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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 PRI TUBING
Device Problems Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964)
Patient Problem Death (1802)
Event Date 05/22/2015
Event Type  Death  
Manufacturer Narrative
No product will be returned per customer. The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation. The root cause of this failure was not identified.
 
Event Description
The customer reported that during the process of adding another iv set to infuse an unspecified medication, the user noted that a previously established iv set began infusing inadvertently, and an entire bag with epinephrine 5mg/255ml infused. The patient had a stroke and subsequently died. The clinician said the event occurred due to a device failure and not human error. The devices were evaluated by the biomedical department at the facility and returned to service. The customer stated that the event disposable set was not saved; although no testing was performed on the set, they reported that it was expected that the safety clamp would engage and the roller clamp was not employed when the nurse removed the tubing from the pump.
 
Manufacturer Narrative
Additional information provided: serial numbers for concomitant devices are (8015) s/n (b)(4) and (8100) s/n (b)(4).
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
On initial report: the suspect product is now a device rather than a disposable and requires a new manufacturer report number. Please reference manufacturer report number 2016493-2017-00243 for mdr reporting.
 
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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 Key5899917
MDR Text Key52858179
Report Number9616066-2016-01160
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPRI TUBING
Device Catalogue NumberPRI TUBING
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2017
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: 08/24/2016 Patient Sequence Number: 1
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