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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 2420-0007
Device Problems Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385); Material Split, Cut or Torn (4008)
Patient Problem No Patient Involvement (2645)
Event Date 05/20/2020
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.
 
Event Description
It was reported from the day surgery unit that just prior to use, the newly primed primary tubing set leaked "normal iv fluid".There was a "minimal delay" caused because a new tubing set had to be prepared.It was observed that the packaging had a little cut on it which the customer thinks is how the tubing set became cut also.There was no patient involvement as this happened prior to use.
 
Event Description
It was reported from the day surgery unit that just prior to use, the newly primed primary tubing set leaked "normal iv fluid".There was a "minimal delay" caused because a new tubing set had to be prepared.It was observed that the packaging had a little cut on it which the customer thinks is how the tubing set became cut also.There was no patient involvement as this happened prior to use.
 
Manufacturer Narrative
The customer¿s report that the tubing set leaked was confirmed.Visual inspection observed a cut/slice on the tubing at 9 inches below the distal adapter tubing.The packaging pouch received was also visually inspected, and it was also noted to have slice cut.A leak was observed from the cut tubing.The cause of the leak in the tubing was identified as damage from a slice cut in the packaging pouch.The root cause of this failure was not identified.Device history record for model 2420-0007 lot 20033350 shows that the set was manufactured on 24 march 2020 with a total of (b)(4) units.There were no qn¿s (quality notification) issued during the production build of this lot for the failure mode reported.
 
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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 Key10110451
MDR Text Key193652062
Report Number9616066-2020-01863
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203021012
UDI-Public7613203021012
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,other
Type of Report Initial,Followup
Report Date 05/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/24/2023
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot Number20033350
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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