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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Material Twisted/Bent (2981); No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/18/2022
Event Type  malfunction  
Event Description
It was reported that an unspecified access set did not flow during infusion. The device was being used with a spectrum iq pump. The tubing at the top of the pump channel was found to have a kink. The tubing and pump were replaced to resolve the issue. This occurred during infusion of heparin during therapy (medication, dose, programmed amount and delivery rate unknown). There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
Manufacturer Narrative
The user facility submitted medwatch mw5108401 for this event. The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameNI
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 Key14459404
MDR Text Key292213507
Report Number1416980-2022-02559
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received04/22/2022
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

Patient Treatment Data
Date Received: 05/20/2022 Patient Sequence Number: 1
Treatment
HEPARIN; SPECTRUM IQ PUMP
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