inforMED
MalfunctionONW

2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP

Received Jul 21, 2022 · Event occurred Jul 6, 2022

Report 0002937457-2022-01215 · MDR key 15076016

Device

Generic name

Hemodialysis System For Home Use

Model number

190395

Catalog number

190395

Product problems

  • Mechanical Problem
  • Reflux within Device
  • Mechanical Problem
  • Reflux within Device

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Description of Event or Problem

A BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT A 2008K@HOME HEMODIALYSIS (HD) MACHINE HAD A SALINE BAG BACKFILL WHILE RECIRCULATING DURING SET-UP FOR USE. THE MACHINE PROVIDED AN AUDIBLE ALARM ALONG WITH A ¿10 FILL PGM IN 1 HR¿ ERROR MESSAGE. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT. THE BIOMED REPORTED THAT THE MACHINE DOES NOT HAVE THE AIR SEPARATOR ADAPTER BOARD INSTALLED. THE FRESENIUS TECHNICAL SUPPORT REPRESENTATIVE ADVISED THE BIOMED TO INSTALL THE AIR SEPARATOR BOARD AND PROVIDED PART INFORMATION. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Description of Event or Problem

A BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT A 2008K@HOME HEMODIALYSIS (HD) MACHINE HAD A SALINE BAG BACKFILL WHILE RECIRCULATING DURING SET-UP FOR USE. THE MACHINE PROVIDED AN AUDIBLE ALARM ALONG WITH A ¿10 FILL PGM IN 1 HR¿ ERROR MESSAGE. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT. THE BIOMED REPORTED THAT THE MACHINE DOES NOT HAVE THE AIR SEPARATOR ADAPTER BOARD INSTALLED. THE FRESENIUS TECHNICAL SUPPORT REPRESENTATIVE ADVISED THE BIOMED TO INSTALL THE AIR SEPARATOR BOARD AND PROVIDED PART INFORMATION. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION WAS PERFORMED BY A FRESENIUS FIELD SERVICE TECHNICIAN (FST). A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE INVESTIGATION DID NOT DETERMINE A CAUSAL RELATIONSHIP BETWEEN THE OBJECTIVE EVIDENCE AND THE ALLEGED EVENT, THEREFORE THE REPORTED ISSUE IS NOT CONFIRMED.