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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); Hole In Material (1293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/22/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: (2) 25ml baxter bag din 00060208, lot number w7l05c1, exp sep 18, 0.9% nacl, therapy date: (b)(6) 2018.The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
 
Event Description
The customer reported that during use, iv fluid was noted to be leaking from the pump.The nurse noticed a small hole at the top of the silicone portion of the set when they removed it from the pump module.There is no report of patient harm.
 
Manufacturer Narrative
The customer¿s report of the set leaking was confirmed.Visual inspection showed that the silicone segment had a tear near the upper fitment measuring 0.0485 inches long.Examination under magnification showed no crush marks to the upper fitment.Functional and pressure confirmed leaking from the silicone tubing near the upper fitment.The root cause of the leak was a tear in the silicone segment.The cause of the tear is unknown.
 
Event Description
The customer reported that during use, iv fluid was noted to be leaking from the pump.The nurse noticed a small hole at the top of the silicone portion of the set when they removed it from the pump module.There is no report of 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
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key7610833
MDR Text Key111434050
Report Number9616066-2018-00777
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 05/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/25/2020
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot Number17107613
Other Device ID Number7613203021012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/25/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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