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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 2420-0007
Device Problems Reflux within Device (1522); Deformation Due to Compressive Stress (2889)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2016
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
The customer reported an unspecified secondary infusion was observed flowing into a primary infusion of normal saline. There was no patient harm.
 
Manufacturer Narrative
The affected product has been received and the investigation is pending. A follow up report will be submitted once the failure investigation has been completed.
 
Event Description
The customer reported a ballooned pump segment noted at the beginning of an unspecified infusion. The set was replaced and there was no patient harm. The customer has stated the description and event date provided was interpreted from other sources not provided to carefusion/bd and may not be completely accurate.
 
Manufacturer Narrative
No product will be returned per customer. The customer¿s complaint could not be confirmed because the product was not returned for failure investigation. The root cause of this failure was not identified.
 
Event Description
The customer reported a secondary infusion was observed flowing into a primary infusion of normal saline and a check valve failure was suspected. There was not patient harm.
 
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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
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key6106526
MDR Text Key60032652
Report Number9616066-2016-01548
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,other
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 10/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2420-0007
Device Catalogue Number2420-0007
Was Device Available for Evaluation? No
Date Returned to Manufacturer12/16/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2017
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

Patient Treatment Data
Date Received: 11/16/2016 Patient Sequence Number: 1
Treatment
SEC TUBING, THERAPY DATE: UNK
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