MAUDE Adverse Event Report: PULSION MEDICAL SYSTEMS SE PROAQT SENSOR; PROBE, THERMODILUTION

Model Number PV8811

Device Problem Break (1069)

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

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

Further information about the event has been requested.Patient data could not be provided as the product has not been used on the patient.A supplemental emdr will be sent when the investigation is completed.The following similar device is under complaint: model #: pv8810, lot #: 22ab05, catalogue #: 6886188, manufacturing date: 2022-01-31, expiration date: 2024-12-31, udi: (b)(4).Device not yet received.

Event Description

It has been reported that while preparing the device for installation, water (liquid) was leaking when setting up the equipment.The leakage has been detected in the connection between proaqt stopcock and line.No harm or clinical consequences for patient or user occurred.Manufacturer reference: (b)(4).

Manufacturer Narrative

It has been reported that water (liquid) was leaking while preparing the device for installation.The complained product has been returned for an inspection.The transducer has been inspected visually and with a leakage test.No damages (e.G.Cracks) could be observed.A functional and a leakage check however, did confirm that the transducer is not fully sealed.No pressure could be applied to the transducer with all stopcocks closed.Furthermore the transducer was clearly leaking water from its housing.The device has been sent to our distributor for further evaluation.They have observed that the polycarbonate was detached from the ceramic of the sensor, possibly due to a too long soldering process, leading to extreme heating of the wires.A training on the soldering of the product will be performed for relevant employees to emphasize the importance of the soldering time.There is no indication for a systematic root cause as a deficiency of design, production or material considering the very low complaint rate (< 0,01 %, considering all types of proaqts).The device failed to meet its specifications and used for setup of advanced hemodynamic monitoring devices.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.

Event Description

Manufacturer reference #(b)(4).

• Brand Name: PROAQT SENSOR
• 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: freya kuppers ; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622 ; 0894599140
• MDR Report Key: 16013140
• MDR Text Key: 306545499
• Report Number: 3003263092-2022-00017
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K192169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

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: PV8811
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 05/10/2023
• Supplement Dates FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other