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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMIN, INTRAVASCULAR.

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CAREFUSION SD ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMIN, INTRAVASCULAR. Back to Search Results
Model Number 2426-0007
Device Problem Separation Failure (2547)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/27/2020
Event Type  malfunction  
Manufacturer Narrative
The product has been received. A follow up report will be submitted with failure investigation results upon completion of the investigation.
 
Event Description
It was reported that the nurse opened the device door in response to an air in line alarm and found that the tubing set had separated from the upper fitment. Customer reported there was no medical intervention and no patient adverse effects caused from this event; however, the patient did not receive approximately 30 ml of their treatment of intravenous immunoglobulin related to the event.
 
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Brand NameALARIS PUMP MODULE ADMINISTRATION SET
Type of DeviceSET, ADMIN, INTRAVASCULAR.
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION SD
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 Key10137528
MDR Text Key194617082
Report Number9616066-2020-01901
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2426-0007
Device Catalogue Number2426-0007
Device Lot Number20036429
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/18/2020
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: 06/10/2020 Patient Sequence Number: 1
Treatment
8100, 8015, THERAPY DATE (B)(6) 2020
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