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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 11607704
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Tachycardia (2095)
Event Date 02/04/2020
Event Type  Injury  
Manufacturer Narrative
No product will be returned. The customer¿s complaint could not be confirmed because the product will not be returned for failure investigation. The root cause of this failure was not identified.
 
Event Description
It was reported there were air-in-line alarms. The nurse tried three different pcus and five different lvps, as well as two different tubing sets. As a result of the event, the patient's heart rate increased, requiring a repeat bolus of cardizem. The patient's heart rate started at 156 bpm to 142 bpm during the event. A bolus dose of 25 mg of cardizem was administered and the heart rate decreased to 110 bpm.
 
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Brand NameALARIS PUMP MODULE ADMINISTRATION SET
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
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9860781
MDR Text Key184387247
Report Number9616066-2020-01084
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number11607704
Device Catalogue Number11607704
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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: 03/20/2020 Patient Sequence Number: 1
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