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

Model Number PV8115

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2019

Event Type  malfunction  

Manufacturer Narrative

Further information has been requested and investigation is still ongoing.No further complaints were received for this batch.A supplemental emdr will be sent when the investigation is completed.Product not returned.

Event Description

Two connections of the monitoring kit detached without any manipulation.The user had to carry out a check of the strength of all connecting valves.No consequences or harm to the patient occurred.Manufacturer reference #: (b)(4).

Event Description

Manufacturer reference#: (b)(4).

Manufacturer Narrative

The concerned product was not returned as it was discarded by the customer.A retain sample of the same batch has been tested, but secured connections did not loosen unintentionally.The failure could not be reproduced, the investigated device did not show any deviations from specification.A dhr review did not reveal any non-conformities relevant to the reported issue.No further complaints have been received for the complained batch and no similar complaint has been received within the last 12 months.Based on the investigation results and the complaint description the root cause is seen in an user error by not securing all connections properly during set-up.As the ifu indicates: "open the package carefully to keep contents sterile.The inside of the package can be used as a sterile storage area.Secure all connectors and ensure that all stopcocks are turned to the required position.Be careful not to overtwist the luer-lock connection." this is supported by the fact that the same device has been used without problems after checking and securing of all connections.The picco technology is used for advanced hemodynamic monitoring.Corrected data: e (address) h3 other text : device has not been returned from the hospital as it was discarded.

• Brand Name: PULSION 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: 9186862
• MDR Text Key: 205342768
• Report Number: 3003263092-2019-00016
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• PMA/PMN Number: K991886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PV8115
• Device Catalogue Number: 6882774
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1