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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE; PUMP, INFUSION
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CAREFUSION ALARIS PUMP MODULE; PUMP, INFUSION Back to Search Results
Model Number 8100
Device Problems Disconnection (1171); Communication or Transmission Problem (2896)
Patient Problem No Information (3190)
Event Date 06/22/2019
Event Type  malfunction  
Manufacturer Narrative
Although requested, patient demographics were not provided by the customer.Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
 
Event Description
During a site visit by a bd representative, the biomed reported the device had a channel disconnect alarm, and could not program the pump or restart the channel.The device then displayed a communication error.Although requested, no further information was received from the customer.¿.
 
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Brand Name
ALARIS PUMP MODULE
Type of Device
PUMP, INFUSION
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 Key8887943
MDR Text Key167022584
Report Number2016493-2019-00980
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K950419
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 07/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8100
Device Catalogue Number8100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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