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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 2420-0007
Device Problem Separation Failure (2547)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/18/2019
Event Type  malfunction  
Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.
 
Event Description
It was reported that the user noticed that the set separated at the upper fitment when in use on a patient.
 
Event Description
It was reported that the user noticed that the set separated at the upper fitment when infusion normal saline at a rate of 100 ml/hr.The set was in use since 3am however unable to provide a start time.The customer stated that there was no harm to the patient.
 
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Brand Name
ALARIS® PUMP MODULE ADMINISTRATION SET
Type of Device
SET,ADMINISTRATION,INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8610569
MDR Text Key145099130
Report Number9616066-2019-01257
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203021012
UDI-Public7613203021012
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 04/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2420-0007
Device Catalogue Number2420-0007
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8100,8015, TD (B)(6) 2019
Patient Age34 YR
Patient Weight59
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