Highlighted Reports
MedSun: Newsletter #79, December 2012

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 September 1 through September 30, 2012. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.

ANESTHESIOLOGY

Device:
Type: Anesthesia Conduction Kit
Manufacturer: Arrow International, Inc.
Brand: Flextip Plus
Model#: Flextip Plus epidural catheter kit
Cat #: SM-05401

Problem:
MD first unable to thread the epidural catheter. After several attempts, we laid the patient to left side and reattempted. The catheter then threaded but she was unable to inject it even using strong pressure. Readjusted catheter and attempted again without success. Suspecting that it could be the blue and black two piece connector, we opened a new kit and, after replacing the connector, the problem persisted. MD finally removed the epidural catheter and tried injecting it while outside of the patient which was exceedingly difficult and only a drop or two was getting through. It was at that time that MD replaced the epidural catheter with a new kit and encountered no problems upon the replacement of the catheter with the new one.


Device:
Type: Generator, Oxygen, Portable
Manufacturer: Invacare Corp.
Brand: Solo

Problem:
There has been a concern expressed about the suitability of the Invacare Solo for a new program that allows patients to go home with the device, with a follow-up evaluation seven to ten days later. The concern raised is the volume of the alarm. For 24/7 use, the alarm may not be audible while the patient is sleeping. The rental equipment provider's management contacted Invacare:

Initially there was a conference call with the Invacare sales rep, which related in a subsequent email to hospital Risk Management that the Invacare representative became defensive and said they have 20,000 units, most being used 24/7, and have not heard any comments on the volume of the alarm. Risk Management assessment was requested, and a voluntary report to MedSun was suggested. Approximately one month later, Invacare contacted the rental supplier and reiterated that their alarm is at the optimum level, there have been no reported patient incidents, and it is cleared by regulatory agencies. They did indicate that their engineers have been looking into the alarm levels, and have developed what they term an "enhancement," to the SOLO2 circuit board that, among other corrections, will allow for a louder alarm. The new circuit board will be in new SOLO2 units going forward, with no current plans to make it available for units already in use. Further, the representative requested that any specific complaints in the future be put in a formal letter from hospital Risk Management.

The following day, the rental provider sent a video back to the sales representative, demonstrating differences in alarm levels. The sales representative and territory manager for Invacare visited the rental provider to hear the sound levels for themselves, and agreed that the alarm was inadequate.


Device:
Type: Ventilator, Continuous, Facility Use
Manufacturer: Carefusion 211, Inc. dba Carefusion
Brand: Avea

Problem:
Respiratory Therapist (RT) responding to ventilator "Circuit Occlusion" alarm. Vent and patient checked - no problems witnessed. This occurred a few times in several minutes with increasing frequency. RT manually ventilated patient and conducted circuit leak check / EST (Extended Self-Test). Vent passed without problems. A very faint musical harmonic was heard coming from the vicinity of the ventilator exhalation valve. At this time, manual ventilation was continued and the ventilator was removed from the patient. A new machine was checked and placed on the patient. The alarm condition ceased. The patient appeared to be unharmed and the ventilator with the alarm condition was saved with all circuitry attached for review.


CARDIOVASCULAR

Device:
Type: Adaptor, Stopcock, Manifold
Manufacturer: Merit Medical Systems, Inc.
Brand: Custom Manifold Kit
Lot #: H373669
Cat #: K09-05755
Other #: Revision F

Problem:
Tubing was being primed prior to use during a procedure. While flushing the male adapter that connected the tubing to the manifold came off. The adapter and the tubing were not bonded (or fused) together. This is the second report related to this particular manifold kit that we have submitted.
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Manufacturer response for Custom Manifold Kit K09-05755 Revision F, (brand not provided) (per site reporter)
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They will send packaging to return the device to them for an evaluation

Device:
Type: Monitor, Central, Physiological, Patient
Manufacturer: Philips Medical Systems
Brand: Intellivue
Model#: RP 5700 Central Station
Other #: Server HPG5

Problem:
Intellivue RP 5700 Central Station, Server HPG5: Yellow O2 sat alarms were not saving to the central monitor (no print or store capability). Initially repaired by Biomedical Engineering. Settings at central monitor found to be unchecked. Settings were re-checked, but settings unchecked spontaneously without staff intervention. Subsequently, intermittently the red and yellow alarm storage and recording funtions turned off on the central monitor, but the audible alarm still occurred. The bedside monitors were not affected. Vendor came onsite to troubleshoot and repair.


Device:
Type: Monitor, Physiological, Patient
Manufacturer: GE Medical
Brand: Transport Pro
Other #: 2020155-001

Problem:
Over the past three years, there have been multiple complaints regarding the loss of communication between the GE Transport Pro and the attached TRAM Module. The complaints have stated that the patient data and waveforms would drop out and no longer be recorded while the patient was in transport around the hospital. This can be a particularly hazardous event, especially when the patients are under intensive care and require a high level of monitoring to ensure their health and safety. Initially, the units were tested in an attempt to reproduce the issue, but no apparent problem was identified and the devices were returned to service. After another complaint, the unit was removed from service and replaced with a spare, and no further issues were reported. The only noticeable difference between the original unit and the spare was the software versions. The original device had a software version 2.0, while the spare had version 2.1.
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Manufacturer response for Patient Transport Monitor, Transport Pro (per site reporter)
======================
Two units were sent to GE Medical for evaluation. We still have 6 broken units and are waiting for GE to respond. They stated they would need two weeks to respond to the hospital once they receive the units.


Device:
Type: System, Thermal Regulating
Manufacturer: Cincinnati Sub-Zero Products, Inc.
Brand: Blanketrol
Model#: 286
Lot #: 10755

Problem:
Patient undergoing hypothermia therapy and Blanketrol was leaking water from hoses. Hose connections were disconnected and reconnected. Hose continued to leak actively at the site where the coupling and hose meet. A new hose was ordered and swapped out for the leaking hose. No further leaking noted from unit after the hose was changed. Patient's temperature has been in the desired range. More water was added to the Blanketrol to replace what was lost.


Device:
Type: Ventricular Assist, Bypass
Manufacturer: Jarvik Heart, Inc.
Other #: Controller 1087; battery 2241

Problem:
Patient up to bathroom with assist of 1. Patient complained of weakness, assisted to floor and called for help. Patient became unresponsive and code called. Patient in V. fib. During code, it was noted the power supply to his LVAD was not connected to the controller, no alarms sounded. Power reconnected, pulse re-established. Patient did not wake up. Transferred intubated with pulse to CCU.


Device:
Type: Wire, Guide, Catheter
Manufacturer: Abbott Vascular
Brand: Hi-torque Balance Middleweight Universal
Model#: 1009661
Lot #: 1100571
Other #: 014" 300cm

Problem:
Patient was undergoing an Intravascular Ultrasound study to assess vessels for potential Trans Aortic Valve Replacement(TAVR) surgery. Guidewire was introduced into femoral site and ultrasound instrument was placed over guidewire. When procedure was completed, the Ultrasound instrument was removed and it was noted that the guidewire had broken into two pieces. The practitioner felt that the wire had become coiled and it was not noted due to product's decreased radiopacity. Team retained two pieces of the guidewire at that time. The patient returned the next day for TAVR procedure. Patient did not have a pulse in previous femoral site and a dissection was found on cutdown. The proceduralist found a retained piece of guidewire in the external iliac. The decision was made to not traumatize the patient with exploration to remove this third piece of guidewire but to place stent in the external iliac for repair of the dissection and to keep the retained wire in place. The opposite femoral site was used as access for the TAVR procedure.


GASTROENTEROLOGY &UROLOGY

Device:
Type: Catheter, Biliary, Diagnostic
Manufacturer: Cook, Inc.
Brand: Formula
Model#: Formula 414RX Renal Balloon Expandable Stent
Lot #: E2885808
Cat #: G56966

Problem:
During Aortogram the stent fell off the balloon before it was deployed and landed distal to the lesion.


Device:
Type: Catheter, Hemodialysis Implanted
Manufacturer: Kendall/Covidien
Brand: Palindrome
Other #: 23 cm

Problem:
The patient was undergoing placement of a tunneled hemodialysis catheter which needed advancement for a kink in the subcutaneous portion under the skin. The peel away sheath was not on the catheter. Glidewires were placed in each catheter lumen and clamps applied to advance the catheter. The catheter was repositioned easily and quickly, with placement confirmed by fluoroscopy. Almost simultaneously as the glidewires were removed, the patient complained that she was short of breath. Her O2 sats and heart rate dropped. She advanced into PEA (pulseless electrical activity) arrest and could not be resuscitated. Fluoroscopy images and post-mortem CT confirmed air embolism as the cause of death. There is currently not a product that we know of that can work as a self-sealing lumen cap/diaphragm that would allow placement of a wire for catheter exchange/advancement without having to briefly open the system for wire removal. In addition, it is unclear, given the volume of air that entered the patient and the short duration of the catheter advancement, whether a catheter clamp popped open without the providers being aware. It is difficult to visually determine when the white clamps, that come attached to each catheter lumen, are opened or closed. The variation between the opened and closed position is slight, so that visually from the height of a person assisting or manipulating the catheter, they may not be able to immediately tell if the clamp is open and air is entering. In addition, the clamps are such that they can easily pop open with very little pressure exerted during catheter advancement and manipulation. A provider and the radiology staff assisting may be looking up at fluoroscopy images, and not immediately recognize an unintentionally opened clamp.


Device:
Type: System, Gastrointestinal Motility
Manufacturer: Given Imaging Ltd
Brand: Manoscan 360
Model#: A120

Problem:
Closed program after it asked user to "Save and Exit" at close of study. Found and clicked on patient file name and prompted to "Delete Shortcut", because file had been "changed or moved". Motility Study done. It was not found in list of patients. - missing. User followed "Guided Protocol instructions" between cases to set up new study and patient info. Given Tech support called. They commented that sometimes the software will not save data on the first or second study if 2 or more studies are performed back to back without exiting and re-entering Manoscan program. The info about exiting the program after each case was not in the Manoview training or instruction sheets. Emphasis in following the "guided protocol" prompts was stressed. Patient will have to return to have test redone.

Manufacturer advises that sometimes when you do two cases back to back it will drop data from one patient, or it will attach the data from the second patient to the previous patient.


Device:
Type: Tubes, Gastrointestinal
Manufacturer: Corpak

Problem:
RN arrived at patient's home for Home Health visit. Mom reported patient coughing and spitting up. NG tube was pulled and then patient vomited a portion of the NG tube. RN found the weighted end of the tube to be broken apart from the remainder of the tube. The metal was contained inside the tube.


GENERAL & PLASTIC SURGERY

Device:
Type: Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Manufacturer: Bard Medical Division
Brand: Reliavac
Cat #: 0070330
Other #: Reliavac Round Drain (Large)

Problem:
About a year ago, patient underwent reconstruction of right chest wall. At that time a Bard Reliavac Drain (Large) was placed. Subsequent to this surgery the drain was attempted to be removed when a portion of the drain broke off within patient. It was decided to leave the retained portion in place. Patient began to experience pain and retained portion removed a few weeks ago in an outpatient procedure.


Device:
Type: Applier, Clip
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Ligaclip
Model#: ER320
Lot #: J4AE49
Cat #: ER320

Problem:
During firing of the LigaClip applier on the common bile duct during lap chole, the clip did not form a tight "v" on the duct, potentially allowing passage of bile into abdomen. Instead it formed a "u" with the tips meeting at the end. Surgeon states this is the third time this clip applier has not formed clips appropriately and he thinks it may be contributing to leaks in past patients. We do not have the lot numbers on the other two patient devices.
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Manufacturer response for Applier, Clip, LigaClip, (per site reporter)
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The manufacturer has agreed to be present at all surgeries using the device to assess end user technique and assure no future problems.


Device:
Type: Dermatome
Manufacturer: Integra LifeSciences
Brand: Padgett
Model#: B

Problem:
The Padgett dermatome did not make a clean cut when obtaining a skin graft. The blade cover was removed and instpected, everything appeared correct. Surgeon began to harvest again, and the results were not up to par. The skin graft was not harvesting deep enough in some areas. The site had been prepped with oil and the skin was held taut at both ends. The resultant graft was only about half the width of the dermatome, but was usable and a second graft was not needed. The blade and the dermatome were sent for evaluation.
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Manufacturer response for Padgett Dermatome, Padgett (per site reporter)
======================
Manufacturer provided RGA for device return evaluation.


Device:
Type: Electrosurgical, Cutting &Coagulation &Accessories
Manufacturer: Covidien, formerly Valleylab, a division of Tyco Healthcare
Brand: Ligasure Impact
Lot #: 234118LX
Cat #: LF4200

Problem:
During Doctor's portion of the cystectomy with ileal conduit and low anterior resection case, the Ligasure malfunctioned therefore causing the blade to go wrong direction (vertical instead of horizontal). This caused light tissue tearing but no significant or permanent damage. Ligasure replaced with different handpiece. Defective Ligasure removed from field and sent to inventory to send back to manufacturer.


Device:
Type: Electrosurgical, Cutting, Coagulation
Manufacturer: Stryker Sustainability Solutions
Brand: Ligasure Impact
Lot #: 1867689
Cat #: LF4200

Problem:
During the procedure, the scrub tech and surgeon reported that they were unable to use reprocessed instrument due to it locking up and not releasing. It is unknown whether the device was locked on tissue. There were no adverse effects to the patient. Instrument was removed from field and another instrument was obtained and used without difficulty. It is unknown if the new instrument was of the same or different lot.


Device:
Type: Electrosurgical, Cutting, Coagulation
Manufacturer: Covidien
Brand: Ligasure Advance
Lot #: 236062X
Cat #: LF5544
Other #: 5mm-44cm

Problem:
During a laparoscopic Roux-en-Y procedure the blue insulated tip broke off of the LigaSure Advance device inside of the patient. The broken pieces were discovered and removed. There were two pieces and they were very small.
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Manufacturer response for LigaSure Advance 5mm-44cm, LigaSure Advance (per site reporter)
======================
This is the second one that has broken. The company is working on the problem and they hope to have something new out in October.


Device:
Type: Laparoscope, General, Surgery
Manufacturer: Stryker Sustainability Solutions
Brand: Xcel Trocar Sleeve
Lot #: 2044768

Problem:
Reprocessed 12mm Ethicon trocar leaked CO2 during procedure causing loss of pneumoperitoneum, i.e. hard to see laparoscopic view. Item was reprocessed by Stryker Sustainability Solutions earlier this year.


Device 1:
Type: Mesh, Surgical, Polymeric
Manufacturer: Boston Scientific
Brand: Polyform
Model#: M0068402410
Lot #: c001487
Cat #: 840-241
Other #: 15 X 20CM

Device 2:
Type: Suprapubic Mid Urethral Sling System
Manufacturer: Boston Scientific
Brand: Lynx
Model#: M0068503001
Lot #: m100000574
Cat #: 850300

Problem:
Patient underwent a laparoscopic supracervical hysterectomy, sacral colpopexy and placement of a mid-urethral sling and cystoscopy. Patient was doing well postop day one and subsequently developed an ileus postoperatively and leukocytosis, which progressed over the subsequent two days. The ileus improved but patient had increase in her white blood count. A CT examination was performed and the empiric antibiotics were initiated. The CT exam demonstrated a 10 cm pelvic abscess. The patient subsequently awoke three days later with an acute onset of abdominal pain, abdominal distention, nausea and vomiting. Exploratory Laparotomy was performed for removal of the pelvic abscess. Intraoperatively serous fluid was found upon entry into the peritoneal cavity. Further exploration demonstrated purulent material along the retroperitoneal and retropubic site of the mid urethral sling. Mesh and sling removed. Patient discharged from hospital after oral antibiotic treatment.


Device:
Type: Microscope, Surgical, General And Plastic Surgery
Manufacturer: Carl Zeiss Microscopy, LLC
Brand: Opmi Pentero 900
Model#: Pentero 900

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Problem:
Neurosurgery case lasting 8 hours. A 7 month old female patient received a burn on the perimeter of the surgical site, approximately 2.5" square area. Burn was not realized until the next day. Reported as a 1st degree burn.
It is not clear what the microscope settings that were used during the case, some of the manufacturer precautionary settings are believed to have been adjusted "out of the way", thus allowing for a high intensity light output.


Device:
Type: Staple, Implantable
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Endo Ils
Model#: ECS29A
Lot #: J4C06X


Problem:
During operation, staff were reconnecting the colon to the rectum. RN was using the 29mm endoscopic curved stapler. It was inserted into the rectum. The spike was deployed. Surgeon connected the anvil that was on the colon to the spike of the stapler.

After the stapler was closed and the colon lined up, the RN fired the stapler. Under inspection from MD, it was noticed that the anastomosis did not hold up. We redid the colon rectal anastomosis using a different endoscopic circular stapler.

MD was not sure if it was user error that caused the staple line the first time not to hold up or if it was the stapler. MD wants the stapler to be checked out to see if it worked properly.


GENERAL HOSPITAL

Device:
Type: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Manufacturer: Cook Medical Inc
Brand: Turbo-ject Power-injectable
Lot #: 3377154
Other #: 4 Fr double lumen

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Problem:
There have been five instances of this event and at least three patients involved. 4 French dual lumen PICCs are breaking at the white hub without any obvious reason. The catheter appears to be pulling out of the hub and three of these breaks occurred when the line was not in use. The five instances of this type of event had the device in place for 18 days, 21 days, 42 days, 24 days, and 18 days when the breaks occurred. All in pediatric patients – one patient is non-ambulatory, one patient was non-ambulatory in ICU for the majority of the time the line was in place, the other was non-ambulatory in ICU for the entire time the lines were in place. No reported issues with tubing or lines being pulled/caught. For all cases, the person who inserted the line was trained and certified in the procedure (an interventional radiologist). All of the PICCs were sutured in place and covered with a dressing. The lines are flushed with a 10 mL-sized syringe. Flush volume: minimum 3-5 mL. These devices are stored on carts in a supply room – the catheters are in opaque packaging (sterile insertion tray).

In one patient, the line was removed and patient completed treatment with peripheral vascular access and repeated venipunctures for labs. One patient requires ongoing, continuous infusion of vasoactive medications and so has had to undergo line replacement 3 times. Additionally, one incident necessitated hospital admission d/t fever and positive blood culture. Pt was treated with antibiotics inpatient for 5 days. One patient was critically ill throughout and required replacement of the line twice.

See device images:

Image of French dual lumen PICC.  Breakage is seen at the edge of the line where it meets the white hub

Close-up of French dual lumen PICC where the line breakage can be seen right at the white hub.

Distant view of the French dual lumen PICC. It is difficult to see where the line has broken from the hub from the angle of this photograph.


Device:
Type: Catheter And Tip, Suction
Manufacturer: Kimberly-Clark
Brand: Kimvent
Lot #: AW218402M
Cat #: 97014

Problem:
Nurse was utilizing the product to suction the patient. Sponge fell off the tip of the suction tube. There were no problems with the remaining sponges in this kit. We were trialing this product. After the event occurred, I spoke to some additional nurses who indicated they had experienced this problem throughout the trial period. The patient did not experience any adverse effect from the event.


Device:
Type: Catheter, Intravascular
Manufacturer: Bard Access Systems, Inc.
Brand: Broviac
Lot #: HUWC1069
Cat #: 0600520

Problem:
This broviac was placed during the summer. The PA was called to evaluate the broviac for repair, which had ruptured in the outer lumen just above the hub. The broviac was only six days old and had a hole in the outer lumen just above the hub. This is the second broviac that failed on this patient. The first broviac was discarded. A third broviac was not placed in the patient. The first broviac was repaired x 3, as the line was open to air with approximately a 1 inch hole in the catheter near the hub. It was repaired per sterile procedure using sterile 4 French broviac repair kit. It is unknown if the 1st and 2nd broviac catheters are of the same or different lots.


Device 1:
Type: Catheter, Intravascular, Therapeutic
Manufacturer: Becton Dickinson
Brand: Insyte Autoguard
Lot #: 2174521
Cat #: 381423

Device 2:
Type: Catheter, Intravascular, Therapeutic
Manufacturer: Becton Dickinson
Brand: Insyte Autoguard
Lot #: 2160691
Cat #: 381423

Problem:
At IV team meeting, some hospitals reported a larger number of IV catheter problems than usual. I asked some nurses to save the IV catheters if they were getting a blood return and the IV "blew" when threading into vein. Today, 2 catheters in 2 biohazard bags were left for me with a note that stated both IVs "blew" after had a good blood return. Lot # 2174521 (2 in one bag) and # 2160691 (2 in another bag). Unknown who left the catheters, message or which patients they were used on.


Device:
Type: Catheter, Intravascular, Therapeutic, Long-term
Manufacturer: Bard Access Systems
Brand: Powerpicc
Lot #: REWC1640
Other #: 3F

Problem:
Catheter capped off at 00:30 as the device was leaking. Checked by MD during the night shift and PICC line was determined unusable. Air was aspirated from the line at that time. RN reported the PICC was leaking and there was air from the line. Catheter had been placed the previous day into left cephalic. VAD RN requested to assess line and redress - PICC was replaced. Purple connector had completely separated from the catheter leaving the patient at risk for air embolism, bleeding and infection. PICC removed and given to manager.


Device:
Type: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Manufacturer: Navilyst Medical, Inc., an AngioDyamics Company
Brand: Navilyst
Lot #: PR02588
Other #: Vessel passive PICC

Problem:
RN noticed leaking PICC (peripherally inserted central catheter) line in left arm, and upon inspection she noted a tear in catheter near the suture ring. PICC was pulled and new PICC line inserted into the right arm. Manufacturer response for Vessel passive PICC, Navilyst (per site reporter) Manufacturer would like device returned for their inspection.


Device:
Type: Pump, Infusion
Manufacturer: B.Braun Medical, Inc.
Brand: Infusomat Space
Model#: 8713050U
Other #: Hospital ID# 24464

Problem:
Pump was operating normally for 36 minutes after the last user interaction, when its programmed infusion completed and it reverted to KVO rate. Two seconds after beginning KVO, an internal error occurred and the pump stopped, giving an audible alarm.

The alarm went unnoticed for 14 minutes, until the patient's physiological monitor alarmed for a decrease in blood pressure. The infusion was then switched to another pump, and the patient's condition was restored.

Later inspection found that the pump's alarm volume was set to its minimum value (set at '1' on a scale of '10'). We have told the manufacturer before that alarm volume, which was specified as a default value in our initial configuration settings, is not actually a default. The pump's alarm volume is retained from the previous user's setting. We think this value should reset and default to at least a setting '5' when the pump is turned on, regardless of previous settings.

The pump was shipped to the manufacturer for testing and repair of the internal failure.

Manufacturer has admitted that the described "default" settings are just initial configuration. No comment re: possibility of making alarm volume a power-on default to mid-range.


Device:
Type: Pump, Infusion
Manufacturer: B.Braun Medical, Inc.
Brand: Infusomat Space
Model#: 8713050U
Other #: Hospital ID# 23943

Problem:
During setup of a new infusion, the nurse selected "Heparin" from the pump's drug library, but entered 700 mL/hr RATE instead of 700 units/hr DOSE (equivalent to 7 mL/hr). The result was an infusion of 25000 units in just 19 minutes.

This rate setting should have been disallowed by the pump, since our drug library specifies a hard high limit of 5000 units/hr (50 mL/hr) for Heparin.

Normally the drug library is entered by pressing the pump's CLEAR button, then responding 'YES' to the question about the drug library. However, if the pump is resting in a rate/volume display, the user can scroll downward to the Special Functions menu, select "DRUG LIBRARY" and the desired drug from there, then select NOT to use pre-set settings, and the pump will allow any rate/volume to be entered, regardless of drug library limits.

Manufacturer stated that "Drug Library" within the Special Functions menu is intended primarily for labeling an infusion with a medication name and not necessarily controlling it via the drug library. Different manufacturer representatives have agreed that this option needs to be renamed, modified, or removed in the next software version.

This was a recovering trauma patient. After the overinfusion was discovered, the patient was given Protamine and Phenylepherine. The patient was transferred to a critical care unit for closer observation due to a previous head bleed. A CT-scan confirmed that head bleed had not progressed any further. No other consequences. Patient was subsequently discharged from the critical care unit.


Device:
Type: Pump, Infusion
Manufacturer: IRadimed Corporation
Brand: Mridium
Model#: 3850R

Problem:
Patient was taken to MRI, and the RN set up a new 60units/100ml vasopressin IV bag to the MRidium pump with new primed tubing. The RN put in the setting of 4ml/hr and total volume 6ml and started the pump. After the MRI was completed, the RN clamped the vasopressin tubing with an IV clamp and disconnected it from patient. The RN then opened up IV cassette and went to switch a new IV bag over to a unit pump and realized the vasopressin IV bag was empty. The RN did not notice any wet areas around the area. The RN then checked patient's blood pressure and it was approximately 158/93. The RN waited a few minutes and rechecked and it was approximately 153/90. The RN informed the physician and monitored the patient's blood pressure every 5 minutes.


Device:
Type: Warmer, Infant Radiant
Manufacturer: GE Healthcare
Brand: Panda
Other #: M0045952


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Problem:
During resuscitation of newborn twins (gestational age 35 weeks) it was noted that one of the two was not responding to oxygen therapy as well as expected. A pediatric resident was providing blowby oxygen followed by CPAP in an effort to improve oxygenation, however the SpO2 continued in the low 80% range with signs of respiratory distress, despite increases in the blender's set FiO2. The respiratory therapist in attendance began troubleshooting the equipment involved and very quickly noted the knob for adjusting FiO2 felt loose. He transitioned the patient to a flowmeter attached to wall oxygen and the patient responded quickly with increased SpO2. In follow-up, after the patients were stabilized, an oxygen analyzer showed the blender was delivering 21% oxygen regardless of setting. Anesthesia maintenance was called to repair the equipment.

Patient status: The patient's oxygen saturation returned to normal limits only after the team discovered the malfunction. The infant received potentially unnecessary treatment (i.e. CPAP) and may have received other unnecessary treatment (i.e. intubation, mechanical ventilation, surfactant replacement therapy) had the malfunction not been discovered

The Panda warmer was repaired. Eighteen Panda warmers were inspected and a similar problem was discovered with one additional warmer, which was also repaired and put back in service. Manufacturer indicated no further action was needed.

ORTHOPEDIC

Device:
Type: Screw, Fixation, Bone
Manufacturer: Stryker Orthopedics
Model#: 1896-5047S
Lot #: K281101
Other #: Screw 5.0 47.5mm Locking

Problem:
Approximately 8 months previously, patient had sustained a mid-shaft fracture of the femur in a traumatic event. Femur was repaired with Stryker gamma nail system. Patient continued to have pain and nonunion. A follow-up X-ray revealed a possible fracture of the distal locking screw and persistent fracture lucency. The patient returned to have the locking screws removed for dynamization and augmentation of bone healing of the nonunion site. The inferior screw was noted to be broken within the nail. The broken screw had extension to the medial cortex of the distal femur, so a 2 mm K-wire was used to tap it out on the lateral side which was then retrieved through a separate medial incision. There were no complications on removal.

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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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