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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS SYRINGE PUMP MODULE; PUMP, INFUSION
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CAREFUSION ALARIS SYRINGE PUMP MODULE; PUMP, INFUSION Back to Search Results
Model Number 8110
Device Problem Disconnection (1171)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
No device will be returned per customer.The customer complaint could not be confirmed because the device was not returned for failure investigation.The root cause of this failure was not identified.
 
Event Description
It was reported that the device gave channel disconnected, non-recoverable error.It was then mentioned that preventive maintenance was done on the device and both iui connectors, and pressure sensors were replaced.All tests were passed.There was no patient involvement.Per customer, no further information will be provided.
 
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Brand Name
ALARIS SYRINGE 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 Key10257176
MDR Text Key200814550
Report Number2016493-2020-01836
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K023264
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8110
Device Catalogue Number8110
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/12/2013
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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