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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET SET,ADMINISTRATION,INTRAVASCULAR

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CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET SET,ADMINISTRATION,INTRAVASCULAR Back to Search Results
Model Number PRI TUBING
Device Problems Fluid Leak (1250); Hole In Material (1293); Material Deformation (2976)
Patient Problems Eye Injury (1845); Local Reaction (2035)
Event Date 01/27/2018
Event Type  Injury  
Manufacturer Narrative
The customer's report of a ballooned tubing which leaked could not be confirmed because the suspect set was not returned for investigation. Review of the pump module event log shows that during an infusion at the reported time the module alarmed during a 6 minute period for patient side occlusion three times, for fluid side occlusion twice and then for check iv set. The root cause of the reported event was not identified.
 
Event Description
The customer reported that the device began alarming for occlusion during a zosyn infusion. Upon opening the lvp door it was noted that the tubing had ballooned and torn, and medication sprayed into the nurse¿s eye. The nurse experienced an allergic reaction to the medication and required an er visit for treatment but did not suffer any lasting harm. There was no patient harm.
 
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Brand NameALARIS PUMP MODULE ADMINISTRATION SET
Type of DeviceSET,ADMINISTRATION,INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
mustafa omar
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key7278693
MDR Text Key100386635
Report Number9616066-2018-00156
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 01/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPRI TUBING
Device Catalogue NumberPRI TUBING
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/16/2018 Patient Sequence Number: 1
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