MEDFUSION 4000 PUMP
Received Dec 2, 2021
Report 3012307300-2021-12172 · MDR key 12921872
Device
Product problems
- Audible Prompt/Feedback Problem
- Audible Prompt/Feedback Problem
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
INFORMATION WAS RECEIVED REGARDING A MEDFUSION 4000 PUMP. IT WAS REPORTED THAT 64 PUMPS HAD SEVEN OR MORE ACU WATCHDOG ALERTS FROM JANUARY THROUGH OCTOBER, 2021. IT WAS LATER ADDED THAT THERE WERE PRIMARY AUDIBLE ALARMS, A SLIGHT CRACK ON THE BATTERY DOOR AROUND THE SCREW, AND A NON-OEM POWER CORD, NON OEM SPEAKER, AND A REMOVED J9 GLUE. CUSTOMER COULD NOT DETERMINE THE CAUSE OF THE ALERTS. IT IS UNKNOWN IF THERE WAS ANY PATIENT, OR CLINICIAN INJURY ASSOCIATED WITH THIS PARTICULAR OCCURRENCE.
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM MANAGER OF CUSTOMER AND TECHNICAL SUPPORT AND ATTACHED IN COMPLAINT: NO FURTHER INFORMATION AVAILABLE. THE CUSTOMER HAS BEEN FILING THESE GENERIC COMPLAINTS BASED ON SERVER REPORTS THEY ARE GENERATING THEMSELVES. AS FAR AS THE CUSTOMER KNOWS, THEY ARE NOT PULLING INDIVIDUAL EVENT HISTORY LOG (EHL) FROM PUMPS, THEY ARE JUST FILTERING REPORTS TO SHOW AUXILIARY CONTROL UNIT (ACU) WATCHDOG FAILURE. THERE WAS NO PATIENT INJURY.
Additional Manufacturer Narrative
THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4) AS A RESULT OF WARNING LETTER CMS#(B)(4). NO MANUFACTURING OR SERVICE ISSUES WERE IDENTIFIED AS CAUSES OF THE CUSTOMER'S REPORTED PROBLEM DURING THE REVIEW OF SERVICE AND REPAIR RECORDS. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED. THE TAMPER SEAL WAS REMOVED/BROKEN ON THE BOTTOM CASE AND A CRACK ON THE RIGHT PLUNGER CASE WAS VISUALLY NOTED. THE EVENT HISTORY LOG (EHL) SHOWED AN AUXILIARY CONTROL UNIT (ACU) WATCHDOG ALARM AND PRIMARY AUDIBLE ALARM POST ALARMS. DURING THE POWER UP PROCESS AND AUDIO TEST THE DEVICE WORKED AS INTENDED. THE FUNCTIONAL TESTING VERIFIED THAT THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS WORKING AS INTENDED AND WAS UNABLE TO DUPLICATE THE ERROR MESSAGES NOTED IN THE EHL. ALL FUNCTIONAL TESTS WERE PERFORMED, AND NO PROBLEM WAS FOUND ON THE MAIN PRINTED CIRCUIT BOARD (PCB). THE EVALUATION WAS UNABLE TO DETERMINE WHAT CAUSED THE INTERMITTENT ERRORS AND THEREFORE, THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE DEVICE PASSED ALL FUNCTIONAL/DELIVERY TESTS., CORRECTED DATA: D1: BRAND NAME.