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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE SET SET,ADMINISTRATION, INTRAVASCULAR

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CAREFUSION ALARIS PUMP MODULE SET SET,ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2432-0007
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Visual inspection of the received sample observed yellowish-colored fluid throughout the set. No other obvious issues or damages were observed. The received sample came in for an unspecified issue in which testing performed observed an immediate leak around the area between the tubing and inlet port of the bottom smartsite valve in which there was a tear noted to be halfway around the pvc tubing p/n 620-00065. Functional testing identified a tear with leaking half way around the tubing between the tubing and inlet port of the bottom smartsite valve. The root cause of the tear/cut could not be definitively identified.
 
Event Description
The customer reported the supply chain received tpn tubing for an unspecified reason on (b)(6) 2019, and the tubing had been used for patient use.
 
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Brand NameALARIS PUMP MODULE SET
Type of DeviceSET,ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
sylvia ventura
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8495269
MDR Text Key141323166
Report Number9616066-2019-00884
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2432-0007
Device Catalogue Number2432-0007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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