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 11/07/2022

Event Type  malfunction  

Event Description

It has been reported that before using the device on a patient, it has been tried to use the device according to the ifu, but it did not work due to leakage.After installation of proaqt sensor, when normal saline flushing between a line kit, normal saline leakage was detected in the proaqt sensor stopcock.No harm or clinical consequences occurred.Manufacturer reference #: (b)(4).

Manufacturer Narrative

Further information about the event has been requested.Patient data could not be provided as the product has not been used on a 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: 01/31/2022, expiration date: 12/31/2024, (b)(4).Device not yet received.

Event Description

Manufacturer reference #: (b)(4).

Manufacturer Narrative

It was reported that before using the device on the patient, it has been tried to use the device according to the ifu, but it did not work due to leakage.No harm or clinical consequences occurred to the patient.The complained product has been returned for an inspection.The complained transducer has been inspected visually and with a leakage test.No damages (e.G.Cracks) or leakage could be observed.The described problem could not be confirmed during product inspection.Based on the fact that no leakage could be reproduced on the device the most probable root cause for the described failure is seen in handling error by a loose connection of the luer-tubing.It has been confirmed that the device has not been used on a patient.During product inspection traces of blood have been detected.It is not known how the blood traces got in contact with the device.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).Overall, investigations did not indicate that the device failed to meet its specification when the event occurred.The ifu indicates: "intended user: this device is intended for use in health care facilities by trained health care professionals." 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.

• 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: 15860112
• MDR Text Key: 304292263
• Report Number: 3003263092-2022-00012
• 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: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2022
• 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
• Date Manufacturer Received: 12/22/2022
• 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