Highlighted Reports
MedSun: Newsletter #86, July 2013

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 June 2013. All other reports can be searched under the ‘MedSun reports’ menu pane.

Device:
Type: Binder, Abdominal
Manufacturer: DeRoyal Industries, Inc.
Brand: Xl Abdominal Binder
Model#: (not provided)
Lot #: 30007271
Cat #: 13664009
Other #: HCPCS code L0325, (01)00749758283298(20)04(22)7300072718

Problem:
Per nurse, "Patient seems to be having a reaction to binder or skin prep. Patient has a raised, reddened rash that has spread across the entire abdomen and also appears on the back around waist area. Hydrocortisone applied". The nurse has seen this at least five times in the last four months. Product states latex free. Per RN, this type of reaction has been seen in patients with C-sections as well as vaginal deliveries; thus, staff do not believe that there is a reaction to the skin prep used for C-section deliveries because the prep is not used in a vaginal delivery. The patient in this incident has no known allergies.

Device:
Type: Cable, Pacemaker
Manufacturer: Medtronic
Brand: (not provided)
Model#: 5487
Lot #: 38785001
Cat #: (not provided)
Other #: (not provided)

Problem:
A semi-permanent pacer was being inserted and although the lead tested and functioned fine using alligators, when the Medtronic adapter cable (#5487) was attached using the usual IS 1 connector capture was absent or intermittent. A second cable (different lot #) was used with same issue. Attending Electro-physiologist was able to determine that repositioning (slightly pulling back) the cable in the connector seemed to fix the problem and capture was attained and maintained. A Medtronic technical representative, came into the lab and observed this and will report the event to Medtronic. This problem seemed to come from inserting the pin "too far" or pushing "too hard" and relieved by slightly pulling back. Medtronic will have a report generated with any suggestions to avoid this in the future.

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Manufacturer response for Medtronic adapter cable (#5487), Medtronic adapter cable (#5487) (per site reporter)
======================
pending

Device:
Type: Cable, Pacemaker
Manufacturer: Medtronic
Brand: (not provided)
Model#: 5487
Lot #: 5117001
Cat #: (not provided)
Other #: (not provided)

Problem:
A semi-permanent pacer was being inserted and although the lead tested and functioned fine using alligators, when the Medtronic adapter cable (#5487) was attached using the usual IS 1 connector capture was absent or intermittent. A second cable (different lot #) was used with same issue. Attending Electro-physiologist was able to determine that repositioning (slightly pulling back) the cable in the connector seemed to fix the problem and capture was attained and maintained. A Medtronic technical representative, came into the lab and observed this and will report the event to Medtronic. This problem seemed to come from inserting the pin "too far" or pushing "too hard" and relieved by slightly pulling back. Medtronic will have a report generated with any suggestions to avoid this in the future.

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Manufacturer response for Medtronic adapter cable (#5487), Medtronic adapter cable (#5487) (per site reporter)
======================
pending


Device:
Type: Container, I. V.
Manufacturer: Baxter Healthcare
Brand: Viaflex
Model#: (not provided)
Lot #: C887406
Cat #: (not provided)
Other #: (01) 00303380117048

Problem:
1000ml bags of Lactated Ringers have been found to have faulty hang tags. The bags are spiked then hung. The tab then breaks causing the bag to fall from the IV pole. There are multiple reports beginning in January.


Device:
Type: Electrosurgical, Cutting &Coagulation &Accessories
Manufacturer: Medtronic
Brand: Peak Plasmablade
Model#: Pulsar II
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
During a surgical procedure the use of a plasma generator resulted in a change in the non-invasive blood pressure measurements. An increase in the pressure measurements of as much as 100 mmHg were noted when the patient's actual blood pressure had not increased.

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Manufacturer response for Plasma generator, Peak Plasma Blade (per site reporter)
======================
The manufacturer hasn't had an opportunity to assess the problem.


Device:
Type: Monitor, Physiological, Patient
Manufacturer: Philips Medical Systems
Brand: Intellivue
Model#: M3001A
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
During a surgical procedure the use of a plasma generator resulted in a change in the non-invasive blood pressure measurements. An increase in the pressure measurements of as much as 100 mmHg were noted when the patient's actual blood pressure had not increased.

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Manufacturer response for Plasma generator, Peak Plasma Blade (per site reporter)
======================
The manufacturer hasn't had an opportunity to assess the problem.


Device:
Type: Needle, Hypodermic, Single Lumen
Manufacturer: Greiner Bio-one
Brand: Vacuette Safety Blood Collection Set
Model#: 450096
Lot #: 12K22
Cat #: (not provided)
Other #: (not provided)

Problem:
Phlebotomist was using a set for blood collection. There was a flash back but no blood flow. Tube was changed but no blood flowed. The patient had to have an additional stick for blood draw. The involved lot was not included in a previous recall.


Device:
Type: Orthopedic Manual Surgical Instrument
Manufacturer: Smith & Nephew, Inc.
Brand: Trigen Entry Portal Handle
Model#: UNK
Lot #: UNK
Cat #: UNK
Other #: UNK

Problem:
After attempt to clean device several times, it was discovered it still was not clean. Instrument totally disassembled and it was discovered there was dried blood inside parts of the instrument. (instrument was not designed for disassembly prior to cleaning) The second device was also disassembled and it was found to also be contaminated. Both instruments were then disassembled and sterilized.
Manufacturer response for Trigen Entry Portal Handle, Trigen Entry Portal Handle (per site reporter)
======================
Account manager provided two newly designed pieces to replace the ones we are having difficulty with. New design has an exposed opening for better water/cleaner flow during decontamination processing.


Device:
Type: Screw, Fixation, Bone
Manufacturer: Synthes
Brand: Synthes Sternal Fixation System
Model#: plate 460.036
Lot #: plate 7183993
Cat #: 04.501.112.01
Other #: sternal plate- pin 460.022e

Problem:
Synthes 12-hole sternal locking star plate became dislodged due to sternal dehiscence. During repair, it was noted that the plates were still well screwed in on both sides. It appeared that the locking pin had come out and was retrieved from the soft tissue. The Synthes reps were present and confirmed that this was apparently what happened. Per their description, they had never heard of this occurring. We then proceeded to clean the wound, and to reapproximate the plates and the sternum together and placed a new pin and modified it as per their instructions.


Device:
Type: Suction Canister Liner
Manufacturer: Cardinal Health
Brand: Medi-vac Brand, Flex Advantage
Model#: (not provided)
Lot #: UNK
Cat #: 65651-930C
Other #: (not provided)

Problem:
Suction canister imploded, made gunshot sound

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Manufacturer response for suction canister liner, (brand not provided) (per site reporter)
======================
Manufacturer's rep came in took description of what happened so he could fill out a PQR and send product in for evaluation.
Rep took product to ship in with report


Device:
Type: System, Magnetic Resonance
Manufacturer: GE Medical Systems, LLC
Brand: Signa Horizon Lx
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: LX2 MRI

Problem:
During an MRI of hip following first routine sequence, the patient complained of a burning hot sensation betweeen her upper thighs. Technologist moved the coil and did not see any evidence of a burn. A cushion was placed between her upper thighs and the exam continued. No other problems were expressed by the patient. Shortly after return to room, patient complained of burning feeling in between legs. Fluid filled blisters were noted on both of her upper thighs.

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Manufacturer response for MRI, GE LX2 MRI (per site reporter)
======================
Currently investigating machine, coil and other possibilities. They are being very responsive.


Device:
Type: System, Measurement, Blood-pressure, Non-invasive
Manufacturer: Zoe Medical, Inc
Brand: Well@home System
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Well at Home Blood pressure not providing accurate reading. The device was reading the systolic blood pressure 20 to 30 mm of Mercury higher than the actual reading. Staff are unsure if the device was checked for accuracy prior placement in the patient's home. Staff believe that the unit was calibrated at the manufacturer. The discrepancy was discovered during a home visit when the manual blood pressure readings did not correlate with the device. The device had been in use for >24 hours when the problem was found.

Further testing and trouble shooting by the Well at Home Coordinator revealed that unit needed to be removed from patient home and sent back to company. Unit removed from patient home. New unit checked for accuracy and placed in patient's home two days later.

There was no change to the patient's plan of care as a result of this event. No patient harm.

The device was returned to the manufacturer. They have since returned the device to the facility for continued patient use. No report from the manufacturer was provided.


Device:
Type: Apparatus, Nitric Oxide Delivery
Manufacturer: INO THERAPEUTICS LLC/dba Ikaria
Brand: Inomax Dsir
Model#: iNOmax DSIR
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Patient was placed on INOvent. The INOvent was running without issues for about 35 minutes when system started alarming Device Failure. The patient's vital signs remained stable and unchanged. The sample line was replaced. The INOvent continued to alarm Device Failure. The nitric tank was then switched to a new unopened tank. The INOvent continued to alarm Device Failure. A low cal was done. The INOvent remained alarming Device Failure. Throughout this time the patient's vital signs remained stable and unchanged. The decision was made to switch out the INOvent.


Device:
Type: Apparatus, Nitric Oxide Delivery
Manufacturer: INO THERAPEUTICS LLC/dba Ikaria
Brand: Inomax Dsir
Model#: INOMAX DSIR
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Nitric oxide monitor failure - would not turn on correctly. The device would boot up to a Device Failure alarm every time it was powered on. IKARIA tech support contacted and the device has been picked up. No logs are available at the user end to download.


Device:
Type: Tube, Tracheal
Manufacturer: Smiths Medical
Brand: Portex
Model#: (not provided)
Lot #: (not provided)
Cat #: H4001S
Other #: 2.5 mm ID 3.7 mm OD

Problem:
A nurse was passing by the bedside of the baby, when she noted that the infant had self-extubated. The tube was hanging, still attached to the ventilator tubings. The pink tape used to secure the ET tube was still attached to the baby's face. The baby was quiet, awake and alert. He was not having any desaturations (Oxygen sats in 79), HR in 150's, and RR 39. The ventilator was not alarming when this happened.

Settings:
Rate = 30
Pc = 18
PEEP = 5
Sensitivity = 2
Insp. Time = 0.45 seconds
Pressure support = 10


Device:
Type: Ventilator, Continuous, Facility Use
Manufacturer: Drager Medical, Inc.
Brand: Evita Infinity
Model#: EVITA INFINITY V500
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Respiratory tech disconnected patient from ventilator (V500) to suction, and was not able to restart the ventilator. When Biomed powered up the device it generated a Device Failure 3 alarm which was not reported by the RT and this was not seen in the logs for the RT incident either. The vent lost its user configurations, there were no logs captured during the time of the incident, and the Standby and Run time hours were reset to "0."


Device:
Type: Ventilator, Continuous, Facility Use
Manufacturer: Maquet Critical Care
Brand: Servo I
Model#: 06487800
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
A nurse was passing by the bedside of the baby, when she noted that the infant had self-extubated. The tube was hanging, still attached to the ventilator tubings. The pink tape used to secure the ET tube was still attached to the baby's face. The baby was quiet, awake and alert. He was not having any desaturations (Oxygen sats in 79), HR in 150's, and RR 39. The ventilator was not alarming when this happened.

Settings:
Rate = 30
Pc = 18
PEEP = 5
Sensitivity = 2
Insp. Time = 0.45 seconds
Pressure support = 10


Device:
Type: Implantable Pulse Generator, Pacemaker
Manufacturer: St. Jude Medical
Brand: Zephyr Xl Dr
Model#: 5826
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Procedure performed: right and left coronary angiography and right iliofemoral angiography. Patient has a permanent pacemaker - ST Jude Medical model number 5826. Programmed in a DDDR mode at 70 beats /minute with a max track of 120 - upon cineangiography of the left main, the patient appeared to develop wide-complex tachycardia from a baseline of atrial pacing. A magnet placed on the pacemaker slowed the rate. It was determined that the pacemaker accelerometer was being activated by the cineangiography.

For the rest of the procedure recorded images on fluoroscopy.


Device:
Type: Instrument, Biopsy
Manufacturer: Medical Device Technologies, Inc.
Brand: Angiotech Biopince
Model#: (not provided)
Lot #: 31192HCS
Cat #: 360-1580-01
Other #: (not provided)

Problem:
The needle misfired leaving a piece of metal "sticking out" of the needle thereby preventing the needle from returning to the guide needle. No specimen could be obtained with this device. The patient was not harmed with the device failure. The biopsy was obtained utilizing a second device.

This is the third such device failure we have experienced in the past 30 days.


Device:
Type: Heated Endoscopic Lens Protector
Manufacturer: NEW WAVE SURGICAL CORPORATION
Brand: D-h. E. L. P.
Model#: UNK
Lot #: UNK
Cat #: UNK
Other #: UNK

Problem:
DURING SURGERY,SURGEONS DETECTED ODOR LIKE "PLASTIC BURNING"; CHECKED AND FOUND OUT SMOKE COMING FROM DEFOG/SCOPE WARMER WHILE BEING USED AND A 5MM SCOPE INSIDE THE WARMER. REMOVED THE ITEM FROM FIELD. CHECKED FIELD FOR INJURY OR BURN TO PATIENT OR DRAPE. NONE SEEN. ITEM SET ASIDE AND SUBMITTED TO CHARGE NURSE.

Device was taken to BioMed to cool off. The device was still warm to the touch, would not shut off and smelled of burning plastic.


Device:
Type: Kit, Iv Start
Manufacturer: Medical Action Industries, Inc.
Brand: Medical Action
Model#: 267014
Lot #: 163473
Cat #: (not provided)
Other #: blue tourniquet MY

Problem:
As the nurse was applying a tourniquet to start an IV, she stretched the tourniquet to place and secure on the arm. It snapped in two causing a welt on her finger. Staff shared that they have had multiple occurrences of this same problem and found that the same IV start kit has one tourniquet but that it may originate from different countries. The one that originates in "MY" is thinner, brittle and snaps apart easily. Nurses have a concern for the potential to injure a patient's fragile skin when it snaps apart.


Device:
Type: Table, Operating Room
Manufacturer: STERIS CORPORATION
Brand: (not provided)
Model#: 4085
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
While setting up for surgery, the RN attempted to unlock the Steris 4085 Surgical Table to reposition it. We were unable to unlock the bed. After multiple attempts, we tried to unlock it by using the manual bypass. When the foot plate was depressed to unlock the table, the foot pedal broke off. Unable to unlock the table, Biomed was called to help. They had to drag the table out of the room and get another table to replace the 4085. Steris has been notified.


Device:
Type: Trocar, Laparoscopic
Manufacturer: Applied Medical Resources Corp.
Brand: Kii
Model#: CFS02
Lot #: 1191613
Cat #: CFS02
Other #: 5 x 100 mm

Problem:
Patient undergoing Laparoscopic Oophorectomy. As the Harmonic Scapel was placed through the trocar, an approximately 1/2 cm circular piece of plastic appeared to dislodge from the port. This was grasped with atraumatic graspers. The nature of the piece of plastic precluded removing the piece through any of the previously placed ports. A 5 mm EndoCatch bag was passed but would not sufficiently open to allow secure placement of the piece of plastic for extraction. A 10 mm EndoCatch was passed and the piece of plastic was carefully placed in the bottom of the bag and the bag removed from the abdominal cavity with confirmation of the entire removal of the said piece of plastic.


Device:
Type: Catheter, Intravascular
Manufacturer: BD Medical
Brand: Nexiva Closed Iv Catheter System
Model#: 383539
Lot #: unk
Cat #: 383539
Other #: (not provided)

Problem:
Staff was changing the IV tubing when the tubing snapped in half leaving the male fitting inside the BD Nexiva female connection. This has happened multiple times. We have sent failed devices and unused samples to both BD and Hospira for evaluation.

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Manufacturer response for Nexiva Closed IV Catheter System, BD Nexiva (per site reporter)
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Manufacturer provided RGA# and shipping container for product return evaluation.

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Manufacturer response for Hospira Primary IV Set, Hospira Primary IV Set (per site reporter)
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Manufacturer provided RGA# and shipping containers for both used product and unused product for evaluation.


Device:
Type: Catheter, Intravascular
Manufacturer: Hospira Inc
Brand: Primary Iv Set
Model#: 20794-48
Lot #: (not provided)
Cat #: 20794-48
Other #: N/A

Problem:
Staff was changing the IV tubing when the tubing snapped in half leaving the male fitting inside the BD Nexiva female connection. This has happened multiple times. We have sent failed devices and unused samples to both BD and Hospira for evaluation.

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Manufacturer response for Nexiva Closed IV Catheter System, BD Nexiva (per site reporter)
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Manufacturer provided RGA# and shipping container for product return evaluation.

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Manufacturer response for Hospira Primary IV Set, Hospira Primary IV Set (per site reporter)
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Manufacturer provided RGA# and shipping containers for both used product and unused product for evaluation.


Device:
Type: Pump, Infusion
Manufacturer: Carefusion 303, Inc.
Brand: Alaris
Model#: 10011274
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Patient was admitted to ED for evaluation of weakness related to complicated medical history. Intubation of patient was necessary to address current respiratory status. A Fentanyl drip was ordered to be delivered through Central Venous line for sedation. Nurse set up IV line and appropriately fed line through Alaris module on 8015 Alaris PC. Roller clamp control on tubing was in the open position. As she closed the module door, the channel alarmed "Close Door Safety Clamp Open" and the nurse was unable to correct the error. Nurse removed the tubing from the module and believed that the tubing would automatically clamp off as expected per usual process when pump was correctly functioning. Nurse then went to find a replacement for the malfunctioning pump. Patient subsequently received free flowing overdose of Fentanyl administration, complicating patient condition and contributing to patient death.


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

Problem:
The nurse hung a prefilled 20 ml epinephrine syringe concentration 0.1 mg/ml. The baby weight is 2.7 kg. The calculation dose was 0.3 mcg/kg/hr. When she programmed in weight and dose, the pump alarmed and gave the message "input out of range, less than minimum value". The nurse then backed out and selected "more". This allowed her to go outside the guardrails and select mcg (should have been mg.) She then put in 0.3 mcg / ml and selected mcg again, entered the weight and this took her to mcg/ Kg/ min. She put in 0.3 mcg/kg/min. The rate was the 162 ml / hour. The entire syringe ran in about 10 minutes. The nurse believed the pump was broken. Upon investigation is was discovered that the problem was a programming error. The nurse had selected the wrong concentration and the pump was then programmed using the dose /kg/min. The syringe was made in mg/ml not micrograms.


Device:
Type: Holder, Head, Neurosurgical
Manufacturer: Integra Lifesciences Corporation
Brand: Mayfield Infinity
Model#: 90619
Lot #: (not provided)
Cat #: (not provided)
Other #: headrest - A2114

Problem:
The radiolucent Mayfield headholder was placed in the usual fashion, and we both verified that the clamp read 60+ lbs. The patient was prepped and draped in the usual fashion. The incision was opened, but while trying to place the second burrhole, the patient was noted to noticeably slip. We immediately stopped the case, stapled the scalp, took the drapes down and noted that the left frontal pin was in the correct position, but the right posterior pins were no longer in a good position. The more anterior pin had moved further anteriorly, and the posterior pin was not in the scalp at all. There was no laceration. The pressure was noted on the clamp to also be at less than 20 lbs. The patient was then re-clamped with the pins placed further posteriorly and fixed at a pressure greater than 60 lbs. The case then proceded without further incident. The patient's head seemed to be somewhat larger than usual, so it may have been that while the Mayfield was engaged, the pins were too far anterior to have adequate purchase on the skull, but this is difficult to tell in retrospect. The Mayfield headholder is now being sent for evaluation.


Device:
Type: Neurological Stereotaxic Instrument, Software
Manufacturer: Brainlab Inc
Brand: Cranial 2. 1Brainlab Neuronavigation Software
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Patient was anesthetized for craniotomy procedure for a brain mass. After her scan was loaded without difficulty, an error message was noted indicating that the navigation software was corrupted. Numerous reboots were attempted without success. The local sales representative was not immediately available and technical support from the company advised that the software rep would have to come in to fix the problem. Another patient disk was attempted to determine if the failure was specific to the patient's disk. The failure was determined to not be related to the disk, but software related. Procedure was continued without the use of the BrainLab neuronavigation. Sales rep came to troubleshoot the issue later and had to reload software. She felt that the malfunction may have occurred due to multiple inappropriate shutdown procedures.


Device:
Type: Insert, Tubal Occlusion
Manufacturer: CONCEPTUS, Inc.
Brand: Essure
Model#: (not provided)
Lot #: B15004
Cat #: ESS305
Other #: (not provided)

Problem:
Per MD dictation: Device deployed prematurely.
The device was inserted, however, resistance was met before the device could be inserted to the appropriate black mark. An attempt was made to remove the device; however, it was felt to catch on surrounding tissue, and the entire hysteroscope was therefore removed with the Essure device. The device was seen to have prematurely deployed despite the fact that the wheel had not been rotated nor had the button been pushed. A second Essure device was then introduced, and an attempt was made to place it similarly, resistance was met, and before the wheel was moved, the device was removed again, resistance was felt, although less than reviously, and again the device upon examination began to prematurely deploy.



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