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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INFUSION
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CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INFUSION Back to Search Results
Model Number 2120-0500
Device Problem Disconnection (1171)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/17/2019
Event Type  malfunction  
Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.Patient age and dob requested but not provided, however, the customer stated the patient was an infant patient.
 
Event Description
It was reported that the rn was holding the infant patient while the baby was attached to the tubing set infusing an unspecified medication via a central line, when the tubing set unintentionally disconnected at connection to the bd blue threaded lock cannula.The customer later stated that there were no adverse effects caused to the patient.
 
Manufacturer Narrative
Additional information added to: d4,d11,g4,h4.
 
Event Description
It was reported that the rn was holding the infant patient while the baby was attached to the tubing set infusing an unspecified medication via a central line, when the tubing set unintentionally disconnected at connection to the bd blue threaded lock cannula.The customer later stated that there were no adverse effects caused to the patient.
 
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Brand Name
ALARIS PUMP MODULE ADMINISTRATION SET
Type of Device
SET, ADMINISTRATION, INFUSION
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9193596
MDR Text Key163050911
Report Number9616066-2019-02872
Device Sequence Number1
Product Code FRN
UDI-Device Identifier07613203012690
UDI-Public7613203012690
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 09/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/16/2022
Device Model Number2120-0500
Device Catalogue Number2120-0500
Device Lot Number19025482
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BD INTERLINK THREADED LOCK CANNULA,TD 9/17/19; CENTRAL LINE
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