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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION SOLUTION ADMINISTRATION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2H5660
Device Problems Backflow (1064); Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/26/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a non-dehp extension set had air in the line and back flow. The set-up is a secondary unspecified chemotherapy iv bag is spiked with a non-baxter device; connected on the other end is a non-dehp extension set. At the opposite end of the non-dehp extension set is a non-baxter closed male luer which is connected to a clearlink system secondary medication set. They then connect to the upper y port of the clearlink system continu-flo solution set. ¿the issue is that when the secondary infusion ran complete the secondary iv set had air in the line but still had fluid in the secondary drip chamber and there was no fluid in the secondary medication bag¿. It is further observed ¿there is back flow from the primary up into the secondary set when this set up is used¿. The event occurred post chemo infusion. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NameSOLUTION ADMINISTRATION SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - CARTAGO
see h10
see h10
cartago 30106
CS 30106
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key13060582
MDR Text Key282622900
Report Number1416980-2021-07505
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K153158
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2H5660
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2022
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 Initial

Patient Treatment Data
Date Received: 12/22/2021 Patient Sequence Number: 1
Treatment
BD PHASEAL DEVICE; CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET; CLEARLINK SYSTEM SECONDARY MEDICATION SET; UNSPECIFIED CHEMOTHERAPY SOLUTION
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