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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 Stretched (1601); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/05/2020
Event Type  malfunction  
Manufacturer Narrative
No product will be returned per customer because the product was discarded.
 
Event Description
It was reported from the bone marrow transplant/oncology unit that while a patient was receiving an infusion of normal saline there was an alarm on the pump for an occlusion on the patient side.It was then discovered that the primary tubing set had a balloon at the top of the silicone pumping segment and it was "pulsating".There were no adverse consequences to the patient as a result of this event.
 
Event Description
It was reported from the bone marrow transplant/oncology unit that while a patient was receiving an infusion of normal saline there was an alarm on the pump for an occlusion on the patient side.It was then discovered that the primary tubing set had a balloon at the top of the silicone pumping segment and it was "pulsating".There were no adverse consequences to the patient as a result of this event.
 
Manufacturer Narrative
No product will be returned per customer.The customer complaint of balloon in the silicone segment was confirmed per customer-provided photo that shows a balloon/bulge in the silicone segment tubing p/n 12088541 near the upper fitment.The root cause for the source of the excessive pressure is unknown.Device history record could not be performed on model 2426-0500 because the lot # for the suspect set 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 Key10113105
MDR Text Key193650885
Report Number9616066-2020-01786
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,health
Type of Report Initial,Followup
Report Date 05/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2020
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2426-0500
Device Catalogue Number2426-0500
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number0
Treatment
8100,8015, TD (B)(6) 2020
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