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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 24602-B007T
Device Problem Reflux within Device (1522)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 secondary infusion unexpectedly started to back flow into the drip chamber of the primary line.Although requested, there were no further details or information provided and no report of harm.
 
Manufacturer Narrative
The customer¿s report of back flow into the drip chamber of the primary line was not confirmed.When proper head height differentials are used for secondary infusion set-up and when the primary set tubing clamp is engaged.The primary set was visually inspected for incomplete bonding engagements, holes/tears in the tubing or damages to the components.No anomalies were observed on the received set during visual inspection.Functional testing resulted in fluid flowing without incident of backflow.This set does not come with a check valve and any secondary infusion needs to have the primary set tubing clamp engaged.The root cause of the customer¿s report was not determined.The suspect set was not returned for investigation.
 
Event Description
It was reported that the secondary infusion unexpectedly started to back flow into the drip chamber of the primary line.Although requested, there were no further details or information provided and no report of patient harm.
 
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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 Key8724992
MDR Text Key148925168
Report Number9616066-2019-01715
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403240980
UDI-Public10885403240980
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,health
Type of Report Initial,Followup
Report Date 06/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24602-B007T
Device Catalogue Number24602-B007T
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SEC TUBING, THERAPY DATE UNK; SEC TUBING, THERAPY DATE UNK
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