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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE PUMP, INFUSION

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CAREFUSION ALARIS PUMP MODULE PUMP, INFUSION Back to Search Results
Model Number 8100
Device Problem Free or Unrestricted Flow (2945)
Patient Problem Therapeutic Response, Increased (2272)
Event Date 01/01/2017
Event Type  Injury  
Manufacturer Narrative
Although requested, the affected device has not been received. A follow up report will be submitted with investigation results should the devices be received for evaluation.
 
Event Description
Received a copy of the customer's medwatch report from the fda which states, "alaris iv pump set up with iv infusion of oxytocin for ob patient in labor. The rate was set at 2cc/hour and the "start" button pushed. Rn examined the iv bag of oxytocin and noted that the medication was being "bolused" into the patient. The infusion was stopped immediately, and the fetal heart rate had a twelve minute prolonged deceleration. A terbutaline injection was given to the mother. Apgars of baby were 7 and 8. Baby and mother discharged two days later. ".
 
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Brand NameALARIS PUMP MODULE
Type of DevicePUMP, INFUSION
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 Key6431742
MDR Text Key70778736
Report Number2016493-2017-00210
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K950419
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number8100
Device Catalogue Number8100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/26/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/24/2017 Patient Sequence Number: 1
Treatment
PRI TUBING,8015, THERAPY DATE (B)(6) 2017
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