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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS® EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION ALARIS® EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 20027E
Device Problem Complete Blockage (1094)
Patient Problem Anxiety (2328)
Event Date 08/30/2018
Event Type  Injury  
Manufacturer Narrative
The customer's complaint of a clogged filter 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 they've had issues with filters occluding with specific medications and needing to change the filters multiple times during infusion. During an infusion of alglucosidase alpha, the filter clogged several times. The customer needed to change the filter out mid-infusion. This caused a significant amount of anxiety/frustration for the patient. The filter was changed, and the infusion resumed.
 
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Brand NameALARIS® EXTENSION 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 Key8001552
MDR Text Key124883629
Report Number9616066-2018-01974
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K790108
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 09/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20027E
Device Catalogue Number20027E
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

Patient Treatment Data
Date Received: 10/24/2018 Patient Sequence Number: 1
Treatment
8100,2420-0007,8015, TD (B)(6) 2018
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