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

Model Number PV8115

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/06/2022

Event Type  malfunction  

Manufacturer Narrative

According to provided information the device is not available as it was discarded.A retain sample of the same batch has been inspected, but no leakage could be detected.Further investigation ongoing.The following similar device is under complaint: (b)(4), lot 22ch16, catalogue #6882818, manufacturing date: 03/31/2022, expiration date: 02/28/2025, udi: (b)(4).A supplemental emdr will be sent when the investigation is completed.

Event Description

It has been reported that after seting up picco monitoring kit (b)(4).And filling it with saline, a leak in the system within the arterial pressure transducer was noticed.It led to the returning patient's blood to the monitoring system.All connections were checked twice and no leakage was noticed within.Fluid outflow was observed at the bottom of the faucet right under the transducer.The leak was impossible to remove and indicated a manufacturing defect.No visible mechanical damage.The whole set was replaced with a new one and monitoring resumed with no further problems.The case is reported to us fda as leaking parts in contact with arterial blood pressure have been reported.No harm or clinical consequences for the patient, the blood loss was less than 2 ml.Manufacturer reference #: (b)(4).

Manufacturer Narrative

It has been reported that during set up of a picco monitoring kit a leakage in the system within the arterial pressure transducer occurred.The issue could be solved by a replacing with a new product.No harm or clinical consequences for the patient occurred.A retain sample of the same batch retained by the manufacturer has been inspected.A visual check did not identify any deviations (e.G.Cracks).No leakage on the transducer housing or fluid system could be reproduced during functional testing.The dhr has been reviewed but did not reveal any non-conformities or deviations relevant to the reported issue.No further complaints have been received for this batch.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 monitoring kit has been reported within the last 12 months.Evaluation of the problem description has been performed and pointed to a leakage in the area of the transparent housing below the 3-way stopcock.The device has been discarded by the user.Therefore it is not possible to determine if the used monitoring kit had any malfunction or any deviation from the specification.Overall, provided information and complaint investigation indicate that a production error could have potentially contributed or caused the described leakage.The problem description does not point to an user error.However, as no inspection of the actual affected device could be performed, it is not possible to further investigate potential user or production errors and confirm the root cause.The supplier has been informed about the issue.The ifu indicates to only use products if no sign of damage is visible: "do not use the kit or accessories if any sign of product damage is visible." and "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." 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.Corrected data: medical device problem code (f10).

Event Description

Manufacturer reference #: (b)(4).

• Brand Name: PICCO MONITORING KIT
• Type of Device: 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: 15474786
• MDR Text Key: 302195009
• Report Number: 3003263092-2022-00006
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K991886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

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
• Device Operator: Health Professional
• Device Model Number: PV8115
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 11/17/2022
• Supplement Dates FDA Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: N/A.
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 90 KG