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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 2426-0007
Device Problem Stretched (1601)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.Patient information was requested, but not provided.
 
Event Description
It was reported that parts of the tubing was swelling into a balloon-like shape which was causing a cease in flow of the iv fluids.It was reported that it doesn't happen instantly, but it does happen more so over a span of an hour after spike.It was reported that no patient care was delayed and it did not contribute to, or result in serious adverse impact to patient.
 
Manufacturer Narrative
The customer¿s report that the tubing was swelling into a balloon-like shape was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Clear liquid was observed inside the tubing throughout the entire set.At the top of the silicone pump segment tubing near the upper fitment, it was observed that the silicone tubing was softened or weakened.The weakened tubing was also found to be at the location where a balloon would naturally occur.Further visual inspection of the silicone tubing confirmed that the tubing's concentricity was within specification.Previously investigated complaints for this same failure mode determined that the ballooning is caused by excess pressure within the silicone tubing segment.The root cause for the source of the excessive pressure is unknown.
 
Event Description
It was reported that parts of the tubing was swelling into a balloon-like shape which was causing a cease in flow of the iv fluids.It was reported that it doesn't happen instantly, but it does happen more so over a span of an hour after spike.It was reported that no patient care was delayed and it did not contribute to, or result in serious adverse impact, to the patient.Although requested, there is no further patient or event information available.
 
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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 Key9350972
MDR Text Key168713421
Report Number9616066-2019-03412
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403227998
UDI-Public10885403227998
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 11/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2426-0007
Device Catalogue Number2426-0007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
THERAPY DATE: UNKNOWN
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