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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 MX9968
Device Problems Fluid Leak (1250); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Although requested, product has not been received. A follow up report will be submitted with failure investigation results should the product be received for evaluation. Patient demographics requested however not provided.
 
Event Description
It was reported that the user was administering a normal saline bolus simultaneously administering a unspecified pain medication when a leak was observed. Upon closer observation the user noticed a slit in the tubing.
 
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Brand NameALARIS PUMP MODULE ADMINISTRATION 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 Key8773089
MDR Text Key150577380
Report Number9616066-2019-01881
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMX9968
Device Catalogue NumberMX9968
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
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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