MAUDE Adverse Event Report: PULSION MEDICAL SYSTEMS SE PULSIOCATH PICCO MONITORING KIT ; PROBE, THERMODILUTION

Catalog Number PV8215US

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

According to received info the device will be returned for investigation.A supplemental medwatch report will be sent when the investigation is completed.

Event Description

It was reported that the tubing of the arterial pressure measuring system disconnected at the 3-way stopcock due to a loose connector.No pt injury, but the risk of a potential blood loss was reported.(b)(4).

Manufacturer Narrative

(b)(6) 2016 02:08 pm (gmt-4:00) added by (b)(6) ((b)(6)): the actual monitoring kit was returned for investigation.The device was visually inspected and each connection was manually tested.A stable connection between the male and the female connectors, at each connection of the monitoring kit, could be acquired.Our conclusion is that there were no malfunctions, or failures, or an inadequacy in the instructions of the medical device.It seems that the user did not secure all connections prior to use, according to the instructions for use(ifu).The ifu indicates that all connectors have to be secured during the preparation of the pressure monitoring kit before use.A review of the dhr could not identify any non-conformities or deviations relevant to the reported issue.Please note, (b)(4) (importer) is submitting the report on behalf of pulsion medical systems se (exemption number e2008006s01).Submitting with updated mfg report # in response to an fda e-mail received january 17 2020 regarding an invalid sequence #.Updated mfr.Report # to reflect the initial emdr report # note- changed the date of this report and updated the evaluation codes- methods and conclusions to reflect current evaluation codes.

Event Description

Manufacturer reference # : (b)(4).

• Brand Name: PULSIOCATH PICCO MONITORING KIT
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622
• MDR Report Key: 5052715
• MDR Text Key: 24906600
• Report Number: 3003263092-2015-00033
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• PMA/PMN Number: K020587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• 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?: Yes
• Date Manufacturer Received: 08/05/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1