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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 Stretched (1601); Deformation Due to Compressive Stress (2889); Material Distortion (2977)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/10/2017
Event Type  malfunction  
Manufacturer Narrative
Gtin number for item: 2420-0007, lot: 17033143 is (b)(4). No product will be returned per customer. The customer declined to return the product for failure investigation. The root cause of this failure was not identified.
 
Event Description
The customer reported that during a continuous infusion of cytarabine, an occlusion alarm was noted, and a bulge in the silicone segment of the tubing was identified. The customer reportedly flushed the line every 4 hrs for blood return per unit protocol. The pharmacist was notified and the tubing was replaced; there were no further issues. There was no report of 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
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key6760217
MDR Text Key81606931
Report Number9616066-2017-01085
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,health
Reporter Occupation
Type of Report Initial
Report Date 07/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/26/2020
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot Number17033143
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/27/2017
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: 08/02/2017 Patient Sequence Number: 1
Treatment
8100,8015, THERAPY DATE (B)(6) 2017
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