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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PULSION MEDICAL SYSTEMS SE PULSION PULSIOCATH THERMODILUTION CATHETERS
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PULSION MEDICAL SYSTEMS SE PULSION PULSIOCATH THERMODILUTION CATHETERS Back to Search Results
Catalog Number PV2015L20-N
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/26/2014
Event Type  malfunction  
Manufacturer Narrative
The reported catheter was returned for investigation.The reported problem could be confirmed.The appearance of the present cracks as well as the breaking behavior during stress tests pointed to the root cause use of application of organic disinfectants.As this is not indicated according to the product's ifu this is seen as an off-label use.Please note, this event is being filed as a retrospective mdr as a result of a review of our complaint database.
 
Event Description
It was reported that during use of a picco catheter on a patient, the luer lock had cracks so the catheter had to be replaced.No known impact or consequences to patient.(b)(4).
 
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Brand Name
PULSION PULSIOCATH THERMODILUTION CATHETERS
Manufacturer (Section D)
PULSION MEDICAL SYSTEMS SE
feldkirchen
GM 
Manufacturer Contact
volker humbert
hans-riedl-str. 17
feldkirchen 85622
GM   85622
945991503
MDR Report Key4994987
MDR Text Key22765833
Report Number3003263092-2015-00008
Device Sequence Number1
Product Code KRB
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K072364
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Nurse
Report Date 02/26/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPV2015L20-N
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/12/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/26/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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