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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 MX9128
Device Problems Excess Flow or Over-Infusion (1311); Free or Unrestricted Flow (2945)
Patient Problems Overdose (1988); No Known Impact Or Consequence To Patient (2692)
Event Date 03/30/2015
Event Type  malfunction  
Event Description
The customer reported the roller clamp on the gravity set released after being clamped and the patient received an additional 200 -300 ml of fluid.When the roller clamp was noted to be ¿open¿ the fluid was running ¿wide open¿ instead of the intended kvo.No patient harm reported.
 
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.
 
Manufacturer Narrative
Correction: initial reporter address.
 
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Brand Name
ALARIS PUMP MODULE ADMINISTRATION SET
Type of Device
SET, 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
sylvia ventura
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key4714910
MDR Text Key5744354
Report Number9616066-2015-00512
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative,company representati
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMX9128
Device Catalogue NumberMX9128
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/22/2016
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 Sequence Number1
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