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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 10013361T
Device Problems Stretched (1601); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/05/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: 1000ml baxter bag lot y300392 exp sep 20, doxorubicin (adriamucin) 16. 4mg, etoposide (toposar) 82mg in sodium chloride 0. 9%, 1000ml chemo infusion;10ml zr swabflush syringe lot 3136603 exp 2020-05-01 0. 9% nacl injection; td 10/05/2019 the devices have been received and the evaluation is pending. A follow up report will be submitted with investigation results once the evaluation has been completed.
 
Event Description
It was reported that the tubing set developed a "bubble" in the silicone segment while attached to a combined chemotherapy infusion bag of doxorubicin (adriamucin) 16. 4m, etoposide (toposar) 82mg/sodium chloride 0. 9%, 1000ml to infuse at a rate of 44. 3ml/hour for a duration of 24 hours with a total vtbi of 1062. 3ml. The customer further stated that there were no iv push medications administered prior to the balloon developing in the tubing set. The customer later stated that there were no adverse effects caused to the adult patient from the event.
 
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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
mustafa omar
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9276513
MDR Text Key189778492
Report Number9616066-2019-03118
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 10/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10013361T
Device Catalogue Number10013361T
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2019
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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