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U.S. Department of Health and Human Services

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

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CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INFUSION Back to Search Results
Model Number 2429-0500
Device Problems Fluid Leak (1250); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Information (3190)
Event Date 04/21/2019
Event Type  malfunction  
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
It was reported that the tubing set had a hole in it and leaked.
 
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Brand NameALARIS PUMP MODULE ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, INFUSION
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 Key8649758
MDR Text Key146367612
Report Number9616066-2019-01474
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2429-0500
Device Catalogue Number2429-0500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2019
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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