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: PULSION MEDICAL SYSTEMS SE PULSION PULSIOCATH THERMODILUTION CATHETERS
  • 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
 

PULSION MEDICAL SYSTEMS SE PULSION PULSIOCATH THERMODILUTION CATHETERS Back to Search Results
Catalog Number PV2015L20-N
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Blood Loss (2597)
Event Date 12/06/2013
Event Type  malfunction  
Manufacturer Narrative
The picco catheter was returned for investigation.The reported problem could be confirmed by ocular inspection.The cause to the detachment is seen as a production error.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 using of a picco catheter on a patient, the extension of the catheter was broken which caused a blood loss.Final patient outcome is no injury.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key4994971
MDR Text Key22744728
Report Number3003263092-2015-00003
Device Sequence Number1
Product Code KRB
Combination Product (y/n)N
Reporter Country CodeTW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other Health Care Professional
Report Date 12/06/2013
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 Manufacturer12/06/2013
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/06/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-