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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 SEC TUBING
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Although requested, patient demographics not provided.
 
Event Description
It was reported that once the piggyback medication finished, the screen indicated that it switched to the primary bag but still pulled from the secondary bag and then the pump alarmed, displaying air in line.Although requested, no further information has been received.
 
Manufacturer Narrative
Additional info: initial reporter info.
 
Event Description
It was reported that once the piggyback medication finished, the screen indicated that it switched to the primary bag but still pulled from the secondary bag and then the pump alarmed, displaying air in line.The clamps were not engaged.Although requested, no further information has been received.
 
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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 Key8533857
MDR Text Key142642267
Report Number9616066-2019-01103
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 03/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSEC TUBING
Device Catalogue NumberSEC TUBING
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8100,PRI TUBING,8015, TD UNK
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