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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; INFUSION PUMP
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CAREFUSION SD ALARIS SYSTEM; INFUSION PUMP Back to Search Results
Model Number 8100
Device Problems Device Sensing Problem (2917); Free or Unrestricted Flow (2945)
Patient Problem Fetal Distress (1856)
Event Date 07/22/2021
Event Type  Injury  
Manufacturer Narrative
The event logs have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.No devices received, log review only.
 
Event Description
It was reported that the patient called out to nurses station because the pump was beeping.The rn went to bedside and found that the pump that was infusing oxytocin (pitocin) 300 milliunits/500ml (rate: 22milliunits/minute, 22ml/hr) was alarming "channel error".The rn assessed the line and noticed that the oxytocin was dripping quickly but the pump was not programmed and was just flashing "red".The rn immediately clamped line and turned the pump off.The rn assessed the patient, her uterus was extremely firm upon palpation and the fetal heart tone dropped to below baseline (prolonged deceleration).The rn called for help and terbutaline was administered subcutaneously.The fetal heart tones returned to baseline after the intervention.The patient was placed in "hands-to-knee" position and the physician was notified.It was then reported that the baby was delivered vaginally at 2315.The baby's apgar score at 1 minute mark was "8" and at 5 minute mark, the score was "9".This report captures the adverse event on the fetus.For the adverse event report on the mother, please refer to pr (b)(6).
 
Manufacturer Narrative
Manufacturer narrative: a review of the complaint history for this serialized unit did not confirm similar complaints, based on the same or related failure mode for this event.A review of the device history record was performed from the date of manufacture to the date of product release for distribution which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.
 
Event Description
It was reported that the patient called out to nurses station because the pump was beeping.The rn went to bedside and found that the pump that was infusing oxytocin (pitocin) 300 milliunits/500ml (rate: 22milliunits/minute, 22ml/hr) was alarming "channel error".The rn assessed the line and noticed that the oxytocin was dripping quickly but the pump was not programmed and was just flashing "red".The rn immediately clamped line and turned the pump off.The rn assessed the patient, her uterus was extremely firm upon palpation and the fetal heart tone dropped to below baseline (prolonged deceleration).The rn called for help and terbutaline was administered subcutaneously.The fetal heart tones returned to baseline after the intervention.The patient was placed in "hands-to-knee" position and the physician was notified.It was then reported that the baby was delivered vaginally at 2315.The baby's apgar score at 1 minute mark was "8" and at 5 minute mark, the score was "9".This report captures the adverse event on the fetus.For the adverse event report on the mother, please refer to pr (b)(4).
 
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Brand Name
ALARIS SYSTEM
Type of Device
INFUSION PUMP
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key12376121
MDR Text Key268445244
Report Number2016493-2021-59060
Device Sequence Number1
Product Code FRN
UDI-Device Identifier10885403810015
UDI-Public(01)10885403810015
Combination Product (y/n)N
PMA/PMN Number
K133532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8100
Device Catalogue Number8100 ALARIS LVP MODULE
Was Device Available for Evaluation? No
Date Manufacturer Received08/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8015; 8015
Patient Outcome(s) Required Intervention;
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