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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 Problems Break (1069); Material Integrity Problem (2978)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
 
Event Description
It was reported that the tubing has been made thinner and likely weaker.This results in lines breaking at the connecting sites during manipulation, such as when attaching to the line to flush and during compounding.
 
Manufacturer Narrative
The customer¿s complaint of the tubing breaking at the connection site was confirmed.No product will be returned per customer.A photo provided by the customer observed that the tubing was torn about ½¿ from the inlet port of the upper fitment.The root cause of the tubing breaking at the connection site was not identified.
 
Event Description
It was reported that the tubing has been made thinner and likely weaker.This results in lines breaking at the connecting sites during manipulation, such as when attaching to the line to flush and during compounding.Breaks in the connection are not as common, but they are still happening more frequently than the past.Although requested, there is no further patient or event information available.
 
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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 Key9147821
MDR Text Key161737392
Report Number9616066-2019-02795
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2019
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
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SYRINGE
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