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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PCA PUMP TUBING SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION ALARIS PCA PUMP TUBING SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number PCA TUBE
Device Problems Fluid Leak (1250); Material Puncture/Hole (1504)
Patient Problem Hypoxia (1918)
Event Date 10/30/2019
Event Type  Injury  
Manufacturer Narrative
Report source: csc product recovery specialist. No product will be returned per customer. The customer complaint could not be confirmed because the device/product was not returned for failure investigation. The root cause of this failure was not identified. The customer stated that the patient was an infant.
 
Event Description
It was reported that the infant patient was noted to have an increased fio2 requirement and increased transcutaneous monitoring (tcms) in the beginning of the shift at approximately 0700. A fentanyl bolus was administered from the bag at approximately 0945. At approx. 1020 the alaris pump alarmed "air in line". Upon assessment, it was noted that there was a significant amount of air in the tubing. The infusion was paused, the tubing set clamped when the nurse began to "flick" air out of the tubing. When the tubing set was "flicked", fentanyl leaked out of a hole near the upper fitment. The md was notified and at 1045 a one time fentanyl syringe bolus was ordered due to the infant not receiving the correct fentanyl dosage for an unknown period of time. The bolus was given at approximately 1045. Pharmacy was notified and a new fentanyl bag was delivered and hung at approximately 1105 and the infant's fio2 requirement and tcms were noted to have decreased during the 12:00 vitals. There were no lasting adverse effects caused to the infant due to the event. The customer stated that there is no further event information available.
 
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Brand NameALARIS PCA PUMP TUBING
Type of DeviceSET, 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 Key9787297
MDR Text Key188361835
Report Number9616066-2020-00637
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial
Report Date 02/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCA TUBE
Device Catalogue NumberPCA TUBE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/04/2020 Patient Sequence Number: 1
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