" shaped perforation in the center of the lid of the STERIS 20 container. She also noted obvious fading of the blue color of the graphic design in the center of the lid. This same defect was noted in at least 4 other individual containers within the same case, although not all of the individual boxes holding the containers were opened and inspected. None of the damaged containers were used to process endoscopes.
Manufacturer response for Sterilant Concentrate, Steris 20
The manufacturer was notified and is replacing that case and several others.


Device: Surgical Sponge Detection System; RF Detect USP Type VII Gauze
Model #NON21430RF
Manufacturer: Medline Industries, Inc.
Problem: The RF detect wand was used to scan the patient at the end of the procedure. The drapes had been pushed to the foot of the patient. When the wand was brought to a level below the patient's knees, it alarmed. There was nothing apparent on top of the drape that the team could see but the drape was bunched-up. The drape was picked up and moved and the wand continued to alarm. The RF chip from a sponge was found between the patient's legs. The clinical team believes it fell from the drape when it was moved. All of the sponges were examined and one sponge was found to have a hole in the pouch that holds the RF chip. The chip was missing from this sponge. All of the other sponges had chips intact. The manufacturer believes that the sponge was compromised during use, which caused tearing in the pouch that holds the RF chip. The manufacturer has also indicated they are changing the material they use and the way it is stitched as a result of this event.

Device: Robotic System; da Vinci S Surgical System
Manufacturer: Intuitive Surgical, Inc.
Problem: While using the Intuitive Surgical Inc.'s daVinci S robotic system in an elective coronary bypass surgical procedure, the robotic camera remote control function failed. The remainder of this surgical procedure was successfully completed using the robot, with manipulation of the camera arm performed by surgical staff.

Device: Handpiece, Harmonic Scalpel; Harmonic Focus
Lot #ERK49M
Manufacturer: Ethicon Endo-Surgery, Inc.
Problem: Surgeon was performing a total thyroidectomy and parathyroid exploration using the harmonic scalpel. It was reported that the harmonic focus handpiece became very hot. REF FCS9. It was also noted that on at least one occasion this device had burnt through the surgeons gown as well as leaving small marks on the patient's neck due to the heat of this handpiece. Staff had also noted on five other occasions the device to not work as intended. These devices were placed in the nurse manager's office for handling. However, staff did not provide any patient identifiers or specific product identifiers other than the device themselves. One other lot number was identified to have been one of the five other devices. It is lot number D4JP12.

Device: Forceps, Robotic Accessory PK; Dissecting Forceps
Catalog #420214
Manufacturer: Intuitive Surgical, Inc.
Problem: Patient undergoing robot-assisted laparoscopic-assisted vaginal hysterectomy. During the procedure the PK Dissecting Forceps were placed through the trocar and was connected to the cautery. The pedal on the cautery was depressed several times yet the forceps did not respond. When the forceps were removed from the trocar a broken wire was detected. Post-op the patient developed a purple mark around the site of the trocar. Initially it was thought to be a bruise, after further examination, it was thought to be a burn.

Device: Tubing, Suction Irrigation; Clear ESS II RP
Model #0041-6153
Other device #: Reorder #0041-6153
Lot #805606
Manufacturer: PhotoMedex, Inc.
Problem: The nurse reported that the Clear ESS II RP suction and irrigation tubing was stuck so it was constantly on. The physician was unable to get the device to irrigate properly. New clear ESS tubing was obtained which functioned appropriately. We have had four separate incidents of this problem, and it appears that the same lot number has been involved in three of these cases. Therefore, the lot has been removed from the shelves and the devices will be returned to the manufacturer, as they have asked us to return product for evaluation. We are in the process of getting a return authorization number so that we can return these devices to them. There has been no patient harm as a result of these failures.

Device: Scalpel, Harmonic
Lot #160687
Other device #: Reprocessed Device
Brand Name: Ethicon ACE23P
Manufacturer: Ascent Healthcare Solutions
Problem: The white plastic tip inside the Ethicon ACE23P harmonic scalpel jaw came off during surgery. The location of the tip after coming off could not be determined. Although the device is manufactured by another manufacturer, the problem may have stemmed from reprocessing done by Ascent Healthcare Solutions. Ascent has requested the ability to come examine the device, which we will allow them to do.


Device: ECT Machine; Thymatron; System IV
Manufacturer: Somatics, LLC
Problem: The electroconvulsive therapy machine continued to generate current to the patient through patches placed on the patient's temporal area after the physician stopped the treatment. The nurse attempted to remove the patches and received a shock. The machine was immediately turned off and the patches were removed. The patient was observed in PACU, transferred to a nursing unit for routine observation, and discharged home that day.


Device: Pump, Arthroscopy
Manufacturer: Stryker Endoscopy

Device: Pump, Arthroscopy
Manufacturer: Stryker Endoscopy

Problem: The nurse reported during the Surgeon's first case of the day, a shoulder arthroscopy, it was noted the pump was using an excessive amount of arthroscopy fluid (34 bags total). The pump was recalibrated partway through the case and seemed to work better. For the Surgeon's second case of the day, a different pump (but same make/model) was used and the same problems began to occur. The doctor made the decision to continue operation with gravity fluid rather than continue using the pumps due to safety concerns. The first patient had a moderate amount of fluid extravasation to right shoulder and breast, yet not unusual for this type of surgery. It appeared there was no significant or unexpected injury to the patients. However, it does appear the pumps may have issues with maintaining their calibrations. Of note, a previous report, with the same issue/equipment was filled, which required extended hospital stay.

Device: Implant, Total Knee; Plus VKS Total Knee Arthroplasties
Manufacturer: Smith and Nephew, Inc.
Problem: Plus VKS Total Knee Arthroplasties (Smith & Nephew) have failed in this and 4 other patients. No bonding between the prosthesis and cement mantle, early failure less than 1 yr after TKA.


Device: Delivery System, Vacuum Assisted Mityvac M-Style
Lot #65910
Other device #: Ref # 10007LP
Manufacturer: Cooper Surgical
Problem: Physician placed the M-Style Mityvac at 10 mm Hg then pumped it up to 50 mm Hg one minute later. The physician pulled for 20 seconds until delivery. Once delivered, the vacuum was released, but the doctor was unable to remove the suction device from the baby's head for approximately one minute. Finally, the doctor had to place their finger under vacuum head to release the suction. Small marks noted on the head of the baby. After a few hours, the marks were no longer visible, and the baby was discharged home with no further complications.


Device: Therapy Unit, Electroconvulsive
Model #DGX
Manufacturer: Somatics, LLC
Problem: The patient was scheduled to have electroconvulsive therapy (ECT) treatment. The patient was attached to the ECT machine, and when the unit was turn on, while the doctor was checking the electrical amount to be administered, the machine shocked the patient without the doctor pressing the treatment button. The machine was immediately unplugged and the anesthesia and medical staff assessed the patient for any problems. When the device was returned to the manufacturer, the factory found that the actual push button for the Treat switch was inserted the wrong way. This could have caused the switch to stick in the treat mode, and could have caused the problem. One way, the switch works smoothly, the other way it can stick in the "in" position. The manufacturer stated that with the red button, if it is put in upside down, it will stick every 2-3 times. Therefore, they have started using a yellow button, (Part# SW201P for $14) because it can be inserted in any orientation and it will work appropriately. However, the equipment used during this incident already had a yellow button (not a red one), which apparently can not be inserted "upside down". Additionally, the unit had been used for months and has not stuck before, thus, this explanation did not apply to our unit. Currently, the cause of the problem has not yet been identified.

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