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

Model Number N/A

Device Problem Occlusion Within Device (1423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/20/2017

Event Type  Injury  

Manufacturer Narrative

The concerned product is an electrostatic filter combined with a heat and moisture exchanger intended to be used in intensive care ventilation and anesthesia applications.The product is susceptible to increased humidity levels in the breathing gas as well as to liquids and secretions since these substances may clog the filter medium and lead to increased airway resistance resulting in insufficient ventilation.Dräger derived from the user's report that the problems were not present when the hme filter was introduced; the airway resistance was obviously increasing continuously over a period of several hours.In follow-up of the event was determined that a medication nebulizer was positioned between patient and filter.The ifu describes that the product is designed for a maximum use period of 24 hours and must not be reused or reprocessed.The user is furthermore advised to check the product on a regular base for liquids or secretion and to replace it if visible deposits are observed.A separate warning is included which explains that active humidifiers or medication nebulizers must not be used in combination with this hme filter since the filter may become clogged with pressure buildup and insufficient ventilation being the consequence.Dräger finally concludes that the reported problems were not product-related and do not incorporate a previously unidentified or falsely assessed risk.The hme filter had been used outside the conditions laid down in the ifu.Warning messages which are clearly and explicitly referring to the particular misuse are embedded therein.The ventilator reportedly detected the impairments in ventilation and alarmed the decrease in minute volume.

Event Description

It was reported to dräger that the user had difficulties to ventilate the patient.The etco2 readings increased significantly and the capnography curve showed an obstructive pattern.Anti-obstructive medication was administered.The problem could be solved by replacing the hme filter which was in use for some hours only.Two similar issues have reportedly occurred within a short period of time.Beyond the performed medical intervention in the one case no patient consequences have been reported.

• Brand Name: TWINSTAR 55
• Type of Device: FILTER , DISPOSABLE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; lübeck 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 6299554
• MDR Text Key: 66433670
• Report Number: 9611500-2017-00034
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Model Number: N/A
• Device Catalogue Number: MP01805
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: No
• 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