MAUDE Adverse Event Report: PULSION MEDICAL SYSTEMS SE PULSON PULSIOCATH THERMODILUTION CATHETERS

Catalog Number PV2015L20-A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 07/22/2015

Event Type  Injury  

Manufacturer Narrative

Further information surrounding the event has been sought.A supplemental medwatch report will be sent when the investigation is completed.

Event Description

Patient had a femoral picco catheter placed.Circulation was reduced and the affected leg was amputated.Manufacturer reference #:(b)(4).

• Brand Name: PULSON PULSIOCATH THERMODILUTION CATHETERS
• Manufacturer (Section D): PULSION MEDICAL SYSTEMS SE; feldkirchen ; GM
• Manufacturer Contact: volker humbert ; hans-riedl-str. 17; feldkirchen 85622 ; GM 85622 ; 9459914503
• MDR Report Key: 5048850
• MDR Text Key: 24896694
• Report Number: 3003263092-2015-00032
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K072364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PV2015L20-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability