MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FILTER CARESTAR 45

Catalog Number MP01755

Device Problems Complete Blockage (1094); Gas Output Problem (1266)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 01/06/2021

Event Type  Injury  

Manufacturer Narrative

Nevertheless, the affected carestar filter was requested for investigation to rule out any device failure.But as it was in contact with a covid patient it has already been disposed by the customer.Independent from that, the available information allow for a plausible conclusion.The use of an inappropriate filter (without hme) has caused the reported event.The patient did not receive sufficiently humidified gas and consequently, viscous sputum emerged in the bronchial tubes and finally clogged the tracheal tube.No indications for a malfunction of the carestar filter were found.

Event Description

It was reported that a patient suffered a cardiopulmonary arrest due to an occlusion in the tracheal tube.Resuscitation was successful.Further health impact has not been reported.The users have not alleged any malfunction of the filter used during the procedure but rather conceded the use of a wrong type of breathing filter.Instead of a dräger twinstar which features a heat moisture exchanger (hme), a dräger carestar was used.Carestar does not feature a hme.

• Brand Name: FILTER CARESTAR 45
• Type of Device: FILTER
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11215345
• MDR Text Key: 228220028
• Report Number: 9611500-2021-00035
• 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: company representative,user f
• Type of Report: Initial
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MP01755
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/22/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening