Highlighted Reports
MedSun: Newsletter #43, December 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 September 1 through September 30. 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: Flexible Patient Circuit With Filter
Manufacturer: Viasys Healthcare, Respiratory Care
Brand: Flexible Patient Circuit With Filter For 3100b Hfov And Fisher &Paykel Mr850 Humidifier.
Model#: P/N 16390-102
Lot #: 050409
Cat #: (not provided)
Other #: P/N L2712-102A also MO11163901

Problem:
Two Viasys HFOV (High Frequency Oscillatory Ventilator) Circuits were defective at the connection near the control valve. It keeps slipping off, not staying sealed, like it should have been glued but was not. Neither circuit was connected to a patient, so there was not any harm. One was noticed after it had been in storage and the other one was found yesterday as it was getting checked prior to patient use as it would not pass calibration.


Device:

Type: High Frequency Oscillatory Ventilator
Manufacturer: Care Fusion Cardinal Health
Brand: Sensormedics
Model#: 3100A
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
During setup prior to connection to patient, respiratory technician was unable to calibrate mean circuit pressure on high frequency oscillatory ventilator (HFOV). Respiratory therapist noted that the mean pressure adjust knob had turned past its mechanical stop and the RT was unable to calibrate ventilator. Ventilator exchanged and sent to Biomedical for repair.

Biomedical noted that the adjustment knob pointer was also used as the adjustment stop for the knob in the 5 O'clock maximum setting point. The stop post is a 2-56 threaded screw extending from the control panel. What we noted was the knobs pointer was forced past the stop post and the user could not calibrate the ventilator after that point. The knob can easily slip past the stop post with little or no user effort. Biomedical temporarily thickened the stop post by adding a 1/8" length of shrink tube over the screw. This prevented the knob from slipping past the stop post. We concluded that a minor design change may be needed to prevent the knob from going past the max adjust point.
Comment from FDA: Good example of Human Factors issue.


CARDIOVASCULAR

Device:

Type: Catheter, Ep, Mapping
Manufacturer: St. Jude Medical Cardiac Rhythm
Brand: Inquiry Optima
Model#: (not provided)
Lot #: K12445
Cat #: 1120-7-1(4.5)-SM-OPT25
Other #: (not provided)

Problem:
During the procedure, the catheter would no longer deflect or change the position of its curvature. The catheter was replaced with a new one. There was no harm to the patient.


Device:

Type: Defibrillator, External
Manufacturer: Zoll Medical Corporation
Brand: RSeries Defibrillator
Model#: R series
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
There was NOT a specific event involving a patient. We have discovered a design issue with the Zoll Medical R series defibrillators. Our facility has purchased 75 of these defibrillators which were placed on the nursing units one month ago. Since that time we have noted several issues:
(1) Zoll has supplied non hospital grade pigtail extensions,
(2) There is no locking device for the pigtail extension to the defibrillator, thus the connection is regularly being inadvertently disconnected and
(3) The pigtail extension does not properly connect with the hospital grade gray power cord. All of the components in this report are original equipment issued from the manufacturer.

First, in Zoll’s assembly recommendations, we followed the instructions that tell us to place the pigtail extension between the defibrillator and the hospital grade ac power cord (clearly marked hospital grade). This pigtail extension is 12 inches in length. But nowhere on the pigtail extension itself does it indicate that it is hospital grade. All hospital equipment used on patients must be powered by a hospital grade power cord per our facility policy. Zoll has informed us that this pigtail is not hospital grade. We are not sure of the purpose of this pigtail extension.

The second issue, there have been 9 trouble calls in our hospital where the pigtail extension is coming loose from the inlet receptacle on the defibrillator and is not charging the defibrillator battery. These problems were noted by nurses during daily defibrillator inspections. As an acting strain relief, a tie wrap was provided by the manufacturer along with illustrations on assembling the tie wrap to the unit to hold the pigtail extension. These were assembled prior to placing the defibrillators on the nursing units. However, this tie wrap does not sufficiently hold the pigtail extension in place to the (IEC receptacle) defibrillator causing it to come loose and not charge.

Third, we have also noticed the pigtail extension does not connect properly with the gray power cord. There is a 1/16 inch gap between the two connections and it appears the gray cord has a longer molded body which exceeds the female end of the pigtail cable.

Manufacturer response (as per reporter) for defibrillator, R series defibrillator

Our Director of Bio Medical has contacted the manufacturer to discuss our concerns. We have been informed by Zoll that they have received similar complaints of these issues from other facilities.

See device image
RSeries Defibrillator



Device:

Type: Defibrillator, Icd
Manufacturer: St. Jude Medical Cardiac Rhythm
Brand: Atlas +Dr
Model#: V-243
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
The patient is an adolescent with a history of catecholamine induced ventricular fibrillation and cardiac arrest. He has normal left ventricular systolic function. He received his initial ICD system after suffering an out of hospital cardiac arrest. Approximately 1 month ago, he was at the dinner table, got up and was carrying his plate and received a shock from his defibrillator. On interrogation of his device, shocks were inappropriate and secondary to likely fractured right ventricular (RV) lead conductor fracture. Per his request, his defibrillator was turned off. He was admitted for ICD lead removal with submuscular implantation of his ICD. After the RV lead was completely extracted, it was noted that a 2mm portion of the lead had fractured.
Since the ICD was almost 3.5 years old, it was not uncommon to change it out. The patient is doing well.

Manufacturer response (as per reporter) for AICD RV lead and AICD generator:
Awaiting response.


Device:

Type: Hyperthermia Unit, Forced Air
Manufacturer: Arizant Healthcare Inc
Brand: Bair Hugger
Model#: 750
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Post operative patient requested warming blanket. Staff covered patient with a warmer blanket attached to an Arizant 750 warmer. Shortly after staff noticed a "hot" smell near the patient. The smell was quickly narrowed down to the 750 warmer and it was removed from use and Biomed was called. On inspection the Biomed found the molded power cord plug charred. The power cord was replaced and the unit tested OK.

This is the second occurrence of this problem on units purchased last year. The other unit had cord issues ~3 months ago.
Comment from FDA:
For more information about recent power cord issues, please see:
Medical Device Power Cords Safety Investigation: Initial Communication online available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187117.htm and
Safety Investigation of Certain Medical Device Power Cords: Initial Communication online available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm187078.htm



Device:

Type: Interface Cable, Catheter Connector
Manufacturer: Biosense Webster
Brand: Hypertronics 25-pin
Model#: (not provided)
Lot #: 14068577
Cat #: C5MHNAVMHS
Other #: (not provided)

Problem:
The interface cable connection was defective. This was an out-of-the box failure. The cable would not display on the monitor that the catheter was connected. This cable is used between the catheter handle and the patient interface unit (PIU). The cable was replaced, and the catheter was displayed on the monitor. There was no harm to the patient.


Device:

Type: Monitor, Physiological
Manufacturer: Philips Medical Systems
Brand: Intellivue
Model#: MP70
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
After removing a BP cuff from a patient, a critical care nurse placed the rolled up cuff and tubing between the module rack and display of a Philips IntelliVue MP70 patient bedside monitor. This monitor was mounted above and adjacent to the patient bed but the mount was swiveled away from the bedside (not directly overhead). The auto-inflate setting was inadvertently left "on" for BP monitoring and it activated shortly after the RN left the patient's room. As it inflated it lifted the bedside monitor off of the two 1" mounting pins that it normally rests on. A spring loaded mechanical latch must normally be pressed in order to disengage the monitor from these pins but for some reason it had not automatically returned to a safe position. The upward pressure caused by the overinflated BP cuff subsequently caused the monitor to lift off of its mount and crash to the floor. The Philips IntelliVue MP70 is a bedside monitoring "system". Because it employs a modular design the modules themselves (i.e. BP module, SpO2 module, Multi-Measurement Server (MMS) and Pressure modules are all separate from the display monitor. They are contained in a separate module rack but as a whole constitute the IntelliVue Monitoring System. In this case the MMS, specifically the BP circuit, played a major role in this event.

See device images
Philips Monitor 1

Philips Monitor 2


Device:

Type: Stent, Cardiac, Bare Metal
Manufacturer: Boston Scientific
Brand: Liberte Bare Metal Stent
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Patient had a cardiac catheterization with stent placement. The physician requested a Liberte Bare Metal Stent and was given a Taxus Liberte (drug eluting) stent. The Taxus Liberte was deployed and documented by nursing in the patient's medical record. The patient was given a wallet card bearing this information. The physician documented in the medical record that he inserted a bare metal stent. Several months later in the process of clearing the patient for knee surgery, the patient’s primary care provider wanted/needed to discontinue the antiplatelets and discovered a discrepancy between the stent he thought had been inserted vs. the information provided to him by the doctor who performed catheterization/stent placement. There was no harm to the patient; however, it was thought that the surgery might be delayed due to the need to continue aspirin and Plavix therapy. The physician who placed the stent stated that packaging for both stents are identical, same box, same labeling. He does not see the box, and is only handed the equipment. The device type is "microscopically stamped" on the equipment itself but "who can see that?"

Comment from FDA - UPDATE: Boston Scientific has changed the name of the company's Liberté Bare-Metal coronary stent to VeriFLEX. The company took this action after reports that Liberté Bare-Metal stents were inadvertently implanted instead of TAXUS Liberté Drug-Eluting stents, and vice versa. The TAXUS Liberté Drug-Eluting stents will keep the same name. The company is re-labeling the outer boxes of all Liberté Bare-Metal stents currently in facilities' inventories. However, the pouch label, patient guide and directions for use card for these products are not being re-labeled at this time and will still bear the Liberté name. Boston Scientific is offering to provide hospitals and cath labs with additional information and training.

See device image
Liberte Bare Metal Stent

Taxus Liberte Drug Eluting Stent


For more information visit:
FDA Patient Safety News (video) - Liberté Coronary Stent Now Called VeriFLEX – November 2009 online available:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=92#4 and

Boston Scientific Field Correction Notice. Important Notice about the use of Liberté Bare-Metal coronary stents and TAXUS Liberté Paclitaxel Eluting coronary stents. September 18, 2009 online available:
http://www.bostonscientific.com/templatedata/imports/collateral/Coronary/liberte-field-action-091109.pdf



EAR, NOSE, & THROAT

Device:

Type: Cochlear Implant
Manufacturer: Advanced Bionics LLC
Brand: Advanced Bionics
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
First cochlear implant was defective. Second cochlear implant was implanted. Per audiology testing, there was a "hardware connection problem while communicating with implant." Audiologists checked connections and did the test a few more times, with the same result. Kept implant in patient, hoping that computer software is malfunctioning, rather than the implant.


GASTROENTEROLOGY & UROLOGY

Device:

Type: Biopsy System, Breast
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Mammotome (R)
Model#: MRP08XP
Lot #: E4M2LU, E4KE7G
Cat #: (not provided)
Other #: probe-F4NX66 and target set F4P57M (last case), PI1-46R2HK, PI1-46EOCY

Problem:
Patient had an MRI guided core biopsy as part of our trial of the J&J Mammotome system. MD noted that samples have what appears to be "black" looking material with the actual biopsy tissue. 8 samples taken on this pt - all but one had this visible black material. Vendor rep present stated she had not seen this before. Tried system again with different patient and different lot number and saw the same thing. Trial discontinued. Pathology evaluation described pliable, amorphous without architecture or structure under the microscope.

Manufacturer response (as per reporter) for percutaneous breast biopsy, Mammotome (R)

We are waiting for the results of their quality analysis. Several manufacturer reps were present at the time this was identified - it is my understanding that all expressed that they had not seen this phenomenon before.


Device:

Type: Hemodialysis, Crrt
Manufacturer: Gambro Renal Products, Inc.
Brand: Prismaflex
Model#: Prismaflex
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Machine was alarming increased negative pressure. Lines flushed without difficulty. Machine continued to alarm therefore attempted to inverse the lines. Upon completion attempted to continue therapy and the screen was frozen. The filter then became clotted.


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.


GENERAL & PLASTIC SURGERY

Device 1:

Type: Blade Electrode, Esu, Coated
Manufacturer: COVIDIEN LP
Brand: Edge
Model#: (not provided)
Lot #: (not provided)
Cat #: E1455
Other #: (not provided)

Device 2:

Type: Electrode, Esu, Handswitching Pencil
Manufacturer: COVIDIEN LP
Brand: Valleylab
Model#: (not provided)
Lot #: (not provided)
Cat #: E2515
Other #: (not provided)
Device 3:
Type: Esu
Manufacturer: Covidien Valley Lab
Brand: Force Fxc
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
The physician was performing a breast reconstruction procedure when the single-use ESU pencil hand piece sparked and physician's finger was burned (a minor burn). An arc from the ESU pencil's cord sparked across a surgical staff member's arm (no injury). The ESU pencil and blade electrode were sent to Biomedical Engineering for inspection. (The ground pad was discarded and so was not available for inspection.) The technician noted a large amount of debris built up on the electrode tip. The power out of the ESU was tested and passed. The pencil's cable assembly was flexed and there was no effect on power delivery noted. A new pencil electrode blade was placed on the ESU and results were the same. The Valley Lab Force FX was placed back into service. The single-use ESU pencil and blade electrode are available by request if the manufacturer would like to further inspect them.

Comment from FDA: Please see ValleyLab’s website for more information about ESUs and coated electrodes online available: http://www.valleylab.com/education/poes/poes_30.html


Device:

Type: Electrosurgical Unit
Manufacturer: COVIDIEN LP
Brand: Force Fx
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Patient was undergoing open heart surgery for mitral valve replacement and coronary artery bypass. The electrosurgical unit was under the surgical drapes when a cracking noise was heard. The drape was removed revealing a half-dollar sized full thickness burn. The bovie was immediately taken out of service and sent to Bio Medical Engineering. The surgeon documented in the OR report that there appeared to be a defect in the cautery cord which then conducted through a clamp and burned the patient's thigh. The OR staff thought the burn might have been caused by user error by a Physician Assistant. They commented that the bovie may not have been placed back in the holster under the drapes with the cord lying on top of the thigh.


Device:

Type: Instrument, Mallet
Manufacturer: Biomet, Inc.
Brand: No Bounce Mallet
Model#: (not provided)
Lot #: 124080
Cat #: 740042
Other #: (not provided)

Problem:
A sterile mallet broke open during a surgical procedure. The interior contents of pellets and powder spilled onto the sterile field into the wound. This was immediately isolated. Extra antibiotics were given to the patient. X-rays were taken and read as negative.


Device:

Type: Stapler, Anvil
Manufacturer: Covidien United States Surgical Corporation
Brand: Dst Series Eea Orvil
Model#: EEAORVIL21
Lot #: U8K126
Cat #: EEAORVIL21
Other #: (not provided)

Problem:
The ORVIL anvil would not position to attach to the EEA stapler like it is supposed to; so the Orvil device on the delivery tube had to be removed. A new Orvil device was used to complete the procedure. No apparent harm.


Device:

Type: Stapler, Reload, Surgical
Manufacturer: Covidien United States Surgical Corporation
Brand: Endo Gia
Model#: (not provided)
Lot #: N8D203
Cat #: 030426
Other #: US200902-0175, straight 45mm x 2.0mm

Problem:
Surgeon tried to use stapler but there was a loud pop and a small piece (about 1cm) of the mechanical linkage broke off the staple load and fell into the patient. It was retrieved but the stapling could not be completed.

Manufacturer response (as per reporter) for Stapler, Reload, Surgical, Endo GIA
[The device was a straight load but was reported to the company with the catalog number of an articulating one.] Quality Assurance and Engineering evaluated a partially applied ENDO GIA™ II 45-2.0mm Single Use Loading Unit and were unable to detect any discrepancies related to components or manufacture of the product. However, it was observed that the anvil was severely bowed, and the clamp bar had fractured at the hook above the knife blade. Material testing on the fractured clamp bar noted no abnormalities. Replication of damage such as anvil deformities and fractured clamp bars may occur under the following conditions:
1. Application over tissue that is beyond the recommended thickness range.
2. Firing with an obstacle incorporated in the jaws. In any of these circumstances, it will become increasingly difficult to actuate the firing handle and the instrument return knobs will be difficult to retract. In addition, staples may not form properly and tissue may not be fully transected.
The information booklet which accompanies each product shipment offers the following as a warning and precaution. "1. Preoperative radiotherapy may result in changes to tissue. These changes may. For example, cause the tissue thickness to exceed the indicated range thickness for the staple size. Careful consideration should be given to any pre-surgical treatment the patient may have undergone and in corresponding selection of staple size. 2. Always include the combined thickness of the tissue and any staple reinforcement material in use when choosing the proper staple cartridge."

See device image
Stapler


GENERAL HOSPITAL

Type: Infusion Tubing
Manufacturer: B. Braun Medical, Inc.
Brand: Ultrasite Outlook Safety Infusion System Iv Set
Model #: 470042
Lot #: (not provided)
Other #: US1504HP
Problem:
It has been brought to our attention our staff have been receiving an increase in "System Error 9" alarms from our B. Braun Outlook 100 pumps. Correspondence from B. Braun indicates they have tested various factors that could be contributed to the System Error 9 alarms resulting from the IV pump sets. Typically once the IV tubing is switched out the issue is remedied. B. Braun’s correspondence indicates their (quoted from letter) "testing to date has identified on a small percentage of IV set pump cassettes, the fluid channel was deformed during the manufacturing process. When these sets are placed into the Outlook and/or NXT pump, a system error 9 alarms may occur. The channel deformation has been determined to be a result of the properties of the resin material that was used to mold the rigid cassette. Use of this particular lot of resin has been discontinued." B. Braun has also indicated they will continue to work through this issue.

Clinical Engineering reported they have had 5 pumps returned to them over a two week period which all had "System Error 9" reports. Once the tubing was switched out the pumps ran fine. Unfortunately these incidents had not been reported to our office and our CE department did not retain the tubing in these incidents but have now been encouraged to do so. We have previously reported other "error 9" concerns.
Comment from FDA: MedSun has received similar reports from four different sites.

Device 1:

Type: Bed, Hospital
Manufacturer: Hillrom
Brand: Bed
Model#: P1900 Total Care Bed
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Device 2:

Type: Patient Bed Exit Monitor
Manufacturer: Direct Supply, Inc.
Brand: Economy Alarm
Model#: Attendant
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
A nurse reported that a care alert alarm (portable alarm) was de-activated when it was placed in close proximity to the bed speaker. Biomedical Services was asked to research why the alarm did not sound. Upon inspection, Biomedical Services found that Hill-Rom Bed model; Advance, Advanta, Total Care, and Versa Care bed’s speaker magnet can de-activate the magnetically activated portable alarm. If one of the portable alarms is near the Hill-Rom bed speaker it will not alarm. The bed’s speaker magnet keeps the portable alarm switch from activating. Hand held pillow speakers and beds from another manufacturer side rail speakers do not deactivate the portable alarms. Medical staff should always take care to secure the portable alarms away from any magnetic source. Hill-Rom Tech support was notified, and Biomedical Services were told that they would file a report. No reference number was given.

Manufacturer response (as per reporter) for Bed,

No feedback. He will file a report.


Device:

Type: Bed, Hospital, Electric
Manufacturer: Hill-Rom Company, Inc.
Brand: Total Care Gc
Model#: TOTAL CARE GC
Lot #: NA
Cat #: NA
Other #: NA

Problem:
Patient and two friends in room for stair transfer trial. Bed rail and bed height adjusted for additional right rail support, stair present in front of pt with wheeled walker available anteriorly. Upon repositioning of bilateral upper extremity (UE) support, and during education/discussion of procedure for stair transfer, the patient initiated the stair ascent prior to completion of patient education regarding adherence to bilateral UE force/push/pull restriction. The right bed rail fell while the pt had his right foot on the step, left UE supported by the walker. No fall occurred. Pt remained in place with gait belt support and started to walk away from the step and resisted cues for return to sitting position on bed. Nursing, nurse practitioner and resident aware, clinical exam initially unchanged, 10" following pt volitionally logrolling and sitting up to edge of bed to walk with nursing assist. Pt reported a change in left below knee numbness and was unable to maintain 5/5 left dorsiflexion.

Manufacturer response (as per reporter) for Electric Bed - Hospital, TOTAL CARE GC

Manufacturer is in process of modifying side rails.


Device:

Type: Enclosed Chemotherapy Administration Set/phaseal Injector
Manufacturer: Carmel Pharma
Brand: Phaseal
Model#: N35
Lot #: various
Cat #: (not provided)
Other #: Connector C45

Problem:
The Phaseal closed chemotherapy delivery system is problematic on our pediatric floors in a variety of ways. The injector contains a needle, and in order to prevent the needle from tearing a hole in the clave and causing a leak, we have to use a PhaSeal connector.

We give chemotherapy to our pediatric patients via three methods: push with a syringe, an IM injection or as a continuous infusion with a bag. The first issue is that the PhaSeal device is not compatible with the syringe pump we use (Medfusion), so in order to push a syringe, we have to use an infusion pump. We use Abbott Plum A+ pumps. The second issue that we have frequently experienced is the pump not infusing with the set up we have to use (injector/connector/clave). There's a pressure reading on the pump that needs to be below a certain level in order for it to infuse. The addition of the connector seems to raise the pressure and cause the pump not to infuse. The third, and most concerning issue is needle exposure. The addition of the connector makes it difficult to engage and disengage the needle injector from the infusion pump. It's awkward, and it is possible to apply enough twisting force to cause the safety mechanism on the injector to fail, exposing the needle when the device is removed.

We have also experienced tearing of the clave, despite having the connector on. A nurse was exposed to a chemotherapy agent when the membrane tore and the chemotherapy agent sprayed out from the connection. When we try to give an IM injection, the set up is unstable and difficult to use, particularly on an uncooperative patient. Finally, we are not able to use the device to its full potential because we cannot leave a needle connected to a child’s central line when infusing continuous chemotherapy.

Manufacturer response (as per reporter) for enclosed chemotherapy infusion, PhaSeal

Representative came out and spoke with the nursing staff, took photographs, but did not feel they needed the devices themselves. We have retained four devices where the needle was exposed, and the one in which the clave was torn.

Updates from the site:
The clave tearing is a separate issue from the trouble they’ve had disconnecting the device in general and exposing the needle. The clave was torn in the process of connecting the clave to the connector. The IV tubing was hooked into injector. When the pump suddenly stopped infusing, it indicated an occlusion at injector site. The nurse tried to troubleshoot by disconnecting and switching out the injector. When the pump continued to alarm indicating an occlusion again, she disconnected the connector, and chemotherapy sprayed. That’s when it was discovered that the needle had torn the clave.

Comment from FDA: Good example of Human Factors issue.

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.

See device images
Kendall Kangaroo Full

Kendall Kangaroo Valve


Device:

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

Problem:
The Syringe pump, under normal operation, loses approximately 1 minute per week from the system clock. This was discovered during repairs and preventive maintenance service in the clinical engineering department. The protocol requires insuring the system clock is correct. After setting the clock during an inspection, it was found that the clock was incorrect after several weeks in-use during the next inspection.

Manufacturer response (as per reporter) for syringe pump, Medex Syringe Pump:

Smiths Medical responded very quickly. They reviewed the issue and stated that the system clock was 'low priority' for the microprocessor and the pump was never designed to be an accurate time keeper. They maintain future software releases will correct the time issue. Wireless pumps will synch with server time each time they communicate.


Device:

Type: Infusion Pump
Manufacturer: Hospira Global Medical Affairs
Brand: Plum Infusion Pump
Model#: Plum XL and Plum XL3
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
To update the drug library on our Hospira Infusion Pumps using Mednet 5.1 software version, a new drug library is sent to the pump over the wireless infrastructure in the hospital. After the pumps receive the new drug library, it is supposed to prompt the user that the new drug library is available when the unit is turned off. Users will often turn on and then turn off a device to initiate the prompt when a device is not in use. It has been found that sometimes the pumps do not prompt when a new drug library is available.

An operator may assume that the infusion pump has the latest version of the drug library because the pump does not prompt that a new version is available. Drug library changes may have different drug limits and/or drug concentrations.

Manufacturer response (as per reporter) for Infusion Pump, Plum Infusion Pump:

The manufacturer has suggested a change to the process of initiating the prompt. Hospira recommended that when the pump is turned on, the user will need to leave it on for two minutes and then turn it off. Alternatively, the user may place a cassette in the unit and then turn it on and then off. When this process was employed, then the pumps consistently prompted the user when a new drug library was available.


Device:

Type: Infusion Pump
Manufacturer: Hospira Global Medical Affairs
Brand: Symbiq
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: Hospital # 207935

Problem:
The infusion pump was programmed for an Insulin infusion on Channel B of the device, and placed in a standby mode. When the clinician attempted to start the infusion, the pump malfunctioned with error code S421, Subgroup 9, pump bolus overshoot. The malfunction caused a delay in care to a critical cardiac post-operative patient.

The alarm history and event logs were reviewed by our Biomedical Department. Upon powering the device back on, the cassette was removed from Channel B of the infusion pump. However, Channel B would not close and could not be reset. The pump was sent to the manufacturer for analysis.

Prior to the recent recalls, we had reported several similar problems with error codes S321 and S421 which caused delays and interruptions in therapies. However, our pump inventory was swapped out and new software was downloaded to correct the issues we were previously reporting. To our knowledge, this is the first failure of this kind since our pumps were upgraded by Hospira post-recall.


Device:

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

Problem:
A critical PICU patient was on continuous vasopressors via an infusion pump, including epinephrine and norepinephrine. Without intervention, the channel that was infusing the norepinephrine drip spontaneously beeped and turned itself off reading "Channel Disconnect.” The drip was moved to another channel. Later, during transport to CT scan, two channels (norepinephrine and midazolam drips) also stopped. The patient’s blood pressure dipped slightly, but recovered quickly when the channels were restarted.

Comment from FDA: Please see Class 1 Recall Alaris System Inter-Unit Interface (IUI) Connectors online available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=82452 and
FDA Patient Safety News (video) - Alaris (Medley) Infusion Systems Recalled – October 2009 online available:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=91#4


Device:

Type: Iv Tubing
Manufacturer: Baxter Healthcare Corporation
Brand: Clearlink System Extension Set
Model#: 2N8378
Lot #: (not provided)
Cat #: 2N8378
Other #: (not provided)

Problem:
IV extension set, Baxter 2N8378 has been noted on several occasions to restrict the flow of IV fluid. This item is used on nearly all IV tubing. In the past couple of weeks, we have had 4 known instances where it greatly restricted the flow by gravity of the fluid. When replaced with another, the flow is much better. On one occasion it was assumed that the IV that had just been established was bad and this malfunctioning piece caused extra IV attempts for the patient, increasing discomfort and risk of infection. When the piece was replaced the problem was solved.


Device:

Type: Iv Tubing
Manufacturer: Hospira Global Medical Affairs
Brand: Lifeshield Plumset Iv Tubing
Model#: 11943-12
Lot #: 770405H
Cat #: (not provided)
Other #: (not provided)

Problem:
Several nurses have reported the threaded connector does not seal properly (the tubing will not screw into the blue port and becomes disconnected easily). It continues to spin as one attempts to establish a tight connection.

Manufacturer response (as per reporter) for IV Plum tubing, (brand not provided):

The manufacturer representative visited the impacted facility to evaluate the reported problem. The representative reported this particular device had been "upgraded" approximately eight months previously, but that it should work the same way. The facility was not aware of the "upgrade" and how and if any changes to the device would cause the device to operate differently.


Device:

Type: Steam Sterilizer
Manufacturer: Getinge
Brand: 733 HC Sterilizer
Model#: 733 HC
Lot #: 05E06109
Cat #: (not provided)
Other #: (not provided)

Problem:
14 trays being sterilized for surgery. 1 tray was wet when opened after 7 other trays from load were used already.

Manufacturer response (as per reporter) for Steam sterilizer, Sterilizer

Reps came out twice to evaluate. Replaced jacket trap and replaced drip leg trap then released unit for use.

Device:

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

Problem:
A patient was transported from the OR on multiple IV pumps infusing vasopressors. Shortly after anesthesia left the bedside, the IV pump with the carrier fluid for the vasopressors failed with no warning. The patient's blood pressure dropped acutely, and the patient required an Epinephrine spritzer and two fluid boluses of 5% Albumin. The IV pump was quickly changed out, and the patient was stabilized after the pump was changed. The pump did not beep low battery in the ICU or down in the OR per the anesthesiologist. When the pump was plugged in after the event, the readout said 0% battery power. The response time was immediate, and having spare IV pumps in the Clean room is a life saver in these kinds of instances.

Our Biomedical Department evaluated the pump and determined the issue to be related to a defective battery, and the battery will be replaced.


Device:

Type: Temperature Probe, Rectal/esophageal, Single Use
Manufacturer: Cincinnati Sub Zero
Brand: Steri-probe
Model#: 491B
Lot #: D727416
Cat #: (not provided)
Other #: (not provided)

Problem:
The machine operated for approx. 6-8 hours, then "Check Probe" message came on and the machine stopped working in the middle of ECMO therapy.
Additional information obtained from the site:
There are only 2 left from that lot number. The department recently ordered another batch. The sheathing looks different so they may have changed designs or gone to another supplier.
Biomed was made aware of this situation through a repair call and not an occurrence report. the patients' outcome in this case are UNK. We learned that the department had been dealing with this issue for a while and rectifying the problem on the floor by swapping out probes.

Health Professional's Impression:
Original probe was removed from patient and discarded. Another probe from the same lot number was tested by Biomed. It produced the same problem. Further testing revealed that there was a problem with the RJ-11 connector.

Biomed test result:
Biomed initially duplicated complaint under normal setup conditions. Then they cut off RJ-11 and connected directly to cable/device using alligator clips. The device ran for several hours with no problems. Physical examination of the remaining connector revealed that the wires were loosely attached and pulled out easily.


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.

Comment from FDA: For more information please view a FDA Patient Safety News (video) - Inaccurate Readings with Philips Avalon Fetal Monitors – November 2009 online available:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=92#5


PHYSICAL MEDICINE

Device:

Type: Stretcher, Hospital, Electric
Manufacturer: Stryker Medical
Brand: (not provided)
Model#: 1550
Lot #: (not provided)
Cat #: 1550
Other #: (not provided)

Problem:
During venous ultrasound, Pt was placed in extreme reverse trendelenburg. The Stryker model 1550 electric stretcher actually makes contact with its own parking brake release mechanism when the table is placed in a 50-60 degree position and it trips the brake - leaving a patient in a compromised position with the ability for the entire stretcher to free-wheel around the room. This is a risk for patient injury.

Manufacturer response (as per reporter) for Stretcher, Hospital, Electric:

They are looking into it and will be in contact.


RADIOLOGY

Device:

Type: Radiation Shield With Support Arm
Manufacturer: Ti-Ba Enterprises, Inc.
Brand: Mavig
Model#: OT25U50 10KG
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
The metal arm and radiology shield broke off from the machine while the machine was being positioned over the patient. The broken part struck the staff person who sustained only minor injuries.

This is the third arm that has come off a machine.

Device 1:

Type: Ultrasound Gel Warmer
Manufacturer: Ideal Products, Inc.
Brand: (Not Provided)
Model #: GW208
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Device 2:

Type: Ultrasound Gel
Manufacturer: Parker Laboratories, Inc.
Brand: Scan
Model #: Scan
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Ultrasound gel warmer shorted out and burned the bottles of gel to the warming plate. Smelled like burning rubber.

The gel warmer (Ideal Products) had heated the gel product (Parker Laboratories) to a point where the gel bottles at the top were disfigured (they had expanded) so that the bottles could not be removed without dismantling (unit is held together by rivets which had to be drilled). Upon inspection of the internal components it was noted that on the right hand heating receptacle for the gel bottles the metal tape (used to hold the heating element to the cylinder) had come loose and as such the shielding had become overheated.

The recommendation of the manufacturer in the operation of these units is that the warmer be turned off overnight and on the weekends as some gels and lotions tend to break down and separate when exposed to heat for extended periods of time. We discussed the unit with Ideal and they told me that the unit is equipped with a thermoswitch (rated at 160 degrees) in case the unit overheated.

There are no plans to return the device to the manufacturer. The only sign of heat damage was the wiring which was taped to the receptacles and at points that would be expected during normal operation.

See device images
Gel Warmer

Gel Warmer Bottles



~~~~
Type: Fluid Container
Manufacturer: Ross Pediatrics/Abbott Nutrition
Brand: Similac Glucose Water, Pedialyte, Similac Water
Model#: 34450 FAN 8405
Lot #: Unknown
Cat #: Unknown
Other #: Not applicable

Problem:
The pediatric nursing floor is concerned regarding the packaging of Similac Glucose Water, Pedialyte and Similac Water. All of these products are in identical blue plastic containers/bottles. The labels are different but not distinctively different. The staff are concerned that they will give the wrong product to a patient. They have expressed concern more than once. They would like the packaging changed.

The three items are all the same size, color and all have the same lid. The containers are identical, only the labels differ.

Comment from FDA: Please note that this is product is not a device.


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