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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - CARTAGO CLEARLINK CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR
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BAXTER HEALTHCARE - CARTAGO CLEARLINK CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2H8537
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
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 an unspecified number of clearlink continu-flo solution sets continually cause ¿upstream occlusion¿ alarms without any obvious cause.These were identified during patient infusions and while in use on a pump; further described as ¿especially when the customer inserts a secondary tubing into the distal y site of the primary tubing¿.There was no report of patient injury or medical intervention associated with these events.No additional information is available.
 
Manufacturer Narrative
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.
 
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Brand Name
CLEARLINK CONTINU-FLO SOLUTION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE - CARTAGO
cartago
MDR Report Key8442202
MDR Text Key139614702
Report Number1416980-2019-01531
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K961225
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2H8537
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received04/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
COLLEAGUE PUMP; SECONDARY SET; COLLEAGUE PUMP; SECONDARY SET
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