Highlighted Reports
MedSun: Newsletter #89, November 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 October 2013. All other reports can be searched under the ‘MedSun reports’ menu pane.

Device:
Type: Nebulizer (Direct Patient Interface)
Manufacturer: CareFusion
Brand: Airlife Asthmacheck Peak Flow Meter With Asthma Management Zone System
Model#: (not provided)
Lot #: (not provided)
Cat #: 002068
Other #: (not provided)

Problem:
RT (respiratory therapist) obtained a peak flow meter from clean supply stock. Package was intact without signs of tampering. RT opened and handed PF to patient. Patient noticed that mouthpiece was dirty and appeared used prior to putting the device to their mouth. Upon close inspection, it appeared that there was a dried light brown/white color substance completely surrounding the mouthpiece of the device in a lip-mark pattern. Peak flow meter removed from patient room and patient was given another new device.

The device/packaging involved in this event came from the clean supply room. All other devices were checked and none had lip-mark patterns or substances on them. It is unknown how/when the device was soiled or how a soiled device was placed in with the clean supply.

Note: This product packaging does not have a seal that needs to be broken upon 1st use. Another new product in packaging was obtained. We were able to remove the device from the packaging without having the package appear that it had been opened. It was easy to put the device back into the packaging without appearing that the packaging had been opened. If the packaging had a full edge seal (e.g.: clam shell ) or was sealed in a plastic bag, this type of event could be avoided.


Device:
Type: Emergency, Manual, Resuscitator
Manufacturer: CareFusion
Brand: Airlife
Model#: (not provided)
Lot #: Y3K1032
Cat #: 2K8005
Other #: 4251A

Problem:
Patient had an episode of apneic breathing, became unresponsive and code was called. Ambu bag pulled from crash cart and respiratory therapist attempted to use it on patient. The ambu bag was squeezed per normal procedure, but the bag would not reinflate. It was set aside and a different ambu bag had to be used.


Device:
Type: System, Balloon, Intra-aortic
Manufacturer: MAQUET CARDIOVASCULAR LLC
Brand: Sensation
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
IABP alarming - Leak in IAB Circuit. No condensation, fluid, blood in lines and all lines checked for secure connections. No breaks found. Auto filled IABP per manufacturer's instructions and alarm continued every 30 min, fixed with autofill. Datascope (Maquet) was called to notify them of the alarm. They gave one more troubleshooting option, which was to autofill 3 times in a row. Completed. Maquet rep instructed us to leave the balloon in - there is no harm to the patient as long as blood or condensation is not in the tubing, and as long as balloon is augmenting. Catheter is to be saved on removal for Datascope to inspect.


Device:
Type: Surgical Table
Manufacturer: Steris Corporation
Brand: Steris
Model#: 4085
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Patient was being moved at the completion of a surgical procedure from the Steris bed to the gurney. Several failed attempts at trying to lock the Steris bed and failed each time. In order to move the patient, the Steris bed was steadied by multiple staff to transfer the patient to the gurney.


Device:
Type: Pump, Infusion, Pain Control
Manufacturer: Caesarea Medical Electronics LTD
Brand: Colorvision
Model#: 575
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Patient's morphine (1mg/mL) PCA prescription was interrupted when the pump alarmed for air-in-line. In order to purge the air, the nurse turned off the pump, then restarted it, which is necessary to gain access to the priming function. After successfully re-priming the tubing, the nurse chose "Select Protocol" as prompted by the pump, and then chose the same protocol as was previously in use. Even though she indicated to the pump that this was not a new patient, the pump reverted to its default values for the selected protocol which were different from the settings actually in use.

It was confirmed that this is proper behavior for the pump, and nurses are concerned that it puts the patient at risk of incorrect infusion if they do not notice that default values are set instead of the previous values.
Later it was discovered that instead of selecting the drug protocol when prompted by the pump, there is also the option to exit the menu without making a selection. This brings the user back to the original drug protocol with the same settings as were previously in use, and gives the option to resume the infusion.

The pump's menu display does not present the option to exit instead of selecting a drug protocol, nor is it explicit in the pump's Operator's Manual, although the manual does include a statement that the "Stop" button can be used to exit from a pump menu.

This problem primarily occurs when an existing infusion is interrupted then restarted. Otherwise the protocol has completed and there is no need to restart with previous settings.

Manufacturer response, per reporter: Manufacturer accepted comments for consideration and possible revision of user manual or pump operation, as needed.


Device:
Type: Set, Blood Transfusion
Manufacturer: BAXTER HEALTHCARE CORP
Brand: Clearlink
Model#: (not provided)
Lot #: (not provided)
Cat #: 2C8750S
Other #: 112" 170-260 micron filter

Problem:
primed tubing was loaded into pump backwards so it was upside down. The patient's blood was being pulled out of the patient and pushed backwards into the blood primed tubing. The pump allowed the backward flow of blood to be processed through the pump delivery. The connection of primed blood tubing was made into a central venous catheter. Because blood was the product being administered, the nurse did not immediately notice it was backward and blood was being pulled from the patient.


Device:
Type: Appliance, Fixation, Nail/blade/plate Combination
Manufacturer: Synthes
Brand: (not provided)
Model#: 03.123.010
Lot #: (not provided)
Cat #: (not provided)
Other #: Insertion guide, for 3.5 mm LCP Periarticular Proximal Humerus plate

Problem:
Surgical procedure: Open reduction, internal fixation of the right shoulder utilizing the Synthes proximal humeral locking plate. Following the procedure, patient was taken to the recovery room where it was noted that x-ray revealed that the guide that was on the plate was not removed. Therefore, the patient was taken back to the OR and the guide was removed by opening 3 staples in the middle of the wound which revealed the guide to be delivered with the screwdriver and it was removed. The guide has no identifying information that indicates it is not a permanent part of the hardware.


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