MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FILTER SAFESTAR 55 PLUS; FILTER, DISPOSABLE

Catalog Number MP05790

Device Problems Mechanical Problem (1384); Obstruction of Flow (2423); Structural Problem (2506)

Patient Problems High Blood Pressure/ Hypertension (1908); Pulmonary Edema (2020)

Event Date 04/06/2023

Event Type  Injury  

Event Description

It was reported that the ventilation pressure increased up to the set maximum values with a simultaneous drop in tidal volumes.After replacement of the filter, ventilation with normal pressures was possible.During this rapid rise in ventilation pressure and the short period of apnea, a hypotensive circulation situation occurred.Consequences: ventilation stop, hypercapnia, increase in pulmonary arterial pressures, decrease in systemic blood pressures.Questionable cause for a passaged pulmonary edema observed postoperatively.

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Manufacturer Narrative

According to the provided information, the filter was placed between tube and breathing hose and permanent nebulization was used.In combination with active humidifiers or medication nebulizers, the filter may only be used on the device-side and not on the patient-side as reported.Only water-based drugs may be nebulized.When the filter is used together with a medication nebulizer, the filter¿s period of use is significantly reduced.Excessive resistance or compliance values may lead to insufficient ventilation and injury of the patient.If a too high resistance value is achieved, the filter must be replaced immediately.A manufacturing error can be excluded as all filters are resistance inspected.The clogged filter was caused by an user error.H3 other text: device not available for investigation.

Event Description

It was reported that the ventilation pressure increased up to the set maximum values with a simultaneous drop in tidal volumes.After replacement of the filter, ventilation with normal pressures was possible.During this rapid rise in ventilation pressure and the short period of apnea, a hypotensive circulation situation occurred.Consequences: ventilation stop, hypercapnia, increase in pulmonary arterial pressures, decrease in systemic blood pressures.Questionable cause for a passaged pulmonary edema observed postoperatively.

• Brand Name: FILTER SAFESTAR 55 PLUS
• Type of Device: FILTER, DISPOSABLE
• 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 16823106
• MDR Text Key: 314088212
• Report Number: 9611500-2023-00154
• 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
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MP05790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NA.; NA.
• Patient Outcome(s): Other