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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 Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/07/2019
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 during a blood transfusion, the iv tubing from the blood bag stopped dripping blood into the chamber with 75cc left in the bag to be infused.The tubing set was changed out and the infusion completed without any issue.There was a pall filter in use.The infusion was programmed at a rate of 125cc/hr.For 3 hours.There was no patient impact.
 
Event Description
It was reported that during a blood transfusion, the iv tubing from the blood bag stopped dripping blood into the chamber with 75cc left in the bag to be infused.The tubing set was changed out and the infusion completed without any issue.There was a pall filter in use.The infusion was programmed at a rate of 125cc/hr.For 3 hours.There was no patient impact.
 
Manufacturer Narrative
Correction: disregard file (after further review, this file is deemed not reportable).
 
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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 Key9525735
MDR Text Key190980001
Report Number9616066-2019-03744
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 other
Type of Report Initial,Followup
Report Date 12/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/27/2019
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age78 YR
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