Summary of MedSun Reports Describing Adverse Events With Cardiovascular Programmable Diagnostic Computers
MedSun: Newsletter #55, December 2010

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs (1).

Among general cardiovascular programmable diagnostic computers, there are several different device descriptions which further define this class of products:

Hemodynamic Catheterization System:
A hemodynamic monitoring system is used, “for monitoring vital signs before, during and after catheterization procedures.” It is intended to, “acquire, display, store, analyze and process vital signs and log all cath lab activity (2).”

Cardiovascular Mapping System:
A mapping system designed to, “acquire and analyze individual data points, and use this information to display 3D electroanatomical maps of the human heart in real-time (3).”

Cardiology Data Management System:
An ECG management system is used for, “importing ECG waveform data, reviewing and performing measurements, diagnosis and comparison of ECG procedures and storing the data for future review and management (4).”

Over the past 2 years, MedSun has received 10 adverse event reports associated with cardiovascular programmable diagnostic computer devices manufactured by Biosense Webster, G.E. Healthcare, McKesson Corporation, St. Jude Medical. Two MedSun reports contained multiple device problems. The reports were submitted by 8 hospitals between November 2008 and November 2010.

The reported device problems were:
•Software issues to include:
-Freeze - 1
-Failure to initialize - 1
-Display amplitude affective analysis algorithm - 1
-Unable to correlate catheter location properly - 1
-Loss of ECG display - 1
-Inability to archive images – 1

•Could not steer catheter - 1
•Could not identify the reference catheter - 1
•Defective amplifier - 1
•Defective DVD preventing software initialization - 1
•Interference causing image shift on display - 1

None of the reports involved a patient death. One report involved a minor injury to the patient and four reports were identified as potential for harm. Two MedSun reports resulted in multiple patient problems. The patient problems listed below were reported in 4 of these 10 reports:
•Patient converted to ventricular tachycardia requiring cardioversion - 2
•Patient received additional radiation/fluoroscopy – 2
•Increased procedure time – 2
•Redo of catheter procedure - 1

Of the reports that listed patient age, no reports had a patient age listed as less than 21 years and 8 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 1 report involved a female patient and a total of 6 reports involved male patients.

FDA follow-up with the manufacturer resulted in multiple recalls. The following recall(s) are noted to be associated with the Cardiovascular Programmable Diagnostic Computer.

Recall 1:
Date Posted: July 09, 2010
Recall Number: Z-1974-2010
Product: Horizon Cardiology Hemo Component Schiller Argus Pro PB-1000 Monitor unit. Argus Pro PB 1000 firmware versions 2.41+M NIBP and 2.42.01+M. A programmable diagnostic computer intended for acquiring, digitizing, storing, displaying and reviewing hemodynamic data for use in hospital cardiac catheterization laboratories. The system is cleared for us with a component physiological data collection unit - the Schiller Argus Pro
PB 1000 Monitor unit.
Code Information: Argus Pro PB 1000 firmware versions 2.41+M NIBP and 2.42.01+M Serial numbers prefaced with PB-1000: 765.001471, 760.001566, 760.001793,760.001882, 760.001920, 760.001934, 760.001970, 760.002043, 760.002113, 765.001168, 765.001307, 765.001520, 765.001553, 765.001599, 765.001609, 765.001510, 765.001632, 765.00165, 765.003014, 760.001320, 760,001552, 760.001555, 760,001920, 760.002107, 765.001224, 765.001306, 765.001608.
Recalling Firm/Manufacturer: McKesson Provider Technologies - Medical Imaging Group 1639 State Rt 10 Ste 100 Parsippany, New Jersey 07054-4506
Reason for Recall: McKesson has recently discovered that certain Horizon Cardiology Hemo systems were running specific Schiller Argus-Pro PB 1000 firmware versions that might cause a delay in the display of physiological parameters on the Horizon Cardiology Hemo Real Time Monitor Screen.
Action: The firm, McKesson, sent an "Advisory Notice" letter dated April 15, 2010, to all customers. The letter describes the problem, products affected, and actions to be taken by customers. The customers were instructed not to use the Emergency Replacement Hemo kit until they receive a replacement Schiller Argus Pro PB-1000 and they have contacted McKesson Support department at 1-866-777-0202. If you have any questions regarding this notice, please call our Customer Support department at 1-0866-777-0202 and ask to speak to your support Manager.
Quantity in Commerce: 26 units; 19 in operational use, 8 as emergency replacement units.
Distribution: Nationwide distribution: CA, CO, MD, NH, NT, NY, TN, and TX.

"Medical & Radiation Emitting Device Recalls." FDA U.S. Food and Drug Administration. U.S. Department of Health and Human Services, 9 July 2010. Web. 18 Nov. 2010.

Recall 2:
Date Posted: June 24, 2010
Recall Number: Z-1899-2010
Product: Horizon Cardiology Hemo Monitoring System A programmable diagnostic computer intended for acquiring digitizing, storing, displaying , and reviewing hemodynamic data for use in hospital cardiac catherization laboratories.
Code Information: Serial numbers: 2008052847, 2008072107, 2008092609,
2008092608, 2009010800, 2008121714, 2008101609, 2008101608, 2008101618,
2008110391, 2008110390, 2008110389, 2009020226, 2009020227, 2009030603,
2009030602, 2009030601, 2009110399, 2008110398, 2008051520, 2008051519,
Recalling Firm/Manufacturer: McKesson Provider Technologies - Medical Imaging
Group 1639 State Rt 10 Ste 100 Parsippany, New Jersey 07054-4506
Reason for Recall: McKesson has identified a potential hardware configuration problem in some Horizon Cardiology Hemo systems which may cause delay and/or loss of the patient's physiological parameters on the Horizon Cardiology Hemo screen and on the patient record.
Action: The firm, McKesson Israel Ltd., sent notification letter dated January 27, 2010 to customers. The letter describes the product, problem and action to be taken by customers and the firm. McKesson's will be contacting the customer to coordinate replacement of the sound component of the Horizon Cardiology Hemo system and will provide the additional sound adapter for all affected systems at your facility at not cost. The customers were instructed to please immediately conduct the following instructions to disable sound operations-1) Open McKesson Management Console and locate the Windsurfer>Monitor Settings; 2) Uncheck "Enable QRS beep" in the sounds section; 3) Locate Windsufer>Hardware Settings in McKesson Management Console, and 4) Uncheck "Enable QRS beep" in the Analog Output, QRS Beep Section. If you have any questions, please do not hesitate to contact Ronen Gans directly at (973) 355-9900.
Quantity in Commerce: 22 devices
Distribution: Nationwide distribution: CA, CT, FL, LA, NC, TN, WA, and WV.

"Medical & Radiation Emitting Device Recalls." FDA U.S. Food and Drug Administration. U.S. Department of Health and Human Services, 24 June 2010. Web. 18 Nov. 2010.

Recall 3:
Date Posted: April 10, 2009
Recall Number: Z-1156-2009
Product: NurseMate with Physio Module; Remote Review, Monitoring and Charting Station; USA EP MedSystems, Inc. Cooper Run Executive Park, 575 Route 73 North, Unit D, West Berlin, NJ 08090. Outer box labeled as Smiths Medical. The NurseMate Remote Review Station is an integrated review station for the EP WorkMate Computer recording system that allows a separate user to review and edit patient study date stored on the SP Work Mate System and monitor patient data from the EP WorkMate during a Patient study.
Code Information: Smith Medical Part Number: 87-1785-0000; Serial
Numbers: AM08080015, AM08080016, AM08080017, AM08080018, AM08080019, AM08100004, AM08100005, AM08100006, AM08100007 and AM08100008.
Recalling Firm/Manufacturer: St. Jude Medical 575 Route 73 North, Bldg D Cooper Run Executive Park West Berlin, New Jersey 08091
Reason for Recall: Installation problem: there is a risk that the monitor may not be adequately secured to the stand, resulting in the monitor falling off which may cause injury.
Action: St. Jude Medical received a recall notice dated January 16, 2009 from its supplier, Smiths Medical PM, Inc. St. Jude Medical prepared and sent their own recall letter dated February 13, 2009 to affected customers. The recall letter described the issue and possible associated risks and provided instructions to customers. A St. Jude Medical representative will contact customers to facilitate replacement of the fasteners. Questions should be directed to your St. Jude Medical sales representative.
Quantity in Commerce: 4 units
Distribution: Nationwide Distribution -- CA, NV, and FL.

"Medical & Radiation Emitting Device Recalls." FDA U.S. Food and Drug Administration. U.S. Department of Health and Human Services, 10 Apr. 2009.. Web. 18 Nov. 2010.>

Recall 4:
Date Posted: February 05, 2008
Recall Number: Z-0710-2008
Product: Horizon Cardiology Hemo Monitoring System; Horizon Cardiology Hemo External Control Unit;~100 - 230 VAC 50-50 Hz, Medcon Telemedicine Technology LTD.,Tel Aviv, 697190, Israel.
Code Information: Serial Numbers of subassemblies (ECUs) that contain
the affected power supply: A0199, A0200, A0201, A0205, A0208, A0209, A0210,
A0225, A0232, A0233, A0234, A0235, and A0236
Recalling Firm/Manufacturer: McKesson Provider Technologies 628 State Route
10 Whippany, New Jersey 07981-1522
Reason for Recall: Power supply reliability: McKesson received word from their manufacturer of the medical grade power supply that some power grade supplies may not provide reliable power output.
Action: Recalled by letter sent to the firm's customers beginning on 11-12-2007, advising them that the field correction would be completed by the recalling firm service technicians.
Quantity in Commerce: 13
Distribution:Nationwide to hospital and medical centers in LA. CA, PA and IL,

"Medical & Radiation Emitting Device Recalls." FDA U.S. Food and Drug Administration. U.S. Department of Health and Human Services, 5 Feb. 2008. Web. 18 Nov. 2010.

The following table lists the MedSun reports that are described in the device problem summary above.
[Note: The reports have been edited for clarity]

Adverse Events Table
Device IdentifiersCatalog #, Model #, Lot # Event Description
Biosense Webster, Carto 3 P1-40S0TY (Carto 3); P1-40SOYH (generator); P1-40S14C (Cool flow pump); P1-40S91R (navistar thermocool catheter) During an ischemic VT case, the Carto 3 system failed to correctly route pacing resulting in 3 total cardioversions that would have otherwise been unnecessary. The first instance resulted when the physician could not get the ablation catheter to pace due to failed routing. The second instance occurred as the physician could not get the pacing on the ablation catheter to disable through Carto 3, and thus RF could not be applied. In this case, the patient went into clinical VT, became unstable and required cardioversion. The third instance occurred when the user could not effectively ablatedue to a defective Redel cable. This Redel cable was reading low temperatures and the RF (radiofrequency) could not be turned on. A cable was changed and the issue was resolved. The vendor was notified along with a request for an investigation into the Carto 3 issues, especially the pace routing. The patient stabilized despite these equipment malfunctions.

Products in Use:
The Carto 3 system
The Stockert generator
The Cool Flow Pump
The Navistar Thermocool catheter.

Health Professional's Impression
During Ischemic VT ablation case, the Carto 3 system failed to correctly route pacing resulting in 3 cardioversions that would have otherwise been unnecessary.

Manufacturer response for EP mapping system, CARTO 3 System
St. Jude Medical, EnSite Velocity with NavX The EnSite unit has three components, a control, slave monitor and an amplifier. This unit is used as a mapping system to assist the physicians in locating areas that need radiofrequency ablating. The procedure can be performed without the system, however, it is more efficient with it. With the system in use,it was not properly identifying the reference catheters. The St. Jude rep was here to support the unit until the staff are trained. While on site, the representative identified the problem with the system and contacted their technical services where they determined the problem was with the amplifier. The EnSite seemed to be mapping okay once the rep worked with it a little. There were then no questions about where the lesions were made. The reference catheter was not seen visually on the screen until you reduced the magnification. But according to the rep and my understanding, the unit recognized the reference catheter as being in the proper location. Once the rep confirmed with St. Jude's tech service that the amplifier was the problem, they made arrangements to send out a new amplifier. The new amplifier is the same type as the as the original.

Health Professional's Impression
The Amplifier part of system was not working.

Manufacturer response for 3D Mapping (NAVX), St. Jude
Company replaced equipment.

St. Jude Medical, EP MedSystems EP Med Software Version 4.1.0 The electrophysiology (EP) four channel stimulator is connected to the EP Med recorder. While pace-mapping, during a ventricular tachycardia (VT) ablation, the EP Med froze and would not respond to the "HALT pacing" button on the keyboard. Pacing continued at a rate of 250 ms (240 beats per minute) instead of stopping after three to four beats while the EP Med system lagged, it continued to pace for four seconds, sixteen beats. The patient went into rapid, hemodynamically unstable ventricular tachycardia and required 200 joule external cardioversion. VT is induced intentionally as a normal course of the procedure, but this specific episode was unintentional. The procedure continued as planned and the patient suffered no harm. This software "freeze" prevented the EP Med system from communicating with the EP-4 stimulator, so pacing could not be stopped using the usual "HALT" pacing keyboard button until the computer lag resolved (4 seconds later). The prolonged rapid pacing in the ventricle resulted in a VT that was accelerated from the patient's baseline VT and caused hemodynamic collapse.
McKesson Corporation, Horizon Cardiology Release 12.2 McKesson has identified that when reporting ECG files from Mortara ECG carts, while the DICOM interface is in use, the Horizon Cardiology ECG management system does not display the amplitudes of the waveform properly.

Health Professional's Impression
The ECG waveform amplitude is 20% higher or lower than it actually is in comparison to the cart printout, affecting the waveform analysis algorithm in the ECG management system. This inaccuracy may result in false negative or false positive diagnosis. Cardiologist's believe patient safety is low.

Manufacturer response (according to reporter) for ECG Management, Horizon Cardiology
A software patch is in test environment.
McKesson Corporation, Horizon Cardiology CE-TCSHEM003 The patient was brought to cath lab for an emergent temporary pacemaker. The monitor tech initiated the Horizon cardiology program for monitoring the patient and documenting the case. The system failed to initialize. An error message appeared "Internal". IS was contacted, but they were unable to resolve issue. McKesson support was also contacted for assistance. The situation was not resolved until case was completed. All documentation and vital signs are done manually. There was no harm to the patient.
G.E. Healthcare, CardioLab/Mac-Lab/ComboLab Hewlett Packard XW8400, 2037934-003 The CardioLab system closed out of the application and returned to the Windows desktop during a procedure. The case could not be restarted. After consulting with GE tech support, the removable DVD disk was replaced and a new case started. Tech support recommended replacing the removable DVD disk. The engineer also stated that the application will close out of the program if it can not write to the DVD disk, even in the midst of a procedure. The field engineer was dispatched, confirmed the engineer's statements and download the applications and systems logs along with the patient study.
St. Jude Medical, EnSite Velocity The mapping system was not correlating the location of the ablation catheter correctly. It was displaying movements that were clearly not taking place when we looked under fluoroscopy. The system was connected correctly and configured correctly. The rep was operating the equipment and did not understand why this was happening. Tech services was called. It appears it was a software issue. In the meantime, we've adjusted some settings and still use the system with fluoroscopic verification of catheter placement. Manufacturer response: A software patch is coming out in March to address this issue.
Biosense Webster, Carto XP CARTOXP Approximately 15 minutes after the surface EKG leads had been placed on the patient, the EKG surface lead tracings on EP MedSystems went from showing sinus rhythm to showing no tracings (flat line). All surface lead and ground connections were confirmed. The Carto XP Com unit (processing unit) was turned off and all surface lead tracings instantly returned. The Carto system was rebooted. No further incidents occurred during the remainder of the case. There was no injury to the patient.
Biosense Webster, Carto XP M-4700-96 Carto has an issue with their equipment in one of our EP labs. When creating a map using Carto, the map itself will shift on its own. At first it seems as if the patient has moved when in actuality it is a glitch in the Carto system. This has happened multiple times in this particular lab. We do not believe that this is a disposable equipment problem. It is a problem with the mapping system (CARTO) and possibly how it is interacting with the X-ray system. This is an intermittent problem that happens during ablation procedures. The problem is not a direct patient safety issue. It does necessitate the use of more fluoroscopy and lengthen the procedure time which can lead to a patient safety issue. Carto updated software to version 9. We suspect a software issue. The mapping area is detecting a larger area with this new software which includes part of the x-ray system outside of the patient.
McKesson Information Solutions LLC, Horizon Cardiology and Siemens Medical Solutions USA, Inc., Axiom Artis

Images from the Siemens Axiom Artis system are supposed to be archived automatically by the McKesson Horizon Cardiology Information system. Sometimes this does not happen. Departmental policy is that at the end of each case the monitoring tech is supposed to verify that the images have transferred over. Once the transfer and archiving is verified, the images can be deleted from the Siemens system. In this case the team member noted that the images were missing, but didn't attempt to archive them. The team member then accidentally deleted the images from Siemens. Once deleted, these images can't be recovered. The cath procedure was re-done.

Additional Information:

1. "Programmable diagnostic computer." 21CFR870.1425. 2010.

2. Summary of Safety and Effectiveness. U.S. Food and Drug Administration, Web. 18 Nov. 2010.

Nov. 2010.

3. 510(K) Summary. U.S. Food and Drug Administration, Web. 18 Nov. 2010.

4. Chapter 2 - 510(k) Summary. U.S. Food and Drug Administration, Web. 18 Nov. 2010.

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