SINGLE ROLLER PUMP MODULE
Received Feb 26, 2015 · Event occurred Jan 19, 2015
Report 8010762-2015-00118 · MDR key 4562023
Device
Product problems
- Device Displays Incorrect Message
- Insufficient Device Problem Information
Patient
Not reported
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT ONE OF THE RPM 20'S RAN AT FULL SPEED MOMENTARILY. THIS HAPPENED JUST AFTER THE CASE WHILE EMPTYING THE VENT LINES. NO REPORTED PATIENT EFFECT. (B)(4).
Additional Manufacturer Narrative
FIELD SAFETY TECHNICIAN HAS BEEN INVESTIGATED AND FOUND FAILURE REPORTED. HE ADDED THE GROUNDING AND NO FURTHER INSTANCES SINCE THEN. THUS THE FAILURE COULD BE CONFIRMED. 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.
Additional Manufacturer Narrative
A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). BOTH PRODUCTS ARE COMPONENTS OF THE HL20 INTEGRATED PERFUSION SYSTEM CLEARED UNDER 51(K) K943803.