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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA TWIN STAR 55 PLUS; FILTER, DISPOSABLE
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DRÄGERWERK AG & CO. KGAA TWIN STAR 55 PLUS; FILTER, DISPOSABLE Back to Search Results
Catalog Number MP05805
Device Problems Mechanical Problem (1384); Obstruction of Flow (2423)
Patient Problem Low Oxygen Saturation (2477)
Event Date 02/06/2023
Event Type  Injury  
Event Description
It was reported that an intubated patient with no signs of deterioration for more than 24 hours desaturates for no apparent reason.A twinstar 55 plus filter was in use.Despite the increase of the fio2 the patient does not improve his oxygen level.It was tried to infuse oxygen manually, but there were not changes.The patient had to be sedated and curarized again.After 5 minutes, the filter was changed and the patient recovered a normal oxygen level.Reportedly, the filter was so saturated that it was impossible to ventilate the patient.
 
Manufacturer Narrative
The investigation is still on-going.The results will be provided with a follow-up report.H3 other text : on-going.
 
Manufacturer Narrative
For investigation the affected filter was requested and questions have been asked.Unfortunately, we have neither received the component nor answers to our questions, so that a case-specific analysis was not possible.Laboratory tests carried out to date have not shown any deviation from the product specification, nor has it been possible to identify a production failure.Nevertheless, we received similar cases of increased inspiratory resistance resulting in insufficient ventilation, which may be related to formation of condensate in the filter housing.The current ifu advises the user to replace the filters once there is condensate visible on the device side of the filter.It was concluded that this is not sufficient and the risk assessment determined that the residual risk is not acceptable.All customers of hme twinstar plus filters are informed about the identified risk with a field safety notice.They will be advised that the hme twinstar plus products can be continued to be used as long as both airway pressure and volume are permanently monitored and alarm limits for each patient are suitably selected.The user is also advised that in case of an increased resistance the filter needs to be replaced.The instructions for use will be revised accordingly.H3 other text : device not available for investigation.
 
Event Description
It was reported that an intubated patient with no signs of deterioration for more than 24 hours desaturates for no apparent reason.A twinstar 55 plus filter was in use.Despite the increase of the fio2 the patient does not improve his oxygen level.It was tried to infuse oxygen manually, but there were not changes.The patient had to be sedated and curarized again.After 5 minutes, the filter was changed and the patient recovered a normal oxygen level.Reportedly, the filter was so saturated that it was impossible to ventilate the patient.
 
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Brand Name
TWIN STAR 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 Key16945483
MDR Text Key315372691
Report Number9611500-2023-00186
Device Sequence Number1
Product Code OFP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberMP05805
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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