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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 2426-0007
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/05/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: 72213n; 50ml pfizer bag ndc 0206-8861-01, lot ln109871, exp 15sep18, piperacillin-tazobactam; td (b)(6) 2018. The customer¿s report of an air-in-line alarm prior to the completion of an infusion, and the iv bag was empty although the pump indicated remaining medication, was not confirmed. Visual inspection of the set did not reveal any discernible damage or abnormalities. Functional testing resulted in no abnormalities in fluid flow or formation of air pockets. The root cause of the failure was not determined.
 
Event Description
The customer reported that zosyn 3. 375 grams in a 50 ml bag was to infuse over 4 hours at 12. 5/hr. The zosyn was started at 2043 then at approximately 2330 the pump alarmed due to air in line with approximately 6 inches of visible air. Zosyn was restarted and the pump displayed 30 ml left in the bag although the bag appeared to be empty. 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 Key7451471
MDR Text Key106403710
Report Number9616066-2018-00522
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial
Report Date 02/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2426-0007
Device Catalogue Number2426-0007
Other Device ID Number10885403227998
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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