MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA SAFESTAR FILTER

Catalog Number MP01790

Device Problems Mechanical Problem (1384); Obstruction of Flow (2423)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/04/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported that during the case in question, there was an increase in ventilation pressure accompanied by small tidal volumes.Subsequently, a drop in oxygen saturation and rr was observed.Decision to perform cpr with administration of suprarenin, which led to stabilization of circulatory parameters.Striking noises on the hme filter prompted disconnection and replacement of the filter.An abrupt improvement of the ventilation situation with normal ventilation pressures and tidal volumes was observed.

Event Description

It was reported that during the case in question, there was an increase in ventilation pressure accompanied by small tidal volumes.Subsequently, a drop in oxygen saturation and rr was observed.Decision to perform cpr with administration of suprarenin, which led to stabilization of circulatory parameters.Striking noises on the hme filter prompted disconnection and replacement of the filter.An abrupt improvement of the ventilation situation with normal ventilation pressures and tidal volumes was observed.

Manufacturer Narrative

The description of the on-site situation showed that nebulization took place between the tube and the filter and that the filter was used between the tube circuit and nebulization, i.E.On the patient side.In the instructions for use of the safestar filter used, it is described as a warning that the medical device may only be used in combination with active humidifiers or medication nebulizers on the device side and under control of the pressure build-up.In the present case, however, the filter was used on the patient side, contrary to the instructions for use, so that during the expiration phase the medication was nebulized directly into the filter and led to the reported occlusion.It can be concluded that the incorrect positioning of the filter and the continuous nebulization, as reported, finally led to the clogging of the filter.With a blocked filter, the airway pressure increases as a consequence.This is detected by the connected anesthesia machine and a corresponding alarm is posted as soon as set alarm limits are reached.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.

Event Description

It was reported that during the case in question, there was an increase in ventilation pressure accompanied by small tidal volumes.Subsequently, a drop in oxygen saturation and rr was observed.Decision to perform cpr with administration of suprarenin, which led to stabilization of circulatory parameters.Striking noises on the hme filter prompted disconnection and replacement of the filter.An abrupt improvement of the ventilation situation with normal ventilation pressures and tidal volumes was observed.

• Brand Name: SAFESTAR FILTER
• Type of Device: FILTER
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 12056987
• MDR Text Key: 261546005
• Report Number: 9611500-2021-00274
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2022

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 Catalogue Number: MP01790
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 06/24/2021
• Supplement Dates Manufacturer Received: 08/10/2021; 08/10/2021
• Supplement Dates FDA Received: 08/24/2021; 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown