Highlighted Reports
MedSun: Newsletter #29, October 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 July 1 through July 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: Airway Adapter, Pediatric, ETCO2
Lot #27110700
Catalog #8000-0361
Manufacturer: Zoll Medical Corporation (manufactured for Zoll by Respironics, Inc.)

Problem: The adapter has a clear, plastic ring that comes attached to the purple spring-like coil in the adapter. This ring separated from the coil and lodged into the trach tube causing respiratory decompensation from airway obstruction. Normal attempts to establish a patent trach were unsuccessful until the entire trach tube was emergently removed by a physician and a new one inserted. Examination of the obstructed trach tube revealed the presence of the clear ring as the cause of the obstruction. Upon examination of packaged/unopened product the clear ring easily popped off with just a slight touch.

Device: Nasopharyngeal Airway
Lot# 07E01
Other device# 123128
Manufacturer: Rusch Inc., A Division of Teleflex Medical

Problem: Nasal airway was inserted into right naris of patient for nasotracheal suctioning. While inserting suction catheter through nasal airway, the soft rubber flange of nasal airway collapsed and entire nasal airway advanced out of view into the patient's nasopharynx. Flashlight and hemostat immediately procured and used to remove nasal airway from nasopharynx. Although patient was not harmed, the potential exists for complete blockage of airway or advancement of nasal airway into esophagus.
The flange of the nasal airway is made of soft rubber and collapses easily; flaw in design of product. If just the flange were produced with a more firm rubber/plastic substance, it would not collapse so easily and have the potential of slipping into a patient's airway and blocking it, creating a respiratory emergency.

Device: CO2 absorbent; Sodasorb
Lot#CWO2-P115-21 and CWO1-P115-19
Other device #008870 and 008870
Manufacturer: Smiths Medical

Problem: While performing an atrial septal defect/ventricular septal defect repair on a 7 wk old baby, we noted ST segment elevation without changes in hemodynamics. This happened about 10 min after desflurane was initiated. We checked a CO-Ox blood gas and the carboxyhemoglobin level was 5.2% (significantly elevated). Of note, the chest was open and we looked directly at the coronary arteries and there was no evidence of any compression or perfusion abnormalities. The physician suspected that the elevated carboxyhemoglobin levels were the result of a bad batch of C02 absorbent. It has been documented in the literature that carbon monoxide is produced if volatile anesthetics (i.e. desflurane, enflurane, halothane, isoflurane and sevoflurane) come in contact with dried or desiccated CO2 absorbents, such as soda lime. Elevated carboxyhemoglobin levels in the patient can result. This particular patient’s condition stabilized after removal from the anesthesia unit. Since the CO2 absorber had been correctly changed the day prior (both canisters), we suspect that a bad batch of absorbent was received. Immediately following the incident the CO2 absorbent supplier was contacted. The canisters in question were sequestered, and were sent to an outside test lab. Areas of investigation will be lot numbers, climate control storage and the review of other hospitals with similar incidents. The anesthesia machine had undergone preventive maintenance 3 months prior, and will be tested again by Biomedical Engineering to verify correct operation.

Device: Module, Gas, Anesthetic; IntelliVue
Model #M1019A
Manufacturer: Philips Medical Systems

Device: Module, Gas, Anesthetic; IntelliVue
Model #M1019A
Manufacturer: Philips Medical Systems

Device: Module, Gas, Anesthetic; IntelliVue
Model #M1019A
Manufacturer: Philips Medical Systems

Device: Monitor, Physiological
Manufacturer: Philips Medical Systems

Problem: We have reported ongoing concerns with multiple Philips G5 Intelliview Anesthetic Gas Modules in our OR's. These machines are relatively new to our facility. Our facility began using the G5 IntelliVue anesthetic gas modules (model M1019A) earlier this year. The facility immediately had problems with the G5 "locking up." The gases (desflurane, isoflurane, sevoflurane, halothane, enflurane, CO2, nitrous oxide, etc.) were displaying ???'s on the display patient monitor instead of displaying the measurement of what the gas was. This was occurring during different stages of the case, and even after the case when the pt. has been disconnected and out of the room. Philips decided to replace the original 12 machines with new ones thinking the facility received a bad batch. The facility continued to have problems. Philips sent technicians from Germany and Andover to troubleshoot issues as well as having Radio Frequency and Power experts look at possible environmental concerns. Their testing showed no obvious reasons for what was happening. The work-around that the facility uses when the problem occurs is to power down the system and/or remove the data cable from the patient monitor for 10-15 seconds and then plug back in so the data will repopulate. The problem has not affected other patient information such as the ECG and SPO2.

We have had three additional incidents reported to us, which now brings our total number of occurrences to at least 48. In communications with Philips, it has been decided to downgrade the current software in these machines to the previous version in an attempt to alleviate these issues. We have continued to troubleshoot with Philips and are hoping for a remedy shortly.

Device: Breathing Circuit, Infant
Model #: RT235
Lot #: 080326
Manufacturer: Fisher & Paykel Healthcare, Ltd.

Problem: Ventilator circuit (Fisher & Paykel RT235) patient "wye" will snap-off and cause a significant air leak with a drop in ventilator pressure.
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Manufacturer response for Ventilator Circuit, Evaqua RT235
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spoke with company rep and he said they are aware of the problem and would work to correct the problem. Also, would send a case of circuits.

Device: Mask, Oxygen
Manufacturer: Cardinal Health

Problem: Patient was on venturi mask set for FIO2 of 50%; mask not delivering set amount of O2 and patient sats dropped to low 80's. Flow meters discharged out, ran off a tank, and verified with an analyzer, with the white entrainment device. The highest FIO2 analyzed was 25%. The staff then placed on 31% with the blue entrainment device and the highest FIO2 analyzed was 25%. Staff tried 3 different venturi devices of the same brand with the same results. Every patient in the hospital checked to see if using this device; none found in use elsewhere. Venturi masks removed from use in entire facility, pending resolution by materials management.


CARDIOVASCULAR

Device: Defibrillator, Biphasic; M Series
Model #M Series with Xtreme Pack
Other device #CE 0197
Manufacturer: Zoll Medical Corporation

Device: Defibrillation Pad; PadPro
Model #REF 2001Z-C
Manufacturer: CONMED Corporation

Problem: During an Electrophysiology Study, sustained polymorphic ventricular tachycardia was induced x2. Cardioversion was performed on this morbidly obese patient with a Zoll defibrillator using 200 joules, biphasic. During the first episode the first of 2 shocks was ineffective at converting the rhythm. The second shock was effective. During the second episode the first and second of 3 shocks were ineffective at converting the rhythm. The third shock was effective. The energy was applied to the patient via hands free defibrillation pads. For the first event the pads were placed on the right upper chest and left apical area. The pads were replaced after the first event with new pads placed in the center of the chest, and center of the back.

Device: Defibrillator, Biphasic; M Series
Manufacturer: Zoll Medical Corporation
Problem: Patient with afibrillation (afib); history included coronary artery disease s/p stent, congestive heart failure, cardiomyopathy, hyperlipidemia. Unable to cardiovert afib using Zoll biphasic M Series device 200 joules using counter pressure. Two attempts failed to convert the patient's rhythm. Changed to a different manufacturer's 360 joule biphasic device and cardioverted to sinus rhythm with one attempt.
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Manufacturer response for Defibrillator, M Series, Biphasic
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They are not convinced of a problem by our interpretation of our experience.

Device: Intermittent Pneumatic Compression Device
Model #: AC600/US
Catalog #: 00679252044959
Manufacturer: Huntleigh Healthcare

Problem:
We have had 8 units at our facility fail at the connection where the hose(s) attach to the unit. When this connector pulls apart there are wires that are exposed and damaged. We are aware of at least two other facilities that are experiencing the same problem.

Device: Monitor, Physiological
Manufacturer: GE Medical Systems Information Technologies
Problem: Entire room of DASH 4000 monitors simultaneously alarmed NIBP failure. All patients checked and were fine. Monitors were all reset and problem did not reoccur. I was told that the monitors in our newly opened cardiovascular center alarmed the same failure at the same time.

Device: Monitor, Physiological
Manufacturer: GE Medical Systems Information Technologies

Problem: Mother witnessed monitor go blank and called RN. All of the RN's in room verified that CIC central station (installed as back-up alarm system) did not alarm and was also blank. Monitor was able to be restarted by shutting the power off and turning it back on again.


ORTHOPEDIC

Device: Drill, Orthopedic, Pneumatic; Black Max Drill
Manufacturer: Anspach Companies

Problem: Surgeon was using the "Black Max" drill when a loud "pop" sound was heard. The pneumatic hose attached to the drill exploded due to pressure build up in the hose. Large tear resulted in hose on distal end near drill connection. The physician was escorted to the Emergency Department for evaluation of hearing and possible ear damage. None reported. Upon review of the event, it was noted the level of oil in the Black Max foot pedal was at minimum. It was also noted that the pneumatic hose was slightly pinched under the foot of a step stool causing the pressure in the tubing to build resulting in the rupture. The hose is a double-lumen hose, and it is speculated that the exhaust section is the one with the build up and rupture. Recommend design improvement to alert to increased pressure such as alarm, pressure release value or pressure gauge.

Device: Impactor, Femoral
Model # 7401-2811
Manufacturer: Smith and Nephew

Problem: The Smith and Nephew Journey brand femoral impactor, model number: 7401-2811 has peeling and chipping issues from the black plastic coating of the CAM arms. This was brought to the attention of the OR by the manager of CSR. This issue was discussed with the sales representative and with the OR staff. Consensus was that this may be related to dried cement being chipped off. The sales rep. for this device indicated that Smith and Nephew is aware of this issue, and have had a few other cases reported. They are currently looking for a more durable product that will not chip off. The OR staff was advised of the issue/concern and will be mindful of the need to clean cement off before it hardens/dries. Smith and Nephew replaced both of the arms. Smith & Nephew, Inc.


GASTROENTEROLOGY/UROLOGY

Device: Fecal Management System; Flexi-Seal
Model# 411100
Manufacturer: Convatec, A Bristol-Myers Squibb Co.
Problem: The patient developed loose stools. A Flexi-Seal was applied to contain the stool and prevent skin breakdown. The patient became febrile and foul odor was noted, described as rotting flesh by staff. The Flexi-Seal balloon was deflated and noted to have 85 ml of fluid (the recommended amount is 45ml). Some necrotic tissue was noted on the tip, and was expelled from the patient. The patient had a rectal scope which did not show additional rectal erosion or necrosis. The Flexi-Seal had been in place for three days. Balloon over inflation could potentially lead to necrosis.


GENERAL & PLASTIC SURGERY

Device: Surgical Pack, EP, Custom
Lot #489260
Manufacturer: AVID Medical

Problem: We opened 5 EP surgery packs for a pacemaker and all 5 of them were contaminated. One with hair and 4 others with cardboard pieces.

Device: Tourniquet; Zimmer 34 inch Tourniquet Cuff, Single Port Single Bladder, Luer Lock Connector, Brown Trim
Lo t#174267
Catalog #60-7075-006
Manufacturer: Ascent Healthcare Solutions
Problem: Circulator removed surgical drapes at the end of the case and noted the thigh tourniquet on patient's right leg had "curled" up onto itself and was "hard and crunchy." No injury to the patient noted.

Note from FDA: Please see Safety Tip titled, "FDA Safety Tip: Pneumatic Tourniquet Cuffs,With a Tourniquet System" posted in January 2007's Newsletter online available:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=11#1

Also see this month's Reporting Tip titled, "Reporting Tip: Reporting Problems with Reprocessed Single Use Devices to FDA"

Device: Surgical Marker
Model #: 1451
Manufacturer: Viscot Medical, LLC

Problem: A Viscot brand surgical marker was used to mark a patient's left leg for a phlebectomy in the pre-op area. Sometime after the marking procedure, the patient crossed his legs, and the marker ink was transferred to the right leg, making an exact mirror copy of the correct mark, which was on the left leg. After the patient was transferred to the operating room, the right leg (with the incorrect transferred mark) was draped and prepped. The correct surgical mark on the left leg was not detected by the staff, during the time-out procedure. However, during efforts to secure the patient's legs from thrashing, prior to the procedure, the surgical mark on the left leg was observed and procedure preparation was stopped. The correct surgical site was then verified, prepped and the procedure was preformed as planned. To prevent this issue from occurring in the future, the operating surgeon will clearly write the word 'YES' on the operative leg, which if transferred to the other leg, will result in a backwards image. A smiley face or other identifiable symbol was not selected since the mirror image would be an exact duplicate of the original, and not alert staff of an incorrect transferred mark. In addition, patients will now not be allowed to leave the preoperative area without a 'YES' mark, and staff members are also revisiting current operating room procedures, and are working with surgeons to get them more actively involved in the time-out procedure.


RADIOLOGY

Device: Gamma Camera System
Model #E-Cam
Manufacturer: Siemens Medical Solutions USA, Inc.

Problem: A series of studies were done on a particular patient. Staff were unable to locate one of the studies afterwards and it was discovered in a different patient’s file. The second patient was scanned nearly a year prior. Since staff were initially unable to locate the study, a repeat procedure was necessary. The vendor states that the technician must have selected the wrong patient, but the number of steps necessary to accomplish this, along with other details, suggest this was more likely a software error. This is particularly true since it was not a currently scheduled patient. Selecting a patient from many months prior is unlikely. The technician is convinced this was a software error and not a staff error for a number of reasons.
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Manufacturer response for Gamma Camera System
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Vendor says this was user error but our staff do not agree with that finding.

Device: X-Ray, Cardio/Vascular; Integris Allura AP
Manufacturer: Philips Medical Systems

Problem: Physician inserted 5 stents, recorded fluoroscopy time of 67.5 minutes. Discharged home two days later. Approximately two weeks after implant of stents, patient returned to Emergency Room complaining of chest pain. As planned, one month after initial implant physician inserted another stent, recorded fluoroscopy time of 107 minutes. Discharged home the next day. Nine days after second implant, patient discovered a red area on his back between the shoulder blades that looked like sunburn. It measured 3 inches by 3 inches. The area got progressively worse. The area looked more inflamed. Patient went to a dermatologist approximately 3 wks after discovery. Dermatologist examined the area and took a biopsy sample. The dermatologist said it looked like a radiation burn. Pathologist reported a differential diagnosis including a fixed drug eruption, erythema multiforma, or an autoimmune connective disease; subacute radiation dermatitis also in the differential diagnosis. Dermatologist put patient on Topicort Cream (Desoximetasone) and then Mimyx Cream.
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Manufacturer response for Cardio/Vascular X-Ray, Integris Allura AP
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Device was inspected by a third party. The X-Ray equipment was found to substantially comply with state and federal regulations as well as National Performance Standards established for good radiological compliance.


OPTHALAMIC

Device: Laser, Ophthalmic; VisX Excimer Laser WaveScan Software 3.9/3.901
Other Device #AMO WaveScan WaveFront Systems Software Version 3.9/3.901
Manufacturer: Advanced Medical Optics

Problem: Six patients undergoing LASIK received an over-correction due to machine software generating inappropriate treatment tables. The manufacturer has sent us an urgent device correction notice, and has provided us with upgraded software (version 3.92)

Recall Online Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=55273


GENERAL HOSPITAL

Device: Infusion Pump; Outlook 100
Model #13215
Manufacturer: B. Braun Medical Inc.

Problem: Our facility has previously reported ongoing issues with our new B. Braun Outlook 100 Pumps. Approximately 150 of our 700 pumps have been known to “lose” their drug libraries (i.e. the pumps default to their factory preset and prompt the user to enter the dosing information rather than allowing the user to pull information from the drug library -- this does not impact the patient as our staff can revert to manually inputting rates but it is not allowing us to utilize these pumps in the manner intended). Initially, the manufacturer provided us with software upgrades, which did not solve the problem. They have now replaced the batteries in approximately 60 of our pumps, and this seems to have resolved the issue. B Braun believes they may have gotten a bad batch of batteries from their supplier, and that it is possible these batteries ended up in our pumps. Additionally, they are working on another software enhancement to complement the new batteries, so that as the batteries age the problem of losing the drug library does not recur. B Braun has also acknowledged that two other facilities have experienced this problem.

Device: Infusion set, huber needle
Manufacturer: Bard Access Systems

Problem: Patient's mother called RN to room. Bard MiniLoc Huber Needle (female end of luer lock) broke off rest of line with needle intact. Patient was immediately re-accessed. Line flushed well with blood drawn back. Mom at bedside during procedure. MiniLoc needle examined by Clinical Engineering. Appears tubing came unglued from luer lock end. There are on-going issues with MiniLoc needles. Bard has verbally said they changed the manufacturing gluing process in April 2008, and sent us all new needles to replace old stock. Replacement began in inventory control on 5-8-08
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Manufacturer response for Safety Infusion Set, MiniLoc ======================
Bard has said they changed the manufacturing procedure in April 2008. We changed out all our lots and have not had a problem since we changed.

Device: Pump, IV, module pump, IV,CPU
Manufacturer: ALARIS Medical Systems, Inc.

Problem: Alaris infusion pump with syringe module seems to reset itself for total volume infused. Pump reports 0.19cc infused. A hour later, it was reported that 0.15cc infused without manual reset by user. Syringe started with total volume of 50cc. At time that variance noticed, volume in syringe not less than 49cc. Infusion started 3 1/2 hours prior to the variance. Pump changed, tagged, and removed from the room. Clinical Engineering evaluation: investigated keystroke logs of syringe module and PCU involved in incident. Were not able to verify the issue, however it was noted that a pressure sensing disk was used on the syringe module. Shortly after the infusion started, the syringe module log notes "disc present = true", while the PCU notes "disc present = false". The PCU should have read "true", therefore there is thought to be an unknown software or hardware issue with the PCU. Both the syringe module and PCU, as well as the LVP attached to the pump at the time will be sent to Alaris for further investigation.
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Manufacturer response for Infusion pump and syringe module, Alaris System ======================
No response yet.

Device: Pump, IV Infusion
Manufacturer: Sigma International

Problem: Patient was to receive Septra at 500ml/hr for a 1036ml bag in which there was 36ml of Septra and 1000ml of D5. The primary IV (.9NS) fluids were set to run at 125ml/hour. When the secondary IV infusion rate of 500ml/hour was supposed to have switched back to the primary rate of 125ml/hour; it didn't, and the secondary rate of 500ml continued for an amount of time unknown to the nurse. The infusion of the Septra that was mixed in the D5 took 2hrs and 45minutes to run, when it was programmed to run over 2 hours. This was due to the fast rate and subsequent running in of some of the primary fluids at the same time as the secondary fluids (Septra/D5). Between the scondary rate of 500ml/hr of running the primary fluids (.9NS)for a time, and the primary fluid (.9NS) dripping in with the Septra/D5, the patient received approximately 240-345ml of NS at the rate of 500ml/hr. Staff unsure if flow rate was set incorrectly or if something happened with the pump. This could be prevented by staff checking the patient when the secondary fluids should be finished, and also confirming the pump set up is correct. The nurse should also be sure that the primary fluid bag is hung low enough to not flow in at the same time as the secondary infustion. Clinical Engineering evaluation: A review of the event log within the pump correlated to the event information. The staff, per order attempted to infuse a secondary infusion at 500ml/hr. Operational testing of the pump in the stated configuration showed that without the primary line clamped, siphoning would occur. Current pump software does not prompt the user to monitor and clamp, if necessary, the primary line when infusing a secondary infusion above 300ml/hr. Staff to be advised to monitor any secondary infusions for siphoning of the primary bag as evidenced by primary line drip chamber activity specifically at rates nearing or above 300ml/hr.

Device: Tubing, suction irrigation; Clear ESS II RP
Device model # 0041-6153
Device 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: Thermometer
Manufacturer: Covidien (Kendall)
Problem: Several cases of inaccurate temperature have occurred: 1)Oral temperature registered 104 deg. F on a patient that had no clinical findings to support the increased temperature. Approximately 2-3 minutes later the temperature was rechecked and the unit read 98 deg. F. 2)Unit is taking 45 minutes to register on patients coming from OR. 3)Attempt to take oral temperature resulted in unit alternating between fast mode and slow mode and pointing to oral and axillary. Not successful in obtaining temperature. 4)Attempt to take oral temperature in patient with a slightly elevated temperature resulted in unit reading 95 deg. F. After several attempts the unit registered 99.5 deg. F. Biomed checked all thermometers involved for accuracy and speed. Temperature was within range and reached temp in 30 seconds.


PHYSICAL MEDICINE

Device: Heat Therapy Pack
Lot #: V8E135
Catalog #: 30104
Other #: SKU# 3014003983
Manufacturer: Cardinal Health

Problem: Staff RN was preparing an Instant Insulated Hot Pack for use on the patient. Following the package instructions the nurse squeezed the package and the package exploded through the top seal and sprayed the nurse in the face and upper body with the liquid contents of the heat pack.


OBSTETRICS/GYNECOLOGY

Device: uterine manipulator
Manufacturer: ConMed EndoScopic Technologies

Problem: V-Care manipulator broke into pieces after procedure. The entire device was accounted for post-procedure. No Patient Harm. We have had prior problems with this device, and recently received additional in-service training from the manufacturer. During the training we did not identify any procedural issues that would explain the failures.


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