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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 2426-0500
Device Problems Stretched (1601); Communication or Transmission Problem (2896); Material Deformation (2976)
Patient Problems Therapeutic Response, Increased (2272); Decreased Respiratory Rate (2485)
Event Date 11/13/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: 30873; 2426-0500; (2)8100; 8120; 8015; 10 ml bd syringe; 60 ml bd syringe; 1000 ml baxter bag, lot: y318055, exp: mar 2021, 0. 9% sodium chloride injection; 1000 ml baxter bag, lot: y316075, exp: feb 2021, lactated ringer's injection; 1000 ml baxter bag, lot: y315341, exp: feb 2021, lactated ringer's injection; therapy date (b)(6) 2019. The affected product has been received and the evaluation is pending. A follow up report will be submitted once the evaluation is completed. Patient age and dob requested but not provided, however, the customer stated that the patient was an adult patient.
 
Event Description
It was reported that the patient called the rn into the bathroom because the device was alarming "air in line" on the pump module infusing lactated ringers iv fluids. The patient had a pcu with a pump module infusing lactated ringers 1000 ml and a pca pump module infusing dilaudid 25 mg/nacl 0. 9% 50 ml. The rn changed the lactated ringers bag and restarted/reset the device. The device continued to alarm for "air in line". The rn then replaced the lactated ringer iv bag again and the tubing set only to have the device continue to alarm, however, this time the alarm stated a "channel error. " a new pump module was added to the pcu and programmed for the lactated ringers iv fluids. The new pump module also alarmed "channel error. " at this time the charge rn entered the bathroom to assist. In review, it was decided to change the entire pump set-up, when the lactated ringers tubing set was found to have a balloon in the silicone segment. At 11:30, the pca channel was cleared with demands 1; administered 1; and total drug administered: 2. 9. The rn and the charge rn verified the programming to be correct as 1. 4 mg/12 min/8. 4 mg per hr. The customer later clarified that it is believed that the patient received an additional dilaudid dose which required additional monitoring for respiratory depression, however, there were no medical interventions required to counteract the adverse effects caused to the adult patient from the event.
 
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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 Key9433936
MDR Text Key193989967
Report Number9616066-2019-03543
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 health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2426-0500
Device Catalogue Number2426-0500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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