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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 10015862
Medical Device Problem Codes Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/29/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical products: b braun 0.9% sodium chloride bag.Field left blank: no available code for undetermined or unknown cause.The customer complaint of a chemo spill was confirmed.The customer¿s video was evaluated and fluid was observed to be leaking from the top cap of the drip chamber.The root cause of this customer's report was not identified.
 
Event or Problem Description
The customer reported that a 1000ml bag of 0.9% ns containing rituxin had a spike connection that was loose and the set dislodged from the bag causing a chemo spill after the bag was hung on the pole.Fluid spilled on the patient, her clothing and shoes but there was no patient harm.
 
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Brand Name
ALARIS® PUMP MODULE ADMINISTRATION SET
Common Device Name
SET,ADMINISTRATION,INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8091707
Report Number9616066-2018-02321
Device Sequence Number1225286
Product Code FPA
UDI-Device Identifier10885403221866
UDI-Public10885403221866
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K944320
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number10015862
Device Catalogue Number10015862
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/20/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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