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U.S. Department of Health and Human Services

MedSun: Newsletter #64, September 2011

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Newsletter #64, September 2011

Articles

ShoulderFlex Massager by King International: Safety Communication - Risk of Strangulation

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FDA MedWatch Safety Alert

FDA is aware of reports to the Consumer Product Safety Commission of one death and one near-strangulation associated with the ShoulderFlex Massager. These incidents occurred when a necklace and clothing became caught in a piece of the device that rotates during use. Two other reports involved clothing and hair became caught in the device. Do not use or recommend use of the ShoulderFlex Massager. Dispose of the device components separately so that the massager cannot be reassembled and used.

Additional Information:

FDA MedWatch Safety Alert. ShoulderFlex Massager by King International: Safety Communication - Risk of Strangulation. August 26, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm269765.htm

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GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH)

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FDA MedWatch Safety Alert

The HCH device may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient. Customers have been directed to NOT use the anesthesia circuits containing the Vital Signs Devices Passive Humidification Device (Hygroscopic Condenser Humidifier, or "HCH"), or the stand alone HCH device with the affected product item numbers and lot numbers, and to isolate all affected product.

Additional Information:

FDA MedWatch Safety Alert. GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH). August 3, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm266580.htm

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Arrow International, Inc. Arrow NextStep Antegrade Chronic Hemodialysis Catheter

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FDA MedWatch Safety Alert

FDA notified healthcare professionals of a Class I recall of the Arrow NextStep Antegrade Chronic Hemodialysis Catheters, due to reports of breakage and/or separation of the stylet. The affected products were manufactured between April 14, 2011 and May 9, 2011. See Customers should check their stock, cease use and distribution, and quarantine all affected product.

Additional Information:

FDA MedWatch Safety Alert. Arrow International, Inc. Arrow NextStep Antegrade Chronic Hemodialysis Catheter. August 3, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm266526.htm

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CDC issues checklist for infection prevention in out-patient settings to accompany new guide

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The Centers for Disease Control (CDC)

Facilities using this checklist should identify all procedures performed in their ambulatory setting and refer to appropriate sections to conduct their evaluation. Certain infection control lapses (e.g., re-use of syringes on more than one patient or to access a medication container that is used for subsequent patients; re-use of lancets) can result in bloodborne pathogen transmission and should be halted immediately. Identification of such lapses warrants immediate consultation with the state or local health department and appropriate notification and testing of potentially affected patients.

Additional Information:

CDC. Infection Prevention Checklist for Outpatient Settings: Minimum Expectations for Safe Care. July 12, 2011.
http://www.cdc.gov/HAI/settings/outpatient/checklist/outpatient-care-checklist.html

CDC. Guide to Infection Prevention in Outpatient Settings: Minimum Expectations for Safe Care Website. May 2011.
http://www.cdc.gov/HAI/settings/outpatient/outpatient-care-guidelines.html

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LabNet

8 Safety Tips for Working with Reproductive Hazards

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Lab Manager Magazine

The United States Department of Labor defines reproductive hazards as "substances or agents that may affect the reproductive health of women or men or the ability of couples to have healthy children." To minimize the danger of agents that fall into the category of reproductive hazards, managers and workers can follow these tips.

Additional Information:

Lab Manager Magazine. 8 Safety Tips for Working with Reproductive Hazards. August 3, 2011.
http://www.labmanager.com/?articles.view/articleNo/4982/article/8-Safety-Tips-for-Working-with-Reproductive-Hazards

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HeartNet

External Defibrillators: Strategies for Home Users and Public Access AED Owners to Maintain Readiness of Automated External Defibrillators

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FDA Website

Automated External Defibrillators (AEDs) are critical life-saving devices that are used successfully thousands of times in the U.S. each year to treat patients experiencing sudden cardiac arrest. The FDA recognizes the important life-saving benefits of AEDs and that users trust they will operate properly. It is unlikely that an AED will malfunction; however, the FDA is aware of infrequent problems with AEDs that impact patient safety. The following are strategies for home users and public access AED owners to maintain readiness of automated external defibrillators.

Additional Information:

FDA Website. External Defibrillators: Strategies for Home Users and Public Access AED Owners to Maintain Readiness of Automated External Defibrillators. November 11, 2010.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/ExternalDefibrillators/ucm233450.htm

External Defibrillators. FDA Website.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/ExternalDefibrillators/default.htm

External Defibrillator Improvement Initiative. MedSun Newsletter. December 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=55#12

Summary of MedSun Reports Describing Problems with External Defibrillation and Multifunction Electrodes. MedSun Newsletter. July 2011.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=62#19

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HomeNet

Health Care Comes Home: The Human Factors

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The National Academies Press

Health Care Comes Home reviews the state of current knowledge and practice about many aspects of health care in residential settings and explores the short- and long-term effects of emerging trends and technologies. By evaluating existing systems, the book demands and the capabilities of users. Health Care Comes Home recommends critical steps to improve health care in the home. The book’s recommendations cover the regulation of health care technologies, proper training and preparation for people who provide in-home care, and how existing housing can be modified and new accessible housing can be better designed for residential health care. The book also identifies knowledge gaps in the field and how these can be addressed through research and development initiatives.

Additional Information:

The National Academies Press. Health Care Comes Home: The Human Factors. 2011.
http://www.nap.edu/catalog.php?record_id=13149

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KidNet

Details Crucial When Reporting Adverse Events Due to Medical Devices

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The American Academy of Pediatrics (AAP) Newsmagazine

Rapid identification of adverse events associated with medical devices is essential to prevent injury or death. Unfortunately, many adverse events reported to the Food and Drug Administration (FDA) do not include vital information such as the patient’s age, which may delay identification of problems in the pediatric population and result in under-reporting of serious adverse events in children.

Additional Information:

AAP News: The American Academy of Pediatrics Newsmagazine. Details Crucial When Reporting Adverse Events Due to Medical Devices.
http://aapnews.aappublications.org/content/32/4/10.2.full

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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 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.
======================
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
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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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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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Medical Device Problem Summaries

Summary of MedSun Reports Describing Problems With Implanted Subcutaneous Ports and Catheters

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Implanted subcutaneous ports and catheters consist of an implanted reservoir that connects to a long-term intravascular catheter which allows for repeated access to the vascular system for infusion of fluids, medications, and sampling of blood. Specially designed ports may also be used for power injection of contrast media. The portal body with a resealable septum and outlet is made of metal, plastic, or a combination of these materials. The catheter is either pre-attached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design (Code of Federal Regulation, Title 21). Over the past year MedSun has received 51 adverse event reports associated with implanted port devices manufactured by the following firms: AngioDynamics, Bard Access Systems, Inc., MedComp, Navilyst Medical, and Smiths Medical. The reports were submitted by 33 hospitals between June 2010 and June 2011.

The reported device problems were:
• 13 reports associated with breaks
• 18 reports associated with cracks, splits, and fractures
• 6 reports associated with device separation
• 3 reports associated with retained foreign body
• 3 reports associated with hole/torn material
• 3 reports associated with leaks
• 2 reports associated with failure to aspirate/inoperable
• 1 report associated with a wrinkled sheath
• 1 report associated with the device expiration
• 1 report associated with migration

There were no reports that resulted in patient death and 36 reports had no patient problems reported. In the reports where a patient problem was identified, one or more problems may have occurred. In 15 reports the patient problems reported were:
• 5 reports of pain
• 3 reports of extravasation
• 2 reports of erythema
• 2 reports of device fragments in patient
• 2 reports of swelling, and bruising
• 1 report of infection
• 1 report of embolism
• 1 report of a needle stick

Of the reports that listed patient age, 6 had a patient age listed as less than 21 years and 37 reports had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 20 reports involved female patients and a total of 17 reports involved male patients.

These MedSun reports summarized above, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems.

The following recall(s) are associated with implanted ports since June 2010 through June 2011. The MedSun Reported events may, or may not, be involved in the recall(s) listed.

Recall Number: Z-2671-2011
Date Posted: June 27, 2011
Product: B. Braun Celsite Venous Access Port
Code Information: Reference # Model# Lot# 04430425 ST301 J31396U 04430095 ST305V J312177U 04433823 ST301G J313197U K021193U 04437025 ST501G J312178U 04436725 ST315 J295789U
Recalling Firm/Manufacturer: B. Braun Interventional Systems
Action: B. Braun Interventional Systems, Inc. sent an Urgent Medical Device Recall letter on April 16, 2011 to all affected customers.
Distribution: NY, ND, OK, PA
Link: http://www.accessdata.fda.gov/scripts/cdrh/cjdosc/cfRES/res.cfm?id=100140

Recall Number: Z-2235-2010
Date Posted: August 17, 2010
Product: MedComp ® Low Profile CT Port with Pre-Attached Chronoflex ® Polyurethane Catheter
Code Information: Lot# MAZL603, Exp. 04/2015
Recalling Firm/Manufacturer: Medical Components, Inc.
Action: Medcomp sales reps and foreign distributor were notified via email on 7/1/2010. Product is to be returned to Medcomp.
Distribution: Worldwide and country of Israel.
Link: http://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfres/res.cfm?id=93071

Recall Number: Z-1874-2010
Date Posted: July 1, 2010
Product: Navilyst Medical, Inc. Vaxcel ™ Port Titanium Standard Port with 8F Silicone Catheter
Code Information: Catalog no. 45-320, UPN# M001453200, Sterile, Rx only. Previously distributed by Boston Scientific Corporation. Lots 1264960, 1283256, 1342235, 1371638
Recalling Firm/Manufacturer: Navilyst Medical, Inc.
Action: Navilyst sent Urgent Medical Device Recall-Immediate Action Required letter/recall notification packages on May 12, 2010
Distribution: Worldwide and countries of Belgium, Brazil, Canada, Colombia, Croatia, Germany, Greece, Hong Kong, Italy, Saudi Arabia, South Korea, Spain, Tunisia, and United Kingdom.
Link: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=91839


The following table lists the MedSun reports that are described in the device problem summary above.

Additional Information:

CFR - Code of Federal Regulations Title 21. Online available:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=880.5965

MedSun Reports Describing Problems with Implanted Subcutaneous Ports and Catheters
Device Manufacturer and BrandDevice Identifiers (Catalog Number, Model Number, Lot Number) Event Description
AngioDynamics Catalog# CT96STSD 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.
AngioDynamics/Smart Port Ct Catalog# CT66LTPD Lot# 534770 Smart Port was being prepared to be implanted in patient. It was flushed with heparin and the tubing was seen to be leaking. A second port was opened and utilized to complete the procedure.
Medcomp Catalog# MRCT166041M Lot# MBDJ570 Staff believe the peel away sheath was defective. It wrinkled and would not insert. A second catheter was used with no trouble.
Bard Access Systems, Inc./PowerPort Model# 1808060 Lot# RESE0776 Patient came in for port catheter removal. MD removed right internal jugular PowerPort. Patient later identified lump under skin; ultrasound revealed a small piece of plastic from the PowerPort retained after port catheter removal.
Bard Access Systems, Inc./PowerPort Model# 1808000 Lot# REUA0625 Patient has stage III ovarian cancer. PowerPort implanted for administration of chemotherapeutic medication. During CT scan, a hole was discovered in the catheter when contrast was being pushed.
Bard Access Systems Inc./MRI Low-Profile Implanted Port Catalog# 6603880 Port implanted four years ago. Two months ago the patient returned to the Emergency Department with complaints of pain under left breast. The CT angiogram showed the catheter had fractured just distal to the catheter hub. The port and catheter were successfully removed.
Bard Access Systems Inc./MRI Low-Profile Implanted Port Lot# REUD1022 Patient presents to facility with non-functioning port. The port was accessed and would not flush or aspirate. The port was believed to be occluded. The patient was brought to the OR for a revision. The port was accessed and contrast was injected. Extravasation contrast was noted at the port hub connection. The port was removed.
Bard Access Systems, Inc./Groshong Catheter with PowerPort Catalog# 1808560 Patient with recurrent leiomyosarcoma of uterus had Groshong catheter PowerPort placed in the left subclavian. The device was removed a month later. During removal the catheter broke off device, which then required removal by Interventional Radiology. The port catheter fractured at the base where it attaches to the port. This was discovered when saline was ran through the port.
Bard Access Systems, Inc./PowerPort Unknown Port catheter was noted to have a 6-mm vertical split in subclavian region upon scheduled removal.
Bard Access Systems, Inc./X-Port ISP Catalog# 0607555 Lot# REUI1270 The guide wire was threaded through the needle that was inserted into the internal jugular vein. The skin was incised in preparation for insertion of the port. The silicone catheter was tunneled under the skin using the tunneling device. The dilator was threaded over the guide wire. The guide wire was removed through the patent dilator. At the completion of the procedure, the surgeon noted that the guide wire core was broken and the outer wire surrounding the core appeared to be unraveled.
Navilyst Medical/Xcela Power Injectable Port Catalog# H965451030 RN in ER accessed patient's port with a power loc safety needle because he had a port catheter device card that indicated the port was an Xcela Power Injectable Port suitable for IV contrast injection. RN used this card as identifier, but when patient went to CT x-ray of chest was done as second identifier and the "CT" symbol that was supposed to be second ID was not on the port. This made the port unusable per our policy and since patient refused to have IV started for contrast CT had to be done w/o contrast. Product is supposed to have this symbol on their ports suitable for use with IV contrast and with the power loc needle.
MedComp Catalog# MR594048P Lot#MAWN690 Patient had a low profile 4.8 Fr. indwelling medication port. A bubbly blood return was detected during a port check. The port was flushed and the dressing became wet. Intraoperatively, the patient was noted to have a hole through the back wall of the port. The port was explanted and replaced with a new port. The explanted port had two needle punctures through the plastic needle stop backing.
Bard Access System, Inc. Model# 605420 Malfunctioning port was removed. According to the surgeon, it was leaking. Notes from the history and physical: “Recently she developed some symptoms including pain and swelling with access and injection of the port. A portogram demonstrated a leak in the proximal portion of the catheter and she now presents for removal of that catheter." Notes from the operative report. "The port was examined. I did not see any obvious crack or erosions in the catheter." There were no complications. The patient tolerated the procedure well.
Bard Access System Model# 607540 Lot# REUA1232 An 8 French catheter was being inserted in preparation for chemotherapy. The introducer to the catheter broke while being inserted. The patient was not injured.
Bard Acesss Systems Catalog# 1808560 Lot# RETJ0442 Bard Groshong Catheter with Power Port implanted. Fifteen months later patient having port flushed when physician noticed approximately 20 cm of distal tip of guide wire sticking out of the catheter.
Bard Access Systems Model# 9954 Bard Mediport part catheter tip broke off into two pieces inside patient and the tip traveled to the left ventricle. Pieces of the catheter and port were successfully removed. Mediport and two pieces of catheter were saved and returned to patient after taking pictures.
AngioDynamics/Vortex TR Vascular Access Port Model# SSAX-16-1 Five months ago a port was removed from a patient who had completed cancer treatment. Unbeknownst to the surgeon at the time, the strain relief sleeve was retained subcutaneously in the soft tissue of the patient's left upper chest wall. The strain relief sleeve is a piece of silicone tubing about 2cm long that fits over the connection of the port reservoir stem and the catheter. No record could be located for the port lot number. However, at the time the operating room was using the above model for that size port exclusively in patients on the pediatric service. Recently the surgery team was first made aware that the patient was complaining of discomfort from an object under the skin medial and adjacent to the port incision scar. The shape of the object matches the size of the catheter sleeve seen on the chest x-ray.
Bard Access Systems, Inc./PowerPort Groshong Lot# RETK005 Patient had a malfunctioning port. He receives chemotherapy. Patient was taken to the OR and a break in the catheter was found. Catheter was replaced and is functioning.
Bard Access Systems, Inc./PowerPort* isp M.R.I.* Implantable Port Catalog# 1808560 Port catheter was inserted. A piece of the port sheared off and ended up in pt's right ventricle. The doctor removed the port and catheter immediately. The field rep retrieved the defective port/catheter and reported to FDA. Patient had a port reinserted on the other side.
Bard Access Systems, Inc. Catalog# 0602240 Lot# RETH0831 Patient had port catheter removed due to positive blood cultures and a tender incision site. The wound was angry and pus filled. The physician was trying to manipulate the port as little as possible during the removal dissection process. The patient learned a year later there was a small retained piece in the soft tissue of the pectoralis muscle. There are 3 pieces to the port catheter. The tubing, the hub mechanism, and the port itself. It was the hub mechanism that was retained. It was superficial and safely removed. The hub mechanism is not radiopaque.
Bard Access Systems, Inc./PowerPort Catalog# 1808060 Lot# RETK0668 The port catheter used for chemotherapy was scheduled to be removed. Upon removal it was noted that a crack was in catheter.
AngioDynamics/SmartPort CT Catalog# CT80STPD Lot# 503654 Port catheter was removed from patient. Catheter was non-functioning and had a fracture in the tubing.
AngioDynamics/SmartPort CT Catalog# CT80STPD Lot# 995830 Port catheter was removed from patient. Catheter was non-functioning and had a fracture in the tubing.
Smith Medical MD, Inc./Gripper Plus Power p.a.c. Model# 21-3362 Lot#470x38 While deaccessing a patient's port catheter, the device was very difficult to remove and required pulling more firmly. It finally came out, but did not retract into the foam covering resulting in a needle slice to the nurse's left thumb.
Bard Access Systems Inc./PowerPort Catalog# 1808000 Lot# RES80919 Upon removal of PowerPort, the catheter was noted to be split.
Smiths Medical MD Inc. Model# 21-4483 Lot# 1807288 Physician was implanting a Deltec single lumen PowerPort in patient. When advancing the catheter onto the port hub the catheter tore off with a portion of the catheter remaining on the port. A new port was needed and the catheter was trimmed to fit on the new port. The same catheter remained.
Bard Access Systems Inc./PowerPort Catalog# 1808000 Lot# RETE0243 PowerPort was removed. It was noted that a crack was in the catheter.
Angiodynamics/SmartPort CT with Vortex Port Catalog# CT96STSD Lot#519430 Patient had port catheter placed in left subclavian and returned seven months later with suspicion of access line fracture of the catheter. The catheter was evaluated and during this process ruptured into the proximal portion. The fractured port catheter was successfully removed. There was no patient injury.
Angiodynamics/Vortex SmartPort Catalog# CT965TSD Lot# 994828 Patient had port catheter placed in left subclavian. The patient returned nine months later for a non-functioning catheter. Chest x-ray revealed a fracture of the catheter between the first rib and the clavicle with tip in the right atrium. The catheter was successfully removed the following day. There was no patient injury.
Angiodynamics/CT SmartPort Catalog# CT96STSD Patient had a port catheter placed in left subclavian at this facility and returned seventeen months later due to a non-functioning catheter. A portogram showed a fractured catheter at the junction of the first rib and clavicle. The distal tip was in proper position and the catheter was tested. However, the surgeon was unable to demonstrate any type of leak from the catheter. The catheter was removed successfully the following month and a new one was placed in the right subclavian. The removed catheter was sent to pathology for evaluation. There was no patient injury.
Angiodynamics/CT SmartPort Catalog# CT96STSD Lot# 995828 Patient had port catheter placed at this facility and returned six months later due to non-functioning catheter. Upon removal, it was noted the port tubing had broken completely apart and the detached portion had migrated to the patient's heart. The remaining portion of the tubing was removed successfully in tact. There was no patient injury.
Bard Access Systems Inc. Model# 602660 Lot# REUD0913 During general surgery a split sheath broke at the handle externally to the percutaneous site.
AngioDynamics/Vortex VX Vascular Access Port Lot# 25384 The low profile AngioDynamics catheter stopped working. The surgeon decided to remove the catheter and discovered that it was broken during the explantation process.
AngioDynamics Catalog# MP-P5SAT Lot# 503882 Patient scheduled to have a mediport dye study for assessment of mediport. This study was being completed due to the fact that the parents, homecare, and outside hospital were not having success with blood returns even with interventions such as altepase. After mediport accessed and an image was taken, it was noted by MD that the catheter was detached from the mediport. The tubing and port were removed and was replaced with new line.
Bard Access Systems, Inc./Port Low Profile Catalog# 605840 Lot# REUA0729 During chemotherapy treatment it was noted the staff had some difficulty accessing her port. The patient states that the same evening she had pain around the port in her left chest. The patient noted some redness and slight swelling. The patient apparently had a problem with extravasation of some of the chemotherapeutic agents in the subcutaneous space around her left subclavian port hub site. There is an impression from the surgeon that a linear tear of about .5 cm was apparent in the catheter.
Bard Access Systems, Inc./PowerPort Duo Lumen Model# 1829500 The port was removed about thirteen weeks later due to non-functioning.
Boston Scientific Lot# 1123660 Patient had this Infusaport implanted four years ago for chemotherapy administration. A few weeks ago, after having determined that the port was dysfunctional, this patient went to surgery to have the port removed. The surgeon placed the catheter in traction and immediately noted that the catheter separated from the port apparatus with minimal pressure. It sheared off at the hub. This was a clean cut. The patient did not suffer an adverse event. However, the surgeon believed this port had fatigued, which probably caused this event.
Bard Access Systems, Inc./PowerPort Catalog# 1808060 Lot# RETK0974 Port had been implanted earlier this year. The catheter was split rendering it unusable. Six months later the device was removed and replaced.
Bard Access Systems, Inc./ PowerPort Unknown The PowerPort catheter was removed after it was found to have two splits in catheter. The device was replaced with new PowerPort.
Bard Access Systems, Inc./PowerPort Unknown The PowerPort catheter was due for removal, as patient had completed chemotherapy. Upon removal of catheter, surgeon noted that the catheter was split.
Bard Access Systems, Inc./MRI Low Profile Implanted Port Catalog# 0603880 Lot# REUF0110 Surgeon reports that the outer sheath is almost impossible to split and remove.
AngioDynamics/Vortex Port-A-Cath Catalog# MP-P5SDT Lot# 949904 Catheter broke into multiple pieces upon removal.
AngioDynamics/Vortex Port-A-Cath Catalog# MP-P5SDT Lot# 29209 Catheter broke into multiple pieces upon removal.
AngioDynamics/Vortex Port-A-Cath Catalog# MP-P5SDT Lot# 26330 Catheter broke into multiple pieces during removal.
AngioDynamics/Vortex Port-A-Cath Catalog# MP-P5SDT Lot# 947059 The locking collar separated from the main body of the Vortex port, and the port catheter fractured at the tip of the spigot. A second incision was made superior to the port pocket and the catheter shaft was exposed. The catheter shaft was encircled with loops. The shaft was severed and a microwire was passed through the residual catheter fragment into the venous system and manipulated down into the inferior vena cava. The port collar and small fractured catheter fragment were then dissected free from the site of the port pocket. Next came the removal of the internal port catheter fracture, which required blunt and sharp dissection around the subcutaneous tunnel all the way up to the root of the neck where the catheter entered the internal jugular vein. This was performed from the secondary incision circumferentially around the catheter. Thus, the remaining catheter fragment was explanted intact.
Bard Access Systems, Inc./PowerPort Catalog# 1809600 Lot# REUDO409 After the port was inserted the nurse was not able to aspirate blood. However, the port flushed with ease. 500ml of saline was infused and a cardiac drug was given. After infusing a portion of a unit of blood, the patient had swelling surrounding the port site. The transfusion was discontinued at that site and a peripheral IV was started.
Smiths Medical/Port-A-Cath II Model# 21-4055 Lot#M39098 Patient had a port catheter placed five years ago for monthly IVIG (intravenous gamma globulin injections). The day before admission, the IVIG was attempted to be placed in the port-a-catheter, but there was extravasation confirmed by a dye study. The patient developed pain at the site and faint erythema over the breast. She was taken to the operating room where the port itself came out. There was a split in the catheter right at the port insertion site, which explained the extravasation. The catheter absolutely would not leave the tract. It was dissected down to where the catheter dived underneath the first rib, clavicle, and sternum, but would not dislodge. After intraoperative phone conversation with a chest surgeon, a decision was made that the most prudent thing was to just ligate the catheter, cut it, and leave it in the end of the subcutaneous space. Although this is not ideal, it seemed more appropriate than actually going into her chest after the catheter. The patient received intravenous antibiotics overnight, and the following morning the slight erythema over her chest was improving. There was slight bruising at the site of removal, otherwise it looked benign. She was therefore discharged to home with another six days of oral antibiotics. Plans are to have a new port placed once she has been without any evidence of infection for approximately a week.
Bard Access Systems, Inc. Model#1806061 Lot#RESJ007 A port was placed in the patient. After completion, it was noticed that the product had expired.
Bard Access Systems, Inc. Model# 602270 Lot# REUC1573 The physician was inserting an implantable port. After the port was secured in place, the physician attempted to remove the introducer. There are two tabs on either side of the introducer that are used to do this. As the tabs were pulled, one of them broke off in the surgeon's hand. The surgeon was able to remove the introducer without incident. The patient was not harmed. However, the surgeon said he considers this to be very dangerous as the event had the potential to have ruptured the patient's artery. The surgeon and staff involved in the event are very experienced and have performed this procedure hundreds of times. No one involved in the event, including the physician, has had this happen before. There were no obvious defects to the device that were seen before implanting the port. No unusual/excessive force was used to pull the tabs. The tabs were not twisted, flexed, or dorsiflexed. The surgeon believes there may be a problem with the way this device was manufactured. The port itself remains inside the patient. The introducer and tabs as well as device packaging are being returned to the manufacturer. We are awaiting their device return kit at this time. The surgeon believes there may be a problem with the way this device was manufactured.
Bard Access Systems/PowerPort Catalog# 1088061 Lot# RESE0885 The patient had surgery to remove the cracked Bard PowerPort. The PowerPort was originally inserted approximately 22 months ago by the same surgeon. The surgeon replaced with a new Bard PowerPort. The cracked explant was sent to the lab with instructions to then forward the device to Risk Management.
Navilyst Medical/VAXCEL Catalog# 46-363 Lot#1373199 During outpatient infusion of chemotherapy through a port catheter inserted approximately seven weeks ago, a leak was noticed by patient's oncologist. Patient with history of breast cancer returned to OR for ambulatory removal of the port catheter and insertion of a new port catheter. The leak was found at the base of the device.

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Updated September 1, 2011

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