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U.S. Department of Health and Human Services

MedSun: Newsletter #30, November 2008

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Newsletter #30, November 2008

HeartNet

Review of the Registry's Second Year, Data Collected, and Plans to Add Lead and Pediatric ICD Procedures

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By Dr. Bruce Lindsay, et al
PubMed

Summary in process by PubMed

Additional Information:

Review of the Registry’s Second Year, Data Collected, and Plans to Add Lead and Pediatric ICD Procedures. By Dr. Bruce Lindsay, et al. PubMed. September 2008.
http://www.ncbi.nlm.nih.gov/pubmed/18774117?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDoc

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LabNet

Problems with Medical Devices Used in Point-of-Care Testing

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Lynn Henley, M.S., M.B.A., Mingdong Zhang, M.D., Ph.D., Ruth Chesler, M.T., and Ann Chappie, M.T., Center for Devices and Radiological Health, Food and Drug Administration

This is the second in a series of articles discussing point-of-care (POC) testing in the clinical setting. The first provided an overview of point-of-care testing (http://www.fda.gov/cdrh/medsun/.) The second will address adverse event data regarding point-of-care devices received in the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Medical Device Reporting (MDR)/Manufacturer and User Facility Device Event (MAUDE) database.

A search for adverse event data was conducted on June 2, 2008, consisting of the most common problems reported to the Office of In Vitro Diagnostic Devices (OIVD) in CDRH for a two-year period. The CDRH MAUDE database was searched to find the top 100 reported medical device problems, excluding those with glucose meters, occurring for point-of-care devices during the period from June 1, 2006 through June 2, 2008. Glucose meters are currently responsible for the majority of adverse event problems received for point-of-care devices. This data was excluded due to coverage of the subject in a recent article in the MedSun newsletter entitled, “Analysis of Glucose Meter Medical Device Reporting (MDR)/MAUDE Database,” http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news+21. This article discusses the 10,000 reports received annually involving glucose meters. The reports capture serious adverse events including malfunction, injury and death. The majority of the reports cite inaccurate readings as the problem. FDA is currently working to determine major causes for inaccurate readings of glucose meters and to identify solutions.

Other than reports for glucose meter problems, there were 3,742 reports received by OIVD/CDRH in the MAUDE database during this two-year period. Please note that the CDRH MAUDE database is not representative of all problems that exist with POC devices but is representative of those problems that have been reported. Furthermore, the products listed may or may not be the most commonly-occurring devices in the marketplace. The following products comprise the balance of devices with problems reported in this data search:


Table 1. Point-of-Care devices from Top 100 In Vitro Diagnostic devices listing of adverse events identified in June 2006 to June 2008 data search by product.
PT/INR Testing Systems I, II, and IIIPoint-of-Care Blood Analyzer 6+ Cartridge
PT/INR Testing StripsPoint-of-Care Blood Analyzer CREA Cartridge
Pregnancy Test I and IIPoint-of-Care Blood Analyzer CTNI Cartridge
Home Pregnancy Test I and IIPoint-of-Care Blood Analyzer
”25” Pregnancy TestHuman Chorionic Gonadotropin Test System


Within this product group, the most commonly-reported device problems were “replace” (1030 reports or 27.5%), “results inaccurate” (1823 reports or 48.8%), and “high readings/test results” (595 reports or 15.9%). The results of the data search are summarized in Table 2. Please note that device descriptions are listed below the table.




Table 2. Commonly reported problems with point-of-care devices with greater than 10% incidence listed by device name (June 2006 - June 2008).*
Replace Replace as % of All Problem Codes for this DeviceResults Inaccurate Results Inaccurate as % of All Problem Codes for this Device High Readings/Test Results High Readings/Test Results as % of All Problem Codes for this Device False Positive Test Results False Positive Test Results as % of All Problem Codes for this Device Other Problems**Total
DEVICE NAME:
I. Coagulation Devices
CoaguChek S System 958 30.8%150148.2%48914.5%00%1643112
CoaguChek Strips 0 0%120%240%00%2 5
CoaguChek System2428.9%3542.2%1615.7%00%8 83
CoaguChek XS System 43 14.7%23580.5%113.4%00%3 292
II. Pregnancy Kits
Confirm Clearly 00%00%00%1090.9%1 11
Confirm Clearly Home Pregnancy Test 0 0%00%00%1100%0 1
Confirm Clearly Smart Home Pregnancy Test 00%00%00%1100%0 1
Confirm Clearly Smart Pregnancy Test 0 0%00%00%2100%0 2
Icon 25 HCG 00%00%00%00%21 21
III. Critical Care Analyzers
i-STAT 6+ Cartridge16.3%212.5%00%00%13 16
i-STAT CREA Cartridge0 0%00%00%00%14 14
i-STAT CTNI Cartridge00%2559.5%1023.8%00%7 42
i-STAT PT/INR Cartridge1 3.6%414.3%1967.9%00%4 28
Stratus CS Stat Fluorometric Analyzer3 2.7%2017.7%4640.7%00%44 113
TOTAL103027.5%182348.8%59315.91%140.8%282 3742


*Device Descriptions

CoaguChek (Roche): CoaguChek is a portable analyzer that tests prothrombin time.

Confirm Clearly (Mizuho): Confirm Clearly is a pregnancy test. It is no longer on the market.

Icon 25 hCG (Beckman Coulter): Icon 25 HCG is a portable pregnancy tester.

i-Stat (Abbott): i-Stat is a portable blood gas and critical care analyzer that tests blood gases, electrolytes, chemistries, coagulation, cardiac markers, and hematology. The 6+ cartridge tests sodium, potassium, chloride, BUN, glucose, hematocrit, and hemoglobin; the CREA cartridge tests creatinine; the cTnl cartridge tests troponin; and the PT/INR cartridge tests prothrombin time.

Stratus CS Stat Fluorometric Analyzer (Siemens): The Stratus CS Stat Fluorometric Analyzer is a portable analyzer of cardiac markers.

The problem codes listed below in Table 3 represent those problems least commonly reported (<10%):

Table 3. Listing of all codes falling into “other” category from Table 2.

1. Incomplete aspiration
2. Clogged
3. Coagulation
4. Broken components
5. False claim
6. False-negative test result
7. False-positive test result
8. False readings
9. Filling problem
10. Interference
11. Melts
12. Misassembly
13. Misplacement
14. Nonstandard

15. Occlusion
16. Puncture
17. Unable to obtain readings
18. Repair
19. Failure to retract
20. Rupture due to damage from surgical instrument
21. Slippage
22. Accidental spillage
23. Incorrect device
24. Improper/incorrect procedure
25. Other (for use when an appropriate device code cannot be identified)

26. Unknown (for use when the device problem is not known)
27. Blood contaminated device
28. Residue
29. Failure to deliver
30. Malfunction
31. Obstruction
32. Cut(s)
33. Low readings/test results
34. Error message given
35. Difficult to close
36. Folding issue


This data search is the first step in looking at typical problems with point-of-care devices. The problems identified here reflect the need for the laboratory community to ensure that quality controls are in place. For instance, the most common problem identified was replacing equipment or equipment components. If this as well as other quality controls are in place, some of the reported problems could be minimized.

Reporting adverse events to FDA will also minimize POC device problems. As a result of increased reporting by the laboratory community, FDA will be able to work together with healthcare professionals and manufacturers to ensure that our database is more reflective of the types of problems seen in the clinical community so that these issues can be addressed in order to protect the public health.

Acknowledgments are made to Marilyn Flack, Donna Engleman, and Christine King, Center for Devices and Radiological Health, Food and Drug Administration.

Reference:
U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Center for Devices and Radiological Health, Medical Device Reporting Manufacturer and User Facility Device Event Database. Retrieved June 2, 2008, from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm.

Additional Information:

Problems with Medical Devices Used in Point-of-Care Testing. By Lynn Henley, M.S., et al. October 2008.

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FDA Clears New CDC Test to Detect Human Influenza

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FDA and CDC Press Release

The U.S. Food and Drug Administration (FDA) today cleared a new test developed by the U.S. Centers for Disease Control and Prevention (CDC) to diagnose human influenza infections and the highly pathogenic influenza A (H5N1) viruses.

The device, called the Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel), uses a molecular biology technique to detect flu virus and differentiate between seasonal and novel influenza.

The device is used to isolate and amplify viral genetic material present in secretions taken from a patient’s nose or throat. The viral genetic material is labeled with fluorescent molecules, which are then detected and analyzed by a diagnostic instrument called the Applied Biosystems 7500 Fast Dx, also cleared today by the FDA for diagnostic use simultaneously with the CDC’s rRT-PCR Flu Panel.

The test panel and diagnostic system can detect and identify commonly circulating human influenza viruses as well as influenza A (H5N1) viruses. Results can be available within four hours and the system can test multiple samples at once.

“This is a significant achievement for public health surveillance,” HHS Secretary Mike Leavitt said. “The test allows us to better support laboratories on the front line of influenza testing in the United States and abroad.”
“The application of the test to detect an emergent influenza virus would be especially important in the early stages of a pandemic,” Secretary Leavitt added. “This breakthrough allows for a more timely detection of a pandemic virus, which helps in determining when to begin broad control strategies as well as life-saving mitigation measures, such as closing schools, cancelling social gatherings and informing businesses to begin work-at-home policies.”

The test will be available to CDC-qualified laboratories for diagnosing influenza this fall, and some laboratories will be able to obtain reagents (certain substances used in the testing process) at no cost. This test should help ensure the accuracy of influenza testing results among the different qualified laboratories that conduct influenza subtype testing.

“This new test provides us another tool in our toolbox to fight seasonal influenza, a virus that unfortunately kills thousands of people each year in the United States,” said CDC Director Dr. Julie Gerberding. “We’ll now be able to detect influenza in the community faster, which allows us to take steps more quickly to protect and save lives.”
Since influenza viruses are always changing, test reagents need to be evaluated regularly against circulating viruses to ensure the sensitivity and specificity of the test to diagnose current influenza viruses.

“Because the test can tell the difference between seasonal human influenza viruses and novel viruses, it will also provide qualified laboratories with a means to rapidly detect new influenza viruses that have not been identified yet and that could pose a pandemic risk," said FDA Principal Deputy Commissioner and Chief Scientist Dr. Frank Torti, M.D., M.P.H.

The CDC, Applied Biosystems of Foster City, Calif., and the Association of Public Health Laboratories collaborated on the development of this new test. State public health laboratories in Virginia, Iowa, California, Massachusetts, Wisconsin, and Washington performed clinical evaluations of the new flu panel.

Scientists around the world are concerned that the H5N1 virus could one day mutate and acquire the properties needed to quickly spread between people, resulting in a pandemic. H5N1 viruses circulate widely in birds in Asia, Africa and Europe and have caused human illness and death. These viruses have never been detected in the Americas.
For more information, please visit www.pandemicflu.gov, and www.cdc.gov

Additional Information:

FDA Clears New CDC Test to Detect Human Influenza. FDA and CDC Press Release. September 30, 2008.
http://www.hhs.gov/news/press/2008pres/09/20080930a.html

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SightNet

Still Not Seeing Clearly - A Second Look at Intraocular Lens Implant Events

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Pennsylvania Patient Safety Authority

Wrong-side surgery and implantation of an incorrect intraocular lens (IOL) are some of the reported adverse events associated with eye surgery. As a result patients may need a second procedure to implant the correct lens. This article provides recommendations on implementing and following a consistent process for verifying the IOL before implantation.

Additional Information:

Still Not Seeing Clearly – A Second Look at Intraocular Lens Implant Events. Pennsylvania Patient Safety Authority. September 2008.

http://www.psa.state.pa.us/psa/lib/psa/advisories/v5n3september_2008/sep_2008_v5_n3_article_iolimplant.pdf

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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 August 1 through August 31. 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.


CLINICAL CHEMISTRY

Device: Analyzer, Troponin; Centaur
Lot# TNI reagent lot 027/Calibrator
Manufacturer: Siemens Healthcare Diagnostics
Problem: Our technologist noticed an unusual pattern of results for Troponin for patients from the ED. She called the ED and notified them of her suspicions, and told them she was going to investigate a potential instrument malfunction. She told the ED staff that she would notify them of her investigational outcome. The technologist identified the problem as a depletion of a wash 1 solution that caused the instrument to report falsely elevated Troponin results on three patients. She corrected the instrument issue and reran the patient samples on our other instrument and notified the ED of the corrected results. The technologist reviewed and reran


CARDIOVASCULAR

Device: Defibrillator, External, Biphasic; M Series
Manufacturer: Zoll Medical
Problem: Attempted cardioversion on a patient whose BMI=28.9. The first shock was delivered at 120J biphasic, using externally applied pressure. There was no effect. Attempted again with 200J (the device maximum) using externally applied pressure. The patient remained in Afib. Obtained another manufacturer's 360J biphasic defibrillator and successfully cardioverted from Afib with one shock at 360J. The Zoll M Series device was tested by our Biomedical engineering dept and is working within specification.

Device: Shunt, Carotid; 9 F; Pruitt-Inahara Carotid Shunt (Outlying)
Other device #: REF # 2000-49
Manufacturer: LeMaitre Vascular, Inc.
Device lot #’s PIS1157, PIS1157, PIS1345
Problem: During carotid surgery three Pruitt-Inahara carotid shunts did not function as expected. Either the balloon would not completely inflate or deflate and the third one leaked. There was no impact to the patient at any time. The first shunt (lot #PIS 1157) was found to have the balloon not be completely round and would not deflate on testing. The second shunt (lot# PIS 1345) would not inflate evenly and would not deflate. The third and final shunt (lot # PIS1157) was leaking after it was finally inflated.

Device: Proximal Seal System, Anastomosis; HeartString II
Lot #8030771
Other device #REF HSK-2043
Manufacturer: MAQUET Cardiovascular
Problem: Patient scheduled for CABG x 4 with aortic valve replacement. Part of the procedure involves placement of a coiled suture patch (HeartString II Proximal Seal System) which is placed in the aorta prior to anastomosis. After anastomosis, the Seal System was withdrawn with some difficulty, appeared to get "stuck" and the associated anastomosis appeared disrupted. A second Seal system was deployed without incident and repair of the disrupted sutures was performed. The first Seal System strand was measured and appeared to be approximately 8 mm shorter than the expected standard length. It appeared that the Seal System strand had broken off at some point during withdrawal.

Device: Laser, Cardiac Lead Removal System; LLD #1
Lot # LLD080514B
Catalog #518-018
Manufacturer: Spectranetics

Device: Laser, Cardiac Lead Removal System; LLD E
Lot #LLD080512B
Catalog #518-039
Manufacturer: Spectranetics

Problem: The cardiologist was using Spectranetics laser lead removal equipment LLD#1 and experienced the same problem with the first three devices. Each came apart or broke while in use and were no longer functional as the lock failed to hold together. The doctor also attempted the lead removal with a Spectranetics LLD E laser lead removal device. This device failed to unlock and a small portion of it had to be left in the patient within the lead.

Device: Module, Physiologic, Multi-parameter; Ultraview SL Command Module
Model #91496
Manufacturer: Spacelabs Healthcare
Problem: Patient in PICU went into SVT and required cardioversion. Standard procedure requires staff to utilize a Physio-control LP9 defib with sync cable from our Spacelabs Module. They sync cable connects with the "hi01" output jack from the Spacelabs Module to the LP9 defib patient input connector. Staff were unable to obtain ECG signal through to the LP9 defib via sync cable. The situation was resolved by attaching the defib directly to the patient's chest electrodes.

After the event occurred, an organizational wide review of all other Spacelabs Modules identified a total of nine other modules that showed the same problem. The manufacturer was contacted and a field service tech confirmed that device failure. The manufacturer has requested that all nine modules be shipped to them for further investigation. The manufacturer has also made arrangements to over-night send replacement modules. Of interest, the serial numbers for the failed devices are sequential.

Device: Monitor, ECG; Cardio-respirator
Model #M1094B
Manufacturer: Hewlett-Packard Co.
Problem: The neonate was in the NICU for care and treatment, and receiving multiple treatments. The infant's heart rate was noted to be 37 with O2 sats of 32 without the sounding of any alarms. The Cardio-Respirator monitor alert alarms have the ability to be turned off or down so low that they are unable to be heard. This is not a safe feature and compromises the safety of patients. The next revision of software (C.0) prevents caregivers from turning alarm volume to zero or non-audible. Our facility is in the process of moving from software version B.0 to C.0. The infant was resuscitated and is currently doing fine.

Device: Electrode, Defibrillation; stat-padz
Manufacturer: ZOLL Medical Corporation

Device: Defibrillator
Model #PD 1200
Manufacturer: ZOLL Medical Corporation

Problem: Patient was being defibrillated and spark caused small fire resulting in second degree burns to patient's chest. Oxygen was in use at the time.


ANESTHESIOLOGY

Device: Ventilator, Transport; iVent 201
Model #1.4.5 iVent 201
Manufacturer: VersaMed, Inc.
Problem: Transport ventilator was turned on, calibrated and placed on patient. Functioning properly until patient given sedation, and then a red "service alert" alarm flashed. The alarm was silenced and the alarm screen disappeared and the ventilator appeared to function appropriately. Then during transport from PICU to CT scan, the alarm occurred again and the patient began to desaturate. The Fio2 was increased and the saturation improved. In the CT scan room the patient gas source was attached to the wall outlet, and the patient saturation was stable during that time, however the alarm continued intermittently while the ventilator continued to function appropriately. While transporting from CT back to PICU the patient began to desaturate, and when increasing the FIO2 from 40 to 60%, there was no improvement in patient saturation. The patient's saturation was in the mid 80's upon return to the PICU and when placed on another ventilator at a lower FIO2, the saturations were 100%.

The patient had ET CO2 monitoring during the entire transport and this was never compromised, with values maintaining at 38-40%.
The transport ventilator was checked by Clinical Engineering after the event. It was noted that the ventilator does not have a way to display the actual FIO2 values, only the set value. Another problem with the design of the ventilator, is that when a service alert is issued, no details of the problem is given. There is a service code written to the service log, but that information goes away when the ventilator is shut off.

Device: Ventilator, Portable LTV Ventilator
Model #LTV 1000
Manufacturer: Pulmonetic Systems, Inc.
Problem: The patient was placed on a LTV(portable ventilator)for transport to Radiology (power source was the external battery). The ventilator shut itself off. The patient was removed from the ventilator and was manually ventilated with an ambu bag. The ventilator turn itself back on and the alarm LCD window said "RESET." The ventilator appeared to be functioning, but then shut itself off again. The patient was continuously manually ventilated with an ambu bag during transport and was being closely monitored. The patient did not suffer an adverse outcome because of this event. The patient was placed on a new LTV ventilator upon arrival to the Radiology Department. Follow-up: The ventilator was tested by Biomed staff and problem as stated above was repeated approximately eight times while connected to a test lung. This unit was also subject to a manufacturer recall (capacitor) dated 2/22/08 and this facility was still in the process of cycling the affected ventilators one at a time to the manufacturer for the upgrade. This particular ventilator had not been sent in yet for correction. This unit was sent to the manufacturer to address the recall and also to assess the problem that occurred with the ventilator (separate issues). The manufacturer replaced various parts and installed a new battery pack (internal) and the ventilator tested to specifications and was returned to this facility. The ventilator was placed back in service.
======================
Manufacturer response for Portable Ventilator, LTV Ventilator
======================
Unit required repair.

Device: Ventilator; Servo-i
Catalog #06487800
Manufacturer: Maquet, Inc.
Problem: Respiratory therapy set up the NICU ventilator. During the 3 to 7 pm shift an alarm went off; while trouble shooting the reason for the alarm, it was thought that the gray temperature probe wire had a kink in it so it was exchanged. Several hours later, the ventilator alarmed. A second Respiratory Therapist exchanged the entire heater unit. Several hours later, the ventilator alarmed again. A third Respiratory Therapist noted that the inspiratory tube was connected to the expiratory port, and the expiratory tube was connected to the inspiratory port. Because the tubes were connected improperly, the air being inspired was not being heated (wrong tubing was connected) and the temperature of the air was decreasing, causing the alarm. The tubing is able to be connected to either port. There is no color code on the vent to prevent misconnection; there is also no key index on the ventilator or tubing to prevent misconnection. The ventilator would deliver the correct therapy as set on the ventilator; the neonate just would not receive the humidified air.


Device: Ventilator
Model #Servo 300
Manufacturer: Maquet, Inc.
Problem: This is an accumulation of four cases from Respiratory Therapy on the Servo 300 ventilator. Circuit boards numbers 1585 and 1586 burned out when the safety valve opens and the mechanical ventilation is interrupted. On two occasions it was during patient use. Immediate intervention prevented patient injury. There is a very strong burning smell and on two occasions visible smoke occurred during the time of failure.
======================
Manufacturer response for Ventilator, Servo 300
======================
They set up the pick up of the 30 plus units for repair.

Device: Airway, Prongs, CPAP
Manufacturer: Fisher & Paykel Healthcare, Ltd.
Problem: Neonate was extubated from ventilator and placed on long prongs for approximately four hours. Because of patient agitation, the neonate was changed to short prong CPAP (continuous positive airway pressure). Nurse reported bruising of neonate's septum fifteen hours later in care notes and again in shift report. The day shift nurse noted that it was not a bruise, but necrotic tissue found during cares. The CPAP was removed from the neonate, and orders received from MD to change therapy to nasal cannula. Neonatalogist contacted risk on regarding this outcome. Neonate may require some surgery in future to repair depending on healing process. The Respiratory Therapy department has discontinued use of this type of delivery system and will use an alternative.

Device: Airway, Nasal; Robertazzi Nasopharyngeal Airway
Lot #08A03
Catalog #123128
Manufacturer: SunMed Healthcare
Problem: Patient had a latex free #28 nasal trumpet in place. The patient had a large amount of secretions. Patient aspirated trumpet, which was removed with McGill forceps.
Comment from FDA: MedSun has received a similar report discussing nasal airway collapse with the Robertazzi Nasopharyngeal Airway device.


PHYSICAL MEDICINE

Device: Plaster Casting Bandage; Gypsona
Lot #842338
Catalog #C7045
Other device #30-7367
Manufacturer: BSN Medical
Problem: Opening the Gypsona bandage package causes a cloud of plaster dust in the OR. Surgery used to purchase a similar 4" x 5yd plaster casting bandage made by DeBusk but without warning started receiving the Gypsona product by BSN Medical with the DeBusk product label on the box covering the Gypsona name and product info. The individual product package has just the Gypsona name on it.


RADIOLOGY

Device: Catheter, Brachytherapy; Mammosite Balloon Catheter
Lot #06E09
Other device #06K17 and 07C19
Manufacturer: Cytyc Surgical Services, Inc.
Problem: Two mammosite balloon catheters placed were defective. First placement burst in the night; second placement, three days later deemed to be asymmetrical upon evaluation in Radiation Oncology and had to be removed.

Three lot numbers involved: 06E09, 06K17, 07C19 - 100 cc balloon.

Discussed with patient multiple times; to remove first catheter and place second; then of second defective balloon and removal and plan for external beam treatment instead.

Device: Treatment Planning System, Radiation Oncology; ADAC Pinnacle Treatment Planning system
Manufacturer: Phillips Medical Systems
Problem: The patient was to receive radiation therapy to the tonsils for cancer. The Phillips ADAC Pinnacle Treatment Planning System was used. The system apparently has an automatic default that is not well known. The default occurred without the knowledge of the physician or techs. The patient received radiation to the optic nerves unintentionally for a total of 31 times. The problem was discovered when the patient presented with a rash to an unexpected area.

Device: CT scanner, Radiation Treatment
Manufacturer: TomoTherapy Incorporated
Problem: The patient had previous radiation therapy for anal carcinoma, stage IV when the pelvis and inguinal regions were treated and concurrent chemo was given. That treatment was not completed due to another illness. The patient missed the final seven radiation sessions. She returned to have para-aortic nodes irradiated. She refused additional tattoos at first. It was decided to use the previous pelvic tattoos for centering the patient and one additional abdominal tattoo was placed higher on the abdomen over the para-aortic region. The patient was to receive IMRT treatment to the para-aortic region for a total dose of between 4500 and 5500 cGy. No chemo was used. A CT was done to use in setting up the simulation. Instructions were entered into the software in the Tomo machine for this patient to let the therapist know that the pelvic tattoos were to be used for positioning only and the abdominal tattoo was to be used for therapy. The therapist failed to read the note and the pelvic tattoos were used exclusively leading to the dose going to an area 14 cm below the correct region. Protocol calls for the final approval of the region to receive therapy to be given by the physician and the physicist. In this case the original CT taken to set up the plan and the CT taken by the Tomo were fused as expected but because one of the CT's was presented in an almost clear color, the fusion appeared correct when it was not. The other CT was presented in a light blue. Both the doctor and the physicist believed at the time that the fusion was correct and approved the plan. The patient received six doses in the incorrect area. A therapist then noted what looked like a poor fusion and believed the numbers were incorrect. She had the physicist look at the plan and the error was discovered. The Tomo machine allows the CT is be almost changed to a clear color allowing the viewer to look at it and be able to almost look through it. This removes the effect of contrasting colors which adds to the risk of incorrect fusion. The software had recently been updated on the machine and the only specific training provided by the manufacturer was a CD to be viewed by staff. There was minimal mention of the use of the note function and also the effect of changing colors of the CT's.


GENERAL HOSPITAL

Device: Catheter, IV, Safety; Insyte Autoguard
Lot #8066658
Catalog #38144
Manufacturer: BD Infusion Therapy Systems, Inc.
Problem: Multiple reports from maternity nursing unit and anesthesia staff of IV fluid leaking from the same spot, where the cath tubing meets the green hub. All identified as having same lot number. No patient information provided. Lot pulled in all areas.

Device: Lift, Patient; Reliant 450
Manufacturer: Invacare Corporation
Problem: One strap of Mechanical Lift pad slipped off mechanical lift hook as CENA was beginning the lift of the resident. Initial investigation appeared to be human error which led to one on one education with Rehab expert. Seven days earlier an identical occurrence occurred with the Rehab expert who reports that she was positive that the pad loop was secure on the lift but equipment failed when the sling came off the hook as in the first occurrence. Staff called the manufacturer to find out about a sling retrofit hanger upgrade kit. The kit # 1143629 was installed and seems to have solved the problem of the sling coming off of the lift. It was assumed that it was human error by not securing the pad loop on the hook with the first incident until it was repeated with a rehab professional in the second occurrence. Regardless of whether it is human or mechanical error it is a patient safety issue that led to a fractured hip. We are suggesting you consider recalling the old mechanical hanger and replacing with the retrofitted version that prevents the loop from slipping off.

Device: Cabinet, Automatic Medication Dispensing
Manufacturer: McKesson Automation Solutions
Problem: After gaining authorized access to the identified lock-lidded pocket, the security of the other pockets located in that drawer can be easily breached by minimal force using the same method that opened the authorized pocket.
======================
Manufacturer response for Automated Medication Dispensing Cabinet, Automated Medication Dispensing Cabinet
======================
The manufacturers are working diligently to find a solution and may give consideration (safety alert format) to a communication with all users.

Device: Container, Sterilant; Steris 20
Lot #2578B05228 10 03
Catalog #S2000
Manufacturer: STERIS Corporation
Problem: A nurse in our GI suite, while preparing to process an endoscope in the Steris processor, noted an "X" shaped perforation in the center of the lid of the STERIS 20 container. She also noted obvious fading of the blue color of the graphic design in the center of the lid. This same defect was noted in at least 4 other individual containers within the same case, although not all of the individual boxes holding the containers were opened and inspected. None of the damaged containers were used to process endoscopes.
======================
Manufacturer response for Sterilant Concentrate, Steris 20
======================
The manufacturer was notified and is replacing that case and several others.


GENERAL & PLASTIC SURGERY

Device: Surgical Sponge Detection System; RF Detect USP Type VII Gauze
Model #NON21430RF
Manufacturer: Medline Industries, Inc.
Problem: The RF detect wand was used to scan the patient at the end of the procedure. The drapes had been pushed to the foot of the patient. When the wand was brought to a level below the patient's knees, it alarmed. There was nothing apparent on top of the drape that the team could see but the drape was bunched-up. The drape was picked up and moved and the wand continued to alarm. The RF chip from a sponge was found between the patient's legs. The clinical team believes it fell from the drape when it was moved. All of the sponges were examined and one sponge was found to have a hole in the pouch that holds the RF chip. The chip was missing from this sponge. All of the other sponges had chips intact. The manufacturer believes that the sponge was compromised during use, which caused tearing in the pouch that holds the RF chip. The manufacturer has also indicated they are changing the material they use and the way it is stitched as a result of this event.

Device: Robotic System; da Vinci S Surgical System
Manufacturer: Intuitive Surgical, Inc.
Problem: While using the Intuitive Surgical Inc.'s daVinci S robotic system in an elective coronary bypass surgical procedure, the robotic camera remote control function failed. The remainder of this surgical procedure was successfully completed using the robot, with manipulation of the camera arm performed by surgical staff.

Device: Handpiece, Harmonic Scalpel; Harmonic Focus
Lot #ERK49M
Manufacturer: Ethicon Endo-Surgery, Inc.
Problem: Surgeon was performing a total thyroidectomy and parathyroid exploration using the harmonic scalpel. It was reported that the harmonic focus handpiece became very hot. REF FCS9. It was also noted that on at least one occasion this device had burnt through the surgeons gown as well as leaving small marks on the patient's neck due to the heat of this handpiece. Staff had also noted on five other occasions the device to not work as intended. These devices were placed in the nurse manager's office for handling. However, staff did not provide any patient identifiers or specific product identifiers other than the device themselves. One other lot number was identified to have been one of the five other devices. It is lot number D4JP12.

Device: Forceps, Robotic Accessory PK; Dissecting Forceps
Catalog #420214
Manufacturer: Intuitive Surgical, Inc.
Problem: Patient undergoing robot-assisted laparoscopic-assisted vaginal hysterectomy. During the procedure the PK Dissecting Forceps were placed through the trocar and was connected to the cautery. The pedal on the cautery was depressed several times yet the forceps did not respond. When the forceps were removed from the trocar a broken wire was detected. Post-op the patient developed a purple mark around the site of the trocar. Initially it was thought to be a bruise, after further examination, it was thought to be a burn.

Device: Tubing, Suction Irrigation; Clear ESS II RP
Model #0041-6153
Other device #: Reorder #0041-6153
Lot #805606
Manufacturer: PhotoMedex, Inc.
Problem: The nurse reported that the Clear ESS II RP suction and irrigation tubing was stuck so it was constantly on. The physician was unable to get the device to irrigate properly. New clear ESS tubing was obtained which functioned appropriately. We have had four separate incidents of this problem, and it appears that the same lot number has been involved in three of these cases. Therefore, the lot has been removed from the shelves and the devices will be returned to the manufacturer, as they have asked us to return product for evaluation. We are in the process of getting a return authorization number so that we can return these devices to them. There has been no patient harm as a result of these failures.

Device: Scalpel, Harmonic
Lot #160687
Other device #: Reprocessed Device
Brand Name: Ethicon ACE23P
Manufacturer: Ascent Healthcare Solutions
Problem: The white plastic tip inside the Ethicon ACE23P harmonic scalpel jaw came off during surgery. The location of the tip after coming off could not be determined. Although the device is manufactured by another manufacturer, the problem may have stemmed from reprocessing done by Ascent Healthcare Solutions. Ascent has requested the ability to come examine the device, which we will allow them to do.


GASTROENTEROLOGY/UROLOGY

Device: ECT Machine; Thymatron; System IV
Manufacturer: Somatics, LLC
Problem: The electroconvulsive therapy machine continued to generate current to the patient through patches placed on the patient's temporal area after the physician stopped the treatment. The nurse attempted to remove the patches and received a shock. The machine was immediately turned off and the patches were removed. The patient was observed in PACU, transferred to a nursing unit for routine observation, and discharged home that day.


ORTHOPEDIC

Device: Pump, Arthroscopy
Manufacturer: Stryker Endoscopy

Device: Pump, Arthroscopy
Manufacturer: Stryker Endoscopy

Problem: The nurse reported during the Surgeon's first case of the day, a shoulder arthroscopy, it was noted the pump was using an excessive amount of arthroscopy fluid (34 bags total). The pump was recalibrated partway through the case and seemed to work better. For the Surgeon's second case of the day, a different pump (but same make/model) was used and the same problems began to occur. The doctor made the decision to continue operation with gravity fluid rather than continue using the pumps due to safety concerns. The first patient had a moderate amount of fluid extravasation to right shoulder and breast, yet not unusual for this type of surgery. It appeared there was no significant or unexpected injury to the patients. However, it does appear the pumps may have issues with maintaining their calibrations. Of note, a previous report, with the same issue/equipment was filled, which required extended hospital stay.

Device: Implant, Total Knee; Plus VKS Total Knee Arthroplasties
Manufacturer: Smith and Nephew, Inc.
Problem: Plus VKS Total Knee Arthroplasties (Smith & Nephew) have failed in this and 4 other patients. No bonding between the prosthesis and cement mantle, early failure less than 1 yr after TKA.


OBSTETRICS/GYNECOLOGY

Device: Delivery System, Vacuum Assisted Mityvac M-Style
Lot #65910
Other device #: Ref # 10007LP
Manufacturer: Cooper Surgical
Problem: Physician placed the M-Style Mityvac at 10 mm Hg then pumped it up to 50 mm Hg one minute later. The physician pulled for 20 seconds until delivery. Once delivered, the vacuum was released, but the doctor was unable to remove the suction device from the baby's head for approximately one minute. Finally, the doctor had to place their finger under vacuum head to release the suction. Small marks noted on the head of the baby. After a few hours, the marks were no longer visible, and the baby was discharged home with no further complications.


NEUROLOGY

Device: Therapy Unit, Electroconvulsive
Model #DGX
Manufacturer: Somatics, LLC
Problem: The patient was scheduled to have electroconvulsive therapy (ECT) treatment. The patient was attached to the ECT machine, and when the unit was turn on, while the doctor was checking the electrical amount to be administered, the machine shocked the patient without the doctor pressing the treatment button. The machine was immediately unplugged and the anesthesia and medical staff assessed the patient for any problems. When the device was returned to the manufacturer, the factory found that the actual push button for the Treat switch was inserted the wrong way. This could have caused the switch to stick in the treat mode, and could have caused the problem. One way, the switch works smoothly, the other way it can stick in the "in" position. The manufacturer stated that with the red button, if it is put in upside down, it will stick every 2-3 times. Therefore, they have started using a yellow button, (Part# SW201P for $14) because it can be inserted in any orientation and it will work appropriately. However, the equipment used during this incident already had a yellow button (not a red one), which apparently can not be inserted "upside down". Additionally, the unit had been used for months and has not stuck before, thus, this explanation did not apply to our unit. Currently, the cause of the problem has not yet been identified.

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Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events With Long Term Intravascular Catheters and Related Article

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By Elizabeth Eydelman, Patient Safety Staff, 2008

Over the past year and a half, MedSun has received 59 adverse event reports involving long term intravascular catheters associated with 11 manufacturers: Bard Access Systems (32), Becton Dickinson (7), BD Infusion Therapy Systems, Inc. (6), Boston Scientific Corporation (4), Arrow International, Inc. (2), Cook Medical (2), Cardinal Health Medical Products and Services (2), Advanced Medical, Inc. (1), HDC Corporation (1), Vygon Corporation (1), and Medcomp (1). The reports were submitted by 31 hospitals between January 1st 2007 and June 6th 2008. The most frequently reported device problems are:
• Device Breakage (22)
• Defective Device (wire difficulties, cracks, kinks, or leakage, dull scissors from kit) (21)
• Thrombus Development (11)
• Removal/Insertion Difficulties (9)
• Device Migration (4)


There are no MedSun reports that list death or other as the type of adverse event. There are 41 reports that list malfunction as the type of adverse event, 14 do not list event type, and 4 list event type as injury. The most frequently reported patient problems are:
• Need For Additional Treatment or Surgical Procedure (28)
• Need For Removal of Foreign Body (9)
• Need For Reinsertion (9)
• Required Hospitalization (4)

Of the reports that list patient age, 15 reports have a patient age less than 21 years and 37 reports have a patient age listed as greater than 21 years. Of the reports that provide patient gender, a total of 32 reports involve female patients and a total of 25 reports involve male patients.

These reports contribute to FDA’s post-market experience and understanding of problems associated with the use of these devices. The reported events are consistent with umbilical artery catheter problems reported in the literature. Many of these reports involve long term intravascular catheters that are peripherally-inserted central catheters (PICCs), accessing the central venous system via a percutaneous access site, usually in the upper arm. PICC placement combines the benefits that a central line offers for complex medication and fluid administration along with the advantages of peripheral insertion.

The February 2006 MedSun Newsletter Safety Tip, Preventing PICC Fractures, by Roberta Sullivan, RN, MPH stresses the need for health care practitioner awareness of PICC care guidelines to maintain catheter integrity will promote patient safety:

• Follow the manufacturer’s device-specific instructions for catheter placement and insertion site maintenance. Certain chemicals, solutions, or antibiotic ointments should be avoided near catheters made of materials susceptible to damage.

• Position in-line clamps near the center of the distal connector hubs. If the clamps are placed too close to the connector ends, excessive or repeated clamping may lead to tubing fatigue and stress fractures. However, failure to use the clamps may increase the risk of air embolism or blood loss.

• Secure the catheter to prevent occlusion, stress or kinking. Observe and monitor the length of the catheter from the placement site. Catheter migration from the intended placement in the superior vena cava can lead to serious complications such as perforation, erosion, and cardiac tamponade. Pediatric patients with PICCs pose special challenges for securing the catheter. Tubular elastic netting applied over the child’s arm may help prevent dislodgement and the need to repeat line placements in this high risk population.

• Always use at least a 10 cc syringe for flushes and medication administration. Flush the catheter with a brisk push/pause technique. To prevent damage to blood vessels or catheters, infusion pressure should not exceed 25 psi (pressure per square inch). The same force applied to a 3 cc syringe can result in a psi up to 55, compared to only 15 psi if using a 10 cc syringe. When using small gauge (< 4Fr) catheters in pediatric patients, a 10 cc syringe should still be used for medication and flushes, with the appropriate volume.

• Do not flush against resistance. Partial or complete catheter occlusions may be caused by thrombosis, drug precipitates or mechanical factors. Prevention of occlusion includes the use of heparin, positive pressure, and adequate flushing techniques between medications, blood draws, and TPN (total parenteral nutrition). Follow your institution’s protocol for appropriate interventions.

[Note: The reports have been edited for clarity]




MedSun Intravascular Catheter Adverse Event Reports received between January 1st 2007 and June 6th 2008
Device Device Identifiers Event Description
Bard Access Systems/Intravascular Catheter Lot: REQHO327 RN DRAWING BLOOD FROM THE WHITE PORT OF THE PICC WAS UNABLE TO DRAW. REMOVED SYRINGE AND NOTED WIRE IN HUB. TWO PIECES OF WIRE WERE PULLED OUT OF THE WHITE PORT HUB; ONE 1-1/4 INCH AND ONE 1/4 INCH.
Bard Access Systems/Intravascular Catheter Lot: REQHO327 PICC GUIDEWIRE WAS STRETCHED AT HUB - ALL WIRE WAS RETRIEVED.
Bard Access Systems/Intravascular Catheter Lot: REQHO239 WHILE ATTEMPTING TO RETHREAD THE PICC LINE OVER THE EXISTING LINE, THE PICC BROKE AT APPROXIMATELY 39 CM. RETRIEVAL OF THE PICC FRAGMENT WAS SUCCESSFUL.
BD Infusion Therapy Systems, Inc./Intravascular Catheter Device Identifiers Unknown/Not available PT WAS TRANSFERRED HERE FROM ANOTHER FACILITY FOR RETRIEVAL OF PICC LINE WHICH DISLOCATED TO HER RIGHT VENTRICLE. PT WAS BROUGHT TO THE CARDIAC CATHETERIZATION LAB. CARDIOLOGIST REMOVED 5CM FRAGMENT FROM RIGHT VENTRICLE WITH NO COMPLICATIONS. THE REST OF THE CATHETER WAS REMOVED WITH NO COMPLICATIONS. CHILD WAS TAKEN TO NICU. CHILD WAS TRANSFERRED BACK TO ORIGINATING FACILITY AFTER CHILD WAS STABLE. CATHETER WAS DISCARDED IN ERROR.
BD Infusion Therapy Systems, Inc./Intravascular Catheter Lot: 6164550 DURING REVIEW OF CHEST X-RAY PERFORMED THE PREVIOUS EVENING, IT WAS NOTED THAT THE DISTAL SECTION OF A MIDLINE/PICC CATHETER LINE HAD BROKEN. A SECOND CHEST X-RAY CONFIRMED THE PICC LINE HAD BROKEN WITH A PORTION OF THE LINE LODGED IN THE RIGHT ATRIUM AND RIGHT VENTRICLE. INFANT TRANSPORTED TO ANOTHER FACILITY TO HAVE BROKEN PIECE REMOVED. PROCEDURE WAS SUCCESSFUL AND INFANT TRANSPORTED BACK TO NICU TO CONTINUE TREATMENT.
BD Infusion Therapy Systems, Inc./Intravascular Catheter Lot: 6192590 RN ASSESSING BABY AND FOUND PICC LINE BROKEN IN TWO PIECES. ONE PART WAS ATTACHED TO THE PATIENT'S ARM AND THE END PIECE WAS LYING ON THE BEDDING. SOME WETNESS NOTED ON THE SHEETS BY THE BABY'S ARM. PATIENT'S ASSESSMENT UNCHANGED.TEMPERATURE AND VITAL SIGNS STABLE. ACCUCHECK 47. NEONATAL MD NOTIFIED. PICC LINE REMOVED AND SAVED. DEVICE IS AVAILABLE IN RISK MANAGEMENT OFFICE FOR INSPECTION. PERIPHERAL IV LINE STARTED. NO ADVERSE OUTCOME TO THE PATIENT.
Bard Access Systems/Intravascular Catheter Lot: REPL0183 PICC NURSE INSERTED THE LINE WITHOUT DIFFICULTY. GOOD BLOOD RETURN WAS OBSERVED, AND BOTH PORTS FLUSHED EASILY. THE LINE WAS PLACED IN THE RIGHT BASILIC VEIN TO 35CM. PLACEMENT WAS CONFIRMED VIA X-RAY. THE PATIENT DEVELOPED THROMBUS TWO DAYS LATER IN THE BASILIC, AXILLARY AND SUBCLAVIAN VEINS ON THE RIGHT SIDE.
Bard Access Systems/Intravascular Catheter Lot: REPL0688 PICC NURSE INSERTED THE LINE TO 38CM INTO THE RIGHT BASILIC VEIN. GOOD BLOOD RETURN FROM BOTH PORTS WAS OBSERVED, AND BOTH PORTS FLUSHED EASILY. POSITION CONFIRMED VIA X-RAY. PATIENT DEVELOPED THROMBUS TWO DAYS LATER.
Bard Access Systems/Intravascular Catheter Lot: REQCO591 PICC NURSE INSERTED THE LINE INTO THE RIGHT MEDIAL CEPHALIC VEIN. THE PATIENT DEVELOPED A THROMBUS TO THE RIGHT SUBCLAVIAN, AXILLARY AND BRACHIAL VEINS TWO DAYS LATER. THE PICC LINE HAD BEEN INSERTED WITHOUT DIFFICULTY TO 40CM. GOOD BLOOD RETURN WAS NOTED UPON INSERTION, AND THE LINE FLUSHED EASILY. X-RAY CONFIRMED GOOD PLACEMENT.
Bard Access Systems/Intravascular Catheter Lot: REQH0324 PICC NURSE INSERTED THE LINE TO THE MIDLINE IN THE LEFT BASILIC VEIN, WHICH WAS APPROXIMATELY 17CM, WITHOUT DIFFICULTY. EXCELLENT BLOOD RETURN WAS OBSERVED AND BOTH PORTS FLUSHED EASILY. THE PATIENT DEVELOPED LEFT BRACHIAL VEIN THROMBUS TEN DAYS LATER.
Bard Access Systems/Intravascular Catheter Lot: REQG0213 PATIENT DEVELOPED A THROMBOSIS IN THE CEPHALIC, BASILIC, RADIAL AND ULNAR VEINS IN THE LEFT ARM TWELVE DAYS AFTER THE PICC LINE WAS INSERTED. NURSING STAFF DID NOT SAVE THE DEVICE OR THE PACKAGING. LINE INSERTED BY PICC RN WITHOUT DIFFICULTY TO 45CM. LINE FLUSHED EASILY AND HAD GOOD BLOOD RETURN. POSITION WAS CONFIRMED WITH X-RAY AND THE GUIDEWIRE WAS REMOVED PRIOR TO USE.
Bard Access Systems/Intravascular Catheter Lot: REQC0571 PICC NURSE INSERTED THE LINE TO 45CM INTO THE LEFT BASILIC VEIN. THE LINE HAD EXCELLENT BLOOD RETURN, AND BOTH PORTS FLUSHED EASILY. PLACEMENT WAS CONFIRMED VIA X-RAY. THE PATIENT DEVELOPED THROMBOSIS FIVE DAYS LATER.
Bard Access Systems/Intravascular Catheter Device Identifiers Unknown/Not Available
Bard Access Systems/Intravascular Catheter Device Identifiers Unknown/Not Available INTERVENTIONAL RADIOLOGIST MD INSERTED PICC LINE UNDER ULTRASOUND FLUOROSCOPY TO THE LEFT BRACHIAL VEIN AND THREADED TO 38CM. PLACEMENT CONFIRMED UNDER FLUOROSCOPY. GOOD BLOOD RETURN AND BOTH PORTS FLUSHED WELL. MD FLUSHED PORTS WITH HEPARINIZED SALINE. UNKNOWN CONCENTRATION OF HEPARIN FLUSH. PT DEVELOPED THROMBOSIS ONE DAY LATER. RADIOLOGIST DID NOT RECORD ANY DEVICE IDENTIFYING INFORMATION. NO PACKAGING WAS SAVED AND STAFF DISPOSED OF THE DEVICE. IT IS UNCLEAR IF THE THROMBOSIS IS RELATED TO THE PICC LINE.
BD Infusion Therapy Systems, Inc./Intravascular Catheter Lot: 6212018 A PT WITH EXTERNAL JUGULAR PICC LINE WAS DIFFICULT TO FLUSH. THE PT NEEDED TO SIT UP TO BREATHE. PICC WAS BEING REMOVED BECAUSE INABILITY TO DRAW BLOOD. STAFF NOTED CATHETER HUB HAD PULLED PARTIALLY OUT OF THE CATHETER UPON WITHDRAWAL.
Bard Access Systems/Intravascular Catheter Lot: 0909 REQ 100565N PATIENT'S PICC CATHETER CRACKED AT THE RED HUB. IT HAD BEEN FOR SEVERAL MONTHS AND WAS SCHEDULED TO BE CHANGED. IT WAS CHANGED OVER A WIRE WITH NO PROBLEMS. THE PATIENT WAS NOT HARMED.
Boston Scientific Corporation/Intravascular Catheter Lot: 1158324 WHEN THE RN WENT TO FLUSH THE PICC LINE PRE- MEDICATION SHE NOTICED THE BROWN PORT/HUB WAS MISSING FROM THE LUMEN. PICC LINE WAS REMOVED AND NEW ONE WAS INSERTED.
Boston Scientific Corporation/Intravascular Catheter Lot: 1185301 THE PATIENT WAS COMPLAINING OF PAIN FROM THE PICC LINE, A 5.0 FRENCH DOUBLE LUMEN CATHETER. EDEMA WAS NOTED TO BE IN RIGHT UPPER ARM AT APPROXIMATELY 5 INCHES. BOTH PIPERCILLIN AND SOLUMEDROL WERE INFUSING THROUGH THE CATHETER AT THE TIME OF THE INCIDENT. THE PICC LINE WAS DISCONTINUED AFTER A SMALL HOLE WAS FOUND. THE CATHETER LEAKED AT THE HOLE WHEN IT WAS FLUSHED. AN AQUA K-PAD WAS APPLIED TO THE ARM FOR COMFORT.
MEDCOMP/Intravascular Catheter Lot: MAJP9900 A 5FR PICC WAS BEING PLACED AND ADVANCED OVER .018 WIRE THROUGH A 5 FRENCH PEEL-AWAY SHEATH,THE PEEL-AWAY
PORTION DETACHED FROM THE HUB AND WAS PUSHED INTO THE VEIN ALONG WITH THE PICC. THE WIRE WAS LEFT IN THE PATIENT. THE PATIENT'S RIGHT GROIN WAS PREPPED AND THE PHYSICIAN SNARED THE SHEATH VIA THE RIGHT GROIN WITH NO COMPLICATION. PRE-SNARE AND POST-SNARE FILMS WERE TAKEN. A CALL WAS PLACED TO THE VENDOR ABOUT THE INCIDENT. VENDOR WAS TO CONTACT MANUFACTURER. THE HUB WAS SAVED FOR ANALYSIS.
Bard Access Systems/Intravascular Catheter Device Identifiers Unknown/Not Available THE PATIENT WENT INTO CARDIOPULMONARY ARREST AND ADVANCED CARDIAC LIFE SUPPORT (ACLS) WAS INITIATED. DURING THE CODE, IT WAS SUSPECTED THAT THE PICC LINE BECAME INFILTRATED. AFTER THE CODE, THE PICC LINE WAS REMOVED, AND IT WAS
NOTED THAT LINE WAS BROKEN.
Becton Dickinson/Intravascular Catheter Lot: 7030302 THE STAFF FOUND THE PICC LINE COMPLETELY SEVERED JUST BELOW THE STABILIZING WINGS OF THE DEVICE. THE REMAINING TAIL OF THE PICC LINE WAS LEFT IN THE PATIENT. THE NEONATOLOGIST WAS NOTIFIED AND WAS ABLE TO REMOVE THE REMAINING PORTION OF THE LINE WITHOUT DIFFICULTY OR COMPLICATION AT THE BEDSIDE. A PERIPHERAL IV WAS THEN ESTABLISHED. NO HARM CAME TO THE PATIENT. THE DOCTOR DISCARDED THE INDWELLING PORTION OF THE PICC LINE; HOWEVER, THE TOP PORTION OF THE DEVICE IS AVAILABLE IN THE RISK MANAGEMENT DEPARTMENT. THE PICC LINE WAS INSERTED FIVE DAYS PRIOR BY A NURSE TRAINED IN INSERTING SUCH LINES. NO DIFFICULTIES WITH THE MAINTENANCE OF THE LINE WERE REPORTED FROM THE TIME OF INSERTION UP UNTIL THE LINE WAS FOUND TO BE SEVERED. IT REMAINS UNKNOWN HOW THE LINE BECAME SEVERED. STAFF REPORTED THAT THIS IS THE SECOND TIME THEY HAVE SEEN THIS HAPPEN IN THE LAST THREE MONTHS.
Arrow International, Inc./Intravascular Catheter Lot: RF7018265 DURING WIRE REMOVAL THERE WAS NOISE AND TENSION CHANGED. PATIENT WAS HAVING PICC LINE PLACED FOR ANTIBIOTIC THERAPY. "PING SOUND" AND OUTER SHEATH OF WIRE SEPARATED. ENTIRE WIRE/SHEATH REMOVED FROM PATIENT. NO HARM TO PATIENT.
Cook Medical/Intravascular Catheter Lot: 1882268 THE YELLOW HUB OF PICC LINE LEAKED. STAFF NEEDED TO CHANGE THE LINE DUE TO THE LEAK. THE PATIENT WAS NOT HARMED AS A RESULT OF THIS EVENT.
Bard Access Systems/Intravascular Catheter Device identifiers unknown/not available THE PATIENT HAD A PICC LINE PLACED WITH NO RESISTANCE. THERE WAS AN UNUSUAL KINK NOTED AT THE END OF THE PICC LINE BUT THE PICC LINE WORKED FINE. THE TIP WAS DRAWN BACK 1 CM. THIS PICC LINE WAS PLACED IN SAME VESSEL AS AN INTRAJUGULAR (IJ) LINE. THE IJ LINE WAS THEN REMOVED. TWO DAYS LATER PATIENT CODED. SUSPICION THAT INSERTION OR REMOVAL OF IJ LINE CAUSED PERFORATION OF SUPERIOR VENA CAVA (SVC).
Bard Access Systems/Intravascular Catheter Device Identifier Unknown/Not Available PATIENT NOTED TO HAVE SWELLING IN THEIR RIGHT ARM AS WELL AS RASH POSSIBLY DUE TO AN ALLERGIC REACTION TO CEFAZOLIN. A 4.0 FR, 18G PICC, SINGLE LUMEN CATHETER # RERB0508 WAS INSERTED INTO THE RIGHT BASILIC VEIN. THE TIP WAS LOCATED IN THE SUPERIOR VENA CAVA (SVC). ACUTE AXILLARY VEIN DVT WAS CONFIRMED BY A SCAN. THE PATIENT WAS SENT TO THE ER FOR ASSESSMENT AND A PRESCRIPTION OF ANTICOAGULANTS.
Becton Dickinson/Intravascular Catheter Lot: 6156083 PATIENT WAS IN A HYPERBARIC CHAMBER UNDERGOING PRESSURIZED OXYGEN THERAPY WHEN THE INSIDE OBSERVER REPORTED A DISLODGED MIDLINE. THE MIDLINE HAD BEEN INSERTED IN THE LEFT UPPER EXTREMITY TWO DAYS PRIOR TO THE HYPERBARIC TREATMENT. THE RN NOTED THAT, UPON INSPECTION, THE DISTAL END OF THE CATHETER WAS HANGING FREELY AND THE PROXIMAL PORTION WAS STILL IN THE PATIENT'S ARM. THE ENTIRE CATHETER WAS REMOVED. UPON INSPECTION ALL 20 CM WAS REMOVED. THE PATIENT APPEARED TO HAVE NO ADVERSE EFFECTS.
Bard Access Systems/intravascular Catheter Lot: RERE 02714FR PORTION OF GUIDE WIRE BROKE OFF AND WAS RETRIEVED. WIRE BROKE OFF DURING INSERTION OF PICC LINE INTO PT'S RIGHT ARM. WIRE WAS SEEN ON POST PROCEDURE CHEST X-RAY.
Bard Access Systems/Intravascular Catheter Lot: RERA 0778 THE PICC GUIDEWIRE WAS REMOVED FROM THE CATHETER, ONLY 6 INCHES PLUS OR MINUS. THE REMAINDER OF THE PICC CAME OUT WHEN THE GUIDEWIRE WAS REMOVED. IT DID NOT PULL OUT AS ONE UNIT.
Cook Medical/Intravascular Catheter Device Identifiers Unknown/Not Available THIS PICC LINE WAS PLACED AND THREE DAYS LATER A HOLE WAS DISCOVERED. PICC EXCHANGED OVER A WIRE FOR A NEW PICC. INSPECTION OF ORIGINAL PICC REVEALS A VERY SMALL HOLE AT THE PROXIMAL END OF THE "YELLOW" LUMEN. HOLE WAS THEN MARKED WITH MARKER. NO INJURY TO THE PATIENT.
Vygon Corporation/Intravascular Catheter Catalog: 2184.00 A PICC LINE WAS PLACED THROUGH THE SCALP VEIN FOR TPN ONLY. CORRECT PLACEMENT WAS CONFIRMED USING CONTRAST AND AN X-RAY. SUBSEQUENT DRESSING CHANGES BY THE NURSES DOCUMENTED THE LENGTH OF THE CATHETER EXTERNAL TO THE SCALP HAD NO CHANGES. TWO MONTHS LATER THE CHILD WAS WORKED UP FOR SEPSIS. NO BLOOD COULD BE WITHDRAWN FROM PICC FOR CULTURE AND SENSITIVITY (C&S). CONTRAST WAS INJECTED TO CONFIRM THE PLACEMENT OF THE LINE IT WAS DISCOVERED THAT THE PICC WAS COILED IN THE LEFT SIGMOID SINUS.
Becton Dickinson/Intravascular Catheter Lot: 7031548 PICC LINE WAS PLACED IN THE LEFT ANTERIOR SAPHENOUS VEIN. THE PICC LINE WAS FOUND BROKEN OFF JUST BELOW THE HEART. TPN WAS INFUSING THROUGH THE LINE AT THE TIME OF THE EVENT. THE REMAINDER OF THE LINE WAS REMOVED FROM THE PATIENT INTACT.
Bard Access Systems/Intravascular Catheter Device Identifiers Unknown/Not Available AFTER SUCCESSFULLY FLUSHING THE RIGHT UPPER EXTREMITY HANGING ANTIBIOTICS AND PICC LINES, THE PATIENT CALLED THE NURSE BACK INTO ROOM 20 MINUTES LATER. UPON ENTERING THE ROOM, THE NURSE FOUND THE PATIENT WITH BLOOD ALL OVER THEIR GOWN AND RIGHT UPPER EXTREMITY. THE NURSE IMMEDIATELY APPLIED PRESSURE. WHEN SHE REMOVED THE BANDAGE, SHE FOUND THE BLUE PORTION OF THE PICC LINE HAD BROKEN IN HALF. THE WHITE AND RED PARTS WERE STILL CONNECTED TO HALF OF THE CATHETER. A STAT CHEST X-RAY WAS ORDERED WHICH SHOWED 20 CM OF THE CATHETER REMAINING IN RIGHT UPPER EXTREMITY GOING INTO THE RIGHT VENTRICLE. THE PATIENT, WHO HAD STABLE VITAL SIGNS, WAS PREPPED FOR THE REMOVAL PROCEDURE. THE PICC FRAGMENT EXTENDED FROM THE RIGHT AXILLARY VEIN TO THE RIGHT VENTRICLE. A SNARE WAS ADVANCED AND USED TO GRASP THE PICC FRAGMENT. BOTH THE PICC FRAGMENT AND THE SHEATH WERE REMOVED. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO IMMEDIATE COMPLICATIONS. THE LOT AND SERIAL NUMBERS ARE NOT AVAILABLE FOR THIS DEVICE.
Bard Access Systems Lot: RERE0065 PATIENT CAME TO CLINIC COMPLAINING OF PAIN IN HIS LEFT ARM STARTING AT HIS ELBOW AND RADIATING TO HIS SHOULDER. PATIENT DID NOT HAVE ANY SWELLING SIGNS OR SYMPTOMS OF INFECTION AT SITE. MDS PAGED AND ORDERED PICC TO BE REMOVED. DOPPLER STUDIES ORDERED AND PATIENT WAS FOUND TO HAVE A DVT. PATIENT WAS SENT TO ER FOR TREATMENT. PICC PLACED BY VASCULAR APPROXIMATELY ONE MONTH PRIOR.(5 FR., 18 G, DOUBLE LUMEN, POWER PICC).
Bard Access Systems/Intravascular Catheter Lot: RERC0446 IV TEAM NURSES ENCOUNTERED DIFFICULTY INSERTING A PICC LINE INTO PATIENT. THE GUIDELINE "SPLIT" AND BEGAN TO UNRAVEL AND A PORTION OF THE WIRE WAS LEFT IN THE PATIENT. THE WIRE HAD TO BE SURGICALLY REMOVED THE NEXT DAY. PATIENT DID NOT EXPERIENCE ANY FURTHER UNTOWARD EFFECTS.
Becton Dickinson/Intravascular Catheter Lot: 7039277 PATIENT HAD PICC LINE IMPLANTED. APPROXIMATELY, A MONTH LATER CHEST X-RAY REVEALED THAT THE PICC LINE HAD BROKEN. PATIENT TRANSFERRED TO ANOTHER MEDICAL FACILITY TO HAVE PICC LINE EXPLANTED. FOLLOW UP CONDITION NOT KNOWN AT THIS TIME.
Arrow International, Inc./Intravascular Catheter Lot: RF7065441 PICC PLACED BUT UNABLE TO REMOVE WIRE WITHOUT IT BREAKING, SO WIRE AND CATHETER WERE REMOVED AS ONE UNIT. PICC WITH DIFFERENT LOT NUMBER PLACED OTHER ARM WITHOUT INCIDENT.
Boston Scientific Corporation/Intravascular Catheter Lot: 1210616 THE PATIENT HAD A PICC PLACED IN THE RIGHT ARM FOR ADMINISTRATION OF IV ANTIBIOTICS TO TREAT AN INFECTION IN THE LEFT FOREARM. AFTER PLACEMENT OF THE PICC, MEDICATIONS WERE ADMINISTERED. LATER IN THE DAY, IT WAS FOUND THAT THE HUB HAD SEPARATED FROM THE CATHETER. THE PICC WAS PULLED AND A NEW ONE WAS PLACED THE NEXT DAY.
Becton Dickinson/Intravascular Catheter Lot: 7121701 THE BEDSIDE NURSE ASKED THE TRANSPORT NURSE (PICC "TEAM" MEMBER) TO CHANGE THE PICC DRESSING, WHICH HAD LOOSENED. THE CHEST X-RAY SHOWED THAT THE LINE WAS NO LONGER CENTRAL. THE TRANSPORT NURSE ATTEMPTED TO RE-THREAD A NEW LINE. WHILE ATTEMPTING TO REMOVE THE OLD LINE CATHETER, IT BROKE WITH FIVE CM REMAINING IN THE PATIENT. THE PATIENT HAD TO HAVE THE LINE FRAGMENT REMOVED UNDER FLUOROSCOPY.
Bard Access Systems/Intravascular Catheter Lot: RERH0461 RN REPORTS WHILE PLACING A PICC LINE, THE SCISSORS, WHICH ARE INCLUDED IN THE KIT, WERE NOT SHARP ENOUGH TO CUT THE DOUBLE LUMEN PICC. THIS IS THE SECOND TIME THIS RN HAS ENCOUNTERED THIS PROBLEM. THE INCLUDED SCISSORS GNASHED THE PICC LINE MAKING IT IMPOSSIBLE TO GET A CLEAN CUT. BOTH TIMES THIS HAS HAPPENED THE RN HAS RESORTED TO USING THE BLADE FROM THE KIT TO CUT THE LINE. MANUFACTURER RESPONSE FOR DOUBLE LUMEN PICC KIT, BARD:MANUFACTURER WILL BE NOTIFIED BY MEANS OF THIS MEDWATCH. UNFORTUNATELY DEVICE WAS DISCARDED IN BOTH INCIDENTS. WE HAVE EDUCATED OUR STAFF ON RETAINING MALFUNCTIONED ITEMS FOR EVALUATION PURPOSES.
Bard Access Systems/Intravascular Catheter Catalog: RERF0742 ORDERS RECEIVED TO REMOVE PATIENT'S PICC LINE. PATIENT STATES THE LINE HAD BEEN BOTHERING HER. LEFT ARM WAS NOTED TO BE APPROXIMATELY TWICE THE SIZE OF THE RIGHT. PHYSICIAN NOTIFIED AND DOPPLER STUDIES WERE POSITIVE FOR DVT. PATIENT IS CURRENTLY ON COUMADIN
Cardinal Health Medical Products and Services/ Intravascular Catheter Catalog: 81450SG A SINGLE LUMEN POWER PICC WAS PLACED IN THE ARM OF THE PATIENT. THE SCISSORS, PROVIDED IN THE PRESOURCE INSERTION KIT, WERE TOTALLY BLUNT (DULL). THEY WOULD NOT CUT THE PICC CATHETER AND ALSO DID NOT CUT A PLASTIC SHEATH WHEN TESTED LATER. RN RESORTED TO CUTTING THE PICC WITH A KNIFE BLADE AND HAD TO MAKE THE PICC 1 CM SHORTER TO OBTAIN A CLEAN CUT.
Bard Access Systems/Intravascular Catheter lot: RERE0505 A PICC LINE WAS INSERTED MID YEAR OF 2007. A POST-PROCEDURE X-RAY REVEALED GOOD POSITION. FOLLOW-UP X-RAYS OF TWO WEEKS AND THREE MONTHS LATER SHOW A 4 CM WIRE SOMEWHERE IN THE LEFT LOWER LOBE.
Bard Access Systems/Intravascular Catheter Lot: RER10771 THE PICC NURSE WAS CALLED TO INSERT A PICC LINE FOR A PATIENT SCHEDULED TO RECEIVE LONG TERM IV ANTIBIOTICS. THE PICC WAS INSERTED WITHOUT ANY DIFFICULTY. HOWEVER, IMMEDIATELY AFTER INSERTION, A LEAK WAS NOTED ON THE TOP PORTION OF THE PICC LINE BY THE WINGS. UPON CLOSER INSPECTION, A SMALL SLIT LENGTHWISE IN THE TIP PORTION OF THE PICC NEXT TO THE WINGS WAS NOTED. PRIOR TO INSERTION, STAFF DID NOT SEE A SLIT. HOWEVER, THE PICC RN EXPLAINED THAT THIS IS AN UNUSUAL PLACE TO FIND A SLIT AND THAT PICC STAFF WOULD NOT ROUTINELY LOOK CLOSELY AT THIS AREA OF THE DEVICE PRIOR TO INSERTION. ALL OTHER ASPECTS OF VISUAL INSPECTION PRIOR TO INSERTION FOUND NO DEFECTS. THE REP WAS CONTACTED BY STAFF AND THE DEVICE WAS RETURNED TO HER. THE LEAKING PICC LINE WAS REMOVED AND THE PICC RN ATTEMPTED TO DO AN EXCHANGE, WHICH WAS UNSUCCESSFUL. THE PATIENT WAS SENT TO RADIOLOGY, WHERE AN INTERVENTIONAL RADIOLOGIST PLACED A PICC LINE WITH THE ASSISTANCE OF FLUOROSCOPY.
Cardinal Health Medical Products and Services/Intravascular Catheter Model: 81450SG OUR PICC TEAM HAS HAD AN ONGOING ISSUE WITH THE SCISSORS CONTAINED WITHIN THE CARDINAL HEALTH PICC KITS. THESE WERE EARLIER REPORTED AS BELONGING TO A DIFFERENT MANUFACTURER (1 PAIR) HOWEVER ON FURTHER RESEARCH WE HAVE CONFIRMED THESE SCISSORS ARE MANUFACTURED BY SURGICAL DESIGN INSTRUMENTS. OUR PICC NURSES HAVE REPORTED THESE SCISSORS WILL NOT CUT THE PICC LINE IN THE KIT THESE ARE PART OF. THE NURSES HAVE HAD TO RESORT TO USING A SCALPEL WHICH IS ALSO INCLUDED IN THE KIT. PICC LINES NEED TO HAVE A PRECISE CLEAN EDGE,THESE SCISSORS HAVE BEEN GNASHING THE LINE. THESE ARE PART OF A PICC LINE PLACEMENT KIT WE PURCHASE THROUGH CARDINAL HEALTH. OUR REP HAS ARRANGED FOR THESE SCISSORS TO BE SWITCHED OUT TO A DIFFERENT SCISSOR. I DO HAVE 3 PAIRS FOR EVALUATION PURPOSES.
BD Infusion Therapy Systems, Inc./Intravascular Catheter PEDIATRIC CENTRAL VENOUS LINE ("PCVL") IN RT ARM. ALARM SOUNDED "DISTAL OCCLUSION"; IV RATE INCREASED SLIGHTLY-STILL ALARMED. FILTER CHANGED UNDER STERILE CONDITIONS-AFTER 10 MINS ALARMED AGAIN "DISTAL OCCLUSION." MD FLUSHED 3MLS N/S FROM CLOSEST DISTAL PORT, AND 2 PINHOLES WERE SEEN WHERE FLUID LEAKED. PEDIATRIC IV INSERTED; PCVL PULLED OUT.
Bard Access Systems/Intravascular Catheter Catalog: 3164155 PICC LINE WAS FOUND TO BE LEAKING AT THE HUB; WAS REPLACED.
Advanced Medical, Inc./Intravascular Catheter Lot: MAMN530 NURSE WAS FLUSHING PICC LINE WHEN IT WAS NOTED THAT THE PICC LINE WAS LEAKING AT THE HUB. THE PATIENT WAS TAKEN TO RADIOLOGY WHERE THE PATIENT WAS SEDATED. THE PHYSICIAN REMOVED THE OLD PICC LINE. THE REMOVAL CONSISTED OF AN OVER WIRE PROCEDURE. THE SAME VASCULAR ACCESS POINT WAS UTILIZED FOR THE NEW PICC LINE (RIGHT POPLITEAL VEIN).
Becton Dickinson/Intravascular Catheter Lot:7039277 NEWLY INSERTED PICC LINE DISLODGED WHEN IT WAS BEING REPOSITIONED. SEVEN CM OF THE CATHETER REMAINED INSIDE THE PATIENT REQUIRING SURGICAL RETRIEVAL AND THE NEED FOR A CENTRAL LINE TO BE PLACED.
Becton Dickinson/Intravascular Catheter Device Identifiers Unknown/Not Available PATIENT WAS IN THE NICU WITH A PICC LINE. THE NURSE ENTERED THE ROOM AND OBSERVED THAT THE LINE HAD BROKEN AT THE HUB. THE REMAINING CATHETER WAS REMOVED WITHOUT INJURY TO THE PATIENT.
HDC Corporation/Intravascular Catheter Lot: 4FR 1026, 1029, 1030; 5FR 1033 THERE HAVE BEEN MULTIPLE PROBLEMS WITH THE INTRODUCER KITS THAT REQUIRE THE SELDINGER TECHNIQUE. THEY FALL INTO THREE GROUPS:
1) LEADING EDGE OF PEEL-AWAY INTRODUCER IS FLARED WHICH WOULD LIKELY CAUSE INJURY IF PUSHED INTO A VEIN (HAVE SEEN TWICE).
2) TIP OF DILATOR WON'T ALLOW GUIDEWIRE TO PASS. (THIS HAS HAPPENED AROUND FOUR TIMES TO SEVERAL IV NURSES, BUT VISUAL INSPECTION OF KITS REVEALS A NON-CIRCULAR OPENING IN ABOUT 15% OF DILATORS.) THIS RESULTS IN A COMPLETE REDO OF INSERTION WHICH CAN BE DIFFICULT ON SOME PATIENTS.
3) HANDLE ON END OF GUIDEWIRE CAME OFF SO THAT WIRE COULD NOT BE REMOVED PROPERLY (OCCURRED ONCE). THIS REQUIRED A SECOND INSERTION THROUGH THE EXISTING INTRODUCER.
PROBLEM 1) NO RESPONSE YET.
PROBLEM 2) PROBLEMATIC DILATORS COME FROM A COMPANY CALLED ENPATH. HDC HAS SENT DILATORS FROM A DIFFERENT COMPANY. THEY FUNCTION THE SAME WAY. REPORTEDLY, HDC DOESN'T MANUFACTURE THE DILATORS. THEY BUY THEM FROM THIRD PARTIES: ENPATH AND OTHERS.THE ENPATH DILATORS WERE THE ONES THAT WERE HAVING THE PROBLEMS. ANOTHER COMPANY'S WERE OFFERED AS REPLACEMENTS SO THAT THE EXISTING KITS COULD STILL BE USED. THEY COME IN INDIVIDUAL STERILE PACKS.
Bard Access Systems/Intravascular Catheter lot: RERD0689 AT THE COMPLETION OF PICC PLACEMENT, WIRE STYLET BECAME SEPARATED/UNRAVELED DURING REMOVAL. ENTIRE WIRE REMOVED WITH DISTAL (4 CM) TIP INTACT BUT PROXIMAL END AND REST OF WIRE SEPARATED. PICC THEN REMOVED AS IT WOULD NOT FLUSH AFTER WIRE REMOVED, NO RESISTANCE TO REMOVAL, CATH INTACT.
BD Infusion Therapy Systems, Inc./Intravascular Catheter Lot: 7250110 THE PATIENT WAS SCHEDULED FOR A CT SCAN. WHILE IN RADIOLOGY, THE TECH FLUSHED THE PICC WITH 1 ML OF NORMAL SALINE THROUGH LONGEST PORT VIA A 10ML SYRINGE. CONTRAST DYE WAS THEN ADMINISTERED VIA A 10ML SYRINGE. FOUR OF SEVEN ML OF DYE GIVEN. PICC THEN BURST AT THE HUB. NO BLEEDING BACK NOTED. FLUIDS STOPPED, INFANT RETURNED TO NCCC. NNP NOTIFIED IMMEDIATELY. PICC REMOVED. CATHETER APPEARED INTACT.
Boston Scientific Corporation/Intravascular Catheter Lot: 1224626 SEVEN PICC LINES HAVE BEEN IDENTIFIED AS APPARENTLY DEFECTIVE AS PATIENTS HAVE RETURNED DUE TO LEAKING. FOUND ALL HAVE A CRACK IN LEG OF CATHETER. REMOVED AND REPLACED WITH NEW LINE.
Bard Access Systems/Intravascular Catheter Lot: RERL0475 THE NURSE FOUND THAT THE PICC LINE CATHETER HAD FRACTURED AT THE HUB, AND WAS LYING IN THE BED WITH THE OTHER PART OF THE CATHETER STILL IN THE PATIENT. THE PORTION OF THE CATHETER THAT WAS STILL IN THE PATIENT WAS REMOVED WITH THE TIP INTACT. THIS PICC LINE WAS PLACED 16 DAYS PRIOR VIA ULTRASOUND AND FLUOROSCOPIC GUIDED PLACEMENT IN THE RIGHT ANTECUBITAL.
Bard Access Systems/Intravascular Catheter Catalog: 3386105 UPON PLACING A PICC LINE, THE INTERNAL WIRE COIL FRAYED WHEN IT WAS REMOVED FROM PATIENT'S RIGHT ARM AND POSSIBLY LEFT BEHIND A FOREIGN BODY WIRE IN THE ARM.
Bard Access Systems/Intravascular Catheter Lot: RESC0612 THE ORDER WAS RECEIVED FOR A PICC PLACEMENT, AND THE ROUTINE PREPARATION PER PROTOCOL WAS COMPLETED. THE RIGHT BRACHIAL VEIN WAS ACCESSED UNDER ULTRASOUND GUIDANCE. THE GUIDEWIRE WAS ADVANCED THROUGH THE NEEDLE. THE NEEDLE WAS REMOVED, HOWEVER, WHEN THE STAFF MEMBER ATTEMPTED TO REMOVE THE GUIDEWIRE FROM THE PATIENT'S ARM, RESISTANCE WAS MET AND THE WIRE WAS UNABLE TO BE REMOVED. AFTER FURTHER ATTEMPTS TO REMOVE THE GUIDEWIRE, IT UNRAVELED. THE WIRE WAS EVENTUALLY REMOVED, AND PRESSURE WAS HELD AT THE SITE. AN X-RAY OF THE RIGHT ARM WAS COMPLETED TO ASSESS IF ANY RESIDUAL WIRE REMAINED IN THE PATIENT. REVIEW OF FILMS DETERMINED THERE WERE NO FOREIGN BODIES PRESENT. THE PATIENT WAS REFERRED TO INTERVENTIONAL RADIOLOGY FOR LINE PLACEMENT. THE PHYSICIAN WAS CONSULTED, AND NO RIGHT ARM FOLLOW-UP WAS NEEDED.
Bard Access Systems/ Intravascular Catheter Lot: RERJ0658 THE RN ENTERED THE PATIENT'S ROOM AND FOUND THE PICC LINE BROKEN APPROXIMATELY ONE INCH BELOW THE PICC SECURE WINGS. STAFF REPORT THAT APPROXIMATELY THREE INCHES REMAINED UNDER THE TEGADERM, SECURED TO THE SKIN. THE PICC LINE WAS CLAMPED AND THE PICC RN WAS NOTIFIED. THE PICC LINE WAS THEN REMOVED AND A NEW LINE INSERTED. NO PATIENT HARM. THE PICC LINE HAD BEEN PLACED IN THE LEFT BASILIC VEIN WITHOUT DIFFICULTY BY THE PICC NURSE. OUR FACILITY'S PRACTICE IS TO FLUSH PICC LINES WITH SALINE ONLY USING A 6CC OR LARGER SYRINGE BEFORE AND AFTER IV PUSH MEDS AS WELL AS BLOOD DRAWS. THE PORTS ARE CLEANED WITH CHLORHEXIDINE.
Bard Access Systems/ Intravascular Catheter Lot: RERI0505 PICC RN EVALUATING PICC LINE FOR PATIENT AND NOTED THAT THE LINE WAS LEAKING. AFTER REMOVING THE TEGADERM DRESSING, SHE FLUSHED THE WHITE PORT OF THE PICC LINE WITH 0.9 NORMAL SALINE AND NOTED A SALINE STREAM SHOOTING FROM THE PICC LINE AT 53CM. SHE FLUSHED THE RED PORT AND NOTED SOME SALINE LEAKING FROM THE SAME AREA. WHEN THE CATHETER EXCHANGE WAS UNSUCCESSFUL, A NEW LINE WAS INSERTED. OUR FACILITY'S PRACTICE IS TO FLUSH THE SYRINGE WITH 5-10CC OF SALINE AFTER EVERY USE OF THE PICC, INCLUDING MEDS AND LAB DRAWS. THE PORTS ARE CLEANED WITH CHLORHEXIDINE PRIOR TO ACCESS.
Bard Access Systems/Intravascular Catheter Lot: RERJ0460 PICC LINE PLACEMENT DONE PER PICC RN WITH 5 FRENCH DUAL LUMEN CATHETER WITH GOOD BLOOD RETURN AND BOTH PORTS FLUSHED WELL. 34 CM INSERTED WITH 11 CM REMAINING OUT. PLACEMENT CONFIRMED BY CXR AND RADIOLOGIST. WHEN IRRIGATING CATHETER, THERE WAS LEAKAGE BY THE WINGS, FLOOR NURSE AND RADIOLOGIST ADVISED. PT SENT TO SPECIALS FOR INSERTION OF ANOTHER LINE.

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Updated November 1, 2008

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