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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 11607704
Device Problems Stretched (1601); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Patient information requested but not provided.Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
 
Event Description
It was reported that the silicone section of a 3 port iv administration set ballooned while in the an alaris infusion pump channel.There was no harm to patient.
 
Manufacturer Narrative
Additional information provided: d.10, & h.6.(device code).The customer¿s report of ballooning was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted deformation at the top of the silicone pump segment.No other anomalies or evidence of damage were observed upon initial visual inspection.Examination under magnification of the silicone tubing segment walls were found to be concentric.Functional and pressure testing resulted in no ballooning in any clamped testing but has been replicated in unclamped testing when the tubing had been visually observed to be compromised.The root cause for the source of the excessive pressure is unknown.
 
Event Description
It was reported that the silicone section of a (3) port iv administration set "ballooned", while in the alaris infusion pump channel.It was further confirmed that there was no patient harm or impact as a result of this event.
 
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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 Key9319501
MDR Text Key190506681
Report Number9616066-2019-03287
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403228001
UDI-Public10885403228001
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number11607704
Device Catalogue Number11607704
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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