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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 MX9968
Device Problems Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.Patient demographics requested however not provided.
 
Event Description
It was reported that the user was administering a normal saline bolus simultaneously administering a unspecified pain medication when a leak was observed.Upon closer observation the user noticed a slit in the tubing.
 
Manufacturer Narrative
Product grid revised to not sequested.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.
 
Event Description
It was reported that the user was administering a normal saline bolus simultaneously administering a unspecified pain medication when a leak was observed.Upon closer observation the user noticed a slit/hole in the tubing proximal to patient, past second port.The customer stated that there was no patient harm.
 
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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
MDR Report Key8773089
MDR Text Key150577380
Report Number9616066-2019-01881
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403237805
UDI-Public10885403237805
Combination Product (y/n)N
PMA/PMN Number
K051499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 06/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMX9968
Device Catalogue NumberMX9968
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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