Highlighted Reports
MedSun: Newsletter #82, March 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 February 2013. All other reports can be searched under the ‘MedSun reports’ menu pane.


Device:
Type: Automated External Defibrillators (Non-wearable)
Manufacturer: PHILIPS MEDICAL SYSTEMS
Brand: Heartstart Mrx
Model#: M3535A

Problem:
Non-emergent cardioversion performed. Defib pads placed on patient anterior posterior on MRx 1 (defibrillator), machine on sync mode ramped up to 150 joules but no shock delivered. Team attempted again with same pads, same MRx machine, again no shock delivered, no prompt from machine to indicate no shock delivered MRx performing the ramp sound of eeeeeeeeee. Team disconnected the pad cable from MRx 1 and reconnected to MRx 2, ramped up joules to 150 but same outcome of no shock and no message from machine. Team removed pads, grabbed the pink labeled pads (old packaging) and placed pads anterior/ posterior, ramped MRx2 and shock was delivered. No patient harm.
Phillips Adult defib pads in house have 2 different packaging. Phillips changed the packaging, but indicates the product remains unchanged. New package is red, the old is pink. New packaging does appear different in application instructions as it does not show anterior/posterior application for adults, only peds.


Device:
Type: Cutting, Surgical
Manufacturer: Stryker
Brand: Resector Shaveblades
Model#: 0375-552-000

Problem:
Physician was using Stryker shaver blade resector shaver tips for arthroscopy. Both a reprocessed and a new tip left metal shavings in the shoulder tissue. Photos were taken and are stored in the memory of Tower 1 Ortho Video System. The shavers have been sequestered. Reprocessed 4.0 and 5.0 shavers have been removed from stock along with new Stryker shavers of the same lot number. The Stryker and SteriMed reps have been notified of the incident.


Device:
Type: Cutting, Surgical
Manufacturer: Stryker
Brand: Resector Shaveblades
Model#: 0375-554-000

Problem:
Physician was using Stryker shaver blade resector shaver tips for arthroscopy. Both a reprocessed and a new tip left metal shavings in the shoulder tissue. Photos were taken and are stored in the memory of Tower 1 Ortho Video System. The shavers have been sequestered. Reprocessed 4.0 and 5.0 shavers have been removed from stock along with new Stryker shavers of the same lot number. The Stryker and SteriMed reps have been notified of the incident.


Device:
Type: Electrode, Electrodcardiograph, Multi-function
Manufacturer: Philips Medical Systems
Brand: Heartstart
Lot #: 090512-01
Cat #: M3713A

Problem:
Non-emergent cardioversion performed. Defib pads placed on patient anterior posterior on MRx 1 (defibrillator), machine on sync mode ramped up to 150 joules but no shock delivered. Team attempted again with same pads, same MRx machine, again no shock delivered, no prompt from machine to indicate no shock delivered MRx performing the ramp sound of eeeeeeeeee. Team disconnected the pad cable from MRx 1 and reconnected to MRx 2, ramped up joules to 150 but same outcome of no shock and no message from machine. Team removed pads, grabbed the pink labeled pads (old packaging) and placed pads anterior/ posterior, ramped MRx2 and shock was delivered. No patient harm.
Phillips Adult defib pads in house have 2 different packaging. Phillips changed the packaging, but indicates the product remains unchanged. New package is red, the old is pink. New packaging does appear different in application instructions as it does not show anterior/posterior application for adults, only peds.


Device:
Type: Instrument, Surgical, Orthopedic
Manufacturer: Holmed Corporation
Brand: Torque Limit Device
Model#: 106 LBF/IN (12 Nm) Limiting Driver "XIA" Style connect
Other #: Torque Limiting Wrench

Problem:
6 weeks post operative L 2-3 fusion, popping sensation in back. Radiologic evidence of screw end cap disengagement from rods. Operative reports indicates tightening of screws at time of implant. Returned to surgery for repair.


Device:
Type: Lift, Patient
Manufacturer: Prism Medical
Brand: Fixed Ceiling Lift
Model#: C-625

Problem:
The lift was being used to move a patient when it was noted that the plastic piece that covers the connection of the main supporting strap was split. It appeared as though a failure of the strap connection to the patient support structure was occurring that might result in the patient being dropped.

======================
Manufacturer response for Patient ceiling mounted lift., (brand not provided) (per site reporter)
======================
This problem had been observed elsewhere and the manufacturer would replace all units with the plastic cover with new units having a metal cover.


Device:
Type: Prosthesis, Hip
Manufacturer: DePuy Orthopaedics, Inc.
Brand: Depuy Stem
Model#: 20-15-165

Problem:
Patient with painful right metal-on-metal THA (total hip arthroplasty), placed approximately four years ago, initially with a pain-free interval. He underwent R hip aspiration this past fall, given concern for infection. Information was received from microbiology reporting possible Gram positive cocci on preliminary.


Device:
Type: Prosthesis, Hip
Manufacturer: DePuy Orthopaedics, Inc.
Brand: Depuy Ball
Model#: 11-13/40 X 3

Problem:
Patient with painful right metal-on-metal THA (total hip arthroplasty), placed approximately four years ago, initially with a pain-free interval. He underwent R hip aspiration this past fall, given concern for infection. Information was received from microbiology reporting possible Gram positive cocci on preliminary.


Device:
Type: Prosthesis, Hip
Manufacturer: DePuy Orthopaedics, Inc.
Brand: Depuy Metal Cup
Model#: 2589334

Problem:
Patient with painful right metal-on-metal THA (total hip arthroplasty), placed approximately four years ago, initially with a pain-free interval. He underwent R hip aspiration this past fall, given concern for infection. Information was received from microbiology reporting possible Gram positive cocci on preliminary.


Device:
Type: Prosthesis, Hip, Semi-constrained, Metal/metal
Manufacturer: Smith & Nephew
Brand: Birmingham Hip Resurfacing Acetabular Cup W/ Impactor
Lot #: 11hw33934
Cat #: 74122154
Other #: 54 MM diameter

Problem:
Orthopedic surgeon cutting the wires that are attached to the acetabular metal cup implant and the polyetheline disc. The wire is looped through in 3 places and is cut at each loop with wire cutters. The wire cutters did not "snap down" or 'click" to indicate that the wire had been cut. The wire was then cut again. During the post op xray a foreign body was noticed. The patient then returned to surgery the next day to have a 1cm piece of wire removed.


Device:
Type: Pump, Infusion
Manufacturer: Medtronic Neuromodulation, Inc.
Brand: Synchromed Ii B
Model#: 8637-40

Problem:
Patient had a revision of an intrathecal pump in early summer 2012 with low battery. A 20cc ITP was explanted and a 40cc ITP was implanted. The pump was filled with 20cc of medication. Pt was scheduled to return based upon the volume added to the pump (20cc) and the rate of administration, about a 60 day supply. The pt returned to clinic as scheduled and underwent an ITP refill in early fall in the Pain Management Center (PMC). The previous ITP prescription of Morphine/Bupivacaine/Clonidine 20cc was renewed and received from an outside pharmacy. The 20cc of medication was injected in the pump. The pump was interrogated and setting changed to reflect a 5% infusion rate increase. The pump reservoir volume of the refill was set at 40cc, the default setting for this particular pump. The calculated pump refill date was about a 120 days supply. The settings were verified by a fellow and a nurse. Approximately 60 days later the patient was admitted to an outside hospital with complaints of dyspnea and nausea. The patient was transferred to a tertiary care hospital the following day. A cardiac catheterization performed revealed clean coronaries but an Ejection Fraction (EF) of 10%. The patient had a balloon pump placed. The patient was able to have the balloon removed HD4 and was discharged HD14 with improved EF to 20%. The discharge diagnosis was stress cardiomyopathy. The hospital did not contact the PMC during the admission. The EF returned to baseline by the beginning of the next month. The patient returned to the PMC in December as scheduled. The recent medical history was reviewed and the refill error was recognized.

The ITP does not have an internal sensor that alarms when the pump is near or completely empty. The alarm date is a calculation of amount filled and rate of administration.

The reservoir volume setting is not carried over from previous refill, like other settings. The interrogation device defaults to the size of the implanted pump.

A change in the setting from the previous setting does not create an alert for the clinician interrogating the pump. Other changes in rate or medication concentration do create such an alert.

======================
Manufacturer response for Synchromed II B intrathecal pump, Synchromed II B (per site reporter)
======================
Manufacturer aware of event.


Device:
Type: Set, Administration, Intravascular
Manufacturer: Hospira, Inc.
Brand: Microclave
Lot #: 20-688-HE
Cat #: 12512-01

Problem:
Infant found to have TPN leaking from crack in Clave. There were two such devices found to be leaking on different infants. The devices come from the same lot and that lot has been pulled


Device:

Type: Stapler, Left Atrial Appendage
Manufacturer: LAAx, Inc
Brand: Tigerpaw System Ii
Lot #: 0640M
Cat #: TP15AJ07

Problem:
As device was being used on the field it fell apart. This created more time involved to do this case.
No harm to patient.


Device:
Type: Ventilator, Continuous, Facility Use
Manufacturer: Carefusion
Brand: Avea
Model#: CarFus/AVEA
Other #: 402827584

Problem:
Vent failed to adequately oxygenate the patient over 3 days. Verified setting at 100. Vendor determined blender failure. Before vent was identified as culprit, patient underwent other testing in an effort to determine why oxygen levels remained suboptimal.


Device:
Type: Ventilator, Continuous, Facility Use
Manufacturer: Draeger Medical, Inc
Brand: Evita Infinity V500
Model#: V500

Problem:
Drager V500 vent alarm Device Failure. Patient on ventilator without incident when Drager ventilator spontaneously began to chirp a shrill constant alarm. The laptop screen on the ventilator displayed an equipment malfunction message. The RN assigned to this patient went into the patient room and removed the patient from the ventilator and began to ventilate the pt by ambu bag. Second care provider entered the room next to assist in monitoring the pt, third care provider removed the faulty ventilator and replaced it with a functioning ventilator. The pt did not experience any noticeable untoward effects from this malfunction.


Device:
Type: Laryngoscope, Non-rigid
Manufacturer: Teleflex Medical
Other #: 074808, 074807. Sterrad machine 018196

Problem:
The hospital has noticed the end of last year a problem of corrosion with their Miller "0" and "00" laryngoscope blades (around the rubber gasket area). Rusch laryngoscope blades starting to corrode.
From the bedside of our NICU babies we clean the blades with an enzymatic cleaner (Interceptor). We place the blade in a red biohazard bin to be transported to Central Sterile. Once received in the decontamination room in Central Sterile, the blades are cleaned again with Klenzyme, rinsed, and allowed to air dry. Once the blades have dried completely, the blades are placed in a sterile blister pack and sent through the Sterrad machine. These are then transported back to our NICU and they stay in the sterile pack until needed for use on a patient.
They have had 5-7 similar occurrences. The devices with the corrosion appearance have been taken out of service.


Device:
Type: Ventilator, Continuous, Facility Use
Manufacturer: Hamilton Medical
Brand: Hamilton C-2
Model#: C-2

Problem:
Beginning in 2011, the C2 Hamilton vent would malfunction during patient use and show a technical failure of 244011. Although the vents were repeatedly tested, the error was never able to be reproduced. We tracked this issue beginning in June 2012 after several 244011 error messages. Although there haven't been any recent occurrences (last noted in August 2012), there has not been an explanation from the manufacturer as to the origin of the error. Report is being made as a precaution due to the unknown origin of the error message.


Device:
Type: Device, Hemostasis, Vascular
Manufacturer: St Jude Medical
Brand: Angio-seal

Problem:
A similar occurrence was previously reported to MedSun. Two more episodes with same devices are reported below.

1. Device was deployed according to Manufacturer directions, however, the tamp-tube did not deploy downward automatically as it should, to tamp the collagen to arteriotomy. Tech had to "filet" the sheath tube back to expose the tamp-tube, and manually slide and tamp collagen. Tech was able to aid the device to deploy properly as before.

2. Upon using the arterial closure device as per Manufacturer protocol, the tamp tube did not deploy at the correct tension. Tech had to "filet" the delivery sheath of device back in order to manually (with a hemostat) pull down the tamp tube to push the collagen onto the arteriotomy. Having had (at this count) 3 incidences with the device not deploying properly, tech knew what to do to salvage the device and prevent harm to patient who was anticoagulated for the procedure. Tech was able to secure the puncture site and no bleeding was seen.


Device:
Type: Implant, Cochlear
Manufacturer: Cochlear Americas Inc.
Brand: Nucleus Ci512
Model#: CI512

Problem:
Patient status post right cochlear implant about two years ago, with a Cochlear Corporation Nucleus CI512 device. Patient and his wife indicate that following activation of his implant, he had a very serviceable hearing on the right side. However, about seven months later, he had an episode where he noticed the implant shut off for a second and then came back on. He then stated that he noticed a decrease in his ability to hear on the right. He states that he cannot hear with the cochlear implant by itself and that he needs a cochlear implant and hearing aid together in order to have serviceable hearing.


Device:
Type: Implant, Gastric Band
Manufacturer: Allergan
Brand: (not provided)
Model#: B-2240

Problem:
Patient underwent gastric banding approximately 2 years ago for morbid obesity. She had an uneventful postoperative course until the last two months. She experienced a six week history of left upper quadrant pain without fever, chills, nausea, or vomiting. Her weight loss has been maintained after losing an excess of 100 lbs. An endoscopy showed a greater curve erosion with the band, with some granulation tissue around it, and small ulceration. The patient returned to surgery for laparoscopic removal of lap band due to posterior erosion of the band into the gastric mucosa. The band was laparoscopically freed for the entire length, unbuckled and removed. Patient then returned 2 days later for additional laparoscopic surgery due to abdominal pain with increased pneumoperitoneum on abdominal X-ray. A perforation was closed and reinforced with "Modified Thal patch". Patient continues recovery in facility at time of report.


Device:
Type: Set, Administration, For Peritoneal Dialysis
Manufacturer: Fresenius Medical Care
Brand: Safe-lock
Cat #: 020-11008
Other #: PD 8 Prong Safe-Lock Manifold Set

Problem:
One bag of solution was infusing, the other three were clamped per RN. Apparently, within a 1.5 hour period all 4 bags were found to be infused. Patient was unresponsive, CPR and code initiated and patient is currently in the ICU.

Both HD RN and floor RN state all of the tubes were clamped except the one running. Patient was in bathroom for period of time prior to this.

Tubes were noted to be unclamped after event.


Device:
Type: Electrosurgical Generator
Manufacturer: Medtronic Advanced Energy, LLC
Brand: Peak Plasmablade Pulsar Ii
Model#: PULSAR II

Problem:
The electrical panel [Line Isolation Monitor (LIM)] was alarming when the Plasmablade was activated. We have had more abnormalities (lights coming on in equipment with the power off, blanket warmer alarming) with the Plasmablade in different rooms.


Device:
Type: Electrosurgical, Accessory, Forceps
Manufacturer: Microline Surgical, Inc.
Brand: Entceps
Lot #: 206009
Cat #: 110-005D

Problem:
During use, for first tonsil removal encountered no problem. Device working fine, as well as the Starion machine.
At second tonsil for removal, the ENTceps did not work. The Starion machine had the light on, to show it was working, but the green light did not engage when pedal was pushed to indicate that the ENTceps were going to work.

Replaced the disposable, and it then worked.

Did test ENTcep #1 at end of case outside of patient and it still did not work.

The Starion machine was actively engaged with all lights in order and working, so it appears that the disposable was the problem.


Device:
Type: Bed, Hospital, Ac Powered
Manufacturer: Hill-Rom, Inc.
Brand: Advance
Model#: Advance

Problem:
RN gave patient medication in the early AM. RN reported that pt was in his usual mental state (Alert and oriented, and not attempting to get out of bed). Aproximately 1.5 hours later, the RN walked into the room, and found the patient's head between the side rail and the mattress, and his body hanging out of the bed. The staff dislodged the patient's head, and lowered him to the floor. The patient was unresponsive and pulseless.

The patient was placed back into the bed. A code was called, and ACLS protocol was followed. The patient's FSBS (finger stick blood sugar) was 39 at the beginning of the code.


Device:
Type: Pump, Infusion
Manufacturer: Cardinal Health 200, LLC.
Brand: Alaris
Model#: 8100

Problem:
The patient was being recovered in CV recovery room from an open AAA surgery. Patient was very hemodynamically unstable with blood pressures literally from the 50's to 250 systolic, requiring multiple IV drips to be started, stopped, and titrated. During a period of time the patient's systolic BP was approximately 60. I was trying to start an Epinephrine drip and the IV channel (which I had already been using for another drip earlier) suddenly alarmed that it was disconnected and shut down. After restarting/reconnecting it I attempted to again start the Epinephrine drip. This time all the channels failed and the entire pump and all the channels just turned off completely. We had another IV pump in the room but all drips had to be removed and switched over to the other pump, delaying care of the blood pressure on this fresh unstable patient for at least 5 minutes. Pump and channels were sent to Biomed.


Device:
Type: Pump, Infusion
Manufacturer: Cardinal Health 200, LLC.
Brand: Alaris
Model#: 8100

Problem:
The patient was being recovered in CV recovery room from an open AAA surgery. Patient was very hemodynamically unstable with blood pressures literally from the 50's to 250 systolic, requiring multiple IV drips to be started, stopped, and titrated. During a period of time the patient's systolic BP was approximately 60. I was trying to start an Epinephrine drip and the IV channel (which I had already been using for another drip earlier) suddenly alarmed that it was disconnected and shut down. After restarting/reconnecting it I attempted to again start the Epinephrine drip. This time all the channels failed and the entire pump and all the channels just turned off completely. We had another IV pump in the room but all drips had to be removed and switched over to the other pump, delaying care of the blood pressure on this fresh unstable patient for at least 5 minutes. Pump and channels were sent to Biomed.


Device:
Type: Pump, Infusion
Manufacturer: Cardinal Health 200, LLC.
Brand: Alaris
Model#: 8100

Problem:
The patient was being recovered in CV recovery room from an open AAA surgery. Patient was very hemodynamically unstable with blood pressures literally from the 50's to 250 systolic, requiring multiple IV drips to be started, stopped, and titrated. During a period of time the patient's systolic BP was approximately 60. I was trying to start an Epinephrine drip and the IV channel (which I had already been using for another drip earlier) suddenly alarmed that it was disconnected and shut down. After restarting/reconnecting it I attempted to again start the Epinephrine drip. This time all the channels failed and the entire pump and all the channels just turned off completely. We had another IV pump in the room but all drips had to be removed and switched over to the other pump, delaying care of the blood pressure on this fresh unstable patient for at least 5 minutes. Pump and channels were sent to Biomed.


Device:
Type: Pump, Infusion
Manufacturer: Cardinal Health 200, LLC.
Brand: Alaris
Model#: 8100

Problem:
The patient was being recovered in CV recovery room from an open AAA surgery. Patient was very hemodynamically unstable with blood pressures literally from the 50's to 250 systolic, requiring multiple IV drips to be started, stopped, and titrated. During a period of time the patient's systolic BP was approximately 60. I was trying to start an Epinephrine drip and the IV channel (which I had already been using for another drip earlier) suddenly alarmed that it was disconnected and shut down. After restarting/reconnecting it I attempted to again start the Epinephrine drip. This time all the channels failed and the entire pump and all the channels just turned off completely. We had another IV pump in the room but all drips had to be removed and switched over to the other pump, delaying care of the blood pressure on this fresh unstable patient for at least 5 minutes. Pump and channels were sent to Biomed.


Device:
Type: Pump, Infusion
Manufacturer: Cardinal Health 200, LLC.
Brand: Alaris
Model#: 8100

Problem:
The patient was being recovered in CV recovery room from an open AAA surgery. Patient was very hemodynamically unstable with blood pressures literally from the 50's to 250 systolic, requiring multiple IV drips to be started, stopped, and titrated. During a period of time the patient's systolic BP was approximately 60. I was trying to start an Epinephrine drip and the IV channel (which I had already been using for another drip earlier) suddenly alarmed that it was disconnected and shut down. After restarting/reconnecting it I attempted to again start the Epinephrine drip. This time all the channels failed and the entire pump and all the channels just turned off completely. We had another IV pump in the room but all drips had to be removed and switched over to the other pump, delaying care of the blood pressure on this fresh unstable patient for at least 5 minutes. Pump and channels were sent to Biomed.


Device:
Type: Pump, Infusion
Manufacturer: CareFusion 303, INC.
Brand: Alaris Iv Pump
Model#: 8100

Problem:
The patient was being recovered in CV recovery room from an open AAA surgery. Patient was very hemodynamically unstable with blood pressures literally from the 50's to 250 systolic, requiring multiple IV drips to be started, stopped, and titrated. During a period of time the patient's systolic BP was approximately 60. I was trying to start an Epinephrine drip and the IV channel (which I had already been using for another drip earlier) suddenly alarmed that it was disconnected and shut down. After restarting/reconnecting it I attempted to again start the Epinephrine drip. This time all the channels failed and the entire pump and all the channels just turned off completely. We had another IV pump in the room but all drips had to be removed and switched over to the other pump, delaying care of the blood pressure on this fresh unstable patient for at least 5 minutes. Pump and channels were sent to Biomed.


Device:
Type: Pump, Infusion
Manufacturer: Cardinal Health 200, LLC.
Brand: Alaris
Model#: 8100

Problem:
The patient was being recovered in CV recovery room from an open AAA surgery. Patient was very hemodynamically unstable with blood pressures literally from the 50's to 250 systolic, requiring multiple IV drips to be started, stopped, and titrated. During a period of time the patient's systolic BP was approximately 60. I was trying to start an Epinephrine drip and the IV channel (which I had already been using for another drip earlier) suddenly alarmed that it was disconnected and shut down. After restarting/reconnecting it I attempted to again start the Epinephrine drip. This time all the channels failed and the entire pump and all the channels just turned off completely. We had another IV pump in the room but all drips had to be removed and switched over to the other pump, delaying care of the blood pressure on this fresh unstable patient for at least 5 minutes. Pump and channels were sent to Biomed.


Device:
Type: Set, Administration, IV
Manufacturer: Baxter Healthcare Corporation
Brand: Clearlink Continu-flo
Model#: 2C8537S

Problem:
Hung a bag of amiodarone. A foreign body was noticed when the infusion pump started to beep. It was difficult to see but looked like piece of cardboard. Pharmacy determined it was not from the amiodarone but from the IV tubing itself.

The object looks like a piece of cardboard that is in the IV tubing BELOW the check valve, which leads us to believe that it was in the IV tubing and not the Amiodarone Drip. If the floater had come from the drip it would have probably been caught in the check valve. Also there is no cardboard allowed near the hood in the OR IV room, and both the tech and pharmacist involved did check for floaters prior to the drip being dispensed.

Per the OR staff, they use the Baxter Clearlink System CONTINU-FLO Solution Set 2C8537A which is 109 inches with 3 luer activated valves.


Device:
Type: Holder, Head, Neurosurgical
Manufacturer: PRO MED INSTRUMENTS
Brand: Doro
Model#: Headrest System
Other #: K001808DORO

Problem:
The armboard for operating room bed was attached to the DORO headrest system and was bumped. The armboard fell off the bed with patient's arm attached. There was a 1/4 inch too large measurement of the armboard fitting over the DORO headrest side rail. There is no stop method on the railing to prevent it from sliding off the narrow short railing.


Device:
Type: Bone Cement Antibiotic
Manufacturer: Depuy
Brand: Smartset Ghv Gentamicin 40g
Model#: 545035500
Lot #: 3473131
Cat #: 545035500

Problem:
When the box of depuy cement was opened everything seemed intact. The scrub tech opened the peel pack of powder onto the table. The inner pack had a hole in it. The sides were not sealed and powder spilled onto the table. The package was removed from the table and a new table cover was placed on the table. A new box of cement was opened for the procedure. Over the next few days, a total of six boxes of cement were identified with the same problem and all were returned to the manufacturer for evaluation. All were from the same lot#. Multiple boxes of cement were found before patient was involved.


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