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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 2200-0500
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Although requested, device has not been received. A follow up report will be submitted with failure investigation results should the device be received for evaluation.
 
Event Description
During a site visit it was reported that the safety clamp did not engage when it was removed from the device. The clinician stated,"the ¿safety clamp did not activate¿ and the roller clamp was not engaged. Ns [normal saline] flowed out of tubing. " the clinician was exposed to the ns inside the tubing set. This event occurred on the outpatient oncology unit. The tubing was not connected to the patient. There was no patient harm. The pump and the tubing were not sequestered. Tubing ref#2200-0500.
 
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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
mustafa omar
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9868364
MDR Text Key189624767
Report Number9616066-2020-01034
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K931173
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 02/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2200-0500
Device Catalogue Number2200-0500
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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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