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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 Failure to Infuse (2340); Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/27/2018
Event Type  malfunction  
Manufacturer Narrative
No product will be returned per customer. The customer¿s complaint could not be confirmed because the product was not sequestered and will not be returned for failure investigation. The root cause of this failure was not identified. Patient demographics requested however not provided by the customer.
 
Event Description
It was reported that a magnesium infusion was programmed to infuse at an unspecified rate however the infusion would not flow due to unspecified issues with the roller clamp. The user reprogrammed the infusion, unknown if the infusion flowed when the device was reprogrammed. The customer stated no patient harm but a delay in patient care. The event occurred in the micu. Although requested, no additional event, patient or device information provided.
 
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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
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8663322
MDR Text Key146834837
Report Number9616066-2019-01446
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 05/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2018
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot Number15037010
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
Date Device Manufactured03/29/2015
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: 06/03/2019 Patient Sequence Number: 1
Treatment
8100,8015, TD (B)(6) 2018
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