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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 Break (1069)
Patient Problem Not Applicable (3189)
Event Type  malfunction  
Manufacturer Narrative
No device will be returned per customer.The customer complaint could not be confirmed because the device was not sequestered for failure investigation.The root cause of this failure was not identified.
 
Event Description
It was reported that the design and the quality of the plastics are a high failure, which is very costly, making it very high cost to ownership product as the bezels break far too often.There was no patient involvement reported in this event.
 
Manufacturer Narrative
Correction: disregard file, it is a duplicate to manufacturer report number: 2016493-2020-01221.
 
Event Description
It was reported that the design and the quality of the plastics are a high failure, which is very costly, making it very high cost to ownership product as the bezels break far too often.There was no patient involvement reported in this event.
 
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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
MDR Report Key10128803
MDR Text Key194336889
Report Number2016493-2020-01273
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
PMA/PMN Number
K133532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 05/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2020
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 This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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