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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION CLEARLINK SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2R8858
Device Problem Filling Problem (1233)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The devices were 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.
 
Event Description
It was reported that an unspecified quantity of clearlink, paclitaxel sets under infused while attached to a spectrum infusion pump. This was identified during unspecified process steps further described as ¿chemotherapy fluid volumes remaining or variation¿ (no further detail). There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NameCLEARLINK SOLUTION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - CARTAGO
see h10
see h10
cartago
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key12294679
MDR Text Key265613164
Report Number1416980-2021-04883
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K160007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 08/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2R8858
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2021
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: 08/09/2021 Patient Sequence Number: 1
Treatment
SPECTRUM PUMP
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