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

Catalog Number MP01805

Device Problems Complete Blockage (1094); Mechanical Problem (1384); Obstruction of Flow (2423)

Patient Problem Hypoxia (1918)

Event Date 09/06/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the filter clogged during the first nebulization.Due to the massive occlusion, it was no longer possible to ventilate the patient, who became hypoxic and required resuscitation.After changing the filter, the patient's condition improved abruptly.

Manufacturer Narrative

According to the event description, medication nebulization was performed during ventilation when using the twinstar 55 filter.The instructions for use of the hme twinstar filter used describe as a warning that it should not be used in combination with active humidifiers or medication nebulizers, as there is a risk of pressure build-up and inadequate ventilation of the patient.In the present case, nebulization was carried out in combination with the filter contrary to the instructions for use, so that the filter was blocked and it was consequently no longer possible to ventilate the patient.When the filter is closed, the airway pressure increases as a result.This is detected by the connected device and a corresponding alarm is issued as soon as set alarm limits are reached.The number of comparable cases, related to the root cause (user error), is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that the filter clogged during the first nebulization.Due to the massive occlusion, it was no longer possible to ventilate the patient, who became hypoxic and required resuscitation.After changing the filter, the patient's condition improved abruptly.

• Brand Name: TWINSTAR 55
• 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
• MDR Report Key: 12467504
• MDR Text Key: 271310522
• Report Number: 9611500-2021-00387
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MP01805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention