Summary of MedSun Reports Describing Problems With Chemotherapy Transfer Devices
MedSun: Newsletter #71, April 2012

Chemotherapy transfer devices are intended to transport chemotherapy medication from storage containers to patient infusion routes. The National Institute for Occupational Health and Safety, under the Center for Disease Control and Prevention, defines a closed system drug transfer device as, "A drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system." (NIOSH, 2004)

Over the past 2 years, MedSun has received 13 medical device reports associated with chemotherapy transfer devices manufactured by B Braun Medical, Carmel Pharma, Equashield Medical, and ICU Medical. The reports were submitted by 7 hospitals between March 2011 and March 2012.

The reported device problems were:
• 6 reports of leakage
• 5 reports of component separation
• 2 reports of failure to infuse

None of the reports involved a patient death. One report described a healthcare practitioner being exposed to chemotherapy after a medication leakage.

Of the reports that listed patient age, none had a patient age listed as less than 21 years and 4 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 4 reports involved female patients and a total of 3 reports involved male patients.

These MedSun reports summarized above, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems.

The following table lists the MedSun reports that are described in the device problem summary above.
[Note: The reports have been edited for clarity]

MedSun Reports Describing Problems with Chemotherapy Transfer Devices
Device Manufacturer and BrandDevice Identifiers (Catalog Number, Model Number, Lot Number) Event Description
CARMEL PHARMA AB., Phaseal Infusion Adaptor NA, C100, NA During initiation of chemotherapy, while nurse hanging bag, the chemotherapy spilled on nurse. Phaseal infusion adapter dislodged from bag allowing the leakage (approximately 50 mls leaked from bag).
CARMEL PHARMA AB., Phaseal Infusion Adaptor NA, C100, NA Patient discharged home with continuous infusion ambulatory pump with chemotherapy to infuse over 46 hours. Both pump and infusion bag secured in portable carry case at time of discharge by trained personnel. Patient called hospital infusion suite shortly after discharge to report fluid leak from carry case. Patient returned to infusion suite with pump and case. Case opened by nurse who found chemotherapy bag empty which was properly still secured in case. The Phaseal infusion adapter dislodged from infusion bag causing the leakage.
B. BRAUN MEDICAL, INC., Onguard Tevadaptor NA, 412111, M2105C11 The Tevadaptor Onguard vial adapter was found leaking. The chemo therapy drug etoposide is not a restricted drug for this adapter. We were aware of manufacturer's change in process as a result of leaking issues. The adapter was placed on vial for approximately 20 hours when the failure occurred. B. Braun recommends the adapter to be used within 72 hours time frame.

This is the third similar event with this type of device. All events have been reported to MedSun. No cracks were noted on the device or any other manufacturing problems. The vial size was 20 mm and the converter ring was not used. Only one vial of medication was pierced with the adapter.
EQUASHIELD MEDICAL LTD NA, NA, NA Infusion started but would not infuse until device removed from tubing.
EQUASHIELD MEDICAL LTD NA, NA, NA Equashield female and male luer parts were connected to the IV tubing, but chemotherapy drug would not infuse. Adjustments were made without success. The device was removed and infusion ran without further problems.
CARMEL PHARMA AB., Phaseal Infusion Adaptor NA, C100, NA The nurse was adding the final flush via a syringe into the safety port of the bag. The piercing pin ejected from the bag and spilled the residual gemcitabine hcl.
CARMEL PHARMA AB., Phaseal Infusion Adaptor NA, C100, NA The gemcitabine arrived to the unit and it was leaking into the transport bag. The staff was unable to determine the origin of the leak. The whole system was discarded.
CARMEL PHARMA AB., Phaseal Infusion Adaptor NA, C100, NA After change of shift, the on-coming nurse was assessing the chemo infusion (arsenic) when she noticed fluid dripping onto the IV pump and the floor from the infusion set.
CARMEL PHARMA AB., Connection Luer Lock NA, C35, NA A patient alerted the nurse a tubing disconnection. Tubing/infusion was disconnected. The IV flushed well and without resistance. It appeared either the injector or the connector were backed up.
ICU MEDICAL, INC, ChemoClave NA, CH-10, 2284824 Nurse was hanging chemotherapy infusion and a glued cap came off the connector device resulting in a large chemotherapy spill on the floor and IV pump. The pharmacist notified the device representative.
ICU MEDICAL, INC, Spiros NA, NA, NA Patient just finished receIVing her bleomycin IV push. Nurse went to disconnect the Spiros from the port of the IV tubing and the Spiros detached from the syringe instead. Approximately 1cc of fluid leaked out onto the chemotherapy spill pad.; patient just finished receIVing her bleomycin IV push. Nurse went to disconnect the Spiros from the port of the IV tubing and the Spiros detached from the syringe instead. Approximately 1cc of fluid leaked out onto the chemotherapy spill pad.
ICU MEDICAL, INC, Spiros NA, NA, NA Our outpatient clinic has had multiple problems regarding leaking with the spinning Spiros. They have dealt with multiple occasions where the Spiros began leaking from the female luer area. They have reported this to the manufacturer each time, but the manufacturer has done nothing to fix the problem. Their response is that it was a user error. Staff has witnessed that the pin where it fits into the clave will break and instead of locking, the Spiros will continue to spin. They have dealt with multiple leakage issues on staff and patients.
ICU MEDICAL, INC, Spiros NA, NA, NA The Spiros connecter piece that was on the syringe of daunorubicin leaked and spilled out.

Additional Information:

NIOSH Hazardous Drug Safety Working Group (September 2004). Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings. Retrieved from:
http://www.cdc.gov/niosh/docs/2004-165/2004-165d.html


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