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U.S. Department of Health and Human Services

MedSun: Newsletter #92, February 2014

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Newsletter #92, February 2014

Articles

Trufill n-BCA Liquid Embolic System by Codman Neuro: Recall

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FDA MedWatch Safety Alert

Codman Neuro is informing physicians of this incorrect statement and updating the product's Instructions For Use (IFU). The product's IFU incorrectly noted: "A 2:1 (67% Ethiodized Oil / 33% nBCA) for feeding pedicle injections close to the nidus at high flow rates where venous opacification occurs on contrast injections within 1/2 second." The use of incorrectly mixed product can result in the liquid mixture solidifying too slowly in unintended areas, which may lead to embolization or reflux into arteries and pulmonary vessels.

Additional Information:

Trufill n-BCA Liquid Embolic System by Codman Neuro: Recall. FDA MedWatch Safety Alert. January 22, 2014.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm382556.htm

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t:slim Insulin Cartridges by Tandem Diabetes Care: Recall

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FDA MedWatch Safety Alert

Tandem Diabetes Care announced that it is initiating a voluntary recall of specific lots of insulin cartridges that are used with the t:slim Insulin Pump. The affected cartridges may be at risk for leaking. A cartridge leak could potentially result in the device delivering too much or too little insulin, which can lead to a serious adverse event.

Additional Information:

t:slim Insulin Cartridges by Tandem Diabetes Care: Recall. FDA MedWatch Safety Alert. January 14, 2014.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm381606.htm

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Truebalance and Truetrack Blood Glucose Meters by Nipro Diagnostics: Recall

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FDA MedWatch Safety Alert

The company determined that certain isolated TRUEbalance and TRUEtrack Blood Glucose Meters have an incorrect factory-set unit of measure that displays the glucose result in mmol/L rather than mg/dl. If a consumer were not to notice the incorrect unit of measure, it is possible that the meter result could be read as a lower than expected blood glucose result.

Additional Information:

Truebalance and Truetrack Blood Glucose Meters by Nipro Diagnostics: Recall. FDA MedWatch Safety Alert. January 8, 2014.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm380758.htm

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Highlighted MedSun Reports

Highlighted Reports

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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 January 2014. All other reports can be searched under the ‘MedSun reports’ menu pane.


A hospital has reported 4 cases of rapid onset failure of the Mitroflow® Aortic Pericardial Heart Valve manufactured by the SORIN Group:

Device:
Case #1:
Serial #: 279003
Model #: LXA21
Other device #: size 21 mm

Problem:
Case #1:
Death of a young teenager, 23 months after aortic valve replacement (AVR) - AVR as a pre-teenager with 21 mm Mitroflow for unicommissural aortic valve (AoV) with severe aortic regurgitation (AR). Echocardiogram (echo) 8 months post-op with no AR, aortic stenosis (AS) maximal instantaneous gradient (MIG) 18, mean 10. Last echo 16 months post-implant with thickening and decreased motion of single leaflet, MIG 32, mean 20, mild AR. Death occurred 7 months later (23 months post implant) in face of one day severe gastroenteritis. Patient has a history of unspecified connective tissue disease.

On autopsy of Patient 1, there was extensive linear and nodular calcification of all three leaflets with severe left ventricular hypertrophy and diffuse subendocardial ischemia. The cause of death is most likely terminal arrhythmia from decreased cardiac output related to dehydration in the setting of severe prosthetic aortic valve stenosis, left ventricular hypertrophy, and ischemic changes.

Device:
Case #2:
Model#: LXA 23
Lot#: 315604

Problem:
Case #2:
Explant of a young teenager, 20 months after AVR –Placement as a pre-teenager of 23 mm Mitroflow for bicuspid AoV with moderate AR and increasing left ventricular end-diastolic volume (LVEDV) z-scores. Echo 2 months post AVR with no AR, AS MIG 23. A follow up echo 14 months post-implant with thickening of right cusps and fusion of right/non commissure, trivial AR, MIG 35, mean 20. Repeat echo 6 months later (20 months after AVR) shows markedly thickened valve leaflets with very little systolic motion, mild AR, MIG 100 mm Hg. Gradient of 100 mm Hg confirmed in catheterization lab. Patient underwent repeat aortic valve replacement 20 months after Mitroflow placed. Patient has history of Ehlers-Danlos syndrome.

On explant on Patient 2, all leaflets are rigid and fixed in position without significant distortion. Nodular calcification is seen on gross inspection; histology and computed tomography (CT) scan show extensive calcification of the belly of the leaflet and of both commissures.

Device:
Case #3:
Serial#: 300667
Model#: 23 mm

Problem:
Case #3:
Explant of a pre-teenager, 29 months after AVR – Placement as a pre-teenager of 24 mm Mitroflow for dysplastic AoV with severe AR and increasing left ventricular volumes. Echos through 20 months post op with no AR, AS MIG 18-23, good leaflet motion. Last echo 29 months post-implant with poor leaflet excursion, trivial AR, severe AS MIG 102, mean 70. Patient underwent repeat aortic valve replacement 29 months after Mitroflow placed.

On explant on Patient 3, all leaflets are again rigid and fixed in position without significant distortion. Nodular calcification is seen on gross inspection; histology and CT scan show extensive calcification of the belly of the leaflet and of both commissures.

Device:
Case #4:
Serial#: 324377
Model#: 19 mm

Problem:
Case #4:
Explant of a young adult, 18 months after AVR - Placement as a pediatric patient of 19 mm Mitroflow for bicuspid AoV with aortic regurgitation and stenosis. Also has history of interrupted aortic arch and conoventricular ventricular septal defect (VSD) repaired. Gradient at valve by echos through 12 months ~25-35 mm Hg for MIG (multi-level left ventricular outflow tract obstruction), no regurgitation. Last echo 18 months post-implant with new gradient at valve of ~80 mm Hg, mild regurgitation; gradient of 75 mm Hg confirmed by catheterization. Leaflet morphology and function difficult to see on all echocardiograms. Patient underwent repeat aortic valve replacement 18 months after Mitroflow placed. Patient has history of DiGeorge syndrome.

On explant on Patient 4, 1 leaflet was densely calcified and fixed, an adjacent leaflet was moderately calcified with reduced mobility. The third leaflet was minimally calcified with near normal mobility. Mild tissue overgrowth was present around the sewing ring and base of some leaflets. There was no evidence for endocarditis or thrombosis.


Device:
Airway, Oropharyngeal, Anesthesiology
Manufacturer: Teleflex Medical
Brand: Ovassapian Airway
Lot #: 02E1300356
Cat #: BD6075

Problem:
This patient presented with shortness of breath and swelling of the tongue. He required emergent fiberoptic intubation. After the airway was secured, the ovassapian airway was not removed and was not visualized due to the protuberant tongue. 6 days later, the airway was removed at the time of the patient's elective extubation. The airway was not detected on chest x-ray and may have potentially contributed to the patient's need for re-intubation and ultimate tracheostomy.

At the internal review, recommendations were to have a discussion with the manufacturer to determine if the product may be improved to be more easily detected (i.e., color coding of the airway or marking with a radio opaque indicator that would be detected on x-ray). Although this is a very unique event, we would like to provide some assurance that this is not likely to happen again.


<Device:
Type: Intravenous Set, Administration
Manufacturer: CareFusion Inc.
Brand: Smartsite Infusion Set
Cat #: 2420-0007

Problem:
Intact SmartSite Infusion set found to have hair inside package. No patient was involved. The Supply Chain Analyst will be contacting the local vendor to come and pick this up for their internal investigation.


Device:
Negative Pressure Wound Therapy Sponge
Manufacturer: KCI USA, Inc.
Brand: V. A. C.
Model#: (not provided)
Lot #: (not provided)
Cat #: M6275034/10
Other #: (not provided)

Problem:
The patient was admitted from an out-of-state hospital (OSH) for treatment of an abdominal abscess and infected mesh graft from prior abdominal surgeries for ventral hernia. The patient was taken to the operating room (OR) for incision and drainage, pulse lavage and partial mesh removal. She was subsequently discharged with a plan for skilled home nursing care to manage the Vacuum Assisted closure (VAC) dressings. She was readmitted to an OSH 5 days later with sepsis and hypotension requiring intensive care unit (ICU) care, intravenous (IV) fluid boluses, antibiotics and vasopressors. She was then transferred back to our hospital for a possible abscess noted on computed tomography (CT) scan at the OSH. Upon arrival examination of the wound bed, we revealed a white retained VAC sponge. The wound was cleaned and the patient was discharged 2 days later. We have instituted a VAC sponge count policy at our institution to avoid this scenario, since a retained sponge can contribute to wound infection and poor patient outcomes. The white sponges absorb body fluid/blood and take on the appearance of the patient's regular tissue making them difficult to differentiate from tissue, especially if tissue starts to granulate over the sponges. Prior to this event we had asked the manufacturer to change the color of the sponges to something not associated with the human body. This would help with identification in large, tracking wounds, and hopefully lessen the risk of a retained object. In addition the dressings are non-radiopaque and do not show up on radiology images. Had they been radiopaque, it would have been seen on the CT scan performed at the outside hospital, possibly preventing the need to transfer this patient to a different out-of-state facility.


Device:
Ventilator
Manufacturer: DRAEGER MEDICAL
Brand: Babylog
Model#: VN500

Problem:
The ventilator shut off on its own while on a patient and displayed "Disk boot failure, insert system and press enter". Manufacturer response for Ventilator, VN500 (per site reporter): The manufacturer said with a disk boot failure error that it's either one of two things. Corrupt software or a bad sector on hard drive. They told me to try to reload software. I couldn't get past boot up screen. Ordered a new hard drive for VN500. Received and replaced hard drive and loaded software on hard drive. Tested within normal operating limits and put device back in to service.

Device:
Ventilator, Continuous, Minimal
Manufacturer: Respironics Inc.
Brand: Bipap Vision
Model#: 582059

Problem:
Nurse was in room with patient when BIPAP started alarming and went inoperable (INOP).
We reached out to Tech Support to help decipher the error codes. They responded with:
"We need to find out the revision level on the PC board. If the revision is seven or lower the tin contacts for the board connections have shown to cause communication issues per tech support. Boards sold now have gold contacts. They recommend replacing all boards if you have to replace one.

This upgrade kit to include cables is PN 453561505621 ($2562.00).

If the PC board revision is eight or greater, all the boards use gold contacts. It is most likely that the main control (MC) board is at fault. This could be confirmed by swapping MC boards with another BIPAP". Our unit has revision seven.


Device:
Type: Transducer, Blood-pressure
Manufacturer: Navilyst Medical
Brand: Namic
Model#: H749602301480
Lot #: 4697711
Cat #: 60230148
Other #: Namic Convenience Kit

Problem:
The nurse connected the transducer from the convenience kit to the pressure cable and the line to the patient. The nurse attempted to zero and could not. She tried different connections on the GE TRAM module and still it failed to zero. She used a different transducer separately packaged (a transducer by itself) and she was able to zero the transducer and continue with the case.

Device:
Type: Stirrups
Manufacturer: Allen Medical Systems, Inc.
Brand: Yellofin Elite

Problem:
The patient's legs were being positioned and as the surgical technician adjusted the Yellofin Stirrup, it broke. There was no patient injury. The patient ‘s leg was caught before it hit the operating floor. This has occurred on 3 separate occasions.

Device:
Table, Surgical
Manufacturer: Mizuho OSI
Brand: Osi
Model#: 5803

Problem:
Patient was positioned on OSI table with all locks secured. All three lock lights were on. At end of the case, the table spontaneously unlocked and abruptly "airplaned"at a 45 degree angle. Circulating nurse was standing at side of patient and was able to hold patient on table and call for help. Patient was quickly transferred to the hospital bed. The OSI table continued to tilt, airplaning more, and going into a quasi-reverse Trendelenburg at the same time, though nobody was touching the controls. The lights were checked again, and it was noted that the lock light was off, though nobody unlocked it.

Device:
Type: Bed, Pediatric Open Hospital
Manufacturer: Stryker Medical
Brand: Cub Cadet
Model#: FL19H
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
The nurse placed the patient in the crib and placed the side rails up in their locked position with the plastic top latched. The nurse responded to the patient and found him on the floor outside of the crib. The side rails were still in the upright locked position. The plastic cover was noted to be opened slightly. The opened space did not appear to be the mechanism that allowed the patient to exit the crib.
Concern noted that the patient may have been able to reach and unhook the latches on the side rails with the access doors, possibly explaining his exit from the crib.
Question if a device could be placed over the latches on the crib to prevent a child from inadvertently opening the latches.
Question if a visual cue could be added to the crib to validate the locking mechanisms are engaged. Question if a color code of red and green could be added to signify a locked verses an unlocked state.


Device:
Pump, Infusion
Manufacturer: B. Braun Medical
Brand: Infusomat Space
Model#: 8713050U
Other #: Hosp. Control # 23532

Problem:
The infusion pump was programmed to deliver a 50-mL Fentanyl solution at 0.26 mL/hr. The pump operated for 34 minutes before it was manually stopped. This occurred about the same time as the patient became apneic and the ventilator, which had been providing only CPAP, was set for controlled breathing.
About 30 minutes after the pump was stopped, it was noticed that the IV bag was empty. Allowing for some volume lost due to priming, it appeared that the patient received 25-30 mL of Fentanyl solution in about an hour.
Narcan was administered to counter the Fentanyl. The pump was discontinued and sent for testing.

The patient recovered to spontaneous breathing within 12 hours, was extubated some time later, subsequently transferred out of critical care and finally discharged to home approximately a week after the event.


Device:
Pump, Infusion, Syringe
Manufacturer: Smiths Medical
Brand: Medfusion
Model#: 4000
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
The power cord on the infusion pump burned and the unit stopped working. Smoke came out of the device and the case was severely burned and melted.


Device:
Set, Administration, Intravascular
Manufacturer: Hospira
Brand: Plumset Clave
Model#: 14242-28
Lot #: 34030 5H #
Cat #: 14242-28
Other #: Primary Plumset Clave Y-Site, 104 inch, Non-DEHP

Problem:
3 different nurses used Plum pump tubing with the same lot number (34030 5H #). 5 different pumps were used to rule out that variable. The message on the IV pump was consistently saying "distal occlusion" on the Plum pumps. Other Plum pump tubing was used with different lot numbers and infused without difficulty. The entire affected lot # has been pulled so that it will be out of use.

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Updated February 1, 2014

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