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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 Problem Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/08/2018
Event Type  malfunction  
Manufacturer Narrative
Although requested, the affected device has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
 
Event Description
The customer reported that a pump module in the oncology unit alarmed for "channel error" and shut down during an infusion.The customer stated that the iui connectors were corroded and the latches needed to be replaced.There was no report of patient harm.
 
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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
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key7812959
MDR Text Key118246503
Report Number2016493-2018-00643
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 Nurse
Type of Report Initial
Report Date 08/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2018
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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