Highlighted Reports
MedSun: Newsletter #42, November 2009

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.

ANESTHESIOLOGY

Device:

Type: Apnea Monitor
Manufacturer: Respironics, Inc.
Brand: Smart Monitor
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
While the mother of the infant was feeding the baby, the apnea monitor respiration light stopped blinking and the heart rate light started to slow. The baby stopped breathing. The baby's family performed CPR and the baby was transported to the hospital for observation. The patient's family noted the heart rate was greater than 200 BPM, but noted the monitor did not alarm. However, the high heart rate indicator light was showing red; indicating that an alarm had occurred. The alarm settings were HHR=200, LHR=80, apnea delay = 20 seconds. The monitor was removed from the home and sent to the manufacturer for testing.
Initial response has been no problems identified with the monitor; facility is currently awaiting written report. They could see two events, and according to the read out, the alarm sounded both times.


Device:

Type: Co2 Detector
Manufacturer: Covidien Nellcor
Brand: Pedi-cap
Model#: (not provided)
Lot #: 9040068
Cat #: (not provided)
Other #: (not provided)

Problem:
Began ventilating patient with pedi-cap and peds ambubag. Patient began to desaturate immediately. Could not force air through ambu with Pedicap on. Removed pedi cap and ventilation was accomplished. O2 sats improved.

Manufacturer response (as per reporter) for CO2 detector, Pedi-Cap

"Size of the paper in the detector was dimensioned incorrectly causing the device to have a higher flow resistance." Testing other lots to see if same problem exists.

Comment from FDA: See Class I recall online available: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181878.htm

Also see FDA Patient Safety News Story on this issue online available: http://www.accessdata.fda.gov/psn/transcript.cfm?show=92#2



Device:

Type: Endotracheal Tube
Manufacturer: Neotech Products
Brand: Neo Bar Ultra
Model#: (not provided)
Lot #: 29220
Cat #: (not provided)
Other #: (not provided)

Problem:
Neobar came apart (plastic from cloth adhesive) on one side. ETT unsecured but patient remained intubated.


Device:

Type: Epidural Catheterization Kit With Flex Tip Plus Catheter
Manufacturer: Teleflex Medical
Brand: (not provided)
Model#: (not provided)
Lot #: RF9068563
Cat #: AK-05503-L
Other #: (not provided)

Problem:
Epidural catheter stylet did not glide smoothly through the epidural catheter needle: 3 kits of the same lot # were opened and each kit catheter had the same malfunction. Another lot # was opened and the epidural catheter worked fine.
Supplier has switched out 48 Kits to a different lot number. This happened almost immediately and patient care in OB Unit was not disrupted. Teleflex Medical needs time to examine the catheter and stylet before they can comment.


CARDIOVASCULAR

Device:

Type: Blood Pressure Cuff
Manufacturer: Trimline Medical Products Corporation
Brand: Tempa-kuff, Vinyl Cuff
Model#: (not provided)
Lot #: 47883
Cat #: 99869
Other #: (not provided)

Problem:
Upon applying the blood pressure cuff, the cuff was then pressurized. We found that the cuff did not inflate. After a thorough inspection, we discovered the cuff was defective. There were holes in the cuff. This happened not in just one, but several other cuffs. A response from the salesperson was that the holes appear to be caused by a failure in the sealing machine or by trimming the edge too close. The defect was in the same place in all the cuffs.


Device:

Type: Catheter, Introducer, Sheath
Manufacturer: St. Jude Medical, Inc.
Brand: Peel-away Introducer
Model#: (not provided)
Lot #: (not provided)
Cat #: 405112
Other #: (not provided)

Problem:
The tear away sheath on the 8 french x 14 cm peel-away introducer did not completely tear away during the insertion of a triple lumen 7 french x 20 cm Cook Catheter. Due to the even nature of the separation and the fact that the remaining portion of the sleeved removed over the catheter until it was removed. At the time of removal, the sheath came loose and was later identified as a foreign body in the right ventricle. A cardiac cath was required to snare and remove approximately 7 cm portion of the sheath from the patient's right ventricle. Other than the need for the cardiac cath the patient was not injured.


Device:

Type: Defibrillator, Implantable
Manufacturer: Boston Scientific Cardiovascular Division
Brand: Teligen Dr
Model#: E110
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
The patient came to the Electrophysiology Device Clinic for routine follow-up of an implantable defibrillator. Upon interrogation by the staff, a warning advised the pulse generator was in Safety Mode. No further communication could be obtained and the device had automatically been programmed to the Safety Mode parameters. The patient had previously had a remote interrogation 4 days earlier and no problems were identified. The patient had experienced no problems or any events that may have triggered the device to go into safety mode. The ICD had to be explanted and another ICD of the same brand was implanted. There was no harm to the patient.


Device:

Type: Lead, Crt
Manufacturer: Boston Scientific
Brand: Easytrak 2Is-1
Model#: 4543
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
The patient was seen in the device clinic for routine interrogation of her defibrillator. Upon initial interrogation, the LV pacing impedance was noted at > 2000 ohms. No LV capture was noted in all configurations and no LV sensing in configuration LV tip > Ring. LV sensing noted at 6.1mv in LV tip > Coil configuration. Patient states she had been more tired over the last 2 weeks. CXR confirmed break in the LV lead. The patient returned to the EP lab over one month later for a LV lead revision. The device pocket was opened. The LV lead was dissected free from the pocket and the location of the break was noticed under the suture sleeve. Of note, the suture sleeve did not appear to have been tied with excessive tightening. The lead was easily removed transvenously with gentle traction. The lead was sent to Boston Scientific for further analysis. The LV lead may be more subject to fracture than other leads. CXR revealed no evidence of subclavian crush. The location of the lead fracture was in the pocket. This is least the 3rd or 4th fracture of this particular lead at our institution.

Manufacturer response (as per reporter) for Lead, Easytrak 2

No response at this time.


Device:

Type: Lvad, Controller
Manufacturer: Thoratec Corporation
Brand: Heartmate Ii System Controller
Model#: unknown
Lot #: n/a
Cat #: n/a
Other #: n/a

Problem:
Patient paged the VAD Coordinator on call and reported that he had a "replace system controller" alarm. Patient changed to his back-up controller and then drove to hospital to receive another back-up controller.

Manufacturer response (as per reporter) for controller, HeartMate II System Controller

Problem confirmed by Thoratec to be a system controller failure, "Log file identified a ‘time base fault’ flag just before the system controller switched to back-up mode. This flag is related to an internal time-based self-test that is designed to verify that the microprocessor is operating at the correct speed. The root cause is identified as a capacitor on the printed circuit board that is exhibiting excess variation and high temperature conditions may also contribute to this excess variation."


CLINICAL CHEMISTRY

Device:

Type: Continuous Glucose Monitoring System
Manufacturer: DexCom, Inc.
Brand: (not provided)
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Patient came to our clinic about a month ago for placement of a continuous glucose monitoring device. Upon insertion the patient squirmed slightly. Educator checked site and it looked fine. The patient was in no distress. The receiver had "???" and educator called DexCom to validate that this could occur during warm-up period. DexCom agreed. Patient's parents were instructed to call DexCom if any other problems occurred or had questions. The patient returned to the clinic in the afternoon with the site of the monitor removed and the wire remaining in the right abdomen. The doctor instructed the patient to go straight to the emergency department to be evaluated by another doctor.


EAR, NOSE & THROAT

Device:

Type: Cochlear Implant
Manufacturer: COCHLEAR AMERICAS
Brand: Contour
Model#: C124R
Lot #: N/A
Cat #: N/A
Other #: N/A

Problem:
Patient underwent 2 prior cochlear implant procedures in the right ear at another institution. There is evidence for partial failure of the current device with loss of 11 electrodes and decreasing speech perception abilities. In light of this concern, the family presents for patient to undergo explantation of the partially failed right cochlear implant and insertion of a Nucleus Freedom device.


GASTROENTEROLOGY & UROLOGY

Device:

Type: Catheter, Foley
Manufacturer: C.R. Bard
Brand: Tray Foley Center Entry
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: 100% Latex Free foley tray with Bard EZ-Lok Sampling port 16 Fr.

Problem:
Foley catheter was placed in patient. When the balloon was deflated and removed from patient, cuffing was present that caused discomfort for the patient. We had a problem with the foleys earlier and we contacted Bard. They gave us instructions to discontinue the practice of inflating the balloon prior to insertion. We re-educated staff and changed the practice, however the cuffing and discomfort with removal continued. We discarded all foleys from these lots and the problem continued with the new lots. The company told us it was a problem with our technique. We decided to change the brand of Foley we were purchasing and to discontinue using Bard. We have done this and have not had any further problems. The change happened a few months ago.


Device:

Type: Hemodialysis Machine, Cvvhd
Manufacturer: Gambro Renal Products, Inc
Brand: Prismaflex
Model#: Prismaflex
Lot #: NA
Cat #: NA
Other #: NA

Problem:
Patient receiving CVVHD and the machine alarmed.

MALFUNCTION: Scales Circuit Board alarm.
Contacted 1-800 support line who stated it was a technical problem with the machine. The only option was to manually return the blood. The blood was starting to separate in the tubing and I did not want to risk returning clots. The patient was unaffected, and sitting up at the bedside after disconnection.
Gambro tested the device but could not duplicate the problem.


Device:

Type: Intraperitoneal Hyperthermia System
Manufacturer: ThermaSolutions
Brand: Thermochem
Model#: HT-1000
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Thermocare machine was being used with a HIPEC (Heated Intraoperative Intraperitoneal Chemotherapy) case. The perfusionist said the screen froze. Temperature regulation via the machine was disabled and manual temperature regulation measures were used to proceed with the case. There was no effect/injury to the patient. Our BioMed department did not assess the device as it was returned to the manufacturer's representative immediately after the case. (This is not our procedure and that has been addressed at our level). BioMed reports that this is the third time in four cases that we have had problems with an HT-1000 from ThermaSolutions. All the occurrences indicate screen issues. However, there are no other similar devices available per BioMed department.


Device:

Type: Set, Tubing, Hemodialysis
Manufacturer: Medisystems, a NxStage Company
Brand: Bloodline
Model#: (not provided)
Lot #: 9035501
Cat #: SL-2000M2095
Other #: (not provided)

Problem:
Facility reported a total of eleven incidents of fluid leakage past or through the arterial POD membrane. No issues were noted during the set up, priming and recirculation. After initiation of treatment patient lines were observed to have a mixture of blood and saline on the machine side of the arterial POD. Patients blood was returned and new line set up to resume treatment. This happened a total of 11 times with code # SL-2000M2095, Lot # 9035501. Machine side checked for blood in the arterial monitor not present for all cases. No patient injury or medical intervention.


GENERAL & PLASTIC SURGERY

Device 1:

Type: Fiberoptic Illuminator
Manufacturer: Medtronic Sofamor Danek USA
Brand: Mast Quadrant Illumination System
Model#: 9560658
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Device 2:

Type: Cable
Manufacturer: Stryker Endoscopy
Brand: (not provided)
Model#: (not provided)
Lot #: (not provided)
Cat #: 233-065-010
Other #: 055S

Device 3:

Type: Light Source, Fiberoptic, General Purpose
Manufacturer: luxtec
Brand: (not provided)
Model#: 9300 XSP
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
During a minimally-invasivelumbar laminectomy, patient sustained a second-degree burn from contact with a Medtronic illuminator attached to a Stryker cable. Equipment set-up consisted of a Medtronic illuminator with a 5 mm inserted into a 7 mm Stryker Endoscopy cable connected to a Luxtec light source using 300 watts. The burn came from the metal connection between the illuminator and the 7 mm cable. The burn was located after removal of drapes toward the patient's shoulder blades away from the surgical field. Patient sustained a 2 cm x 1.5 cm blister stage 2 burn on midback, no erythema surrounding the burn. Wound care nurse was consulted to evaluate the burn. Treatment consisted of Silvadene and bandaging with Telfa, gauze, and dressing. Three days after occurrence the blister measured 5 cm x 1.5 cm filled with clear serous fluid with no erythema around blister. Patient discharged home Post operation day 3 in good condition with written instructions, supplies, and pain pills.

Medtronic 5 mm illuminator fits into the Stryker 7 mm cable and engages with a snap-lock mechanism. The other end of the cable is connected to a Luxtec light source. Medtronic product contains a cautionary label that states "product is recommended with 100 W light sources and 5 mm fiberoptic cables. Use of larger cables and/or higher wattage light sources may result in high temperatures on the metal connection to the light cable which may result in injury to patient or staff and damage to product. Reduce intensity levels on high watt light sources/large light cables and take precautions to protect patient and staff from injury". Hospital is not aware of any product recalls for the Medtronic illuminator. Hospital sent letter to local representative requesting the history of the cautionary label - no reply from manufacturer yet; product was used since January 2009 without problems when the packaging had no cautionary label that hospital was aware of.

Neurosurgeon has trialed the same equipment set-up using 150 watts and was not able to illuminate the field sufficiently to proceed with surgery. Medtronic rep was contacted. Medtronic does not make any product that meets the surgeon's illumination needs at this time. Bio-Tech obtained a 5 mm screw-on Stryker light cable and did bench testing with Luxtec light source Model 9300 XSP, Medtronic illumination adaptor, and Stryker light cord 5 mm. The temperature reading on a Fluke thermometer measured after 30 minutes was 130 degrees F and within one hour the temperature was 134 degrees F. The bench test was run for 2 hours and temperature maintained at 134 degrees F. After 30 minutes on minimum temperature setting, the temperature was 115 degrees F and after one hour was 81.2 degrees F. Investigation of alternatives is still ongoing. Another bench test was done by Bio-Tech with a 7 mm Stryker cable and the Medtronic Mast Quadrant 5 mm illuminator. The measured temp at maximum output after 1 hour at the junction was 170.2 degrees F; after 2 hours the temp was 169.8 degrees F. At minimum output the test was run for 1 hour; the measured temp was 90.0 degrees F.

Manufacturer response (as per reporter) for fiberoptic illuminator, Mast Qudrant illumination system

Medtronic sales rep was contacted. Neuro team leader at the hospital is working with Medtronic sales rep to discuss alternatives. Medtronic does not make any product to meet hospital's needs at this time.


Device:

Type: Mesh, Hernia, Patch
Manufacturer: C.R. Bard, Bard Medical Division
Brand: Compsix Kugel Hernia Patch
Model#: (not provided)
Lot #: 43EQD891
Cat #: 0010208
Other #: (not provided)

Problem:
Patient first presented after multiple surgical procedures of the abdomen including appendectomy, right colectomy, complication with dehiscence, sepsis, bowel obstruction and resections. Later that month he was admitted for bowel obstruction and large ventral hernia. Taken to surgery for laparotomy, adhesiolysis with no enterotomies or bowel resection and ventral hernioplasty with mesh. Patient returned two months later with cellulitis of the midline incision. Patient was taken to surgery where it was found that the bard mesh was infected with fracture of the plastic ring and one enterotomy with leak and sepsis of the wound.

Pariatex Mesh Defect

Device:

Type: Sling, Transvaginal
Manufacturer: Caldera
Brand: Caldera
Model#: CAL-DS01OV
Lot #: 20066
Cat #: CAL-DS01OV
Other #: (not provided)

Problem:
Accessory string detached prematurely from the Desara Vaginal Sling before the sling was even surgically placed. The manufacturer’s response was there was a design change that stemmed from this problem with the sling. Caldera will be replacing all of our product from the affected lot.


Device:

Type: Stapler, Surgical
Manufacturer: Covidien United States Surgical Corporation
Brand: Endo Gia
Model#: Endo GIA Universal
Lot #: N9EO355
Cat #: 030449
Other #: (not provided)

Problem:
Staff witness report:
"There were 2 Universal Endo GIA staplers up on the sterile field that was not closing; therefore they were unable to be placed inside the trocar port. I took the 2 malfunctioning Endo GIA staplers off the field and attempted to get the 2 devices to close but was unsuccessful. I also had 3 other staff members try to get the devices to close and they were not successful as well. The devices were taken to biomedical engineering for further evaluation. Doctor was quite upset regarding this situation. He was able to finish his surgical case utilizing electrocautery." Clinical Engineering evaluation verified the devices were not working as indicated. Closer examination and comparison to a working example revealed that the device was improperly assembled. The black tubular part (shaft) that is connected to the handle was rotated with respect to the end fittings so that the locking mechanism was jammed. It seems unlikely that this happened during use.

Manufacturer response (as per reporter) for Stapler, Surgical, Endo GIA

We will give the devices to the manufacturer for their evaluation.


Device:

Type: Stapler, Surgical
Manufacturer: Covidien United States Surgical Corporation
Brand: Lds 15
Model#: LDS 15
Lot #: P8K0306
Cat #: 092001
Other #: (not provided)

Problem:
Second stapler did fire but had no staples, did cut tissue.


Device:

Type: Stapler, Surgical
Manufacturer: Covidien United States Surgical Corporation
Brand: Lds 15
Model#: LDS 15
Lot #: P8K0306
Cat #: 092001
Other #: (not provided)

Problem:
LDS stapler failed, (no gas).


Device:

Type: Wound Debrider
Manufacturer: Kinetic Concepts, Inc.
Brand: Vac Freedom
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
A patient called the Nursing Supervisor to complain of an RN that made a visit the day prior to change her abdominal wound vac. The RN changed the dressing three times as the vac kept alarming. The RN believed there was a problem with the seal of the dressing, when in fact the patient noted that there was a crack in the plastic luer lock connecter that was causing the air leakage. Additionally, the nurse forgot to unclamp the tubing between the drsg and the vac. The patient noticed the problem two hours after the visit, called the triage RN, removed the abdominal dressing herself, & had another visit with a wound care RN who resolved the situation. This writer consulted with the home care RN Educator and Wound Care Nurse who showed me the luer lock and two small plastic protrusions (teeth) that sometimes break off as a result of normal use. In this case, one of the small plastic protrusions had broken off at some point during the patient's treatment with the wound vac causing an air leak, a poor seal, and the alarm going off. If the wound vac is off for any time up to two hours the patient should turn the machine off, remove the dressing, apply a wet to dry saline dressing and call the home care to have a nurse come out to assess the situation. The wound can potentially deteriorate if this is not done.


GENERAL HOSPITAL

Device:

Type: Enteral Feeding Set
Manufacturer: Covidien Kendall
Brand: Kangaroo Epump
Model#: (not provided)
Lot #: all lots
Cat #: 773662
Other #: 1000 ml pump set

Problem:
Our institution has been having problems for months with the kangaroo feeding kits not priming consistently. Specifically, it seems to be the white, circular piece encased in a clear purple housing which is sticking (anti-free flow valve?). This piece, which turns, is located at the junction of the tubing from flush bag and the feed bag. The manufacturer is aware, and has suggested that prior to priming the bags, take a key, coin or hemostat and turn the white insert to loosen it. This was suggested as a temporary solution while the manufacturer continues to evaluate ways to correct the problem. We've returned several kits in the past for evaluation. In this particular case, the tubing would not prime, and the entire feeding kit and pump were changed. The nurse turned the valve and the set up appeared to be working. The nurse then bolused the patient with 300 ml fluid and stayed to ensure that the pump and set were working correctly. Instead of water bolusing, tube feed started to bolus. The nurse switched off the pump immediately. There was no patient harm.


Device:

Type: Infusion Pump
Manufacturer: Smiths Medical MD, Inc.
Brand: Medfusion 3500 Syringe Pump
Model#: 3500
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
During an infusion, the syringe pump alarmed "motor rate". The silence alarm button was pressed to allow the infusion to continue. Minutes later, the pump alarmed "motor not running." The silence alarm button was pressed again. Not long after, the pump read "motor not running." The infusion was stopped and a new pump was obtained.


Device:

Type: Infusion Pump
Manufacturer: Baxter Healthcare Corporation
Brand: Colleague 3cx
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
The infusion pump was plugged in to charge prior to patient transport. The patient was transported for a CT scan, and the triple channel pump, which was infusing vasopressors to help stabilize the patient’s blood pressure, failed on the way back to the ICU. The infusion pump had been unplugged for approximately 30 minutes. It alarmed “low battery,” and beeped for the first time. One minute after the low battery alarm, the pump failed. This failure caused the organ donor patient to code. The patient was already “clinically dead,” but the infusion pump therapies were being utilized to stabilize the patient until the organs could be harvested for other transplants.


Device:

Type: Infusion Pump
Manufacturer: Smiths Medical MD, Inc.
Brand: Medfusion 3500 Syringe Pump
Model#: 3500
Lot #: (not provided)
Cat #: 3500
Other #: (not provided)

Problem:
PharmGuard V1.3.1543 software with pump firmware V4.1 was loaded onto the Smiths Medical Medfusion 3500 series syringe pumps. The safety software was implemented in one of the patient care units, and shortly after implementation, the staff questioned the bolus function. The bolus function appears on the pump screen before the general infusion is started. The staff on this unit does not use the bolus function, so their process was to disable the bolus before the normal infusion began. The next phase was to implement the safety software for a different patient care unit. This patient population requires the bolus function for select meds (i.e. sedatives/paralytics/analgesics). Surprisingly, once the function is disabled at the setup of the infusion, the user can never initiate another bolus again during the infusion. This is a serious safety issue when staff must bolus a drug for the safety and well being of the patient. Once the bolus feature is disabled before the infusion begins, at no time during the infusion can staff ever initiate a bolus.

The PharmGuard safety software allows clinicians to enable or disable the bolus function within the drug library configuration at different levels; such as care area or drug which is invisible to the end user on the pump. However, the pump will not allow you to enter a zero value on the screen for a bolus so this work around is not an option.

Our pharmacist was recently contacted by a software specialist from Smiths Medical. After working together, the specialist expressed that the safety software is corrupted or has a glitch.

It should also be noted that one drug (Propofol) can be bolused during an infusion, but Smith's software specialists cannot determine why only this one drug works as the program is designed while all others do not.

The FDA should also recognize a human factors problem with this device. The bolus button must be used as a prime button. The definition of bolus and prime are very different.


Device:

Type: Infusion Pump
Manufacturer: CareFusion Healthcare Cardinal Health
Brand: Alaris System Module
Model#: 8100
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
The first incident involved a pediatric patient who was being transported to the OR (operating room) on a ventilator with an Alaris pump on an IV pole. The Alaris IV pump spontaneously shut off stating "channels disconnected" during transport multiple times requiring nurse to manually restart all channels. The patient was not harmed by event.

The second incident occurred with an adult ICU (intensive care unit) patient. During transport, the Alaris pump was bumped slightly by the transporter which resulted in the pump shutting down. A required manual re-set was done.


Device:

Type: Infusion Tubing
Manufacturer: Hospira Global Medical Affairs
Brand: Lifeshield Symbiq Pump Set
Model#: 16090-28
Lot #: 76202-5H
Cat #: 16090-28
Other #: (not provided)

Problem:
A patient was being treated with IV Doxorubicin Liposomal. The RN accessed the infusaport and began infusing normal saline via an infusion pump using a "primary set" with a back check valve. The RN attached the chemotherapy dose, using a primed secondary set. The infusion was started as ordered. After a short time, the RN noticed the chemotherapy dose, which is red in color, was infusing down the secondary set as it should, but was then flowing up the primary set, through the back check valve and into the drip chamber below the flush bag. A pair of hemostats was used to clamp the primary line above the secondary set attach-point, thus preventing any further flow up to the flush bag. The infusion was completed, and the entire tubing set was discarded as one piece to prevent exposure.

Our facility has recently submitted similar reports of back check valve failures with Hospira tubing. Hospira has indicated to us that the failure is due to particulate matter inside the valve which prevents it from sealing. The size of the particulate matter is between 0.015 and 0.025 inches and has been identified as ABS (plastic) or silicone. In addition to concerns of inaccurate infusions due to the back check valve failure, Hospira advised that this particulate matter could infuse into a patient. This failure may also go unnoticed by clinicians, especially if the secondary medication is clear.

Hospira has indicated that their supplier of the back check valve has implemented several actions to address the back check valve failures. In the meantime, our facility has switched to tubing that does not have back check valves in the majority of our patient population. In those populations that were unable to switch to tubing without back check valves, we have implemented the use of micron filters to prevent patient exposure to the particulate matter.


Device:

Type: Pca Pump
Manufacturer: Hospira Global Medical Affairs
Brand: Pca Plus Ii
Model#: (not provided)
Lot #: (not provided)
Cat #: 01950-04-07
Other #: Hospital ID # 6118

Problem:
Nurse reported that the pump delivered a 5mg bolus instead of 1mg. When she checked the history she only found 1 injection and assumed the machine had malfunctioned. The pump was immediately removed from service for investigation by campus Biomed department. Printouts were sent to Hospira for evaluation. No defect or malfunction detected, printouts analyzed and were correct.
Problem determined to be user error. Pump should have been set to deliver 0.1mg instead of 1 mg which explained why the syringe of medication was used so rapidly. The patient's max dose was set at 6 mg per hour and the patient never received more than the max dose because the pump was functioning properly. The nursing staff were not aware that clearing totals also clears the history and only saves the settings so the lack of information in the history was misinterpreted by the nurse who reported the error. The patient was not harmed and suffered no adverse outcome due to the programming error.

Having no history caused the nurse to misinterpret what had been delivered to the patient. Perhaps a warning that history will be lost if you proceed with clearing totals would alert nurse to rethink clearing. Or perhaps a change in the software so that totals can clear without losing history.


Device:

Type: Pharmacy Administration System
Manufacturer: Siemens Medical Solutions USA, Inc.
Brand: Pharmacy Clinical Workstation
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: Version 24.00.0032

Problem:
During a hospitalization, the patient was on a 250ml bag IV of Neosynephrine and 250ml bag of IV Insulin. The neosynephrine was weaned, but left hanging in case it was needed before expiration. A new bag of insulin was needed, but the nurse accidentally hung a new bag of Neosynephrine instead. This is one of 6 similar events that have occurred since installation of a pharmacy clinical software labeling system 2 years ago. The errors were detected at the bedside and none of the patients were harmed as a result. The incidents occurred in the critical care areas with patients on multiple drips. All of these IV medication bags were labeled using the same labeling system as provided by the pharmacy clinical software labeling system. The IV infusions were prepared and labeled correctly but the medication labels created by the software labeling system are contributing to errors in administration. The font is small and uniform. Tall man lettering or highlighting is not available. A near miss occurred when Norepinephrine was almost infused instead of Epinephrine. No such episodes have been reported with pre-mixed IV infusion bags prepared and labeled outside of the organization that had drug names in very large, clear font, often of another color.
Manufacturer response (as per reporter) for computer system for medication labeling Siemens Pharmacy Clinical Workstation: the hospital has brought this to the pharmacy clinical software company’s attention. They were told they could request special customization or work through a 3rd party vendor.


Device:

Type: Pump, Infusion, Elastomeric
Manufacturer: I-Flow Corporation
Brand: On-q
Model#: (not provided)
Lot #: 622104
Cat #: PM013-A
Other #: On-Q Painbuster kit with On-Q Silversoaker

Problem:
On-Q pain pump catheter inserted in surgery for pain relief. Patient instructed regarding how to remove catheter. Patient returned to hospital, unable to remove catheter. Physician had difficulty removing it and in fact some portion of the soaker catheter was left in place as it broke. Patient returned to surgery on for removal of On-Q pump retained catheter.


NEUROLOGY

Device:

Type: Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Manufacturer: Medtronic Neuromodulation
Brand: Interstim
Model#: 3058
Lot #: (not provided)
Cat #: (not provided)
Other #: 3058 Neurostimulator

Problem:
Non-functioning InterStim secondary to failure of the battery. Also, the lead was not felt to be functioning well. Patient was admitted for removal and replacement.


OBSTETRICS/GYNECOLOGY

Device:

Type: Fetal Monitor
Manufacturer: Philips Medical Systems
Brand: Avalon Fm30, Fm50
Model#: FM30, FM50
Lot #: (not provided)
Cat #: (not provided)
Other #: M2736A, M2735A,

Problem:
Fetal monitoring performance problems have been identified by our clinical team. These have been described as:
1. Problems with tracing early gestation fetuses, multiples (twins, triplets). Requiring separate fetal monitors to trace each fetus.
2. Weak FHR (Fetal Heart Rate) signal
3. Loss of FHR signal
4. Doubling/halving of FHR
5. Monitor Volume at maximum level is still not adequate
6. Artifacts present as decelerations
7. FHR tracing is different from actual audible fetal heart rate signal
Patients are in active labor being monitored with external ultrasound fetal monitors. Staff are concerned that the monitors are not projecting an accurate fetal heart rate.Philips stated that they have designed a new algorithm that is currently being tested to fix the monitor incorrect signals issue.


ORTHOPEDIC

Device:

Type: Screw, Compression, Hip, Instrument, Extractor
Manufacturer: Smith and Nephew
Brand: Intermediate Compression Screw -Pediatric Instrument Set
Model#: (not provided)
Lot #: (not provided)
Cat #: 7113-4052
Other #: (not provided)

Problem:
The surgeon was removing a Smith and Nephew intermediate hip screw and hardware. The bolt/screw extractor broke. The extractor tabs, which mates with lag screw broke in the screw and then the screw became almost impossible to remove. The surgery was extended another hour while the surgeon struggled to remove the broken screw piece. The surgeon had to use a chisel to free up the sides of the screw and slowly advance the screw until the surgeon was able to remove the broken piece of screw.

Manufacturer response (as per reporter) for Extractor, Screw Extractor:

Sales Rep was not in room at the time of this event, but is aware of this event.

Sales rep's feeling was that surgeon did not remove hardware plate off the lag screw before removing the lag screw with the extractor tool, thus causing it to become broken.


RADIOLOGY

Device:

Type: Mammography Unit
Manufacturer: GE Medical Systems, LLC
Brand: Senograph 800t
Model#: Senograph 800T
Lot #: (not provided)
Cat #: (not provided)
Other #: Our asset number 04187

Problem:
The hospital experienced a brief power outage due to a storm. When the power went out, the paddle (which had been elevated) came down unexpectedly. The equipment was not being used for a patient examination at the time of the event.


Device:

Type: Stereotactic Radiosurgery Unit
Manufacturer: Elekta, AB
Brand: Leskell Gammaknife Model C/b-2
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Two patients were scheduled for treatment using a Leksell GammaKnife Model C/B-2 stereotactic radiosurgery unit, which uses an Automatic Positioning System (APS) to automatically change patient position during treatment. The unit is 11 years old but was upgraded in 2005. It appears that an error code came up which was cleared but left the machine out of sync with the second patient's exact position. It appears for this second patient all subsequent treatment points were offset by 4.5 mm in the X-axis. Further evaluation reveals that GammaKnife radiation treatment may not have been administered to the exact intended area for the second patient.


Device:

Type: X-ray System, Cysto Table
Manufacturer: GE OEC Medical Systems, Inc.
Brand: Uroview 2600
Model#: OEC2600
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Patient was in the OR on the cysto Uroview table. Surgery had not yet commenced however anesthesia had been administered at that point. The physician stepped on the fluoro pedal that controls the X-ray, and the power feeding the cysto table X-ray system shut down. The OR staff attempted to reset the breakers with no success. Biomedical was contacted and attempted to restore power to the system by resetting the breakers on the cysto table and the main breaker for the entire room without success. Patient was moved to another OR room without incident. The manufacturer was notified. They evaluated the table and they suspect the problem was in the power supply located in the cysto table.


Device:

Type: X-ray Unit, Mobile, Digital
Manufacturer: Shimadzu Medical Systems
Brand: Mobiledart
Model#: DART
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Patient was in a code - Radiology had responded to bedside - a chest X-ray was requested. The DR X-ray detector was under the patient, and a chest image was acquired. Before the tech could remove the DR plate from under the child, the physician called for defibrillation. Tech said they needed to remove the plate first but defibrillation occurred anyway. The X-ray unit is not working properly now.

Additional Information:

Covidien Pedi-Cap End-Tidal CO2 Detector Class I Recall. FDA MedWatch Safety Alert. September 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181878.htm

Pedi-Cap End-Tidal CO2 Detectors Recalled. FDA Patient Safety News. November 2009.
http://www.accessdata.fda.gov/psn/transcript.cfm?show=92#2


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