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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 Reflux within Device (1522)
Patient Problem Missed Dose (2561)
Event Date 05/06/2019
Event Type  malfunction  
Manufacturer Narrative
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
It was reported that the nurse observed the secondary mini-bag medication back flow into the primary line while priming the tubing set.Although the issue occurred during priming, this resulted in the patient not receiving the ordered medication gravol.The customer further stated that there was no adverse effects cause to the nurse or the patient.
 
Event Description
It was reported that the nurse observed the secondary mini-bag medication back flow into the primary line while priming the tubing set.Although the issue occurred during priming, this resulted in the patient not receiving the ordered medication gravol.The customer further stated that there was no adverse effects cause to the nurse or the patient.
 
Manufacturer Narrative
The customer¿s report of secondary set back flowed into primary was not confirmed.Visual inspection of the set noted no damage or any anomalies.The check valve was visually inspected under magnification.The check valve was noted to be assembled in the set correctly, and the silicone membrane was centered.Functional testing resulted in no air bubbles or fluid going past the check valve or into the primary bag.Disassembly of the check valve resulted in normal findings.No particulates were noted on the diaphragm membrane or any solvent to the check valve component with no damages to the interior of the check valve or to the diaphragm.The root cause of this failure was not identified.
 
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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 Key8672768
MDR Text Key147195609
Report Number9616066-2019-01573
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 foreign,health professional
Type of Report Initial,Followup
Report Date 05/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/05/2022
Device Model Number2426-0007
Device Catalogue Number2426-0007
Device Lot Number19015368
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
100 ML BAXTER BAG 0.9% NACL, TD (B)(6) 2019
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