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

Model Number	PV2014L16-A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported that during normal use, the catheter connector (luer lock) needs to be twisted due to disinfection and the catheter connection is broken.The issue has occurred during use on a patient.No harm or clinical consequences occurred.There was a blood leakage of 3ml, when the product split.Manufacturer reference #: (b)(4).
Additional Manufacturer Narrative
Further information about the event has been requested.Investigation is ongoing.A supplemental emdr will be sent when the investigation is completed.Device discarded by the hospital.
Event or Problem Description
Manufacturer reference: #(b)(4).
Additional Manufacturer Narrative
It has been reported that in normal use, the luer lock connection needs to be twisted and the luer lock connection is broken.The issue occurred after 20 minutes of use.No harm or clinical consequences occurred.Information has been received that about 3ml of blood leaked when the product split.A retain sample of the same batch retained by the manufacturer has been inspected.The luer connector has been inspected visually before and after a simulation check (10x screwing and unscrewing of the luer connection).No cracks nor leakage have been detected at any point during the inspection.The described issue could not be reproduced.A dhr review did not reveal any non-conformity or deviation relevant to the reported issue.A systematic design or production related root cause is considered as unlikely due to the absence of a trend: no further leakage case referring to the catheter luer lock connection has been reported within the last 12 months.The device has been discarded by the user.Therefore it is not possible to determine if the used catheter had any malfunction or any deviation from the specification that could have contributed to the incident.Overall, provided information and complaint investigation did not indicate a production error.Based on the complaint investigation the most probable root cause is seen in an handling error by the user when unscrewing the luer lock connection.However, as no product inspection could be performed, it is not possible to further investigate potential user errors.The ifu states: "warning: the use of any tools or excessive force may damage the connection component and lead to leakiness.The luer-lock connection is to be tightened manually." and "warning: usage of organic solvents for cleaning and disinfection may damage the catheter and lead to leakiness." the customer stated that no tool has been used and the device has not been disinfected, before the issue occurred.Overall, it cannot be excluded that an excessive force has been used to unscrew the connection.Upon the event occurrence the device was involved and used on a patient for advanced hemodynamic monitoring.The issue is monitored on a regularly basis in order to detect early trends.As there is no trend for this kind of issue no additional actions will be taken.With the information stated above the complaint will be closed.H3 other text : device discarded by the hospital.

• Brand Name: PICCO CATHETER
• Common Device Name: PROBE, THERMODILUTION
• Manufacturer (Section D): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622
• Manufacturer (Section G): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622
• Manufacturer Contact: christina carlsohn ; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622 ; 0894599140
• MDR Report Key: 15672187
• Report Number: 3003263092-2022-00010
• Device Sequence Number: 6443851
• Product Code: KRB
• UDI-Device Identifier: 04250094500962
• UDI-Public: (01)04250094500962
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K171620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: PV2014L16-A
• Device Catalogue Number: 6885046
• Device Lot Number: 679298
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 60 KG