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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINSTRATION SET; SET,ADMINISTRATION, INTRAVASCULAR
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CAREFUSION ALARIS PUMP MODULE ADMINSTRATION SET; SET,ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2426-0007
Device Problem Reflux within Device (1522)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.Although requested, patient demographics not provided.
 
Event Description
It was reported that a back check valve failed.There was no pump failure but the infusion line had the same level volume as the bag, whether raised or lowered, suggesting a failed check valve meaning the fluid potentially went into the bag and not into the patient.Although requested, no further information has been received.
 
Event Description
It was reported that a back check valve failed.There was no pump failure but the infusion line had the same level volume as the bag, whether raised or lowered, suggesting a failed check valve meaning the fluid potentially went into the bag and not into the patient.Although requested, no further information has been received.
 
Manufacturer Narrative
The customer complaint of back check valve could not be confirmed due to the product not being returned.The photo of the returned set observed fluid levels on both iv lines to be equal in fluid indicating a possible back flow.The root cause was not identified.
 
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Brand Name
ALARIS PUMP MODULE ADMINSTRATION SET
Type of Device
SET,ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8491755
MDR Text Key141205682
Report Number9616066-2019-00959
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403227998
UDI-Public10885403227998
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,other
Type of Report Initial,Followup
Report Date 03/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2426-0007
Device Catalogue Number2426-0007
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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