MAUDE Adverse Event Report: PULSION MEDICAL SYSTEMS SE PULSIOCATH PICCO MONITORING KIT; KRB

Catalog Number PV8215US

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 03/13/2015

Event Type  malfunction  

Manufacturer Narrative

The product was returned for investigation.The reported problem could be confirmed.Ocular inspection showed that the tubing was cut off, most likely by a sharp item.Investigations by the supplier did not lead to a root cause related to the manufacturing process.

Event Description

It was reported that during the change of a picco monitoring kit that was connected to a patient, the tube on the picco catheter separated from the luer connection and caused a blood loss.As staff was still by the bedside the bleeding could be stopped rapidly and no transfusion or liquid infusion was necessary.The final patient outcome was no injury.Manufacture reference #: (b)(4).

• Brand Name: PULSIOCATH PICCO MONITORING KIT
• Type of Device: KRB
• Manufacturer (Section D): PULSION MEDICAL SYSTEMS SE; feldkirchen ; GM
• Manufacturer (Section G): PULSION MEDICAL SYSTEMS AG; stahlgruberring 28; munich ; GM
• Manufacturer Contact: volker humbert ; hans-riedl-str. 17; feldkirchen 85622 ; GM 85622 ; 9459914-50
• MDR Report Key: 4995029
• MDR Text Key: 22742397
• Report Number: 3003263092-2015-00026
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K020587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Nurse
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PV8215US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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