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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION CLEARLINK SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2H8671
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Increased Respiratory Rate (2486)
Event Type  Injury  
Manufacturer Narrative
The customer reported this event to the fda through medwatch w5090870.(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported during a patient home infusion with a clearlink solution set, the patient experienced increased respiratory effort and rate.It was reported a rapid response was called and the patient was admitted to the hospital, then transferred to the intensive care unit (icu).Treatment for the event was not reported.It was reported the patient stabilized and was transferred out of the icu, then subsequently discharged from the hospital.No additional information is available.
 
Manufacturer Narrative
Additional information: 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 Name
CLEARLINK SOLUTION ADMINISTRATION SETS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - CARTAGO
see h10
cartago 30106
CS   30106
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key9503944
MDR Text Key172239568
Report Number1416980-2019-07066
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153158
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 01/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number2H8671
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/25/2019
Initial Date FDA Received12/20/2019
Supplement Dates Manufacturer Received01/10/2020
Supplement Dates FDA Received01/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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