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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE BLOOD SET SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION ALARIS PUMP MODULE BLOOD SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2477-0007
Device Problems Stretched (1601); Insufficient Flow or Under Infusion (2182)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Although requested, the affected product has not been received. A follow up report will be submitted with investigation results should the devices be received for evaluation. Patient was pregnant.
 
Event Description
It was reported when a nurse hung one unit of packed red blood cells (prbcs) to a pregnant patient. She stated that the tubing was clamped on normal saline (ns) and blood was infusing into patient well. When it was checked later during the infusion, the blood bag was swollen and the pump stated 300+ had infused into patient. Due to the dilution, the necessary amount of product was not given to the patient. With the recreation of the scenario, i found that if tubing not fully engaged, fluid will run through. Although, it was reported that patient care was delayed it did not contribute to, or result in serious adverse impact to patient.
 
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Brand NameALARIS PUMP MODULE BLOOD 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 Key9447514
MDR Text Key196246257
Report Number9616066-2019-03619
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K894842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2477-0007
Device Catalogue Number2477-0007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2019
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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