As discussed, I revisited this issue. From the patientsafe blog I looked at all the identified and suspected cases.
I know this is unwelcome news but I again conclude there is insufficient evidence to continue the investigation. In addition, I find no major inconsistencies between this evidence and that provided by the sponsor.
A summary of my findings is presented below:
(Note: Blog accessed 20 July 2016)
Annual Summary
| Year | Blog Cases (likely/confirmed) | Injuries |
| 2010 | 4 | 0 |
| 2011 | 2 | 1 (?) |
| 2012 | 1 | 0 |
| 2013 | 0 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 0 | 0 |
The table shows a decline in incident rate and no reported injuries since the recall in 2010.
Case Summaries
| A Series “cases of APL valve issues | |||
| Index | Desc | Date | Comment |
| A1 | Gas leak related to Draeger Primus Anaesthetic Machine. Anaesthesia, | July 2010 | Appears related
UK No injury |
| A2 | Cable trapped under Drager Fabius automatic pressure limiting valve causes inability to ventilate. | Mar 2007 | Pre-recall in 2010
|
| A3 | Wires block APL valve interfering with ventilation. APSF newslette | Q4 2011 | Appears related (wires not gas line)
USA No injury |
| A4 | Failure of ventilation due to trapped gas sample line in the adjustable pressure limit (APL) valve | Apr 2010 | Appears related
UK No injury |
| A5 | Draeger APL valve. FDA – Adverse Event Report. | Sep 2012 | Appears related
USA No injury |
| A6 | A potential hazard involving the gas sampling line and the adjustable pressure limiting valve on the Drager Apollo Anesthesia Workstation. Anesthesia & Analgesia. | Aug 2010 | Appears related
USA No injury |
| A7 | Temporary malfunction of an APL valve. BJA | Mar 2006 | Pre-recall in 2010
|
| A8 | Massive Leak During Manual Ventilation: Adjustable Pressure Limiting Valve Malfunction Not Detected by Pre-Anesthetic Checkout. Anesthesia & Analgesia. | Aug 2010 | Appears related
UAE No injury |
| A9 | Failure to Ventilate with the Drager Apollo Anesthesia Workstation. Anesthesiology, | Mar 2011 | Not related |
| A10 | Apollo Anesthesia Workplace. FDA – Adverse Event Report. | Sep 2012 | Same as A5 above |
| A11 | Accidentally opened adjustable pressure-limiting valve. Failure of manual ventilation. Anaesthesist, | Mar 2009 | Pre-recall in 2010
|
| A12 | Drager Apollo Anesthesia Workstation APL Valve on Workstation. FDA Adverse Event Report. | Sep 2014 | Appears related
USA No injury |
| A13 | Cable Trapped Under Dräger Fabius Automatic Pressure Limiting Valve Causes Inability to Ventilate. Anesthesiology | Mar 2007 | Pre-recall in 2010
|
| A14 | A Malfunction of the APL Valve (in German). Anästh Intensivmed, | Feb 2011 | Appears related (German text)
Germany Unknown injury |
| B Series (“suspected” cases posted by the blogger) | |||
| Index | Desc | Date | Comment |
| B1 | Draeger Medical AG KGAA Anesthesia Machine. Adverse Event Report. | Jul 2006 | Pre-recall in 2010
|
| B2 | Primus Anaesthesia Unit. Permanent brain injury. Adverse Event Report. | Apr 2013 | Insufficient information (similar circumstances)
USA Unknown injury |
| B3 | ‘Could not ventilate in manual mode but automatic mode ventilation worked as expected’ | Jun 2015 | May be related (unconfirmed)
USA No injury |
| B4 | ‘No positive pressure ventilation could be achieved in manual/spontaneous mode. Automatic ventilation worked as expected’. | Jul 2011 | May not be related – alternate cause assigned
USA No injury |
| B5 | Patient became hypoxic, hypotensive and bradycardic. | Jul 2011 | Appears to be the same as B4 above |
| B6 | ‘The user almost lost the patient’. | Feb 2009 | Pre-recall in 2010
|
| B7 | Unable to deliver gas flow on induction – however issue seems to exist in automatic mode also | Oct 2013 | Does not appear related – O2 flush |
| B8 | Significant circuit leak. | Jan 2013 | Does not appear related – patient disconnect |
| B9 | ‘After uneventful induction…unable to apply O2 flush or breathing pressure to the patient’ | Jan 2008 | Pre-recall in 2010
|
I have shared this information with my Director and the Principal Medical Officer and I am happy to discuss these findings with you, if required.
best regards,
patientsafe 