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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 2426-0500
Device Problems Material Rupture (1546); Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
 
Event Description
It was reported that the silicone segment ballooned while iv tubing was connected to the patient.Iv set tubing was changed and infusion was continued with the same pump.There was no adverse effects caused to the patient as a result of the event.Although requested, additional information was not provided.
 
Manufacturer Narrative
The customer's report that the silicone segment ballooned was confirmed.Visual inspection observed that the silicone segment area, directly underneath the upper fitment, was misshapen and was of a different appearance than the rest of the silicone segment.Further visual inspection under magnification found the walls of the silicone tubing segment to be concentric.No functional testing was performed due to visual observation.Previously investigated complaints for this failure mode determined that the ballooning is caused by excess pressure within the silicone segment.The root cause for the source of the excessive pressure is unknown.
 
Event Description
It was reported that the silicone segment ballooned while iv tubing was connected to the patient.Iv set tubing was changed and infusion was continued with the same pump.There was no adverse effects caused to the patient as a result of the event.Although requested, additional information was not provided.
 
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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 Key10010265
MDR Text Key189365981
Report Number9616066-2020-01525
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203020992
UDI-Public7613203020992
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,other
Type of Report Initial,Followup
Report Date 04/15/2020
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 Number2426-0500
Device Catalogue Number2426-0500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/29/2020
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8100,8015, THERAPY DATE UNK; 8100,8015, THERAPY DATE UNK
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