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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN CATHETER GAMCATH; CATHETER, HEMODIALYSIS, NON-IMPLANTED
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BAXTER HEALTHCARE - HECHINGEN CATHETER GAMCATH; CATHETER, HEMODIALYSIS, NON-IMPLANTED Back to Search Results
Device Problem Disconnection (1171)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/03/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that after approximately 15 minutes of treatment, there was a disconnection between a gamcath and the return line of a prismaflex st150 set.The lines were clamped.The treatment was continued with the same filter.There was maximum 25 ml of blood loss.There was no 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.
 
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Brand Name
GAMCATH
Type of Device
CATHETER, HEMODIALYSIS, NON-IMPLANTED
Manufacturer (Section D)
BAXTER HEALTHCARE - HECHINGEN CATHETER
hechingen
MDR Report Key8601101
MDR Text Key145655050
Report Number3004367028-2019-00005
Device Sequence Number1
Product Code MPB
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/15/2019
Initial Date FDA Received05/10/2019
Supplement Dates Manufacturer Received04/17/2019
Supplement Dates FDA Received05/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PRISMAFLEX ST150 SET
Patient Age63 YR
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