inforMED
InjuryBTC

ANASTHESIESET VENTSTAR

Received Jan 17, 2019

Report 9611500-2019-00012 · MDR key 8256222

Device

Generic name

Breathing Hose, Disposable

Model number

NA

Catalog number

MP00371

Lot number

NA

Product problems

  • Connection Problem
  • Electrical Shorting

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

THE AFFECTED BREATHING CIRCUIT IS A VENTSTAR WF 180 DISPOSABLE ANESTHESIA KIT, WHERE THE TUBING IS NOT BONDED TO THE Y-PIECE. THE INSTRUCTIONS FOR USE OF THE BREATHING CIRCUITS DESCRIBE THE SETUP OF HOSES, WATER TRAPS AND Y-PIECE SCHEMATICALLY. AS REPORTED, THE HOSES LOOSENED FROM THE Y-PIECE IN THE PACKAGING. THIS IS OBVIOUS TO THE USER. IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, ALL CONNECTIONS MUST BE CHECKED FOR PROPER SEATING AND TIGHTNESS BEFORE USE. THE BREATHING CIRCUIT HAD BEEN RECONNECTED BY THE USER, WHEREBY APPARENTLY BOTH CONNECTORS OF THE Y-PIECE WERE SHORT-CIRCUITED. SUCH AN ERROR IS EASILY RECOGNIZABLE BEFORE USE BECAUSE THE COMPONENTS DO NO LONGER FORM A COHERENT SYSTEM, BUT TWO DECOUPLED SUBSYSTEMS IN THIS PARTICULAR CASE, THE INCORRECT ASSEMBLY APPARENTLY WAS NOT DETECTED PRIOR TO USE AND THE SHORTED SYSTEM WAS USED ON THE PATIENT. AS A RESULT, THERE WERE PROBLEMS DURING THE SURGERY THAT LED TO THE DECISION TO CANCEL THE CASE, WHICH HAD TO BE RESCHEDULED THREE DAYS LATER. SINCE NEITHER PHOTOS NOR THE BREATHING SYSTEM WAS AVAILABLE FOR EXAMINATION, THE REPORTED ERROR COULD NEITHER BE CONFIRMED NOR RULED-OUT. NO FURTHER INCIDENTS WITH THE SAME ROOT CAUSE "TUBE SYSTEM NOT PLUGGED TOGETHER IN THE PACKAGE" ARE KNOWN. DUE TO THE FACT THAT DRÄGER BECAME AWARE OF OTHER EVENTS WITH SHORT-CIRCUITED BREATHING CIRCUITS DRÄGER ISSUED A FIELD SAFETY NOTICE END OF 2018 TO ALERT USERS TO THE NEED FOR CAREFUL PRE-APPLICATION TESTING.

Description of Event or Problem

PLEASE REFER TO THE INITIAL-REPORT.

Additional Manufacturer Narrative

THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW UP-REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THE HOSE SYSTEM HAD FALLEN APART BEFORE OPERATION AND HAD TO BE RE-CONNECTED AGAIN BY THE USER. THEREBY THE BREATHING CIRCUIT HAD NOT BEEN CONNECTED PROPERLY, REPORTEDLY IT WAS SHORT-CIRCUITED LEADING TO PROBLEMS DURING OPERATION AND SUBSEQUENTLY TO A SHIFT OF THE SURGERY. A PERMANENT PATIENT INJURY WAS NOT REPORTED.