AQUABPLUS, B2, HF 1500 KIT
Received Oct 20, 2023 · Event occurred Sep 18, 2023
Report 3010850471-2023-00080 · MDR key 17976523
Device
Product problems
- Thermal Decomposition of Device
- Thermal Decomposition of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D9, H3 PLANT INVESTIGATION: BASED ON THE PROVIDED INFORMATION THE REPORTED EVENT COULD BE CONFIRMED. THIS ISSUE IS KNOWN. THE TECHNICIAN STATED, THAT THE ISSUE WITH THE UNRESPONSIVE KEYS OCCURRED AFTER CHANGING THE POWER SUPPLY UNIT DUE TO TROUBLESHOOTING OF AN POWER OFF FAILURE AT THE AQUABPLUS. THIS FAILURE PATTERN WAS DUE TO A DEFECTIVE POWER SUPPLY. THE DEFECTIVE POWER SUPPLY UNIT WAS DISCOVERED TWO DAYS BEFORE THIS EVENT. MOST LIKELY THE MOTHERBOARD BECAME DEFECTIVE DURING REPLACEMENT OF THE POWER SUPPLY UNIT. THE ISSUE WITH THE UNRESPONSIVE KEYS WAS RESOLVED AFTER THE REPLACEMENT OF THE MOTHERBOARD. NO SAMPLE INVESTIGATION IS REQUIRED. A REVIEW OF DEVICE HISTORY RECORD(DHR) RELATED DOCUMENTATION IS NOT REQUIRED.
Description of Event or Problem
A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THERMAL DAMAGE WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR AFTER THE RO SYSTEM INITIALLY SHUT DOWN. THE REPORTED THERMAL DAMAGE OCCURRED IN STAGE 1. AN ELECTRICAL SHORT OCCURRED ON THE LOW VOLTAGE BOARD. THE BOARD ALONG WITH A CONNECTED CABLE WERE BURNED. NO BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING WERE REPORTED. THE BIOMED STATED THERE WERE NO BLOWN FUSES IDENTIFIED. THE BOARD AND THE CABLE FROM STAGE 2 WERE REMOVED AND INSTALLED INTO STAGE 1 TO RESOLVE THE REPORTED THERMAL DAMAGE. THE BIOMED FOLLOWED UP WITH FRESENIUS TECHNICAL SERVICES TO REPORT THAT THE "UP" ARROW AND GREEN "OK" BUTTON ON THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WERE UNRESPONSIVE FOLLOWING THE REPLACEMENT OF THE LOW VOLTAGE BOARD. THE BIOMED WAS INSTRUCTED BY TECHNICAL SERVICES TO RESEAT THE TOUCHPAD CABLE. DURING ADDITIONAL FOLLOW-UP THE BIOMED REPORTED THAT REPLACING THE MOTHERBOARD RESOLVED THIS ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. THE SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF THESE ISSUES.
Description of Event or Problem
A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THERMAL DAMAGE WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR AFTER THE RO SYSTEM INITIALLY SHUT DOWN. THE REPORTED THERMAL DAMAGE OCCURRED IN STAGE 1. AN ELECTRICAL SHORT OCCURRED ON THE LOW VOLTAGE BOARD. THE BOARD ALONG WITH A CONNECTED CABLE WERE BURNED. NO BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING WERE REPORTED. THE BIOMED STATED THERE WERE NO BLOWN FUSES IDENTIFIED. THE BOARD AND THE CABLE FROM STAGE 2 WERE REMOVED AND INSTALLED INTO STAGE 1 TO RESOLVE THE REPORTED THERMAL DAMAGE. THE BIOMED FOLLOWED UP WITH FRESENIUS TECHNICAL SERVICES TO REPORT THAT THE "UP" ARROW AND GREEN "OK" BUTTON ON THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WERE UNRESPONSIVE FOLLOWING THE REPLACEMENT OF THE LOW VOLTAGE BOARD. THE BIOMED WAS INSTRUCTED BY TECHNICAL SERVICES TO RESEAT THE TOUCHPAD CABLE. DURING ADDITIONAL FOLLOW-UP THE BIOMED REPORTED THAT REPLACING THE MOTHERBOARD RESOLVED THIS ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. THE SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF THESE ISSUES.
Additional Manufacturer Narrative
THE EVENT OCCURRED OUTSIDE OF THE US, THEREFORE THE PRODUCT INVOLVED WAS NOT IMPORTED TO THE US.
Description of Event or Problem
A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT THERMAL DAMAGE WAS IDENTIFIED WITHIN THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM. THE REPORTED ISSUE WAS DISCOVERED DURING MACHINE REPAIR AFTER THE RO SYSTEM INITIALLY SHUT DOWN. THE REPORTED THERMAL DAMAGE OCCURRED IN STAGE 1. AN ELECTRICAL SHORT OCCURRED ON THE LOW VOLTAGE BOARD. THE BOARD ALONG WITH A CONNECTED CABLE WERE BURNED. NO BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING WERE REPORTED. THE BIOMED STATED THERE WERE NO BLOWN FUSES IDENTIFIED. THE BOARD AND THE CABLE FROM STAGE 2 WERE REMOVED AND INSTALLED INTO STAGE 1 TO RESOLVE THE REPORTED THERMAL DAMAGE. THE BIOMED FOLLOWED UP WITH FRESENIUS TECHNICAL SERVICES TO REPORT THAT THE "UP" ARROW AND GREEN "OK" BUTTON ON THE AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM WERE UNRESPONSIVE FOLLOWING THE REPLACEMENT OF THE LOW VOLTAGE BOARD. THE BIOMED WAS INSTRUCTED BY TECHNICAL SERVICES TO RESEAT THE TOUCHPAD CABLE. DURING ADDITIONAL FOLLOW-UP THE BIOMED REPORTED THAT REPLACING THE MOTHERBOARD RESOLVED THIS ISSUE. THE RO SYSTEM HAS BEEN RETURNED TO SERVICE. THE SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THERE WAS NO PATIENT INVOLVEMENT NOR PERSONAL HARM TO ANYONE AS A RESULT OF THESE ISSUES.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: PLANT INVESTIGATION: IT WAS DETERMINED DURING COMPLETION OF THE PRODUCT INVESTIGATION THAT A BAD ELECTRICAL CONTACT AT THE 24V PLUG ON THE POWER SUPPLY UNIT IS THE CAUSE FOR THE REPORTED ISSUE. A BAD ELECTRICAL CONTACT AT THE CONTACT PIN WHICH RESULTED IN TRANSITION RESISTANCE AND HIGH THERMAL ENERGY. THIS CAN RESULT IN AN OVERHEATED AND/OR DISCOLORED ELECTRICAL CONNECTION/24V PLUG LIKE DESCRIBED WITHIN THE COMPLAINT DESCRIPTION. THIS IS A KNOWN FAILURE. A CAPA HAS BEEN OPENED TO ADDRESS THE ISSUE. A DEVICE HISTORY RECORD (DHR) REVIEW OR REVIEW OF THE MACHINE FILES IS NOT REQUIRED IN THIS CASE. TO FIX THIS ISSUE THE POWER SUPPLY UNIT AND THE POWER CONNECTION CABLE WERE REPLACED.