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U.S. Department of Health and Human Services

MedSun: Newsletter #68, January 2012

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Newsletter #68, January 2012

Articles

CareFusion AVEA Ventilator: Recall - Failure May Lead to Lack of Ventilation

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FDA MedWatch Safety Alert

FDA notified healthcare professionals of a class I recall of CareFusion AVEA Ventilators. The AVEA ventilator can develop a failure where the ventilator activates a false extended high peak alarm, opens the safety valve and stops ventilating. Without health care professional intervention, patients may suffer life-threatening injury or death. The AVEA ventilator is intended for continuous breathing support for the care of neonatal through adult patients who require mechanical ventilation. These ventilators are used in hospitals and other health care institutions. The recalled ventilators were manufactured between March 1, 2009 and June 30, 2011.

Additional Information:

FDA MedWatch Safety Alert. CareFusion AVEA Ventilator: Recall - Failure May Lead to Lack of Ventilation. December 23, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm285063.htm

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Smiths Medical Issues Urgent Device Recall of Certain Bivona Neonatal, Pediatric, and Flextend Tracheostomy Tubes

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Recall - Firm Press Release

Smiths Medical announced that it is initiating a nationwide voluntary recall of Bivona Neonatal, Pediatric and FlexTend Tracheostomy Tubes with integrated connector which is not designed to be used with a disconnect wedge. Customers have experienced difficulty disconnecting accessories from the connectors of the Affected Tubes. In some cases, the customer was unable to disconnect the accessory or excessive force led to decannulation of the tube, and an emergency tracheostomy tube change was required. If the accessory is correctly connected to the Affected Tubes, then there will be no issue with disconnection. A copy of the customer notification letter, along with pictures to distinguish the affected tubes, is posted on the Smiths Medical website at http://www.smiths-medical.com.

Please visit the website below for specific instructions as to what actions consumers who have the Affected Tubes should take.

Additional Information:

Recall – Firm Press Release. Smiths Medical Issues Urgent Device Recall of Certain Bivona Neonatal, Pediatric, and Flextend Tracheostomy Tubes. December 22, 2011.
http://www.fda.gov/Safety/Recalls/ucm285191.htm

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Steris System 1 (SS1) Processor: Second 6 Month Extension for Health Care Facilities to Replace STERIS System 1 with a Legally-Marketed Alternative

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FDA Medical Device Safety Alerts

In December, 2009, the FDA announced that Steris had modified the SS1 processor and that the FDA had not approved or cleared the modified SS1 for its labeled claims. STERIS Corporation has chosen not to seek the FDA's clearance of this device so its use should be discontinued.

The FDA’s primary objective is that safe and effective alternative reprocessing devices be identified and placed into use as soon as possible, without compromising either patient care or employee health. During this transition period, the FDA will monitor the availability and supply of legally-marketed replacement products. FDA has extended the transition period to period to August 2, 2012, with some requirements. Please visit the website below for more information.

Additional Information:

FDA Medical Device Safety Alerts. Steris System 1 (SS1) Processor: Second 6 Month Extension for Health Care Facilities to Replace STERIS System 1 with a Legally-Marketed Alternative. December 22, 2011.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm284779.htm

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St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads: Class 1 Recall - Failures with Lead Insulation

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FDA MedWatch Safety Alert

FDA notified healthcare professionals of a Class I Recall of the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads. The silicone insulation covering these defibrillation leads is at risk of premature abrasion. When abrasion occurs, the conductors inside the leads can come out (externalized) of the insulation. Leads with externalized conductors may develop electrical dysfunction and not work as intended. In the event the device does not work as intended, should a life-threatening heart rhythm occur, pacing or defibrillation therapy may not be delivered as intended. This may result in serious adverse events, including death.

The recall includes the following model numbers:
•Riata (8F) Silicone Endocardial Defibrillation Leads
Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592
•Riata ST (7Fr) Silicone Endocardial Defibrillation Leads
Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042

Additional Information:

FDA MedWatch Safety Alert. St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads: Class 1 Recall - Failures with Lead Insulation. December 21, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm284390.htm

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FDA Targets Gastric Band Weight-Loss Claims

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FDA Consumer Update

Beware of ads that glamorize this surgery without giving the risks. FDA has warned eight surgical centers and the marketing firm 1-800-GET-THIN LLC in California about misleading advertising of the Lap-Band - a device implanted in a surgery called gastric banding to help adults eat less and lose weight. FDA has approved two gastric bands: Lap-Band, by Allergan Inc., and Realize Adjustable Gastric Band, by Ethicon Endo-Surgery Inc. These devices are implanted around the upper part of the stomach to create a “pouch.” The small pouch limits the amount of food that can be eaten at one time, making you feel full faster and potentially lose weight. Both bands are approved for use in adults age 18 and older who have not lost weight with non-surgical methods, such as diet, exercise or behavior modification. Health care providers who choose to promote the gastric banding procedure are required to educate patients about the risks involved, which must also be included in any advertising and promotional materials. Patients considering the surgery should read the patient information provided by their doctor and should ask any questions they have about gastric banding before having surgery.

Additional Information:

FDA Consumer Update. FDA Targets Gastric Band Weight-Loss Claims. December 13, 2011.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm279301.htm

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FDA and Partners Working to Prevent Surgical Fires

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FDA Consumer Update

Surgical fires are fires that occur in, on or around a patient who is undergoing a medical or surgical procedure. In 2011, FDA and its partners launched the "Preventing Surgical Fires" initiative to: increase awareness of factors that contribute to surgical fires, disseminate surgical fire prevention tools, and promote the adoption of risk reduction practices throughout the healthcare community. This FDA Consumer Update provides information about how surgical fire events can happen, how to reduce their risk, as well as two stories from a patient and healthcare professional, respectively.

Additional Information:

FDA Consumer Update. FDA and Partners Working to Prevent Surgical Fires. December 9, 2011.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm282810.htm

Preventing Surgical Fires - Collaborating to Reduce Preventable Harm. FDA Safe Use Initiative. October 13, 2011.
http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/PreventingSurgicalFires/default.htm

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CooperVision Avaira (enfilcon A) Sphere Soft Contact Lens: Class 1 Recall - Unintended Residue on Lenses

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FDA MedWatch Safety Alert

FDA notified healthcare professionals of a Class I recall of certain lots of Avaira (enfilcon A) Sphere Soft Contact Lens. These lenses were manufactured from February 1, 2011 through August 24, 2011 and distributed from March 2, 2011 through November 15, 2011. Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment. Affected contact lens wearers should stop wearing their lenses immediately and contact their eye care practitioner for advice.

Additional Information:

FDA MedWatch Safety Alert. CooperVision Avaira (enfilcon A) Sphere Soft Contact Lens: Class 1 Recall - Unintended Residue on Lenses. December 7, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm282756.htm

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Draeger Medical Inc., Infinity Acute Care System Monitoring Solution (M540)

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FDA MedWatch Safety Alert

FDA notified healthcare professionals of a Class I recall of the Infinity Acute Care System Monitoring Solution (M540), Catalog number MS25510. This product was manufactured from March 1, 2011 through September 30, 2011 and distributed only to the Rush University Medical Center (Chicago, Illinois) from July 1, 2011 through September 30, 2011. All serial numbers are affected by this recall. This product is a networked system used to monitor a patient’s vital signs and therapy, review Web-based diagnostic images, and access patient records. This recall is being issued due to incorrect dosage values and vital signs delays at the Infinity Central Station, which could cause serious health consequences to the patient.

Additional Information:

FDA MedWatch Safety Alert. Draeger Medical Inc., Infinity Acute Care System Monitoring Solution (M540). December 6, 2011.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm282461.htm

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Highlighted MedSun Reports

Highlighted Reports

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This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period October 1 through October 31, 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.

CARDIOVASCULAR

Device:
Type: Catheter, Oximeter, Fiberoptic
Manufacturer: Edwards LifeSciences
Brand: Presep Oligon
Lot #: 59046758
Cat #: XA3820KCDCNL

Problem:
The emergency department physician was in the process of inserting a central line. When he was ready to thread the catheter over the guidewire, the catheter would not advance. There were no visual defects--no cracks, kinks, etc. Staff obtained another identical Cordis kit (same manufacturer--lot number unknown)and used the catheter from it. The MD completed the line insertion with no difficulty. There was no harm to the patient. The MD and staff involved in the event are very experienced with this equipment/procedure. All reported they have not had this experience before and do not know why the line would not thread. The catheter and packaging were saved and have been returned to the manufacturer for inspection/analysis.
======================
Manufacturer response for PreSep Oligon oximetry catheter kit, PreSep Catheter kit (per site reporter)
======================
Equipment Distribution notified the manufacturer and returned the device the following day. We are awaiting the manufacturer's findings from their investigation/analysis.


Device:
Type: Catheter, Percutaneous
Manufacturer: Arrow International
Brand: Multi-lumen Central Venous Catheterization Super-kit With Blue Flextip Arrowguard Blue Plus Catheter
Model#: AK45703BSK
Lot #: RFD128906

Problem:
The central line kit wire shredded upon insertion. The clinician removed the wire and another line was later inserted by a different clinician. The lot was removed and returned to the rep. We have had multiple failures with many patients. The hospital has since switched central line kit manufacturers. No patients suffered any adverse effects.


Device:
Type: Clamp, Vascular
Manufacturer: St. Jude Medical
Brand: FemoStop Gold

Problem:
The FemoStop bulb failed. There was no pressure reading on the screen when inflated. Thus we unable to tell how much pressure was exerted on the patient and unable to deflate the bulb. Eventually, the screen read "EEE". Manual pressure needed to be held to the patient's femoral artery with sheath pulling.
======================
Manufacturer response for FemoStop, FemoStop gold (per site reporter)
======================
No response yet


Device:
Type: Device, Hemostasis, Vascular
Manufacturer: St. Jude Medical
Brand: Angio-seal 6f Sts Plus
Model#: 610119
Lot #: 3320260

Problem:
The patient had undergone a diagnostic cerebral angiogram in the interventional radiology room. Access for the procedure was obtained via the right common femoral artery. Upon conclusion of the procedure, an angio-seal vascular closure device was deployed to close the right groin puncture site. Use of the closure device stops the bleeding from the puncture site more rapidly and with little or no manual compression, allowing the patient to ambulate sooner. The device is introduced over the guidewire and a collagen plug is deployed. A suture is attached to the plug and the suture is pulled until the plug is up against the puncture site. Once in place, the plug is then sutured/secured. During this incident, when the collagen plug was released, the telescopic tubing covering the collagen plug/suture apparatus broke in half. All of the tubing was removed from the patient and direct compression pressure was held over the groin puncture site for 15 minutes. The patient's right groin was monitored post procedure per protocol and the groin wound site remained intact without hematoma. The patient was discharged home two days after the procedure in stable condition.


Device:
Type: Filter, Intravascular, Cardiovascular
Manufacturer: Bard Peripheral Vascular
Brand: G2

Problem:
Bard G2 IVC (inferior vena cava) filter was to be placed to the femoral area. Packaging for jugular and femoral vein look identical except for small labeling. The jugular filter was opened for the femoral case. Nurse caught mistake before given to physician for insertion.
======================
Manufacturer response for Bard IVC filter, G2 filter (per site reporter)
======================
Spoke with Bard rep concerning packaging.


Device:
Type: Pacemaker, External, Temporary
Manufacturer: Medtronic, Inc.
Brand: 5388
Model#: 5388
Other #: INVASIVE-12-912A

Problem:
Nursing staff were using a temporary pacer on a patient when the unit unexpectedly and suddenly shut off. Staff changed the batteries, replacing the Cardinal Health batteries in the unit with another set of fresh Cardinal Health batteries, but the unit still would not turn back on. Staff then obtained a set of MED CELL batteries and was able to get the device to run without difficulty. There was no harm to the patient. BioMed was contacted and evaluated the device as well as the batteries in question (both Cardinal and MED CELL). The pacer was determined to be in full working condition. However, BioMed did note that on the 9.7V Cardinal Health battery that the negative terminal was slightly depressed, and the overall terminal height (47 mm) was 1.0 mm less then the Med Cell (48mm). This could possibly have caused the battery to not have proper contact with the pacer's terminals. As a result of this event, we have removed all Cardinal Health batteries from nursing departments that have temporary pacers and replaced them with MED CELL batteries. Clinical Inventory and Equipment Distribution as well as BioMed departments have removed Cardinal Health batteries from our list of available equipment to purchase. Nursing managers have educated staff on their units that only MED CELL batteries should be used in these devices.
======================
Manufacturer response for temporary external pacemaker, Temporary PACEMAKER (per site reporter)
======================
We have not had a response from the manufacturer as of filing this report.

See device images:
Image of the Medtronic 5388 Temporary External Pacer

Image of a 9V Battery Terminal.  Battery top is blue; bottom of battery is silver with small writing.

Image of two 9V Batteries Side by Side to show the differences in the terminals as described in the report.  The battery on the left says Medcell Alkaline and is silver.  The battery on the right has a blue top and silver bottom with small writing.


Device:
Type: Surgical Device, Ablation, Rf, Cardiac
Manufacturer: Ncontact Inc.
Brand: Numeris Guided Coagulation System With Visitrax
Model#: CSK-123
Lot #: DF071101

Problem:
Machine for covergent was not working. All connections were checked and plugs were checked. Power to the machine was okay. Ncontact kit changed out and everything worked fine thereafter. The catheter was faulty. After changing it the machine worked. This out-of-box failure occurred prior to the procedure. There was no patient harm.


Device 1:
Type: Transducer, Blood Pressure, Extravascular
Manufacturer: Edwards Lifesciences
Brand: Disposable Pressure Transducer Kits
Model#: PXMK2197
Lot #: 58896153

Device 2:
Type: Transducer, Blood Pressure, Extravascular
Manufacturer: Edwards Lifesciences
Brand: Disposable Pressure Transducer Kits
Model#: PXMK2197
Lot #: 58896153

Problem:
Patient A: Triple transducer is leaking on the CVP most distal port; has a crack on the plastic Luer lock. The problem was identified preoperatively during set up. The device was switched out and there was no harm to the patient.
Patient B: As setting up for a scheduled open heart case, spiked the Heparin for the triple transducer and flushed it through. Noticed a leak from the bottom of the yellow transducer. It looked like there was a crack where the tubing attaches to the bottom of the transducer; changed out the whole triple transducer. There was no harm to the patient.


EAR, NOSE & THROAT

Device:
Type: Instruments, ENT
Manufacturer: Medtronics Xomed Inc
Brand: Xomed ENT Instruments
Model#: 3722042 and 3724013
Cat #: 3722042 and 3724013

Problem:
Thirty minutes post surgical start time the scrub technician noticed a possible small, approximately 1mm contaminant on the tray that the sterile instruments came in. The instrument tray was on the sterile field, and the instruments were in use at the time this was noted.

The possible contaminant was not visible until the instruments were removed from the tray, thus making it impossible for the scrub technician to know. It was there until the instruments were removed.

The doctor will prescribe post-operative antibiotics and the patient's condition will be monitored.

We sterilized our instruments on site. We just purchased this set a month ago. Yesterday we found rust spots on three of our new instruments that go into this set. We believe that these spots on the tray were caused by the rusted instruments. We reprocessed the set again and rechecked the instruments. We discovered an additional 10 instruments with rusting and pitting spots. Roughly, it has only been processed and sterilized roughly six times. The company has asked that we send the set back to them ASAP. They plan to replace the instruments and possibly the whole set. We are in the process of sending them back to the manufacturer.
======================
Manufacturer response for ENT instruments, Xomed ENT instruments (per site reporter)
======================
No response at this time.

See device images:

Image of one ENT instrument that shows areas of rusting.  Instrument is resting against blue knitted cloth.

Image of one ENT instrument that shows areas of rusting.  Instrument is resting against blue knitted cloth.

Image of two ENT instruments laying side by side, which show many rusting areas.  Instruments are resting against blue knitted cloth. Rust spots are more obvious in this image.

Image of one ENT instrument that shows areas of rusting.  Rusting is significant.  Instrument is resting on a white piece of paper.


GENERAL & PLASTIC SURGERY

Device:
Type: Breast Biopsy Needle, Stereotactic
Manufacturer: Devicor Medical Products, Inc.
Brand: Mammotome St
Lot #: H43J8Y
Cat #: MST 11B
Other #: 11 G (3.1 mm) Bladed Tip stereotactic Probe

Problem:
Core biopsy needle fired into breast and suction tubing was broken. (The suction tubing is the main source which draws the sample into the needle.)

The needle was already in the breast at the time when the needle was fired. But when the needle was fired further into the breast, the tubing must have been too taut and it snapped off. When the needle/gun is fired, it fires it about 2cm throw and if that tubing doesn't have enough slack, then it will break off. The user didn't realize that the tubing was in jeopardy of being broken off.

Device 1:
Type: Clip Applier
Manufacturer: Boston Scientific Corporation
Brand: Resolution Clip
Model#: ML000090C2
Cat #: 2261

Device 2:
Type: Clip Applier
Manufacturer: Boston Scientific Corporation
Brand: Resolution Clip
Lot #: ML000120C2
Cat #: 2261

Problem:
During endoscopic closure of an esophageal tear, four Resolution Endoclips misfired, and two clips would not open. The gastroenterologist reported in the procedural note: "Resolution clips were placed initially at 36 cm, 35.5 cm, 35 cm, and 34.5 cm. As we attempted to place the next clip, the clip malfunctioned and did not open. This could be removed through the scope. The next clip also malfunctioned and did not open, but could be removed from the scope. However, the next four clips malfunctioned by opening within the esophagus, but were not able to close. These clips were intra-luminal left. Finally, two additional clips were placed. The last one appeared to close off any further fluid drainage into the esophagus. Following this, each of the individual clips that were left free in the esophagus and previously malfunctioned was separately removed. The procedure was then terminated.


Device:
Type: Gauze, Sponge
Manufacturer: Covidien
Brand: Dermacea
Lot #: 110001891962
Cat #: 441202

Problem:
Single pack (Dermacea) sponges are used for dressings at the end of a surgical procedure. They are opened with sterile technique onto the surgery sterile back table at the end of the procedure. RN's are reporting chronic problems with the sponge being trapped in the glue seal of the packaging, making the sponge no longer sterile and near impossible to present to the sterile field. The sponge has dried into the glue and it will not move. We suggest the vendor has "packing of sponge equipment" inspected for malfunction.
======================
Manufacturer response for Dermacea 6" x 6.75" Super Sponge, Dermacea (per site reporter)
======================
They will mail a self pay envelope and examine the sponges; They will mail us a free case of sponges for the inconvenience.


Device:
Type: Gauze/sponge
Manufacturer: Cardinal Health
Model#: SBA56LPUCS
Lot #: MFG date 06/13/11 #40 and #7
Cat #: 703587

Problem:
We were setting up for a case and we opened the laparotomy pack and all other supplies. When setting up the case, the scrub personnel looked at the x-ray sponges and noticed a hair crumpled on them. The patient had just come into the OR room, I then took her back to holding to wait while we torn down our case, and then re-set up for the case again. A new pack was opened and we started looking over the pack again, but didn't notice anything out of the ordinary. I then again brought the patient into the room and we were just about to start the general anesthesia, when in between the x-ray sponges we found another hair. We stopped before giving her the general anesthesia, while we tore the case down again. The doctor put a warmer on the patient and gave her a relaxing agent while we again called and set up one more time for the case. We then had the scrub look through the x-rays very carefully and could not see any debris. Two different packs were contaminated with a hair. This is not the first time we have had this problem of finding hair in sterile packs.
======================
Manufacturer response for Custom Laparotomy pack,
======================
No response at this time.


Device:
Type: Instrument, Robotic Surgical, Tip Cover Accessory
Manufacturer: Intuitive Surgical Inc.
Brand: Microtek Da Vinci Tip Cover Accessory
Model#: 400180
Lot #: C10271
Other #: Version -10

Problem:
A recurrent problem has been occurring with the silicone tip covering the scissors and bovie of the da Vinci robotic surgery instrument whereby holes develop in the tip cover at the flexible joint of the instrument. This requires replacement of the tip cover one or more times during surgery. The bovie can fire through this hole, potentially burning blood vessel or bowel.

Device:
Type: Instrument, Ultrasonic Surgical
Manufacturer: Olympus America, Inc.
Brand: Sonosurg
Model#: T3905

Problem:
During a laparoscopic supracervical hysterectomy, the tip of the Sonosurg Device (instrument) broke off in patient. All pieces were retrieved and isolated. An X-ray was taken to assure that no additional pieces were retained. No adverse outcome to patient.


GENERAL HOSPITAL

Device:
Type: Catheter, PICC
Manufacturer: Argon Medical Devices
Brand: L-Cath
Model#: L-Cath
Lot #: 1003476
Cat #: 384539

Problem:
RN noted leaking PICC at insertion line site. Leaking noted at 20cm distal to the lavender strain relief mark on the catheter.


Device:
Type: Catheter, PICC
Manufacturer: B&D infusion therapy systems, Inc.
Brand: L-Cath PICC Catheter
Lot #: 1066280
Cat #: 384539

Problem:
Over the last few day nurses in our New Born Intensive Care Unit reported that 4 out of 20 catheters have failed during use. Nurses reported that after the first time they flushed the catheter they are not able to flush on subsequent attempts making it so they have to replace the catheter with a new one. There is a little plastic sleeve on the catheter. This is the area that seems to clog. Our facility has 14 boxes with 5 kits each, still remaining from this lot. We are in the process of notifying the manufacturer. No patients were harmed except for the fact that another catheter had to be inserted.

See device images:

Up-close image that shows BD Catheter, notably the portion with the plastic sleeve that clogs per the report.  A pen tip points out exactly where the plastic sleeve is on the BD Catheter.

Image that shows BD Catheter, notably the portion with the plastic sleeve that clogs per the report.  A pen tip points out exactly where the plastic sleeve is on the BD Catheter.

A third image that shows BD Catheter, notably the portion with the plastic sleeve that clogs per the report.  A pen tip points out exactly where the plastic sleeve is on the BD Catheter.


Device:
Type: Catheter, PICC
Manufacturer: Vygon Corporation
Brand: Lifecath S PICC Catheter
Lot #: 09111OGC

Lollipop Icon
Problem:
PICC line inserted per RN and seven days later the infant had decreased oxygen saturations following a bath. Thereafter, the infant was in severe respiratory distress with retractions and nasal flaring. Nurse practitioner and attending came to bedside to assess. Infant re-intubated, however, heart rate continued to drop with no recovery. Code called. Ten minutes into code, a physician diagnosed infant with cardiac tapenade and performed emergency pericardiocentesis with 18 gauge angiocath. 14 cc of whitish fluid suspicious for TPN/lipid was aspirated from pericardium. Infant's heart rate immediately recovered. PICC line discontinued and discarded. Head ultrasound, cardiac ultrasound, and MRI essentially normal following the event.


Device:
Type: Catheter, PICC
Manufacturer: Becton Dickinson
Brand: L-Cath
Lot #: 1066281

Lollipop Icon
Problem:
A PICC line was placed in a infant. The line was secured and fluid started to infuse. A few hours later, it was noted that under the Tegaderm dressing there was a collection of fluid. The PICC was then flushed and noted to be leaking below the hub of the catheter. This is not a repairable PICC, so it was necessary to pull the line. This resulted in the infant being "stuck" several additional times before PICC access was obtained.


Device:
Type: Catheter, PICC
Manufacturer: Navilyst Medical
Brand: Xcela Pasv 3f 55cm Intermediate Mst -45 Lido Kit
Model#: Product Number H965457050
Lot #: 4010915D
Cat #: Order Number 45-705

Problem:
When nurse was doing a PICC dressing change, she found that all numbers on the PICC line had been completely wiped off. Instead of visualizing catheter markings to monitor for catheter migration, the nurse had to measure the line with a measuring tape.
Catheter was not removed as patient continued in need of long term antibiotics for cocci osteomyelitis. Patient remains hospitalized at this time, and line remains in place.
======================
Manufacturer response for Power PICC Line, Xcela Pasv 3f 55cm Intermediate Mst - 45 Lido Kit (per site reporter)
======================
None at this time.


Device:
Type: Infusion Set, Port, Implanted
Manufacturer: BARD Access Systems
Lot #: D033618
Cat #: REF 0132010
Other #: 0719977 0811 R, 0719962 0812 R

Problem:
Staff member in Cat-scan states that they have noticed that our PowerPort infusion set needle has been pressure limiting. This has been a problem noted for approximately one year. No harm to patient, but staff noted that they are not able to push contrast as fast as they should be able to, thus patient does not receive contrast as quickly as should be administered. Staff stated that PowerPort injection rate pressure limited at 3.5cc/sec.
======================
Manufacturer response for BARD Power-injectable infusion set, 20Gx1.0in., BARD (per site reporter)
======================
Staff member stated they have notified the Rep and they state they have never heard of this issue before.


Device:
Type: Port, Catheter, Implanted
Manufacturer: Bard Access Systems, Inc.

Problem:
Nurse Manager was advised by physician that patient had a port catheter that required removal due to malfunction. The port catheter was reportedly plastic and father of patient (who is a physician) had asked patient's physician re: follow up for the plastic ports malfunctioning. Nurse Manager reviewed the chart; the port was placed in the OR and eight days later an infiltration was noted during platelets. The following day a dye study showed "not okay to use". Subsequently, the next day the port was removed in the OR. Note states defect to posterior wall of port where fluid was actively extravasating. Report notes port sent to Pathology. I contacted Pathology and Central Processing and was advised that the port was not received in Pathology and not checked into the main lab. Nurse Manager contacted OR Nurse Manager and asked that she discuss with surgeon if removed port was available. The Nurse Manager has not been able to locate the removed port to send to Bard. Our vendor and rep from Bard was contacted regarding the incident and advised that he is not aware of similar incidents with this product. The nurse manager completed Bard's paperwork per the rep's request.


Device 1:
Type: Syringe, General Use, 60cc
Manufacturer: BD Medical
Brand: BD
Cat #: 309653

Device 2:
Type: Injector, Contrast Media, MRI
Manufacturer: Mallinckrodt Inc Liebel-Flarsheim Business (Covidien Co)
Brand: Optistar LE
Model#: Optistar LE

Problem:
A contrast media injector for MRI was prepped and loaded with a BD 60 ml syringe. The technician programmed the parameters for the syringe volume. A circuit in the injector automatically detected the size of the syringe via a microswitch assembly (this is normal). As the plunger mechanism descended during the LOAD PHASE it made contact with the syringe and calculated the syringe volume. However, the syringe did not reliably activate the microswitch because the flange of the syringe is less thick than the previous version. Thus, a very slight movement of the syringe body caused the injector syringe volume setting to toggle between 60ml to 50ml. This caused the plunger to travel in and out (self correct) before the injection command was actually given.


Device:
Type: System, Medication Reconciliation Software
Manufacturer: Siemens Medical Solutions USA, Inc.
Brand: Soarian Mak
Other #: Honeywell bar code scanner

Problem:
Wrong amount of Gadavist was entered into the Siemens MAK (Med Administration Check) system because bar code scanning gun in the MRI scan room is not working properly. The scan gun goes into some type of "sleep mode" and needs to be triggered multiple times, then it will scan correctly. While trying to scan Gadavist barcode, the system registered a dose of 65ml. When I entered the correct dose of 10ml, the system alerted me of a recent contrast administration (within 48 hours). Nurselinks confirmed that 65ml dose was recorded.


Device:
Type: Warmer, Infant Radiant
Manufacturer: Draeger Medical
Brand: Airshields Warmer
Model#: PM78-1

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Problem:
Radiant warmer began to smoke. Power turned off immediately and smoking dissipated quickly.
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Manufacturer response for Radiant Warmer, Airshields Warmer (per site reporter)
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Technician inspected warmer. Smoke was from dust build up on top of the metal heat shield on top of the unit.


Device:
Type: Warmer, Infant Radiant
Manufacturer: GE Healthcare
Brand: Giraffe
Model#: M1118179

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Problem:
Infant was discovered with "sunburn like" marks on the entire right side. Infant skin temperature was the same as the bed temperature. The bed was turned off and another warmer from a different manufacturer was used for treatment.
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Manufacturer response for Radiant Warmer, Giraffe (per site reporter)
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GE feels it could be a staff knowledge concern due to a different design than previous warmers used in the past.


OPHTHALMIC

Device:
Type: Amo Dual Pump Pack
Manufacturer: Abbott Medical Optics
Brand: Amo Fusion Fluidics Tubing Pack
Model#: OPO71
Lot #: CJ00993; CJ01029
Cat #: OPO71

Problem:
Pump pack has a broken connector and staff were unable to get pump to prime. It appears that the connector is broken off inside the end of the tubing. This event has also occurred on two previous dates, with one date having three separate pump pack events. Previous pump pack was returned to manufacturer (no response yet). These will also be returned but AMO appears to be aware of the problem.
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Manufacturer response for AMO Dual pump pack, AMO (per site reporter)
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No response so far.

See device image:

Image of broken tubing connector. Clear tubing connector is broken off inside the end of the tubing


RADIOLOGY

Device:
Type: X-ray Imaging System, O-arm
Manufacturer: Medtronic Navigation, Inc. (Littleton)
Brand: O-arm
Model#: OARMFP1

Problem:
The surgeon required the use of the O-Arm imaging device during surgery. The device was placed around the patient during the surgical case without difficulty and images were obtained. After the images had been taken, staff attempted to open the device, but the device had no power and would not open. Staff checked all of the cables/cords and all were plugged in. There were no obvious defects, frays, or other indications that the device should not be in full operational status. BioMed and the manufacturer's rep were contacted. The Medtronic support staff member came to the OR and also was unable to troubleshoot the device. He used a wrench to manually open the O arm and remove the device from the surgical field. The sterility of the surgical field was maintained and there was no harm to the patient. Per the MD and the OR staff, the patient did not incur extra anesthesia time and there were no problems with the images obtained by the O-Arm device. This particular piece of equipment is less than one year old. However, the staff operating the equipment and the physician using it is very familiar and experienced with this type of device. The Medtronic rep that came to the OR during the case commented that they have seen this kind of problem before and that "you may have a lemon."


Device:
Type: X-ray System, Cath/angio, Biplane
Manufacturer: Philips Medical Systems
Brand: Allura Xper Fd 20 Biplane
Model#: 722013

Problem:
Procedure delay due to equipment failure:
Equipment-Philips Allura Xper FD20 Biplane
The patient was diagnosed with a large right internal carotid terminus artery aneurysm. The plan was for coil embolization of the carotid terminus aneurysm. The cerebral angiogram was underway when an attempt to move the AP image intensifier to a working projection chosen from the 3-D workstation failed (The tube started to move and then clunked to an abrupt stop.) The message on the equipment was "No motorized movement available." Philips technical support was contacted and two reboots were attempted by staff. As it appeared that the equipment would be non-functional until service could make the necessary repairs, the decision was made to move the patient to an alternate angiography suite. The patient was moved to a room with a single plane and was re-prepped and draped in a sterile fashion. The procedure continued and a coil was placed successfully, however, given the fairly suboptimal imaging with the single plane, it was decided that placement of additional coils would have some additional risk, and given the stasis within the aneurysm, the procedure was terminated. The patient tolerated the procedure well and there was no evidence of any complication. The plan was to place additional coils within the aneurysm once the dedicated neuroangiography biplane suite was repaired. Philips service did make the necessary repairs and the next day placement of the additional coils was completed with no equipment issues and there was no evidence of any complications.

The Allura XPER FD 20 Biplane is routinely checked every a.m. and it did work fine prior to the procedure.


Device:
Type: X-ray System, Rad/fluoro
Manufacturer: Philips Medical Systems
Brand: Easydiagnost Eleva
Model#: 706032
Other #: 544113 EasyDiagnost Eleva

Problem:
A spring on the hand control switch on a fluoroscopy machine came off causing the machine to malfunction by continuing to take multiple images (90) and exposing the patient to additional radiation. Staff was unable to shut off the machine. There were no injuries and the patient was moved to another room. Estimated additional radiation exposure was equivalent to a CT scan. Equipment was taken out of service. Switch was disabled by tech from Philips.




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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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Updated January 1, 2012

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