Highlighted Reports
MedSun: Newsletter #88, September 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 August 2013. All other reports can be searched under the ‘MedSun reports’ menu pane.

Device:
Type: Breathing Circuit, Ventilator
Manufacturer: Carefusion, Inc.
Brand: Airlife
Model#: (not provided)
Lot #: (not provided)
Cat #: 003762
Other #: (not provided)

Problem:
Patient in severe respiratory distress. Patient intubated. Patient became agitated and ventilator began beeping. Patient became bradycardic. Took patient off vent to bag with ambu bag. A large amount of air escaped from the ET tube. Patient became calm. Upon examination it was noted that the Continuous nebulizer had popped off circuit. It was replaced on to the exhalation valve and the patient could not exhale. The connections all appear the same and are same size. Even when placed correctly they have a tendency to pop off. Staff will use tape to make the connection snug. This is a work-around and not policy.


Device:
Type: Catheter, Urological
Manufacturer: C.R. BARD, INC.
Brand: Bardex Foley
Model#: (not provided)
Lot #: (not provided)
Cat #: 165812
Other #: (not provided)

Problem:
The RN removed 9cc of fluid from the Foley Catheter balloon in order to remove foley. While attempting to remove the catheter, this nurse met resistance. This RN called the charge RN to attempt. During this time, the patient was screaming in pain. The Surgery NP (Nurse Practitioner) was called, who then called the urology resident to the bedside. Resident attempted to remove as well and was met with resistance. Resident then reinserted the Foley, reinflated the balloon, deflated the balloon and still met with resistance. All this time, the patient was screaming. The Urology Resident then proceeded to pull the catheter out. The patient had some mild bleeding from the tip of the penis, but was obviously traumatized. As a result of the event, patient required additional pain medication. The Resident then showed this RN that the end of the catheter balloon had formed a ridge when deflated, instead of being smooth on the end. He said this was a common problem with our new catheters. The end of the catheter was removed and placed in a bag to show the nurse manager. This facility has had an estimated 20+ such events with this product over the last 5 months. The manufacturer is aware and product has been returned to them for investigation/analysis. There is no difficulty inserting the catheters. The problem occurs when the catheter is removed. This has occurred in both male and female patients. There are no patient factors common to these events.



Device:
Type: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days, Repair Kit
Manufacturer: Bard Access Systems Inc.
Brand: Hickman Dual Lumen Catheter Repair Kit
Model#: (not provided)
Lot #: REVH1321
Cat #: 0601760
Other #: (not provided)

Problem:
Patient was brought to the ED for a broken Broviac catheter. RN was performing repair of a Bard 7 French double lumen catheter. Repair kit appeared to have a clear silicone film sticking out from the outer white sheath that prevented the repair tubes (stents) of the new line from approximating with the indwelling segment. A second repair kit had to be obtained, and although this kit also had the clear silicone film sticking out from the outer sheath, the tubes (stents) stuck out further, allowing repair to be completed.


Device:
Type: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days, Repair Kit
Manufacturer: Bard Access Systems Inc.
Brand: Hickman Dual Lumen Catheter Repair Kit
Model#: (not provided)
Lot #: REV 10933
Cat #: 0601760
Other #: (not provided)

Problem:
Patient was brought to the ED for a broken Broviac catheter. RN was performing repair of a Bard 7 French double lumen catheter. Repair kit appeared to have a clear silicone film sticking out from the outer white sheath that prevented the repair tubes (stents) of the new line from approximating with the indwelling segment. A second repair kit had to be obtained, and although this kit also had the clear silicone film sticking out from the outer sheath, the tubes (stents) stuck out further, allowing repair to be completed.



Device:
Type: Microscope, Operating &Accessories, Ac-powered, Ophthalmic
Manufacturer: Carl Zeiss, Inc.
Brand: Opmi Lumera 700
Model#: OPMILUMERA700
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Patient in the operating room , getting ready to do the case; Resident prepping the eye, when there was a loud boom. Ceiling Microscope light bulb blew up, glass shattered to pieces everywhere on the floor, other equipment in the room and back table. New set up opened. Charge Nurse notified. Biomed notified. Zeiss company notified.



Device:
Type: Pen, Marking, Surgical
Manufacturer: Cardinal Health 200, LLC
Brand: Sterile Surgical Marking Systems
Model#: (not provided)
Lot #: (not provided)
Cat #: MAQ100
Other #: Q100

Problem:
The process of marking the distal pin holes for this procedure is done by removing the tip of the sterile marking pen from the marking pen and securing it in a hemostat to be able to reach the area where the distal femoral pins holes are marked. The tip of the marking pen is not long enough if used as intact in the marking pen. This process of removing the actual marking pen tip is not an unusual standard of practice and is used in other hospitals as well due to the limitations of getting to the distal pin holes.
The missing marker tip was immediately noted by the scrub RN when the hemostat was handed off by he MD and the following processes were implemented to try to retrieve the marking tip:
The tip of the marker went into the hole and despite multiple efforts at trying to extricated it could not be removed. The metal cutting guide was then placed and the knee was placed in extension. Appropriate releases were performed to create a symmetric extension gap and the distal cut was made. Attempts to remove the marker tip through the hole was again unsuccessful. The 2 pin holes in the medial femoral condyle on the extension cut were enlarged again to try to remove the tip of the marker that had buried into the bone. Despite multiple attempts to try to remove it, it could not be seen and it was felt that with all of the probing that it had possibly broken up. The area was irrigated copiously and no further and could be leached from the marker tip. It was felt that the marker tip was deep in the bone and would be sealed by the bone cement and would not cause further problems. Further attempts to remove it would cause more bone destruction and was not felt to be warranted.
Discussion with RN stated that the area was irrigated with 3 litres of fluid using pulse irrigation, used a 25 gauge spinal needle to enlarge the hole and even tried over-drilling the area to possibly disintegrate the marking tip which was felt could have happened due to not visibly seeing it again. The marking pen is in every sterile pack and is made by Cardinal Health.



Device:
Type: Set, Administration, Intravascular
Manufacturer: B. BRAUN MEDICAL, INC.
Brand: Anesthesia Set With Ultrasite Injection Manifold
Model#: (not provided)
Lot #: 0061320489
Cat #: US1275A
Other #: (not provided)

Problem:
Today we had 5 sets of tubing come apart after we had started the IV on the patient despite the fact that we tightened the connections. On one of the patients, we had to change the linen and mop the floor due to the amount blood and IV fluid leaking. A CRNA stated he had 2 sets come apart in OR today. The following is in addition:

1. The tubing connections are either loose or disconnected altogether when pulling new out of the package.
2. Nursing will tighten connections, however in some cases the connection will become loose again an allow IV fluid or blood to pool on and around the patient.
3. The tubing kinks easily.
4. The sample set (for demo & education only) has a small slit in the tubing.

The manufacturer has communicated that they want the failed device as well as all unused product back. The manufacturer identified an alternative product which we are using at this time. We have gathered 89 unused sets as well as 1 failed device which will go back to the manufacturer within approximately 4 days. Multiple lot numbers are involved. We understand that our facility is not the only facility that is complaining about the connections not staying tight.



Device:
Type: Set, Administration, Intravascular
Manufacturer: B. BRAUN MEDICAL, INC.
Brand: Anesthesia Set With Ultrasite Injection Manifold
Model#: (not provided)
Lot #: 0061320489
Cat #: US1275A
Other #: (not provided)

Problem:
Today we had 5 sets of tubing come apart after we had started the IV on the patient despite the fact that we tightened the connections. On one of the patients, we had to change the linen and mop the floor due to the amount blood and IV fluid leaking. A CRNA stated he had 2 sets come apart in OR today. The following is in addition:

1. The tubing connections are either loose or disconnected altogether when pulling new out of the package.
2. Nursing will tighten connections, however in some cases the connection will become loose again an allow IV fluid or blood to pool on and around the patient.
3. The tubing kinks easily.
4. The sample set (for demo & education only) has a small slit in the tubing.

The manufacturer has communicated that they want the failed device as well as all unused product back. The manufacturer identified an alternative product which we are using at this time. We have gathered 89 unused sets as well as 1 failed device which will go back to the manufacturer within approximately 4 days. Multiple lot numbers are involved. We understand that our facility is not the only facility that is complaining about the connections not staying tight.


Device:
Type: Set, Administration, Intravascular
Manufacturer: B. BRAUN MEDICAL, INC.
Brand: Anesthesia Set With Ultrasite Injection Manifold
Model#: (not provided)
Lot #: 0061320489
Cat #: US1275A
Other #: (not provided)

Problem:
Today we had 5 sets of tubing come apart after we had started the IV on the patient despite the fact that we tightened the connections. On one of the patients, we had to change the linen and mop the floor due to the amount blood and IV fluid leaking. A CRNA stated he had 2 sets come apart in OR today. The following is in addition:

1. The tubing connections are either loose or disconnected altogether when pulling new out of the package.
2. Nursing will tighten connections, however in some cases the connection will become loose again an allow IV fluid or blood to pool on and around the patient.
3. The tubing kinks easily.
4. The sample set (for demo & education only) has a small slit in the tubing.

The manufacturer has communicated that they want the failed device as well as all unused product back. The manufacturer identified an alternative product which we are using at this time. We have gathered 89 unused sets as well as 1 failed device which will go back to the manufacturer within approximately 4 days. Multiple lot numbers are involved. We understand that our facility is not the only facility that is complaining about the connections not staying tight.


Device:
Type: Set, Administration, Intravascular
Manufacturer: B. BRAUN MEDICAL, INC.
Brand: Anesthesia Set With Ultrasite Injection Manifold
Model#: (not provided)
Lot #: 0061320489
Cat #: US1275A
Other #: (not provided)

Problem:
Today we had 5 sets of tubing come apart after we had started the IV on the patient despite the fact that we tightened the connections. On one of the patients, we had to change the linen and mop the floor due to the amount blood and IV fluid leaking. A CRNA stated he had 2 sets come apart in OR today. The following is in addition:

1. The tubing connections are either loose or disconnected altogether when pulling new out of the package.
2. Nursing will tighten connections, however in some cases the connection will become loose again an allow IV fluid or blood to pool on and around the patient.
3. The tubing kinks easily.
4. The sample set (for demo & education only) has a small slit in the tubing.

The manufacturer has communicated that they want the failed device as well as all unused product back. The manufacturer identified an alternative product which we are using at this time. We have gathered 89 unused sets as well as 1 failed device which will go back to the manufacturer within approximately 4 days. Multiple lot numbers are involved. We understand that our facility is not the only facility that is complaining about the connections not staying tight.


Device:
Type: Set, Administration, Intravascular
Manufacturer: B. BRAUN MEDICAL, INC.
Brand: Anesthesia Set With Ultrasite Injection Manifold
Model#: (not provided)
Lot #: 0061320489
Cat #: US1275A
Other #: (not provided)

Problem:
Today we had 5 sets of tubing come apart after we had started the IV on the patient despite the fact that we tightened the connections. On one of the patients, we had to change the linen and mop the floor due to the amount blood and IV fluid leaking. A CRNA stated he had 2 sets come apart in OR today. The following is in addition:

1. The tubing connections are either loose or disconnected altogether when pulling new out of the package.
2. Nursing will tighten connections, however in some cases the connection will become loose again an allow IV fluid or blood to pool on and around the patient.
3. The tubing kinks easily.
4. The sample set (for demo & education only) has a small slit in the tubing.

The manufacturer has communicated that they want the failed device as well as all unused product back. The manufacturer identified an alternative product which we are using at this time. We have gathered 89 unused sets as well as 1 failed device which will go back to the manufacturer within approximately 4 days. Multiple lot numbers are involved. We understand that our facility is not the only facility that is complaining about the connections not staying tight.


Device:
Type: Suture, Surgical, Absorbable, Polydioxanone
Manufacturer: Ethicon Inc.
Brand: Stratafix Symmetric Pds Plus Knotless Tissue Control Devices
Model#: (not provided)
Lot #: GEM230
Cat #: SXPP1A402
Other #: (not provided)

Problem:
2 of 4 C-section patients using the #0-Stratifix Suture had a fascial dehiscence. (Note: Fascial dehiscence is uncommon in healthy young women. Typical concerns would be those who are obese, smokers, etc. Neither of these patients was at higher risk for fascial dehiscence.)
Patient #1: Repeat Low Transverse C-Section, Post Operative Post Partum Tubal Ligation. The fascia was closed with 0-Stratifix suture in a running fashion.POD1: Incision C/D/I, non distended, appropriately tender, small amt serosanguinous drainage.POD2: Incision: there is serosanguinous drainage on the steristrips and pad. The skin edges are well approximated. No induration by the incision. It does not look infected. There is probably a subcutaneous seroma or hematoma that is draining out of the incision. Observe. If the incision becomes infected, then will need to open it. RN reported later in day that patient felt it was getting worse - tender to touch. Temp normal. The incision is intact; unable to express any fluid. There is diffuse swelling above the incision but no induration. It does not look infected. Started having reddened incision and edema around site last evening. POD3: When patient stands, there is immediate drainage of more serosanguinous fluid. There is also a visible bulge of likely bowel contents more so left side greater than right. Concern for fascial dehiscence. Patient brought to the operating room. Immediately, there was noted a fascial dehiscence that extended from the middle of the fascial incision and extending all the way to the left lateral corner. The #0-Stratifix suture had been entirely pulled out of the left corner of the fascia and it was still intact holding the right lateral portion of the fascial closure. No evidence of infection was noted. The fascia was then closed with double stranded 0-PDS starting at the left corner meeting in the middle with another strand of double stranded 0-PDS. Both strands were then met in the middle and tied separately from each other. The subcutaneous tissue was closed with a running suture of #3-0 plaingut suture after this layer was vigorously irrigated with warmed normal saline. The skin was closed with a running subcuticular stitch of 4-0 Vicryl. A sterile dressing was applied.
Patient #2: Primary low transverse Cesarian section. Fascia was closed with #-0-Stratifix in a running fashion. The subcutaneous tissue did not require closure. No drainage or incisional issues on POD1 and POD2. POD3: Upon discharge planning for MD noted asymmetrical bulge of left side of incision. CT confirmed suspected fascial dehiscence. Patient brought to OR for laparotomy with repair of fascial dehiscence. There was complete dehiscence of the fascial incision from the midline to the left margin of the fascial incision. The bowel and omentum were protruding through this. The fascia was completely opened and the Stratafix suture was completely removed. There was NO tab on the end of the Stratafix suture and 1/2 of the tab was found, free, at the left most margin lying on the surface of the fascia. The fascia was closed with double-stranded 0-looped PDS suture. The subcutaneous tissue was closed with a running suture of 3-0 plain catgut. The skin was closed with a running subcuticular stitch of 4-0 Vicryl. Steri-strips and a sterile dressing were applied.




Device:
Type: Suture, Surgical, Absorbable, Polydioxanone
Manufacturer: Ethicon Inc.
Brand: Stratafix Symmetric Pds Plus Knotless Tissue Control Devices
Model#: (not provided)
Lot #: GEM230
Cat #: SXPP1A402
Other #: (not provided)

Problem:
2 of 4 C-section patients using the #0-Stratifix Suture had a fascial dehiscence. (Note: Fascial dehiscence is uncommon in healthy young women. Typical concerns would be those who are obese, smokers, etc. Neither of these patients was at higher risk for fascial dehiscence.)
Patient #1: Repeat Low Transverse C-Section, Post Operative Post Partum Tubal Ligation. The fascia was closed with 0-Stratifix suture in a running fashion.POD1: Incision C/D/I, non distended, appropriately tender, small amt serosanguinous drainage.POD2: Incision: there is serosanguinous drainage on the steristrips and pad. The skin edges are well approximated. No induration by the incision. It does not look infected. There is probably a subcutaneous seroma or hematoma that is draining out of the incision. Observe. If the incision becomes infected, then will need to open it. RN reported later in day that patient felt it was getting worse - tender to touch. Temp normal. The incision is intact; unable to express any fluid. There is diffuse swelling above the incision but no induration. It does not look infected. Started having reddened incision and edema around site last evening. POD3: When patient stands, there is immediate drainage of more serosanguinous fluid. There is also a visible bulge of likely bowel contents more so left side greater than right. Concern for fascial dehiscence. Patient brought to the operating room. Immediately, there was noted a fascial dehiscence that extended from the middle of the fascial incision and extending all the way to the left lateral corner. The #0-Stratifix suture had been entirely pulled out of the left corner of the fascia and it was still intact holding the right lateral portion of the fascial closure. No evidence of infection was noted. The fascia was then closed with double stranded 0-PDS starting at the left corner meeting in the middle with another strand of double stranded 0-PDS. Both strands were then met in the middle and tied separately from each other. The subcutaneous tissue was closed with a running suture of #3-0 plaingut suture after this layer was vigorously irrigated with warmed normal saline. The skin was closed with a running subcuticular stitch of 4-0 Vicryl. A sterile dressing was applied.
Patient #2: Primary low transverse Cesarian section. Fascia was closed with #-0-Stratifix in a running fashion. The subcutaneous tissue did not require closure. No drainage or incisional issues on POD1 and POD2. POD3: Upon discharge planning for MD noted asymmetrical bulge of left side of incision. CT confirmed suspected fascial dehiscence. Patient brought to OR for laparotomy with repair of fascial dehiscence. There was complete dehiscence of the fascial incision from the midline to the left margin of the fascial incision. The bowel and omentum were protruding through this. The fascia was completely opened and the Stratafix suture was completely removed. There was NO tab on the end of the Stratafix suture and 1/2 of the tab was found, free, at the left most margin lying on the surface of the fascia. The fascia was closed with double-stranded 0-looped PDS suture. The subcutaneous tissue was closed with a running suture of 3-0 plain catgut. The skin was closed with a running subcuticular stitch of 4-0 Vicryl. Steri-strips and a sterile dressing were applied.




Device:
Type: System, Balloon, Intra-aortic
Manufacturer: Arrow International
Brand: Fiberoptix
Model#: (not provided)
Lot #: (not provided)
Cat #: IAB-05840-LWS
Other #: Datascope tube ref # IAB-02263-002

Problem:
Patient received in the ICU after open heart surgery with IABP inserted. The IABP was not functioning properly. The augmented pressure was 59 and systolic pressure was 100. Balloon volume on monitor was indicating only 2.5 cc for a 40cc balloon. Nursing staff could not auscultate balloon pump sounds in patient. Two separate balloon pump consoles were used to make sure console was not that problem. No changes were noted to suggest that the console was malfunctioning. Investigation and discussion of the incident included product rep. Rep identified that the wrong helium drive line had been attached to the IABP when it was inserted. The IABC kit is provided by Arrow. Packaged within these kits is a Datascope helium drive line for use with Datascope pump consoles in addition to a specific Arrow helium drive line. Datascope lines are not compatible with Arrow console pumps, which is what is used at this facility.


Device:
Type: Apparatus, Autotransfusion
Manufacturer: Medtronic Perfusion Systems
Brand: Autolog Sys 2
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: Console ATLG220

Problem:
Patient's starting Hemoglobin was 12.2, Hematocrit 34.7%. During surgery the H/H on washed blood was 11.2 / 33% with a potassium less than 2.0. Normal Hemacrit on washed blood would be 58 to 62%. Lab values were checked and found correct. The decision was made not to infuse washed cells.

According to the manufacturer, the reported symptom was a level sensor problem. The machine was out of calibration causing the failure.


Device:
Type: Catheter, Esophageal, Edi/nava
Manufacturer: Maquet Cardiovascular
Brand: Nava
Model#: (not provided)
Lot #: 92048389
Cat #: 6685787
Other #: (not provided)

Problem:
NAVA EDI catheter 12 Fr /125 cm placed in patient without difficulty. The catheter would not sense the patient. There was only static. Catheter replaced. The replacement catheter was the same lot and worked correctly



Device:
Type: Catheter, Esophageal, Edi/nava
Manufacturer: Maquet Cardiovascular
Brand: Nava
Model#: (not provided)
Lot #: (not provided)
Cat #: 6685780
Other #: 8 Fr /100cm

Problem:
Because the nurse thought that the NAVA NG tube was obstructed, she removed it. The end of the tube was bent and broken with the inside lead wire sticking out. The bend was approximately 1 1/2 inches from the end of the tube. A second tube with the same lot number was inserted and has been working well.


Device:
Type: Nebulizer
Manufacturer: Westmed
Brand: Uniheart Lo-flo
Model#: (not provided)
Lot #: (not provided)
Cat #: 100850
Other #: (not provided)

Problem:
Patient in severe respiratory distress. Patient intubated. Patient became agitated and ventilator began beeping. Patient became bradycardic. Took patient off vent to bag with ambu bag. A large amount of air escaped from the ET tube. Patient became calm. Upon examination it was noted that the Continuous nebulizer had popped off circuit. It was replaced on to the exhalation valve and the patient could not exhale. The connections all appear the same and are same size. Even when placed correctly they have a tendency to pop off. Staff will use tape to make the connection snug. This is a work-around and not policy.




Device:
Type: Ventilator, Continuous, Facility Use
Manufacturer: Draeger Medical, Inc.
Brand: Evita Infinity V500
Model#: EVITA INFINITY V500
Lot #: (not provided)
Cat #: #48
Other #: (not provided)

Problem:
The ventilator screen suddenly was less sensitive and it became difficult to change values. Drager was contacted and gave instructions via phone in order to calibrate screen. This was attempted 3 times without resolution of the problem. No harm/injury caused to the patient. Ventilator was switched out. Respiratory Care Biomed reported: Unable to calibrate C500 display and RT was unable to make vent changes at the bedside resulting in the need to change out the ventilator which interrupted patient care.


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

Problem:
Entered room - ventilator alarming "internal power supply failure" - "battery discharged". Vent was still running, no harm to patient, exchanged for new vent. Biomed investigation: This vent generated an Internal power supply failure and a battery failure alarm while in use. Draeger Technical Service Rep will be replacing the internal batteries, which have arrived. That is the fix for these alarms - it basically is a battery characteristic software issue that the company is addressing.



Device:
Type: Ventilator, Emergency, Manual
Manufacturer: Ambu, Inc.
Brand: Ambu Spur Ii
Model#: (not provided)
Lot #: (not provided)
Cat #: 5316133010
Other #: (not provided)

Problem:
Tubing mis-connection and employee error. Ambu bag was plugged into the L-shaped connector of a suction canister instead of oxygen. The ambu bag is clearly marked with a green connector for oxygen. The error was noted when the ambu bag did not inflate fully.


Device:
Type: Ring, Annuloplasty
Manufacturer: Edwards Lifesciences, LLC
Brand: (not provided)
Model#: 4450M36
Lot #: 1548447
Cat #: (not provided)
Other #: (not provided)

Problem:
Mitral valve annuloplasty ring was found to be expired after surgeon began seating it into the valve space. This occurred after two checks were done to verify correct size.

Manufacturer response according to site reporter: Expiration dates are only required by FDA regulations but this does not mean product is old or deteriorating or non-sterile.



Device:
Type: Glucose Meter, Point Of Care
Manufacturer: Nova Biomedical
Brand: Statstrip
Model#: AS2001
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Staff have reported "problems" with the glucose meters and upon investigation we have discovered various degrees of the meter battery heating and bulging to the extent of splitting the outside housing of the battery and rendering the meter unusable until we exchange the battery.



Device:
Type: Ligator, Esophageal
Manufacturer: Wilson-Cook Medical
Brand: Instinct
Model#: G18343
Lot #: W3265579/150184
Cat #: INSC-7-230-S
Other #: (not provided)

Problem:
Patient was having a POEM (PerOral Endoscopic Myotomy) procedure. The Instinct Hemoclips were being used to close the incision. The first clip was attempted to deploy and clipped onto the incision but did not come loose from the wire. Unsuccessful attempts by surgeon to remove the clip. Rep from company contacted to advise how to get the clip loose from the wire. The clip had to be pulled from the incision site being clipped taking a piece of tissue along with it.


Device:
Type: Pump, Infusion
Manufacturer: CareFusion
Brand: Alaris
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: CE# 104068

Problem:
Alaris pump was infusing maintenance IV fluids on patient, when the pump alarmed red Alert that states communication failed. The pump was turned off and restarted by RN, however pump red communication failed again. The pump was removed and replaced. IVF continued with no pump. No issue was noted with IVF during this event.



MedSun Newsletters are available at www.fda.gov/cdrh/medsun