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U.S. Department of Health and Human Services

MedSun: Newsletter #88, September 2013

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Newsletter #88, September 2013

Articles

Stryker Spine: Class I Recall

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FDA MedWatch Safety Alert

Recall due to reports of fracture of the pin that connects the implant's tulip head to the plate body. If a patient begins experiencing symptoms including pain, weakness, or numbness, urgent evaluation is needed. For patients who have had a revision surgery, Stryker recommends routine post-operative care and follow-up.

Additional Information:

Stryker Spine: Class I Recall. MedWatch Safety Alert. August 29, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm366724.htm

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Covidien Monoject Prefill Flush Syringes: Recall

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FDA MedWatch Safety Alert

Covidien announced that it has initiated a voluntary recall of certain lots of Monoject prefill flush syringes. This recall is being conducted due to the risk that a number of the syringes were filled with water but not subjected to the autoclave sterilization process. These products are labeled as either sodium chloride flush or heparin lock flush. Some of these syringes have the mismatched syringe tip cap, syringe label, filled volume and wrapper.

Additional Information:

Covidien Monoject Prefill Flush Syringes: Recall. FDA MedWatch Safety Alert. August 20, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm365719.htm

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Hospira Blood Sets: Recall

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FDA MedWatch Safety Alert

Hospira, Inc. announced a recall of certain blood sets. There have been reports from customers of instances in which the outer wall of blood bags were punctured with the piercing pin on certain Hospira blood sets during insertion of the pin into the blood bag. If the piercing pin on this product punctures the outer wall of a blood bag, it may result in spillage of the blood and blood products stored in the bag, resulting in a delay/interruption in therapy.

Additional Information:

Hospira Blood Sets: Recall. FDA MedWatch Safety Alert. August 14, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm364973.htm

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Highlighted MedSun Reports

Highlighted Reports

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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.


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Discussions with Healthcare Providers

The Effects of Severe Weather on Medical Devices

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Introduction

Severe weather-related events can have an impact on the operation of medical devices in health care settings and in the home. In June of 2012, an intense fast moving thunderstorm called a “derecho” occurred crippling many Mid-Atlantic and Midwestern states by causing widespread damage and power outages. The effects of Hurricane Sandy in October of the same year were devastating to homes and healthcare facilities throughout the Northeast causing many power outages that also resulted in unexpected closures of hospitals.

FDA is interested in learning more about the effects of severe weather or storms on medical devices in health care facilities. The information helps the FDA to better understand the clinical perspective and the issues presented in hospitals in austere weather conditions. Feedback from health care providers also helps with determining how to best address the risks and vulnerabilities of medical devices in severe weather particularly when conditions result such as power and network outages, interruptions to transportation, lack of access to fresh water, contamination of water, and temperature and humidity variances.

Methodology

This survey effort addresses how extreme weather events and conditions may affect the safety and quality of medical devices. Survey data was collected using a semistructured questionnaire by telephone with respondents. A small sample of respondents was selected to obtain detailed and in-depth perspectives about experiences with medical devices in the clinical setting during and after severe weather events.

The respondent sample was a voluntary, convenience sample of nine health care providers from hospitals that participate in the Medical Product Safety Network (MedSun) and who have experience with severe weather events in healthcare facilities. Respondents include Directors and Managers from departments of Clinical and Biomedical Engineering, Quality and Risk Management, Plant Operations, and Materials Management. Several respondents also serve on their hospital’s Emergency Preparedness Committees. Respondents’ hospitals are located in the Northeast, Mid-Atlantic, Southeast and Midwest regions of the country.

The survey questions (see attachment) focus on experiences with medical device performance, types of products affected, challenges encountered, and suggestions for improvement to manage the effect of severe weather on medical devices more effectively in the future. When FDA required clarification to a response, additional questions were asked.

The information that follows is a summary of the responses.


Experience with Severe Weather Events

All survey respondents have experience with power outages during severe weather events and have relied on backup electrical power by generators. The severe weather events include hurricanes, tornados, severe thunderstorms, microbursts, lightning strikes, heavy rain causing flooding, extreme heat and cold situations, and earthquakes that have affected some medical devices and general operations in their hospitals. One respondent also describes losing power in the hospital when a section of the city’s area power grid went dark causing their emergency generator to turn on. In a few situations during severe weather, respondents have experienced damage to the backup generator and add that the “dirty power” (spikes or fluctuations in voltage) from the emergency generator resulted in batteries not recharging in medical devices.

A power loss in one hospital due to a tornado also caused damage to the emergency power supply. This event caused overheating of the computerized central monitoring systems in a room where the servers and other equipment are stored. In addition, the air conditioning (AC) system did not work and there was a loss of power to monitoring equipment, imaging systems, and the computer systems for the hospital. The respondent in this situation refers to it as a potential meltdown that almost resulted in an evacuation of the facility. Another respondent recounts a time when a power loss affected exhaust fans that help to provide positive air pressure in specific rooms used for bone marrow transplant patients. Evacuation of the hospital would have occurred if the outage continued for a longer time creating an unsafe situation for patients.

In another occurrence, the impact of a severe storm and subsequent power loss resulted in an influx of people into the hospital’s emergency room with medical equipment that they could not keep charged in their homes. In addition, some individuals did not bring all the device components required for battery recharging. According to the respondent, this situation was occurring across the city. The respondent reports that the primary device problem involved home use oxygen. Individuals in the home had to switch to using oxygen tanks, but because supply companies weren’t able to deliver replacements, individuals went to hospital emergency rooms when their oxygen tanks were empty. The respondent adds that other home use devices affected by the power outage involved continuous positive air pressure devices (CPAPs), ventilators, portable suctions devices, and left ventricular assist devices (LVADs). Although in this situation many home care patients went to hospitals to obtain a power source for their devices, this respondent’s facility also maintains a 96-hour supply of equipment and devices such as ventilators and portable suction, if needed.

Many respondents report experiencing problems when the facility’s power is turned back on and results in a power surge. In one situation, the power surge burnt an AC compressor. In two other facilities, tomography, mammography and other radiology equipment failed as a result of a power surge. All survey participants discuss the importance of a controlled power-up and the impact it can have on devices particularly if devices are powered on at the time of a power loss; even if surge protectors are used. If the biomedical and maintenance departments work together to coordinate when the power is scheduled to turn back on, the changeover may not impact medical devices. Respondents believe that a controlled power-up is essential for some devices such as imaging devices, and communication and coordination among departments is critical to ensure patients are not receiving imaging procedures at the time.

Generator Power

When asked about generator testing, most respondents say they do routine testing. Three specify they do monthly testing. Several individuals conduct all tests as a full load test while others only do full load testing during hot weather. In addition, most respondents report that their hospitals’ emergency generators are located on the second floor above the flood plane.

Uninterruptable Power Supply (UPS) Systems

All respondents use uninterruptable power supply (UPS) systems for small devices and some have larger UPS systems that power areas such as the catheterization labs and where Information Technology (IT) server systems are located. UPS systems can provide near-instantaneous power when power disruptions or outages occur. One respondent currently uses UPS systems for magnetic resonance imaging (MRI) and other high-end radiology equipment after experiencing frequent power fluctuations and outages from severe storms and a lightning strike to a power line. Several respondents say they use UPS systems to bridge time until emergency generators turn on for critical equipment. One respondent believes that physiological monitoring devices and all critical devices whether they are hardwired or wireless should be on UPS systems and emergency power. The respondent adds that this approach helps stop normal power glitches particularly during emergencies. Another respondent emphasizes the importance of UPS systems for specialized high frequency ventilators so that if the power goes off and the emergency power fails, the UPS has 30 minutes of power for providing ventilation to patients.

The majority of respondents test and replace the batteries in UPS systems routinely and believe this maintenance is key to preventing device failures. Respondents also report that not all UPS systems are the same and some may have a shorter lifetime than others. Most respondents say they do battery replacement more frequently than the manufacturer’s recommendations. Overall, respondents believe selecting the right UPS system is critical and that they work well for medical equipment from the perspective of safety and reliability.

Types of Medical Devices Affected by Power Outages
Table 1. Summary of Medical Devices Affected by Power Outages Due to Severe Weather Events As Reported by One or More Survey Respondents



Device Name/Device Area AffectedProblems IdentifiedAdditional Information
Bedside monitors“Dirty power” prevented batteries from recharging.Bedside monitors “flickered” often while power was switching back and forth from normal to emergency power.
Bone Density ScannerDevice shut off due to a lightning strike to the power supply and would not turn back on.
Catheterization Lab equipment (not on emergency power)Loss of visualization occurred during one procedure.Staff determined the need for approximately 10 minutes of battery backup time to prevent reoccurrence. The facility added emergency power capability to the generator.
Central monitors“Dirty power” prevented batteries from recharging. Over time devices went blank.Central monitors were most affected.
Computerized centralized monitoring system (in a room where servers and other equipment located)Overheating occurred and loss of monitoring equipment, imaging systems, and computer systems.Overheating did not cause damage to devices.
CT Scanners (cooling mechanisms for scanners not on emergency power)Excessive room heat caused an error and the software alerted staff to the increased heating of the scanner.Staff brought in an air conditioner system to cool the room temporarily. Another facility placed their ventilation system on emergency power.
Incubators/isolettes in the neonatal intensive care unitThe heat settings reverted to the manufacturer's default setting posing risks to patients. The memory batteries (similar to watch batteries) wouldn't hold settings when power was restored.Nursing staff noticed the change and corrected the settings. No adverse events occurred. The devices are older models with older memory batteries. Memory battery functionality is now part of Preventive Maintenance (PM) checks.
Linear accelerator (not on emergency power)Device could not be used.Outage lasted for several days and patients had to go to other facilities for treatment.
MRI (not on emergency power)Loss of cryogen/helium and failure of the cold head due to the heat change occurred in the magnet.Power outage lasted for a few days. However, a power loss for 2 weeks would cause quenching of the magnet.
Sterilizers (not on emergency power)Devices could not be used.When power was turned back on, test loads and test controls had to be repeated affecting the timing of OR cases and availability of equipment.
Telemetry unitsFunctionality was affected.
Tomography, mammography units“Equipment failure occurred due to power surges.
Ultrasound unitDevice was damaged due to a power surge.
VentilatorsAll piped gas supply was affected which impacted ventilators.Facility used oxygen tanks for patients.

Respondents mention several devices that were affected by power outages in their facilities due to severe weather conditions. Table 1 is a summary of these medical devices and the problems encountered. According to respondents, devices in the radiology department are affected by outages most times; however, devices in other areas can also be affected. Most critical devices used for acute monitoring of patients and defibrillators have backup batteries. Additionally, when discussing problems, respondents report that many devices were not on emergency power at the time of the outage, but now have emergency back-up power.

Respondents say that infusion pumps are less problematic because of the battery backup in the devices. However, one respondent emphasizes the importance of not using third party batteries for infusion pumps because the failure rate can be very high. This particular individual also uses a monitoring device for infusion pump batteries and conducts thorough testing procedures.

One hospital respondent describes difficulties with the Electronic Medical Records (EMR) system during a severe weather event. Clinicians could not access patient records because the medical records server shut down. Staff had to rely on the system at an affiliated hospital to send the forms they needed by facsimile.

Most respondents say that weather conditions such as thunder has not been a problem, but wind and lightning have the most effect on a facility’s power. Good routing grids on roofs (for lightning suppression) and lightning rods on buildings help to prevent severe damage to hospitals. However, a lightning strike in one building did result in a loss of telecommunications equipment. In this particular situation, the respondent thinks the equipment did not have a UPS system and damage to the equipment was due to a power surge. Another respondent says there are additional rods on their buildings to prevent damage to medical devices after experiencing power surges from lightning strikes.

In response to a question about alarm activation in medical devices during severe weather, the majority of respondents did not recall any particular problems. One individual remembers alarms only from the UPS systems that were running on batteries because they didn’t switch to generator power. In this situation, a new microprocessor switch corrected the problem.
Communication Systems

Four respondents describe disruptions to their hospital’s communication system during power outages due to hurricanes, earthquakes and severe storms. All report that communication devices such as pagers, cellphones and two-way radios had weak signals from damage to cell phone towers. Cell phone texting is viewed as the best way to communicate and more effective for communication between Emergency Medical Services (EMS) and emergency room staff. One hospital has its own communication system on site where all antennas reside, but use of the system requires staff training if used as a backup method. Staff is also more familiar with the use of cell phones for communication than a pager system. Another respondent’s hospital that has affiliate sites, is in the process of developing a mobile communications vehicle with satellites, radios, communication resources, etc., that will be used to bring resources into a building to provide temporary relief until communications is restored to the hospital.

Staff Training

When respondents mention staff training, it’s usually in the context of reinforcing the importance of keeping battery-operated medical devices plugged-in when not in use so the battery is charged. One respondent describes a situation when patients were transferred to other hospitals due to a severe weather event and the receiving staff was not as familiar with the infusion pump devices accompanying patients. Additionally, some of the tubing brought in with patients was not compatible with the products the hospital uses. This particular respondent asserts that this type of situation may have implications for training.

Supply shortages

A few respondents mention supply chain issues during a serious weather event. One respondent is going back to having an inventory and keeping a backup of supplies on hand for severe storms. One facility is in an area that floods frequently and depending on the extent of the storm can be inaccessible to supply trucks. The respondent for this facility maintains close contact with the distribution chain and adds that the hospital’s backup supply is sufficient to provide what is needed if area flooding occurs.

Suggestions for handling future challenges

The following is a list of suggestions from respondents about managing future challenges with the effects of severe weather events. Suggestions include approaches for hospitals, the community and device manufacturers.

Hospital:

• Provide staff with a better understanding of critical medical devices and equipment including weaknesses and vulnerabilities;

• Alert staff to environmental warnings, conditions, and device vulnerabilities, if available in the device labeling;

• Encourage a thorough knowledge of the facility and where staff and patients may need to go first to avert a catastrophe;

• Provide emergency supply bags throughout the hospital with items such as flashlights, gloves, first aid kits, batteries, headlamps, etc., for any staff to use during a weather emergency; and,

• Make improvements to the emergency power distribution in the hospital.

Community:

• Determine how to deal with situations when the city’s water supply is affected and impacts water pressure for health care facilities, dialysis centers and patients receiving home dialysis;

• Increase awareness and focus on the medical needs of patients in the community before, during and after a severe weather event;

• Determine ways to prevent vendor interruptions particularly with oxygen supplies for home use;

• Improve communication systems in communities so people know where to go during a crisis such as a severe weather event; and,

• Establish a registry of people in the community and the home medical devices they use to direct assistance to them quickly and avoid a large influx of people to hospital emergency rooms.

Device Manufacturers:

• Incorporate standard labeling on devices to alert hospital staff to environmental warnings, conditions, and other device vulnerabilities; and,

• Design medical devices with built-in UPS systems.

Summary

Overall, respondents have concern about the impact of severe weather on their hospital’s medical devices and equipment and the potential for harm to patients. Although respondents did not mention situations involving patient harm, they discuss device problems, challenges and the potential for harm that exists when their facility experiences a severe weather event. Respondents have procedures in place in the event of austere weather conditions but add that improvements are needed to meet challenges they encounter such as inoperability or damage to devices and patient monitoring systems, disruptions to communication systems, the need for increased patient monitoring by staff, and the impact on the surrounding community that can affect hospitals. In addition, a respondent mentions that following a weather-related disaster situation, it would be helpful to know at what point a hospital can or should use the equipment again. The respondent adds that even if medical devices are functioning after being affected by a severe weather event, is it sufficient to say that they are considered operational? Also, how do hospitals determine whether medical devices are still safe to use? Biomedical department staff are relied upon to help make those decisions but additional information may be needed to determine whether medical devices should be restored and recertified after being affected by a severe weather event and are determined to be safe for patient care.

Survey Limitations
Although the survey findings add to FDA’s knowledge of the effects of severe weather on medical devices, there are several limitations to the survey methodology. These include the small, convenience sample of respondents, and that most survey respondents are from larger institutions. In view of these limitations, the respondents’ perspectives may not represent the perspectives of all health care providers.


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Surveying health care providers and device users is one of many tools the FDA uses to evaluate the public health impact of the potential problems associated with the use of medical devices. Typically, small sample surveys are used to collect qualitative information on postmarket experiences of clinicians or facilities with medical device performance or use. Survey respondents are selected based on their experience with the topic or device, their availability and their willingness to participate.

These findings are one piece of information and are not generalizable. No conclusions can be made about how a device functions in the broader clinical environment based on this report alone. Instead, the report should be considered along with other information that may include adverse event reports, scientific publications, clinical trials, enforcement/compliance information, and other data sources that are part of the FDA’s monitoring of device performance.

The FDA makes our scientific, medical, nursing, and engineering staff aware of the survey results as needed. If the FDA believes there is a significant risk of adverse events as noted from the survey, we will combine those results with data gained from other sources. The FDA will work with the manufacturers and health care provider organizations to make important information known to the clinical community. Additionally, the FDA continues to work with manufacturers to ensure the development, testing, and promulgation of methods for reducing the risk associated with these devices and to minimize the complications from adverse events that may occur in the course of normal usage. If the results of any survey raise serious concerns about the safety of these devices, the FDA may convene a group of clinical, scientific, and regulatory experts to discuss any necessary actions.


Attachment
Food and Drug Administration,
Center for Devices and Radiological Health
Medical Product Safety Network (MedSun)
Small Sample Survey
Topic: The Effects of Severe Weather on Medical Devices
Questions

1. Did your hospital ever experience any loss of power, damage (as a result of severe weather) or need to rely on backup electrical power?

a. If yes, were any medical devices affected by any power outage, damage, or backup power reliance?

i. If yes, what type(s) of devices were they and how many were affected?

2. Did any medical devices malfunction during the severe weather?

a. If yes, which types of devices were affected?

b. Do you know what may have been the cause of the malfunction?

c. Were any of the devices that malfunctioned in use on a patient at the time?

i. If yes, was there patient injury or a delay in treatment?


3. During any of the storms, did lightning strikes or close thunder affect any medical devices?

a. If yes, can you describe what happened?

4. During any of the storms, did device alarms go off that were due to the severe weather?

a. If yes, what device(s) was it and what types of alarms sounded?

5. After the experiences you’ve had, has your hospital put any new or revised procedures in place to better handle any challenges with medical devices as a result of severe weather?

a. If yes, please describe.

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Updated September 1, 2013

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