SOURCE: Based on True Story
AUDIENCE: Risk Manager, Care Personal
ISSUE: In case the medical device is exposed to low frequency vibrations (rotating parts or motors) it may cause the pins within the internal cable that connects to essential parts of the device to become loose over time. The loose pins may prevent data to be transferred between the essential components of the device to the control board, triggering the device to shut down unexpectedly and/or to sound an alarm. An unexpected stop in device therapy may cause serious adverse health consequences, including death.
- Update training programs and perform actions to have appropriately trained personnel
- Give failure probability estimation (Low/Med/High)
- Ensure an alternative form of similar device is available at all times, including intra-hospital transport (e.g. manual transport bag).
- Operate the device as directed in the operator’s manual including:
- promptly attend all alarms presented by the device;
- use an external replacement alternative, and to set the alarm thresholds appropriately;
- ensure the correct circuits identified in the operator’s manual are being used;
- When possible, connect the device to a remote call system.
- List possible error codes and mitigation actions:
- turn the device off
- discontinue use of the device
- use an alternate device
- call your local customer service contact and report the failure by referencing.
On the preventive action you may consider change in the design of those connector and to reinforce the connectors by mechanical secured connection to prevent vibration impact on the connectors due to friction in the connectors pins.
ORCANOS | MEDICAL: Our recommendation with the use of ORCANOS | MEDICAL Risk management system is to include this risk identification in your RMF file managed by ORCANOS system and create traceability to:
- DMS Item – Release new training program
- Requirement Management – New design requirements to address the issue
- RISK – Risk identification
- V&V – Verification and Validation test protocols
- e-DHR System – update working procedures as needed.
- CAPA – Manage CAPA form and traceability to RISK and Complaint
- ECO – Issue new ECO and trace all releases with the ECO