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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 False Alarm (1013)
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.Additional information requested, but was not provided.
 
Event Description
It was reported that the devices experienced nuisance air in line alarms over the past couple of weeks.The nursing staff responded to the device alarms to find no air in the line.The nurse often changed out the pump module and restarted the infusion, only to have the device alarm again.The nurse will then change out the tubing set and the device would take up to 10 minutes to stop alarming.
 
Manufacturer Narrative
Correction: disregard file (after review it was determined that the issue mentioned by the customer is not reportable as there were no reports that the 10 minute delay impacted the patient's infusion therapy and that the issue was addressed after the tubing set was replaced.).
 
Event Description
It was reported that the devices experienced nuisance air in line alarms over the past couple of weeks.The nursing staff will respond to the device alarm to find no air in the line.The nurse will often change out the pump module and restart the infusion, only to have the device alarm again.The nurse will then change out the tubing set and the device will take up to 10 minutes to stop alarming.
 
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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 Key9995261
MDR Text Key188832240
Report Number9616066-2020-01445
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,other
Type of Report Initial,Followup
Report Date 04/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2020
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
(2)8100, (2)8015, THERAPY DATE UNK; (2)8100, (2)8015, THERAPY DATE UNK
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