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

Catalog Number MP05805

Device Problems Material Fragmentation (1261); Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the filter housing fragmented during detachment from tube.No patient injury was reported.

Event Description

It was reported that the filter housing fragmented during detachment from tube.No patient injury was reported.

Manufacturer Narrative

The filter twinstar 55 plus in question was available for the investigation and was analyzed.The described issue could be confirmed, the lower part of the housing was fragmented.Several laboratory tests have been performed to provoke a similar breaking in order to reproduce the error pattern.This was not possible as a comparable damage could only be provoked by an external acting load, which is unusual for everyday clinical use.The error pattern could not be reproduced with intact housings when using an external force appropriate for the application.So a possible root cause might be that the affected filter was pre-damaged and the material gave way under the force exerted during disassembly.Additionally, the production documentation of the corresponding lot was analyzed.The filters are subject to a 100% leakage test before shipment.As no corresponding deviations were documented a pre-damage within production can be ruled out.Finally, it was not possible to determine the exact root cause.The number of comparable cases is within the originally assumed range of the underlying risk assessment and is therefore accepted.Dräger concludes that the user is readily aware during interaction with the product in case cracking occurs.Since the item is a hospital consumable, replacement shall be at hand immediately.

• Brand Name: FILTER TWINSTAR 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: 17008835
• MDR Text Key: 316308900
• Report Number: 9611500-2023-00200
• Device Sequence Number: 1
• Product Code: OFP
• 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
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MP05805
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1