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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESYNT INCORPORATED OMNICELL I.V.STATION ONCO; PHARMACY COMPOUNDING DEVICE
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AESYNT INCORPORATED OMNICELL I.V.STATION ONCO; PHARMACY COMPOUNDING DEVICE Back to Search Results
Model Number I.V. STATION ONCO
Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/29/2019
Event Type  malfunction  
Event Description
On (b)(6) 2019 a spill involving a paclitaxel chemotherapy drug preparation occurred inside the i.V.Station onco device.The spill was identified and subsequently cleaned by the user.There is no adverse patient effect related to this drug spill within the device.
 
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Brand Name
OMNICELL I.V.STATION ONCO
Type of Device
PHARMACY COMPOUNDING DEVICE
Manufacturer (Section D)
AESYNT INCORPORATED
51 pennwood place
warrendale PA 15086
Manufacturer (Section G)
HEALTH ROBOTICS
kraska ulica, 4
sezana, 6210
SI   6210
Manufacturer Contact
david vanella
500 cranberry woods drive
suite 400
cranberry township, PA 16066
7247418115
MDR Report Key9376063
MDR Text Key170487184
Report Number3011278888-2019-00100
Device Sequence Number1
Product Code NEP
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial
Report Date 11/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberI.V. STATION ONCO
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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