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 07/28/2022

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 a patient.Initial inspection of the returned device confirmed a leakage.Further investigation is ongoing.A supplemental emdr will be sent when the investigation is completed.

Event Description

It has been reported that water was visible inside proaqt sensor when valve is in ¿off¿ position during calibration (zeroing).No harm or clinical consequences occurred.The device has not been used on a patient.The leakage was discovered during testing straight after installation.Manufacturer reference #: (b)(4).

Event Description

Manufacturer reference #: (b)(4).

Manufacturer Narrative

It has been reported that water was visible inside proaqt sensor when valve is in ¿off¿ position during calibration (zeroing).No harm or clinical consequences occurred, the device was not used on a patient.Water inside the proaqt sensor indicates a leakage.A dhr review did not reveal any non-conformity or deviation from specification relevant to the reported issue.The complained product has been returned for inspection.A visual inspection could reproduce the reported problem.The most probable cause for the malfunction is seen in improper bonding of the sensor to the body during production.This phenomenon can happen as a result of insufficient quantity of glue or due to missing/asymmetrical placement of glue on both sides of the sensor.Due to the fact that the sample received was tested and leaked on the sprint device used during production, it is highly suspected this product was found unproper during production and placed by mistake in the good parts.The most probable root cause for the case is seen in a human error during production.Actions have already been implemented in production to avoid such failures.The affected sensor lot has been produced before the implementation of the actions.The trend rate is very low for similar complaints ((b)(4)).No further complaints have been received for this proaqt sensor batch.Overall, investigations indicate that the device failed to meet its specification when the event occurred.Upon the event occurrence the device was involved, but not used on a patient.The issue is further monitored in order to identify early trends.As there is no trend for this kind of issue, no additional actions will be taken.Based on this, 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: christina carlsohn ; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622 ; 0894599140
• MDR Report Key: 15256610
• MDR Text Key: 298201965
• Report Number: 3003263092-2022-00004
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K192169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• 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
• Date Returned to Manufacturer: 08/08/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose