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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 2426-0007
Device Problem Product Quality Problem (1506)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
No product will be returned per customer. The customer 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 product complaint from the er department with the new alaris pump module set taping configurations. It was reported that the carefusion set had two tapes on the tubing keeping the tubing intact when priming. The new bd set has only has one tape on the tubing, when the tape is being torn apart from the tubing the user then grabs the spike to insert into the solution bag however the rest of the tubing falls to the floor causing a "health issue". The ed/icu/ccu director reported that they have seen an increase in infections in the last few months and feel that this may be the reason, due to the product change in the tape configurations.
 
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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
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key7943012
MDR Text Key123050025
Report Number9616066-2018-01809
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial
Report Date 09/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2426-0007
Device Catalogue Number2426-0007
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

Patient Treatment Data
Date Received: 10/08/2018 Patient Sequence Number: 1
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