MAQUET HL20 TWIN PUMP
Received Feb 3, 2015 · Event occurred Sep 25, 2014
Report 8010762-2015-00053 · MDR key 4491482
Device
Product problems
- Device Stops Intermittently
- Device Displays Incorrect Message
Patient
NA · Unknown
- No Consequences Or Impact To Patient
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE SAFETY-S ERROR REFERS TO A FAILURE REGARDING A RECURRING DEVIATION BETWEEN THE MEASURED AND THE SET VALUE OF PUMP SPEED OF AT LEAST 10%. EXAMPLE: THE PUMP SPEED IS SET WITH 1000 ROUNDS PER MINUTES (RPM) AND THE ACTUAL SPEED IS MEASURED ON THE PUMP HEAD WITH GREATER THAN 1100 RPM. IN ORDER TO PROTECT THE PUMP FROM EXCESSIVE PUMP SPEED, AN AUTOMATIC PUMP STOP IS GENERATED TOGETHER WITH THE SAFETY-S ERROR. IN ORDER TO RESTART THE PUMP, THE USER HAS TO FOLLOW THE INSTRUCTION IS THE USER MANUAL. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT DURING SURGERY, THE CARDIOPLEGIA SLAVE PUMP (ON THE TWIN ROLLER PUMP) STOPPED WITH THE ERROR MESSAGE SAFETY-S. NO REPORTED PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).
Additional Manufacturer Narrative
UNABLE TO CONFIRM THE FAILURE DUE TO NOT GETTING INFORMATION FROM THE CUSTOMER. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.
Description of Event or Problem
ADDITIONAL INFORMATION: REFERENCE: (B)(4).