Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAXTER HEALTHCARE CORPORATION CLEARLINK CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number JC8537
Device Problem No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/18/2021
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 there was no flow of medication through a clearlink system continu-flo solution set.The device was setup to deliver a 0.9% sodium chloride using a single channel pump; however, the customer received a downstream occlusion alarm and no flow through the solution set.The issue was identified during patient infusion.To resolve this issue, the setup was troubleshooted by setting up with a new clearlink system continu-flo solution set, repriming the micron filter, omitting the non-baxter closed male luer, and the tubing was straightened (instead of taped on the patient¿s arm in a loop).There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CLEARLINK CONTINU-FLO SOLUTION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key12468555
MDR Text Key271301126
Report Number1416980-2021-05690
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberJC8537
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received09/24/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
0.22 MICRON FILTER (2H8671); 0.9% SODIUM CHLORIDE; ARISURE CLOSED MALE LUER; CISPLATIN; COLLEAGUE SINGLE CHANNEL PUMP; MANNITOL; ONE-LINK CONNECTOR (7N8399); PERIPHERALLY INSERTED CENTRAL CATHETER; PRIMARY TUBING (JC8109); 0.22 MICRON FILTER (2H8671); 0.9% SODIUM CHLORIDE; ARISURE CLOSED MALE LUER; CISPLATIN; COLLEAGUE SINGLE CHANNEL PUMP; MANNITOL; ONE-LINK CONNECTOR (7N8399); PERIPHERALLY INSERTED CENTRAL CATHETER; PRIMARY TUBING (JC8109)
-
-