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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMIN, INTRAVASCULAR.
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CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMIN, INTRAVASCULAR. Back to Search Results
Model Number PRI TUBING
Device Problem False Alarm (1013)
Patient Problems No Consequences Or Impact To Patient (2199); 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.
 
Event Description
It was reported that the tubing caused the device to alarm air in line.The anesthesiologist stated they are experiencing air-in-line alarms with no visible air noted in the tubing.No additional information was available.
 
Event Description
It was reported that the tubing caused the device to alarm air in line.The anesthesiologist stated they are experiencing air-in-line alarms with no visible air noted in the tubing.There was no patient harm.No additional information was available.
 
Manufacturer Narrative
Supplemental created to update b5 and h6.
 
Manufacturer Narrative
***upon clinical review of this file, revised global reportability tab to non-reportable as nuisance alarms are not reportable if the alarms do not impact the delivery of the medication or fluid to the patient.Generally, nuisance alarms can be resolved with troubleshooting measures to maintain the infusion without affecting the therapeutic effect.There was no report of adverse effects caused to the patient from the event, therefore this file is revised to non-reportable***.
 
Event Description
It was reported that the tubing caused the device to alarm air in line.The anesthesiologist stated they are experiencing air-in-line alarms with no visible air noted in the tubing.There was no patient harm.No additional information was available.
 
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Brand Name
ALARIS PUMP MODULE ADMINISTRATION SET
Type of Device
SET, ADMIN, INTRAVASCULAR.
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9792961
MDR Text Key193052230
Report Number9616066-2020-00729
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 company representative,health
Type of Report Initial,Followup,Followup
Report Date 02/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2020
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
8100,8015,THERAPY DATE UNKNOWN
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