Highlighted Reports
MedSun: Newsletter #84, May 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 April 2013. All other reports can be searched under the ‘MedSun reports’ menu pane.

Device:
Type: Accessories, Cleaning, For Endoscope
Manufacturer: Custom Ultrasonics
Brand: System 83 Plus 9

Problem:
Around mid-day one of the techs noticed that detergent wasn't flowing from the gallon pump bottle into Bay 1 of the reprocessor; Bay 2 was fully functional and continues to work properly. Endoscopy personnel were asked to use only scopes that had been reprocessed in Bay 2. In attempting to determine which patients may have been affected, we discovered that the electronic data for the machine is either inaccessible or irretrievable at this time. The service technician believes we may be able to gain access to the data, but a special code is required. He is currently working on getting the code and has also been asked to perform a site visit as soon as possible to address the problem with Bay 1. We attempted to determine when detergent was changed last and were unable to. Usually techs replace the bottles when they run low-about every 1.5 weeks

======================
Manufacturer response for Olympus Reprocessor, Custom Ultrasonics 83+9" (per site reporter)
======================
There is no alarm or notification on the printout when detergent doesn't reach the machine.
The machine is certified for both washing and Disinfection; although the use is "off-label", it can be used just for disinfection.
By following the cleaning criteria described (utilization of pre-cleaning and Scope Buddy), there is no increased risk from a patient standpoint.
No violation.
No need for patient notification.


Device:
Type: Cerclage, Fixation
Manufacturer: Pioneer Surgical Technology
Brand: Sternal Cable System
Model#: 400-690
Lot #: 139998

Problem:
There have been four cases of sternal infections and/or wound dehiscence since February 2013 that are believed to be related to the use of the Pioneer sternal cable system. Prior to these four cases, there were two sternal surgical site infections identified in September 2012 and May 2011. It was noted that in the beginning of this year (2013), a new sternal cable system was utilized for wound closure. Chart review was conducted and each of the four patients were considered to be in a "risk 1" category or higher due to ASA score or duration of procedure. All have other risk factors for infection (BMI > 30, smoking history, etc.) 3/4 patients had the first Dr. with Duraprep site prep. 1/4 patients had the second Dr. with Chloraprep. 4/4 with appropriate antibiotics prophylaxis. 4/4 had wound closure with cable system. Of the three coronary artery bypass graphs, 2 off-pump and 1 on-pump. 3/4 with positive wound cultures (1 staph species and 2 staph aureus).

Patient 1. Readmitted approximately 15 days after discharge. Sternal wound started draining and had an increase in pain. Has sternal dehiscence with drainage and sternal instability. Placed on antibiotic therapy. Wound culture grew staphylococcus aureus. Plastics consulted. Three procedures during hospital stay: 1. debridement and wash out; 2. debridement with vac change; 3. sternal flap closure utilizing bilateral pectorals musculocutaneous advancement flaps.

Patient 2. Readmitted approximately 5 days after discharge for wound dehiscence of his sternal incision (severe coughing vs. significant clinical infection). Underwent redo sternotomy, removal of cables and placement of wound VAC for poor tissue integrity and wound healing. Plastics was consulted. Next, underwent sternal debridement; musculocutaneous right vertical flap to the sternum. Wound culture came back positive for a staph species.

Patient 3. Readmitted approximately 5 days after discharge with difficulty breathing and HR in the 140s and in atrial fibrillation. The patient had significant pain from surgical site. The proximal aspect of the incision had some erythema and dehiscence of sternal wound. Keflex was started. Pain had improved at time of discharge.

Patient 4. Readmitted 1 day after discharge. Patient became wheezy and short of breath a short time after being discharged and was readmitted with some coughing and congestion. Five days later, the patient was found to have a sternal wound dehiscence with possible abscess formation. Had a washout in the OR performed and eventual wound closure by plastics. Received antibiotic therapy.

First Dr. switched back to a wire closure system and all surgeons have switched to using Chloraprep. Additional recommendations may be forthcoming. Will continue to monitor for cases.



Device:
Type: Cerclage, Fixation
Manufacturer: Pioneer Surgical Technology, Inc.
Brand: Sternal Cable System
Model#: 400-690
Lot #: 142013

Problem:
There have been four cases of sternal infections and/or wound dehiscence since February 2013 that are believed to be related to the use of the Pioneer sternal cable system. Prior to these four cases, there were two sternal surgical site infections identified in September 2012 and May 2011. It was noted that in the beginning of this year (2013), a new sternal cable system was utilized for wound closure. Chart review was conducted and each of the four patients were considered to be in a "risk 1" category or higher due to ASA score or duration of procedure. All have other risk factors for infection (BMI > 30, smoking history, etc.) 3/4 patients had the first Dr. with Duraprep site prep. 1/4 patients had the second Dr. with Chloraprep. 4/4 with appropriate antibiotics prophylaxis. 4/4 had wound closure with cable system. Of the three coronary artery bypass graphs, 2 off-pump and 1 on-pump. 3/4 with positive wound cultures (1 staph species and 2 staph aureus).

Patient 1. Readmitted approximately 15 days after discharge. Sternal wound started draining and had an increase in pain. Has sternal dehiscence with drainage and sternal instability. Placed on antibiotic therapy. Wound culture grew staphylococcus aureus. Plastics consulted. Three procedures during hospital stay: 1. debridement and wash out; 2. debridement with vac change; 3. sternal flap closure utilizing bilateral pectorals musculocutaneous advancement flaps.

Patient 2. Readmitted approximately 5 days after discharge for wound dehiscence of his sternal incision (severe coughing vs. significant clinical infection). Underwent redo sternotomy, removal of cables and placement of wound VAC for poor tissue integrity and wound healing. Plastics was consulted. Next, underwent sternal debridement; musculocutaneous right vertical flap to the sternum. Wound culture came back positive for a staph species.

Patient 3. Readmitted approximately 5 days after discharge with difficulty breathing and HR in the 140s and in atrial fibrillation. The patient had significant pain from surgical site. The proximal aspect of the incision had some erythema and dehiscence of sternal wound. Keflex was started. Pain had improved at time of discharge.

Patient 4. Readmitted 1 day after discharge. Patient became wheezy and short of breath a short time after being discharged and was readmitted with some coughing and congestion. Five days later, the patient was found to have a sternal wound dehiscence with possible abscess formation. Had a washout in the OR performed and eventual wound closure by plastics. Received antibiotic therapy.

First Dr. switched back to a wire closure system and all surgeons have switched to using Chloraprep. Additional recommendations may be forthcoming. Will continue to monitor for cases.


Device:
Type: Cerclage, Fixation
Manufacturer: Pioneer Surgical Technology, Inc.
Brand: Sternal Cable System
Model#: 400-690

Problem:
There have been four cases of sternal infections and/or wound dehiscence since February 2013 that are believed to be related to the use of the Pioneer sternal cable system. Prior to these four cases, there were two sternal surgical site infections identified in September 2012 and May 2011. It was noted that in the beginning of this year (2013), a new sternal cable system was utilized for wound closure. Chart review was conducted and each of the four patients were considered to be in a "risk 1" category or higher due to ASA score or duration of procedure. All have other risk factors for infection (BMI > 30, smoking history, etc.) 3/4 patients had the first Dr. with Duraprep site prep. 1/4 patients had the second Dr. with Chloraprep. 4/4 with appropriate antibiotics prophylaxis. 4/4 had wound closure with cable system. Of the three coronary artery bypass graphs, 2 off-pump and 1 on-pump. 3/4 with positive wound cultures (1 staph species and 2 staph aureus).

Patient 1. Readmitted approximately 15 days after discharge. Sternal wound started draining and had an increase in pain. Has sternal dehiscence with drainage and sternal instability. Placed on antibiotic therapy. Wound culture grew staphylococcus aureus. Plastics consulted. Three procedures during hospital stay: 1. debridement and wash out; 2. debridement with vac change; 3. sternal flap closure utilizing bilateral pectorals musculocutaneous advancement flaps.

Patient 2. Readmitted approximately 5 days after discharge for wound dehiscence of his sternal incision (severe coughing vs. significant clinical infection). Underwent redo sternotomy, removal of cables and placement of wound VAC for poor tissue integrity and wound healing. Plastics was consulted. Next, underwent sternal debridement; musculocutaneous right vertical flap to the sternum. Wound culture came back positive for a staph species.

Patient 3. Readmitted approximately 5 days after discharge with difficulty breathing and HR in the 140s and in atrial fibrillation. The patient had significant pain from surgical site. The proximal aspect of the incision had some erythema and dehiscence of sternal wound. Keflex was started. Pain had improved at time of discharge.

Patient 4. Readmitted 1 day after discharge. Patient became wheezy and short of breath a short time after being discharged and was readmitted with some coughing and congestion. Five days later, the patient was found to have a sternal wound dehiscence with possible abscess formation. Had a washout in the OR performed and eventual wound closure by plastics. Received antibiotic therapy.

First Dr. switched back to a wire closure system and all surgeons have switched to using Chloraprep. Additional recommendations may be forthcoming. Will continue to monitor for cases.


Device:
Type: Cerclage, Fixation
Manufacturer: Pioneer Surgical Technology; Inc.
Brand: Sternal Cable System
Model#: 400-690
Lot #: 139998

Problem:
There have been four cases of sternal infections and/or wound dehiscence since February 2013 that are believed to be related to the use of the Pioneer sternal cable system. Prior to these four cases, there were two sternal surgical site infections identified in September 2012 and May 2011. It was noted that in the beginning of this year (2013), a new sternal cable system was utilized for wound closure. Chart review was conducted and each of the four patients were considered to be in a "risk 1" category or higher due to ASA score or duration of procedure. All have other risk factors for infection (BMI > 30, smoking history, etc.) 3/4 patients had the first Dr. with Duraprep site prep. 1/4 patients had the second Dr. with Chloraprep. 4/4 with appropriate antibiotics prophylaxis. 4/4 had wound closure with cable system. Of the three coronary artery bypass graphs, 2 off-pump and 1 on-pump. 3/4 with positive wound cultures (1 staph species and 2 staph aureus).

Patient 1. Readmitted approximately 15 days after discharge. Sternal wound started draining and had an increase in pain. Has sternal dehiscence with drainage and sternal instability. Placed on antibiotic therapy. Wound culture grew staphylococcus aureus. Plastics consulted. Three procedures during hospital stay: 1. debridement and wash out; 2. debridement with vac change; 3. sternal flap closure utilizing bilateral pectorals musculocutaneous advancement flaps.

Patient 2. Readmitted approximately 5 days after discharge for wound dehiscence of his sternal incision (severe coughing vs. significant clinical infection). Underwent redo sternotomy, removal of cables and placement of wound VAC for poor tissue integrity and wound healing. Plastics was consulted. Next, underwent sternal debridement; musculocutaneous right vertical flap to the sternum. Wound culture came back positive for a staph species.

Patient 3. Readmitted approximately 5 days after discharge with difficulty breathing and HR in the 140s and in atrial fibrillation. The patient had significant pain from surgical site. The proximal aspect of the incision had some erythema and dehiscence of sternal wound. Keflex was started. Pain had improved at time of discharge.

Patient 4. Readmitted 1 day after discharge. Patient became wheezy and short of breath a short time after being discharged and was readmitted with some coughing and congestion. Five days later, the patient was found to have a sternal wound dehiscence with possible abscess formation. Had a washout in the OR performed and eventual wound closure by plastics. Received antibiotic therapy.

First Dr. switched back to a wire closure system and all surgeons have switched to using Chloraprep. Additional recommendations may be forthcoming. Will continue to monitor for cases.


Device:
Type: Device, Neurovascular Embolization
Manufacturer: MICRUS ENDOVASCULAR
Brand: Deltaplush Microcoil
Lot #: G13507
Cat #: CPL 100256-30

Problem:
Coil did not detach during attempted embolization of an aneurysm. Physician was able to pull the entire coil out without harm to the patient.


Device:
Type: Hypothermia Unit
Manufacturer: Cincinnati Sub Zero
Brand: Electri-cool Ii
Model#: 767

Problem:
Patient had a cooling pad on his right knee per protocol after a right total knee replacement. R.N. caring for patient identified that the water in the hypothermia unit was hot to the touch, the tubing was warm and the patients knee was warm. R.N. removed machine, placed ice pack to right knee and obtained new machine. Machine was inspected by biomed. range on machine is set for 5-7 degrees Celsius, however when machine was tested it was at 15 decrees Celsius


Device:
Type: Needle, Hypodermic, Single Lumen
Manufacturer: Becton Dickinson
Brand: Bd Precisionglide
Lot #: 1214753
Cat #: 305122

Problem:
Patient undergoing eye surgery for treatment of glaucoma. Surgeon noticed shiny speck in iris of right eye. Further evaluation noted tip from an injection needle had broken off. The surgeon decided to leave the particle in the eye. An attempt was made to remove the particle, but this was embedded in stroma and the more removal attempt was made as the bigger the wound became. He decided at this point to leave the particle in the cornea. This particle was approximately 0.1 mm in size. It was buried in the stroma. The surgeon did not believe it will cause any long-term difficulties. There was additional follow up on the patient by the surgeon the next day for evaluation. No one has an idea of what may have contributed to this event.


Device:
Type: Set, Blood Collection
Manufacturer: Becton, Dickinson & Company
Lot #: 3047784
Cat #: 367344

Problem:
This morning the Lab Supervisor identified an issue with recent shipment of BD item REF 367344 green butterfly needles, Lot#3047784, expiration date of 02/2015. The Lab Supervisor notified the BD rep of the issue. There is a defect in some of these that can be visually seen as holes in the tubing. This appears to be a recent lot shipment. We have pulled all of this item from Lab and Network Reference Lab draw sites and have them in the lab.


Device:
Type: Supplies, Blood-bank
Manufacturer: Typenex Medical, LLC
Brand: Barcode Blood Band For Handwriting
Lot #: M081612
Cat #: 4R4610
Other #: Series HRI

Problem:
Feedback from our post-partum obstetrical nursing manager that the Typenex bracelets for mothers & their newborns are deteriorating. The plastic cellophane covering is peeling off. A new mother who was breast feeding became very alarmed when a small piece of the cellophane covering fell on to her breast while nursing her newborn. No patients have been harmed. The bracelets are in place for 1-3 days. These bands are used to identify individual patients and to match the correct mother to the correct infant.

1) Post-partum unit collected 5 more examples of unacceptable bracelet. All bracelets were on patient for less than 3 days and deteriorated. All 5 bracelets were essentially illegible.
2) The product code 4R-46-10- confirmed lot (01)892159002024(10)M081612 Typenex series HRI as a problematic lot. There are other lots that have same problem, in particular lot with Typenex series HSE.

======================
Manufacturer response for Typenex Bracelet, Barcode Blood Bank Bands for Handwriting Catalog Code -4R4680 Yellow (per site reporter)
======================
Per e-mail from Regional Acct Mgr, "Please send the effected band samples to the address below included with my signature. Once we receive the bands we can complete testing and come up with reasons for why this is happening as well as next steps. I am not aware of any changes in material or production that have been made to your current band. It would be helpful if you can provide lot numbers associated with the bands."


Device:
Type: Supplies, Blood-bank
Manufacturer: Typenex Medical LLC
Brand: Barcode Blood Band For Handwriting
Cat #: 4R4680
Other #: Series HSE

Problem:
Feedback from our post-partum obstetrical nursing manager that the Typenex bracelets for mothers & their newborns are deteriorating. The plastic cellophane covering is peeling off. A new mother who was breast feeding became very alarmed when a small piece of the cellophane covering fell on to her breast while nursing her newborn. No patients have been harmed. The bracelets are in place for 1-3 days. These bands are used to identify individual patients and to match the correct mother to the correct infant.

1) Post-partum unit collected 5 more examples of unacceptable bracelet. All bracelets were on patient for less than 3 days and deteriorated. All 5 bracelets were essentially illegible.
2) The product code 4R-46-10- confirmed lot (01)892159002024(10)M081612 Typenex series HRI as a problematic lot. There are other lots that have same problem, in particular lot with Typenex series HSE.

======================
Manufacturer response for Typenex Bracelet, Barcode Blood Bank Bands for Handwriting Catalog Code -4R4680 Yellow (per site reporter)
======================
Per e-mail from Regional Acct Mgr, "Please send the effected band samples to the address below included with my signature. Once we receive the bands we can complete testing and come up with reasons for why this is happening as well as next steps. I am not aware of any changes in material or production that have been made to your current band. It would be helpful if you can provide lot numbers associated with the bands."


Device:
Type: Gas-machine, Anesthesia
Manufacturer: DRAEGER MEDICAL SYSTEMS, INC.
Brand: Apollo
Model#: Apollo 8606500-52

Problem:
Patient undergoing hypospadias repair. ASA 2. Patient with LMA breathing spontaneously on Sevoflurane exhibiting elevated expirated CO2 levels (60-78) during surgery. Patient was placed on pressure support with a resulting reduction in expired CO2 from 80-60 for the remainder of the case.
Surgery concluded no sequelae.


Device:
Type: Gas-machine, Anesthesia
Manufacturer: DRAEGER MEDICAL SYSTEMS, INC
Brand: Fabius Gs Premium
Model#: 860700055

Problem:
Patient undergoing an orchipexy for undescended testicles. ASA 1. Patient with LMA breathing spontaneously on Sevoflurane exhibiting persistent elevated expirated CO2 levels (60-80) during duration of surgery. Surgery concluded no sequelae.


Device:
Type: Device, Hemostasis, Vascular
Manufacturer: St Jude Medical
Brand: Angioseal Evolution
Other #: 23417-000

Problem:
The integrated "tamp-tube" did not slide down upon withdraw of the device. Added tension in the device was felt. CV tech had to fillet the end of the sheath to extract the "tamp-tube" and manually slide and pact the collagen onto the arteriotomy. Due to having experience with this similar event, the device was able to be deployed with minimal to now bleeding in the access site.


Device:
Type: Device, Hemostasis, Vascular
Manufacturer: St Jude Medical
Brand: Angioseal

Problem:
The integrated "tamp-tube" did not slide down upon withdraw of the device. Added tension in the device was felt. CV tech had to fillet the end of the sheath to extract the "tamp-tube" and manually slide and pact the collagen onto the arteriotomy. Due to having experience with this similar event, the device was able to be deployed with minimal to now bleeding in the access site.

NOTE: this is the fifth event this year with this device at our facility.


Device:
Type: Monitor, Physiological, Wall Mount
Manufacturer: Philips Medical System
Brand: Gcx
Cat #: AG-0021-25
Other #: MP50

Problem:
During routine servicing on the monitor, the clinical engineer grabbed the monitor to lift it up and his fingers got pinched between the cable organizer bracket and the arm. It happened because the organizer bracket is able to spin around. The risk is for anyone adjusting the height of the monitor, either nursing or biomed employees who place their hands in an incorrect position near the GCX monitor mount.


Device:
Type: Oxygenator, Cardiopulmonary Bypass
Manufacturer: Medtronic, Inc.
Brand: Medtronic Affinity Carmeda Oxygenator
Model#: Affinity
Lot #: 206208584

Problem:
Medtronic oxygenator was found to have an area that was cracked and sheared off during a coronary bypass surgery. This happened as the perfusionist was setting up his equipment to prepare for cardiopulmonary bypass (prior to the pump being started). A huge hole blown in top of unit and luer connection sheared off. There have been at least six other occurrences at a near by hospital for this product. Surgeons have expressed the use of this device is concerning.


Device:
Type: Transducer, Blood Pressure, Extravascular
Manufacturer: ICU Medical, Inc
Brand: Transpac
Model#: 42584-05
Lot #: 2613339

Problem:
On at least three occasions, the Transpac IV tubing "snapped" at the connection just proximal to the flush adaptor leaving the male connector portion within the female. The tubing was under pressure, however staff report the pressure bag was not over-inflated at the time of either incident. When the tubing separated it created the potential for an "open" system (unless either of the two distal stopcocks were turned off to the patient). It also allow fluid, under pressure, to saturate the surrounding area unless the roller clamp was quickly closed. The remaining kits, with the same lot number, were removed from stock and no further incidents have been reported.


Device:
Type: Wire, Guide, Catheter
Manufacturer: TERUMO MEDICAL CORP
Brand: Stiff Shaft
Lot #: 110906
Cat #: GS3805
Other #: 0.038 inches, 150 cm, 3 cm flex tip angled stiff shaft glidewire

Problem:
Physician gained vascular access through a venous fistula utilizing the outbound tract. Vessel had arterialized pressure. Venograms were performed times two. An occlusion of the subclavian vein was visualized by the venogram. Attempts were made by physician to recannulize the occluded vessel. Physician asked for a .038 cm Stiff Shaft Glidewire to attempt re-opening the occluded vessel. The distal tip of the stiff shaft glidewire has an angled tip and is semi-flexible. The proximal end of the glidewire is very stiff, and relatively inflexable. The angled tip of the glidewire was inserted into the long sheath introducer. Attempts to cross the occlusion was not successful. The physician then turned the glidewire around, and inserted the proximal stiff end into the introducer and attempted to cross the lesion.
It was noted that the wire perforated the blood vessel. The physician upon seeing the issue, removed the wire and cancelled the procedure. Vital signs according to the nurses and technicians involved in the case remained stable. The patient was returned to the nursing unit for post procedure observation and care. It is questionable if the use of the wire was appropriate following manufacturer guidelines for use.

Upon review of package literature, and talking with the manufacturer territory sales representative, there is no documentation suggesting that the proximal end of the guidewire cannot be utilized during the procedure. It falls to the judgment of physician to determine appropriate use of the wire.


Device:
Type: Tray, Catheter, Foley
Manufacturer: Bard Medical
Brand: Complete Care Lubri-sil I. C.
Lot #: ngwk1701
Cat #: 300416A

Problem:
Patient with latex allergy had a latex foley inserted - no harm to the patient upon discovery. Foley was removed and patient treated with steroids.

Human error - staff concerned with look alike packaging for the latex free and the latex Foleys.

The packaging has the the same color fonts, packaging labeling for latex free Foley to the right of label it is written "latex free" same color print. The label slides within the packaging during shipping. making it difficult to the read "latex free" text.


Device:
Type: Hemostatic Matrix
Manufacturer: Baxter Healthcare Corp.
Brand: Floseal
Lot #: 121218
Cat #: 1503350
Other #: Case of 6

Problem:
Floseal matrix never dissolved with the thrombin/saline mixture. Defective product. Unable to mix items for use. Product removed -not used. Another Floseal product used without problem. This never went into the patient.


Device:
Type: Chair, Medical, Examination
Manufacturer: Stryker Medical
Brand: Symmetry Plus
Model#: 3500-000-710
Cat #: 3500-000-710

Problem:
Patient in recliner to be examined. Nurse Practitioner pulled the footrest handle to elevate the feet and it snapped sharply upward. Patient complained she heard a loud pop in her left knee and a few minutes later it started to cause pain and swelling. Examination showed some swelling. X-ray showed moderate effusion and next day patient was in pain. Patient had MRI which showed large hemorrhagic joint effusion of left knee with no major structural anomolies identified. Possible strain of bicep femoris muscle.

Nursing in two different sites report workarounds with this chair as it does have a strong spring and can cause hyper-extension to patient's knees. They will hold the foot rest down with their hands or tell patient to hold feet up until the footrest is in place.


Device:
Type: Incubator, Neonatal
Manufacturer: GE Medical Systems
Brand: Giraffe Omnibed
Model#: Giraffe OmniBed

Problem:
This is a recurring issue with this model, not just this one device. The humidifier heater in the front, behind the water container gets very hot and weakens the area close to it. We then have to replace the chassis and sometimes the heater as well. This is a costly and time consuming repair. We sometimes replace the chassis in two years. Many times the chassis is not available and on back order, which increases the down time. Also the price of the chassis and heater have increased steadily.


Device:
Type: Lift, Patient, Ac-powered
Manufacturer: ArjoHuntleigh, Inc.
Brand: Maxisky 1000
Model#: LF21019

Problem:
Lift motor and gantry was assembled in the room for use with an 842 pound patient in mid-January 2013. Original lift motor failed to operate reliably due to weak or depleted batteries, charger problem, or other issues. It was replaced approximately 2 weeks later with a second motor. This motor would lift the patient but would not hold in position without slowly dropping downward.

The patient was then lowered back into the bed and disconnected from the lift. Using its control pendant, the lift motor was moved to its park position. Shortly after reaching the park position, with no buttons being pressed on its control pendant, the lift motor spontaneously moved from the park position toward the nurse and patient.

The lift assembly was then removed from the patient's room. It was reassembled within the Biomedical Engineering department for testing, and it was confirmed that a sequence of lift, release, and move to park position would result in spontaneous movement from the park position toward the opposite end of the gantry.
The lift was not used again, and was eventually removed by the vendor.

The manufacturer's representative present for testing, and observed spontaneous movement.


Device:
Type: Set, Administration, Intravascular
Manufacturer: CareFusion
Brand: Alaris
Cat #: MS3500-15

Problem:
The item numbers that were involved were; 2441-0007 (Burette Primary Pump Set), 2426-0007 (3 Port Primary Pump Set) and MS3500-15 (Secondary Set). When the RN was running a piggy back she would use the secondary set (MS3500-15) and hook this into the Burette Set (2441-007). She noticed a leak at the Y-Site where these two items connected. She then tried using the primary pump set (2426-0007) and again there was a leak. This helped the RN identify the issue being with the secondary set (MS3500-15) and not the other two items.

The following is response from our area Alaris Tubing rep to the hospital:
I have contacted my Clinical Nursing Consultants that cover Southern California because this secondary set (MS3500-15) is used in many local facilities. They have not been notified or seen this same issue in any other facilities. This leads me to believe that hopefully this issue was just with this one set and not an issue with a case/lot of MS3500-15. Based on this information I think it would be best for us to simply keep our eye on this and see if the issue happens again. I also will report to this to my clinical advocacy department who will follow up to research further.


Device:
Type: Uterine Manipulator
Manufacturer: Conmed Corporation
Brand: Vcare
Lot #: 130108-1
Cat #: 60-6085-202

Problem:
Balloon for this product would not work.

Three more or the same product were opened and all three failed.

All products from this lot have been pulled from the shelves and manufacturer to be notified.


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