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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 2420-0007
Device Problem Reflux within Device (1522)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/12/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical product: non-bd ext set; 500 ml hospira bag lot 80-718-fw exp aug 2019 0.9% sodium chloride injection; 100ml braun bag ref s8004-5264, (b)(4), 0.9% sodium chloride injection, therapy date (b)(6) 2019.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 primary back flowed into the secondary bag, after the secondary bag completed its infusion.The primary infusion was 500ml of ns programmed to infuse at 50ml/hr at the competition of the 250ml secondary infusion of an unspecified antibiotic.There was no harm.
 
Event Description
It was reported that primary back flowed into the secondary bag, after the secondary bag completed its infusion.The primary infusion was 500ml of ns programmed to infuse at 50ml/hr at the competition of the 250ml secondary infusion of an unspecified antibiotic.The customer further stated that there were no adverse effects caused to the patient from the event.
 
Manufacturer Narrative
The customer¿s report that the primary back flowed into the secondary bag, after the secondary bag completed its infusion was confirmed.Visual inspection of the set noted clear liquid was observed in both the primary and secondary sets¿ drip chambers and entire length of tubing.The sets were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No abnormalities were observed.Functional testing confirmed back flowing into the secondary set¿s tubing towards the iv bag.No alarms or any other issues were noted by the device.Attached photo reviewed and event as described was confirmed.The root cause of the reported primary back flowed into the secondary bag was not definitively determined.
 
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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 Key8781739
MDR Text Key150737678
Report Number9616066-2019-01927
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 06/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/03/2022
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot Number19055354
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
8100,8015,NON-BD SEC SET, TD (B)(6) 2019; 8100,8015,NON-BD SEC SET, TD (B)(6) 2019
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