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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 PRI TUBING
Device Problem Deformation Due to Compressive Stress (2889)
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 device be received for evaluation.
 
Event Description
It was reported that the iv tubing tends to kink in the alaris pump causing air-in -line alarms.Although requested additional information was not provided.
 
Event Description
It was reported that the iv tubing tends to kink in the alaris pump causing air-in -line alarms.Although requested additional information was not provided.
 
Manufacturer Narrative
Correction: disregard file (after further review this file is not-reportable as there was no indication of patient impact or adverse effects caused to the patient as a result of this event.).
 
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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 Key10105111
MDR Text Key193046909
Report Number9616066-2020-01837
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 05/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPRI TUBING
Device Catalogue NumberPRI TUBING
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8015,8100, THERAPY DATE UNK; 8015,8100, THERAPY DATE UNK
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