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

Model Number	PV2014L16N
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information has been requested and investigation is ongoing.A supplemental emdr will be sent when the investigation is completed.Device has not been returned by the hospital.
Event or Problem Description
It has been reported that during use, when the picco catheter puncture has been completed, the connection between the picco catheter and monitoring kit leaked (only a few drops).The defective picco catheter has been replaced immediately.No harm or clinical consequences occurred.Manufacturer reference #: (b)(4).
Additional Manufacturer Narrative
A product analysis was not possible as the complained device was discarded by the hospital.A retain sample of the same batch has been investigated: the retain sample worked as specified during functional testing.No deviation could be detected during visual testing by naked eye and under the microscope.The investigation results did not indicate a systematic material or production deficiency.This is supported by the very low complaint rate < 0,01 % (considering all types of picco catheters).A review of the dhr could not identify any non-conformities or deviations relevant to the reported issue.Considering the issue description, investigation results and historical data analysis it is considered as likely that a handling error during use occurred.The ifu states: "usage of organic solvents for cleaning and disinfection may damage the catheter and lead to leakiness." and ¿the luer-lock connection is to be tightened manually.The use of any tools or excessive force may damage the connection component and lead to leakiness.¿ overall, investigations did no indicate that the device failed to meet its specification when the event occurred.Upon the event occurrence the device was used on a patient for advanced hemodynamic monitoring.The issue will be further monitored on the market to identify trends.H3 other text : device has not been returned by the hospital as it was discarded.
Event or Problem Description
Manufacturer reference #: (b)(4).

• Brand Name: PICCO CATHETER
• Common Device Name: PROBE, THERMODILUTION
• Manufacturer (Section D): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622
• MDR Report Key: 11035547
• Report Number: 3003263092-2020-00016
• Device Sequence Number: 11076880
• Product Code: KRB
• UDI-Device Identifier: 04250094500658
• UDI-Public: (01)04250094500658(17)220228(11)170314(10)619483
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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: 02/28/2022
• Device Model Number: PV2014L16N
• Device Catalogue Number: 6885052
• Device Lot Number: 619483
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1