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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PRIMUS; ANESTHESIA UNITS
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DRÄGERWERK AG & CO. KGAA PRIMUS; ANESTHESIA UNITS Back to Search Results
Device Problems Complete Blockage (1094); Gas Output Problem (1266)
Patient Problem Low Oxygen Saturation (2477)
Event Date 11/24/2021
Event Type  Injury  
Event Description
It was reported, that after starting an anesthesia case with a dräger primus anesthesia workstation the patient could not be ventilated.The patient desaturated and finally required resuscitation.Reportedly the filter was blocked.
 
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Manufacturer Narrative
The affected safestar 55 was available for investigation.The reported blockage/occlusion could be confirmed.An isolated manufacturing failure was identified as the root cause.During the manufacturing process glue is applied to fix the filter medium inside the housing.It cannot be completely avoided that excessive glue causes an occlusion of the filter medium.In order to detect occlusions the manufacturing process of the safestar 55 includes an automatic 100% resistance test including and an automized destruction of those parts which fail the test.Based on the analyses performed at supplier site, this particular case could be attributed to a maintenance of the production equipment.During the time of the maintenance (first week in march 2021), the manufacturing process was performed in a manual mode, in which the automatic destruction routine is not active.As a result, this occluded filter was not scrapped and finally shipped.The supplier has already performed addtional training of the relevant staff to ensure that the automatic process must be followed at any time.Based on the numbers of devices sold and the estimated time periods for delivery and usage, dräger concludes that safestar 55, manufactured during this particular week in march 2021, are no longer in the market.The instructions for use contain a corresponding warning: ¿risk of malfunction obstructions, damage and foreign matter can lead to malfunction.Check all system components for obstructions, damage, and foreign matter before installation¿ in case completely occluded safestar 55 is put into operation anyway, the patient cannot be ventilated.This will be readily apparent for the user by means of the main device¿s pressure and flow and fio2-monitoring.Corresponding alarms will be generated.
 
Event Description
It was reported, that after starting an anesthesia case with a dräger primus anesthesia workstation the patient could not be ventilated.The patient desaturated and finally required resuscitation.Reportedly the filter was blocked.
 
Manufacturer Narrative
Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field.H3.- not returned to manufacturer.
 
Event Description
It was reported, that after starting an anesthesia case with a dräger primus anesthesia workstation the patient could not be ventilated.The patient desaturated and finally required resuscitation.Reportedly the filter was blocked.
 
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Brand Name
PRIMUS
Type of Device
ANESTHESIA UNITS
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM   23542
MDR Report Key12915240
MDR Text Key281653739
Report Number9611500-2021-00489
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K042607
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
NA.; NA.; NA.
Patient Outcome(s) Required Intervention; Life Threatening;
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