Highlighted Reports
MedSun: Newsletter #64, September 2011

This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period June 1 through June 30, 2011. 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: Soft Reusable Sensor
Manufacturer: Masimo Corp
Brand: Lncs Dbi
Lot #: 11DBR and 10HC8
Cat #: 2653

Problem:
False readings on Masimo LNCS DBI finger probes used on Philips Viridia and Intellivue Patient Monitoring Systems, recorded problems with Masimo Lot 11DBR and 10HC8. However, recently we tried a different lot number (11DFX) with the same results.

Summary:
Two lots of Masimo LNCS DBI probes are extremely sensitive to slight movement. These are not reprocessed and exhibit the problem immediately upon use. When monitored patients detach from this style of finger probe, the monitoring system may continue to interpret changes in impedance on the Masimo cable as pulsatile waves.
Philips Healthcare bedside monitors in the Viridia and Intellivue with Philips Fast SpO2 may interpret the impedance changes for extended periods (recorded up to seven minutes) thus giving the primary medical staff false diagnostic monitoring, trigger erroneous physiologic alarms, or record data in the EMR [Electronic Medical Records] that is not consistent with the patient's condition during hospitalization.

Background:
Clinical Engineering Department is investigating problems reported with the use of Masimo LNCS DBI pulse oximeter probes and Philips Viridia and Intellivue monitors. Reports from nursing staff members came to the CE [Clinical Engineering] Department's attention within days of standardizing Masimo manufactured probes on all systems for which Masimo states it offers a compatible probe. Masimo representatives conducted an exchange of all probes mentioned. Clinical Engineering heard reports of false signal readings a few days after the exchange.

Initially brought to the CE Department's attention during rounds with the Intermediate Medical Care Unit (IMC) at the hospital, Clinical Engineering immediately asked to speak to staff members who had observed the reported problem. IMC was the first department to report false signal readings from the Masimo LNCS DBI sensor. Several staff members reported that in various rooms with various bedside physiologic monitors, patients would remove the SpO2 [Saturation of Peripheral Oxygen] finger probe or it would detach from their finger. When these style probes were detached, SpO2 readings would continue with a pulsatile, non-physiologic wave or an oxygen saturation reading of approximately 84%, or the combination of the wave and low SpO2 reading.

While the staff reported these problems to a Clinical Engineering Technician, the problem recurred in an adjacent room and staff members observed that though the probe rested between the mattress and side rail, detached from the patient's finger, the bedside monitor displayed a non-physiologic waveform and SpO2 of 84–87%. The waveform persisted at most for a recorded six minute interval while the erroneous oxygen saturation continued the entire time. During this window, Clinical Engineering worked with the nurse educator to determine why the false readings continue. At one point the probe was placed on an end table, horizontally without noticeable movement. This did not resolve the problem. This instance of erroneous readings was resolved only when the probe was placed back on the patient's finger.
Though this was the first time Clinical Engineering observed the reported complaint, Clinical Engineering and a Masimo representative have reproduced this problem in other situations in an attempt to determine the likelihood of external interference from fluorescent or ambient light or other sources of electromagnetic interference or movement. The most pronounced example of why Clinical Engineering concludes that movement is a key element of these false readings occurred under evaluation with Masimo and Clinical Engineering: A Masimo DBI probe was covered in a black bag and placed horizontally on an empty bed. When the mattress top was depressed as much as three feet away from the probe to a depth of no more than one and one half inches, the Philips bedside monitor began to record pulsatile waves and an oxygen saturation consistent with reports and previous observations.

A DBI probe from another lot (11BEW) was used without excessive sensitivity in this trial to determine if Masimo has issues with the two lots the hospital received. No reports of recurrence have been brought to Clinical Engineering.

As a measure, Masimo, attempted to swap out 120 sensors, but the result was the same. As a final step until we can get some answers to why the DBI (Boot) sensor is not compatible, Masimo will immediately change out the DBI sensors for the LNCS DCI Clip Finger Sensor that seems to be working ok.

In discussions with Philips, the Masimo LNCS DBI has not been validated for use with Philips Healthcare technology.
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Manufacturer response for Soft Reusable Sensor, LNCS DBI (per site reporter)
======================
Coordinating review and testing, compatibility testing. Masimo told us the probes were compatible but we found out that the DBI sensors have not been tested against Philips Fast SPO2 algorithm.


CARDIOVASCULAR

Device:
Type: Cardiac Angiography Pack
Manufacturer: Medline Industries, Inc.
Brand: Angiography/angioplasty Kit
Lot #: 11CB833
Other #: reorder # DYNJ33727

Problem:
The blade in cardiac angiography pack had no safety cap and two of the 32oz graduated bowls were punctured by the blade. The pack was not used and was replaced by a new pack.


Device:
Type: Cardiology Data Management System
Manufacturer: McKesson
Brand: Horizon Cardiology

Problem:
Fluoro from a previous catheterization was missing from Horizon Cardiology. McKesson (vendor) researched, and found numerous studies which were not migrated by McKesson from old to new long term archive in 2008. Vendor letter and spreadsheet of missing studies was forwarded to Risk Management.


Device:
Type: Catheter, Mapping, Cardiac
Manufacturer: St. Jude Medical
Brand: Refexion Bi-directional Decapolar
Lot #: 3328191
Cat #: 402800

Problem:
The catheter did not show all poles on the 3D Ensite (ESI) mapping equipment. There was artifact on the electrograms and they would not match up on the screen. A new catheter was used; procedure was successful and patient recovered well.


Device:
Type: Catheter, Mapping, Cardiac, Reprocessed
Manufacturer: Ascent
Brand: Daig Supreme Fixed Curved
Lot #: 156061
Cat #: 401443

Problem:
As the Diag Supreme Fixed Curved EP Diagnostic catheter was removed at the end of the procedure it was noted that the tip was separated from the rest of the catheter and was only attached by the internal wires. The catheter was removed completely. There was no harm to the patient. This was a reprocessed catheter on its third reprocessing cycle.


Device:
Type: Catheter, Ultrasound, Intravascular
Manufacturer: Boston Scientific
Brand: Atlantis Sr Pro
Lot #: 14258155
Cat #: 338942
Other #: H74938942D

Problem:
Patient was undergoing cardiac stent procedure. IVUS catheter used to view stent placement in RCA. IVUS then removed and approximately 5cm noted to be missing and retained in the RCA. Snare used for attempt to retrieve tip, unsuccessful. Patient required transfer to tertiary care center for possible removal of catheter tip.
Recall online available at: http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm259063.htm


Device 1:
Type: Implant
Manufacturer: Thoratec Corp
Brand: Heartmate II
Model#: Heartmate II
Device 2:
Type: Telemetry
Manufacturer: Spacelabs Medical, Inc.
Brand: Spacelabs Telemetry Transmitter With Ultraview
Model#: 90347-05
Problem:
Left Ventricular Assist Device (LVAD) patients are hooked up to telemetry but the system we have shows interference on the EKG monitors. Therefore, there is no way to know what the patient's heart is really doing for the monitoring Techs. This problem is happening with all the LVAD patients in the hospital.


Device:
Type: Network, Wireless, Physiological Monitoring
Manufacturer: GE Healthcare
Brand: Enterprise Access
Other #: Z10020-006 (Primary Synchmaster)

Problem:
Sixty five days after the brand new General Electric (GE) Enterprise Access patient Monitoring System Network went down at 0200 hours in the morning. GE was contacted and their technician determined that the Synchmaster was out. The network was down for approximately 5 hours. When the system was switched over to the backup Synchmaster it also did not work. The primary data cable was then switched from the primary Synchmaster to the backup Synchmaster; again no system functionality. The hospital Biomed personnel were asked to reboot all 88 access points and this along with the switch over to the backup Synchmaster put the telemetry system network back online. We believe there are two design issues:
(1) If the primary Synchmaster fails there should be an automatic switch to the back up Synchmaster without needing to turn the primary "off" and the backup "on", and
(2)There should not be any need to "re-boot". This failure affected over 250 of potentially 300 patients as the entire telemetry, wireless monitor network when it went down.
Manufacturer response for Network, Wireless, Physiological Monitor, Enterprise Access:
Representatives of GE switched out the primary Synchmaster for a new Synchmaster. They are also reviewing the entire system.


GENERAL & PLASTIC SURGERY

Device:
Type: Electrosurgical, Cutting & Coagulation & Accessories
Manufacturer: Angiodynamics, Inc.
Brand: Rita Starburst Console

Problem:
This is not really a device report - rather a failure of response of manufacturer rep. We did not receive the software upgrade or notification of need for software upgrade so the probe would not work properly. Malfunction could not be identified until after probe had already been placed in patient. Company rep did not arrive for procedure nor return phone calls about need for new software.
======================
Manufacturer response for Rita Starburst Console, Rita Starburst Console (per site reporter)
======================
Manufacturer will be providing software upgrade prior to next scheduled procedure. Since original sales rep non-response company has been VERY responsive to issues relating to needed software upgrade. We consider this matter now resolved.


Device:
Type: High Power Single Use Laser Fiber
Manufacturer: Boston Scientific - Marlborough
Brand: Flexiva 365 High Power Single Use Laser Fiber
Lot #: 1ML1020702
Cat #: 840-392
Problem:
MD using Holmium laser lithotripsy for right ureteral stone. While using laser, approximately 2 mm size piece of the end of the laser fiber tip broke off. The surgeon notes that no fragments were visualized in bladder following basket extraction. The operative note states: "Ureteroscopy was carried out to the mid proximal ureter and there was no evidence of retained fragments. The safety wire and cystoscope were then used to deploy a 4.8 French x 26 cm double-J ureteral stent, which was deployed in good position. The bladder was emptied. The patient was taken to recovery room in stable condition."


Device:
Type: Laser, Surgical
Manufacturer: American Medical Systems, Inc.
Brand: Greenlight
Model#: CTS1188347

Problem:
While the greenlight laser was in use, power was raised from 100 watts to 120 watts and a message flashed asking "Did you want to raise power?" with "Yes" or "No" on the screen. "Yes" was selected and power was raised. It was then noticed that power and time used was reset on screen. Laser tech support was called and they stated it was possible that there was a glitch in the software and there was nothing they could do to retrieve lost information. Support stated that the fiber would have to have been removed from the machine to have lost the numbers. Doctor was able to add Joules displayed before the loss to the numbers at the end of case to approximate the power and time used.


Device:
Type: Pack, Sterile, Surgical
Manufacturer: Cardinal Health
Cat #: SNU12VAMWM

Problem:
The sterile venous access pack was opened in preparation for inserting a PICC catheter. The tech preparing the tray, donned in appropriate head covering, noticed a hair under the gauze sponges. The tray was immediately removed from the procedure room and another tray was prepped. The hair was discovered prior to the patient entering the procedural suite.


Device:
Type: Wound Dressing
Manufacturer: Centurion Medical Products Corp
Brand: Sorbaview Shield
Cat #: SV353UDT
Other #: Stock# 57015711

Problem:
Our facility has documented several events that occurred with the dressing used to secure the peripherally inserted central catheter or PICC line on patients. Beginning last summer our facility stopped suturing in PICC lines. This was because of advice received from the CDC and the INS that suggested this practice be stopped. Last year we documented seven cases where the dressing was intact, but it was discovered that the PICC line was pulled out or partially pulled out. One such event stated patient found with PICC line dc'd; Pt sometimes confused; and sometimes pulls at lines, tubing, bedding; RN feels the Sorbaview dressing did not adequately secure the PICC line. Another such event stated, PICC line accidentally pulled most the way out; patient got up from chair; line caught on chair. No suture at site; Hub pulled out from under the Sorbaview dressing. Dressing was intact.
Since the beginning of this year we have had three such events reported. With the last event reported two months ago. The event states, "This event report is being prepared to document the failure of the SorbaView Shield to secure the patient's PICC line. This patient was preparing to be discharged and the PICC line was to be removed. When RN was removing the PICC line, it was noted that the line was only in the patient's arm approximately twelve inches, which was much shorter than it should have been to be a properly placed PICC. It was obvious the PICC line had slipped out sometime during the hospital stay due to failure of the SorbaView Shield dressing to secure it. There was no consequence to the patient as she was not using any IV fluids or IV antibiotics that needed to be infused through a central line." Because of the number of reported events this report has been filed.


GENERAL HOSPITAL

Device:
Type: Catheter, PICC
Manufacturer: Medcomp
Lot #: MBCQ060
Cat #: MR17012601

Problem:
The product is a MedComp 2.6 FR Dual lumen PICC. On the 23 gauge lumen, the junction of the clear extension piece and the white Luer piece had fluid leaking around the junction. We just began using this product about 4 or 5 months ago, and our utilization has not been very high to date. The loss of this catheter was costly for the patient. This particular patient required a catheter exchange. She continued to require central access and the family and service did not wish for her to return to the operating room for a new line. The day after the catheter was exchanged the patient decompensated with a septic type of picture and was transferred to the ICU. To date the blood cultures have remained negative.


Device:
Type: Catheter, PICC
Manufacturer: Bard Access Systems
Brand: Broviac Catheter 2. 7 Single Lumen
Lot #: REVA0630
Cat #: REF060040

Problem:
The physician ordered a dressing change and an application of medication to the patient's broviac catheter site. As the nurse removed the dressing, it was noted that the broviac catheter was broke in half. The catheter was immediately clamped by the nurse and then discontinued by the physician.


Device:
Type: Infant Crib
Manufacturer: Stryker
Brand: Strykercub
Model#: FL19H
Cat #: FL19H
Lollipop Icon
Problem:
No patient involvement with this event. After patient was discharged, housekeeper was cleaning an infant crib when metal coated bars were noted to be peeling. Peelings very sharp and dangerous. Crib taken out of commission due to safety concerns. Manufacturer notified. Sample shavings available.


Device:
Type: Port, Catheter, Implanted
Manufacturer: AngioDynamics
Cat #: CT96STSD

Problem:
During the placement of the AngioDynamics Vortex Smart Port (ref CT96STSD), the blue protective cover of the metal tunneling device was not removed, but inadvertently left on the tunneling device during the tunneling. It moved down the tunneling device and was left over the catheter in the subcutaneous tissue. The blue cover was not visualized on fluoro or x-ray. The port and catheter was removed ten months later because the patient did not need the port any longer. However, the blue cover was not visualized and was not removed. Approximately two weeks later the patient returned for removal of a retained foreign body.

Device problem that contributed to the user error:
1. The blue tunneling cover is the same color as the blue locking mechanism.
2. The blue tunneling cover is not marked with a radiopaque marker.
3. The blue tunneling cover can slide down the tunneling device. It is not a Luer or twist off cap.


Device:
Type: Pump, Infusion, Elastomeric
Manufacturer: I-FLOW CORPORATION
Brand: On-q
Model#: CB-6004
Lot #: 112951

Problem:
I-FLOW On-Q Pain Pump Model# CB-6004, Lot#112951, Exp. Date: 2/13. Pump returned as defective because the "Select-A-Flow" rate controller spins freely and will not click into a specific rate. Without a definite click, the medication will not flow from the pump.


ORTHOPEDIC

Device:
Type: External Rib Fixation System
Manufacturer: Synthes
Brand: Synthes Matrixrib

Problem:
A patient who presented post MVA with significant flail chest on the left side initially did not require mechanical ventilation but deteriorated. Then patient required mechanical ventilation and was showing no progress towards weaning from mechanical ventilation. Per adopted trauma service protocol, the patient and his family were offered operative fixation of his rib fractures to correct the flail segment. The family after full discussion of risks and benefits and after a second opinion had been obtained from thoracic surgery decided to proceed with the operation. Multiple rib segments were stabilized with an external fixation segment without problems. An intramedullary stent was used to stabilize a posterior segment of 5th fib, with comminuted segments, in close proximity to the spinal column. The patient subsequently demonstrated paraplegia. CT scan indicated that the stent was in contact with the spinal cord at the T4 level. The patient was returned to the OR for removal of the intramedulary stent. Intraoperative exploration indicated that the stent had exited the intramedullary canal at the site of a fracture. Following removal, the patient continued to demonstrate significant neurological deficit. Neurosurgery was consulted and MRI/MR Angiography of spine was completed, which indicated spinal cord trauma.


RADIOLOGY

Device:
Type: Bone Densitometer
Manufacturer: GE HealthCare
Brand: GE Lunar Prodigy Advance

Problem:
The GE Lunar system had to be reset. When it was reset the population comparison group needed to be selected. The comparison group "USA" was selected, not "USA/NHANES" This caused the wrong calculation of bone loss. Staff reported that when the comparison group is selected the list of comparison groups is so long that one needs to scroll through many selections and the proper reference database is not seen easily. The list of comparison groups includes many countries outside of the US that would not be selected in the US. If the list was not as long it was felt that there would not be the risk of selecting the wrong reference database. Staff suggested that the list be modified for US users so that so many unneeded comparison groups do not appear.

The result was incorrect data for 223 patient exams.

The settings were corrected. The manufacturer was contacted and instructions were given on how to correct and reanalyze the data. The exams were reanalyzed to correct the results.


Device:
Type: Catheter, Radionuclide Applicator, Microspheres
Manufacturer: Sirtex Medical, Inc.
Brand: Sir-spheres

Problem:
Sirtex 2.8 French micro catheter used in Nuclear Medicine was occluded and drug could not be delivered in full. A patient was prescribed a dose of 3 GBq received approximately 0.7 GBq Y-90 microspheres (Sirtex SIR-Spheres) for the treatment of cancer in the left lobe of the liver. Based on the residual activity measured at the completion of the treatment, the patient may have received 20 – 23% of the prescribed dose. Instead of the intended absorbed dose of 63 Gy to the left lobe of the liver, the patient received less than 14.8 Gy. The most likely root cause of the occlusion was that a relatively high concentration of Y-90 SIR-Spheres occluded the lumen of the Sirtex micro-catheter. The AU (authorized user) terminated the therapy administration because an occlusion in the micro-catheter prevented the delivery of the microspheres to the treatment site. An incident report was filed by Sirtex, the Y-90 microsphere manufacturer, several days after the event. Once adequate decay in storage has occurred (estimated 60 days), the Y-90 delivery set and shipping vial used in this medical event will be returned to the manufacturer (Sirtex) for analysis. Full decay time is estimated to be 60 days. Once received by Sirtex, the analysis takes about 2 weeks. This event was reported to the U.S. NRC Operations Center. No adverse effects on the patient are expected from this under dose. The patient was subsequently successfully treated with compensating dose activity of 2.6 GBq of Y-90 microspheres to left lobe of the liver.


Device 1:
Type: MRI, 3T
Manufacturer: GE Medical Systems, LLC
Brand: GE Discovery 750
Model#: GE Discover 750
Device 2:
Type: Monitor, Physiological, MRI
Manufacturer: Medrad Inc.
Brand: Veris
Model#: 8600
Problem:
After MRI, The patient had 2nd degree burn in the shape of the EKG wire on chest and stomach (MR Monitoring System ECG leads used on patients while in the MRI scanner).


Device:
Type: MRI, 3T
Manufacturer: GE Medical Systems, LLC
Brand: GE Discovery 750
Model#: GE Discover 750

Problem:
Patient has MRI compatible shunt. After MRI completed, patient complained of her head "heating up" and a burning/stinging sensation in the location of her shunt. Technologist looked at area of interest, no redness or RF burns; however, the area was warm.


Device:
Type: MRI, 3T
Manufacturer: GE Medical Systems, LLC
Brand: GE Discovery 750
Model#: Discover 750

Problem:
Patient complained of a burn on left hand and left hip that occurred during MRI scan.


Device:
Type: X-ray System, Cath/angio
Manufacturer: Philips Healthcare
Brand: Allura Xper Fd10
Model#: Allura XPER FD10

Problem:
The Philips Allura XPER FD10 system has an intercom system for communication between the operative suite and the control room, but the intercom in the control room only has a desk-top speaker and microphone. In a noisy environment, this speaker and microphone are not able to provide enough volume/control to be able to listen to to the Cardiac Cath Lab suite conversation/directions. We have asked Philips to provide a headset option which is available from the OEM of the intercom system but have not had a timely response. The OEM of the intercom is Hago Electronics. Philips has OK'd the modification of the Hago intercom.

The local service manager and sale rep have sent the request to the production floor to see if it is possible to make the modification.

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Lollipop Icon
Special Note: The lollipop icon distinguishes highlighted reports that describe medical device events involving neonatal or pediatric patients, or those events involving a medical device that is indicated for use in neonatal and pediatric patient populations. FDA defines pediatric patients as less than 21 years of age.


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