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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ACCESS SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION ACCESS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Free or Unrestricted Flow (2945)
Patient Problem Low Apgar Score (1718)
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
A patient experienced an over infusion of oxytocin with use of an unknown access set. It was reported that the infusion was discontinued, and the tubing was removed from the pump; however, ¿the infusion was left connected to the patient¿. Subsequently, the medication ¿infused via free flow into the patient¿. After the infusion was stopped, the patient required an emergent cesarean section. It was reported the baby had a low apgar score (no further details provided). It was reported that the patient and baby recovered without any long-term effects. No additional information is available.
 
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Brand NameACCESS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE CORPORATION
ni
ni
ni
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key12513950
MDR Text Key272736055
Report Number1416980-2021-05851
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
NI
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 10/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received10/21/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 09/22/2021 Patient Sequence Number: 1
Treatment
SPECTRUM PUMP
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