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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZYNO MEDICAL LLC ZYNO SET, ADMINISTRATION, INTRAVASCULAR

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ZYNO MEDICAL LLC ZYNO SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number B2-70072-F
Device Problems Burst Container or Vessel (1074); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/12/2018
Event Type  malfunction  
Event Description
Etoposide (vp16) was running on a pump for a patient. The pump was alarming, so the rn checked on the pump. Pump read occlusion, so the tubing was changed, and the drug started running again for some time. The pump alarmed for occlusion again, so the rn checked the filter on the tubing. The filter exploded, spilling etoposide on the chemo gown, goggles, iv pole, and floor. A chemo spill kit was used to clean the area. No harm came to the patient and treatment was eventually completed. The faulty administration sets were not saved due to the chemotherapy contamination.
 
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Brand NameZYNO
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ZYNO MEDICAL LLC
117 pine st.
natick MA 01760
MDR Report Key7305825
MDR Text Key101307711
Report Number7305825
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB2-70072-F
Device Catalogue NumberB2-70072-F
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/26/2018
Device Age0 YR
Event Location Outpatient Treatment Facility
Date Report to Manufacturer02/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/01/2018 Patient Sequence Number: 1
Treatment
CHEMOTHERAPY; INFUSION PUMP, ZYNO MEDICAL, SPECIFIC PRODUCT INFO
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