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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINSTRATION SET; SET, ADMINISTRATION, INFUSION
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CAREFUSION ALARIS PUMP MODULE ADMINSTRATION SET; SET, ADMINISTRATION, INFUSION Back to Search Results
Model Number 2420-0007
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/04/2019
Event Type  malfunction  
Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
 
Event Description
It was reported that the pump was pulling from the primary line instead of the secondary line of ivig while connected to a pediatric patient in the hematology/oncology unit.The infusion was programmed to infuse at an unspecified titration.There was no harm.
 
Manufacturer Narrative
The customer report that the pump was pulling from the primary line instead of the secondary line was not confirmed or replicated.The sets were visually inspected, no anomalies or damages were observed with the sets or at the each component.Functional testing was performed by repriming the sets via gravity with their original bags.The sets were primed successfully while observing no backflow, occlusions, or leaks.The sets were loaded into a lab pump module and the primary infusion was programmed at a rate of 125ml/h and vtbi at 125ml.The secondary infusion was programmed at a rate of 100ml/h and vtbi of 100ml.The secondary iv bag infused completely with no signs of backflow and there were no alarms observed or any issues noted during the second infusion.The primary set observed no changes in fluid levels during the secondary infusion.The sets were pressure tested while submerged underwater.Air pressure was incrementally increased from 5 psi to 30 psi.No leaks or occlusions were observed.The root cause was not identified.
 
Event Description
It was reported that the pump was pulling from the primary line instead of the secondary line of ivig while connected to a pediatric patient in the hematology/oncology unit.The infusion was programmed to infuse at an unspecified titration.There was no harm.
 
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Brand Name
ALARIS PUMP MODULE ADMINSTRATION SET
Type of Device
SET, ADMINISTRATION, INFUSION
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8632231
MDR Text Key145781561
Report Number9616066-2019-01399
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203021012
UDI-Public7613203021012
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 04/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/05/2022
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot Number19025335
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8100,8015, THERAPY DATE (B)(6) 2019; 8100,8015, THERAPY DATE (B)(6) 2019
Patient Age3 YR
Patient Weight16
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