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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 10012144
Medical Device Problem Codes Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The customer¿s complaint of a break and leak at the silicone segment could not be confirmed due to the product was not returned for failure investigation.The root cause of this failure was not identified.
 
Event or Problem Description
The customer reported that the patient arrived on the unit with normal saline infusing by gravity.The user attached the tubing to the device and continued the infusion without difficulty, hrs.Later a pca module was attached and the patient went to x-ray.Upon arriving back to the unit, the user noted a leak, with further examination it was reported that the tubing broke at the upper fitment of the silicone segment and leaked.There was no report of 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 Key8043712
Report Number9616066-2018-02117
Device Sequence Number19198419
Product Code FPA
UDI-Device Identifier07613203021159
UDI-Public7613203021159
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K944320
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 10/12/2018
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 Number10012144
Device Catalogue Number10012144
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/06/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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