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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 2420-0500
Device Problems Contamination (1120); Material Separation (1562)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 08/02/2019
Event Type  Injury  
Manufacturer Narrative
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
 
Event Description
Customer advocacy received a copy of the customer's medwatch report which states, "the iv tubing was connected to a patient infusing oxytocin.During delivery the tubing disconnected from the connection port.The actual disconnection happened where the tubing should remain intact in the lowest portion of the connection port.This caused the site and iv tubing to become contaminated resulting in the patient requiring a new iv site and new tubing and meds to be started on a patient during delivery.Fda safety report id# (b)(4).".
 
Manufacturer Narrative
After file review, in the absence of clarification from the customer, file updated to serious injury based on the report from the medwatch received.
 
Event Description
Customer advocacy received a copy of the customer's medwatch report which states, "the iv tubing was connected to a patient infusing oxytocin.During delivery the tubing disconnected from the connection port.The actual disconnection happened where the tubing should remain intact in the lowest portion of the connection port.This caused the site and iv tubing to become contaminated resulting in the patient requiring a new iv site and new tubing and meds to be started on a patient during delivery.Fda safety report id#(b)(4)." although requested, there is no additional patient or event information available.
 
Manufacturer Narrative
The customer¿s report that the tubing disconnected from the connection port was not confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Clear fluid was observed throughout the set.No anomalies or damages were observed with the set.Functional testing did not observe any disconnections from the female/male ports or any issues with the administration set.Visual inspection and pressure testing also found no anomalies with the returned set.The mating components that were in use at the time of the customer event were not returned for investigation.The root cause that the tubing disconnected from the connection port was not identified.
 
Event Description
Customer advocacy received a copy of the customer's medwatch report which states, "the iv tubing was connected to a patient infusing oxytocin.During delivery the tubing disconnected from the connection port.The actual disconnection happened where the tubing should remain intact in the lowest portion of the connection port.This caused the site and iv tubing to become contaminated resulting in the patient requiring a new iv site and new tubing and meds to be started on a patient during delivery.Fda safety report id#(b)(4)." although requested, there is no additional 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 Key9175249
MDR Text Key162028743
Report Number9616066-2019-02854
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203012430
UDI-Public7613203012430
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,Followup
Report Date 09/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2420-0500
Device Catalogue Number2420-0500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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