BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FR-4

    MDR report key: 1822771 · Received August 30, 2010

    Report

    Report Number
    3019131-2010-00001
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    May 3, 2010
    Report Date
    August 30, 2010
    Manufacturer
    G.E.M. WATER SYSTEMS INT'L LLC
    Product Code
    FIP
    PMA / PMN Number
    K944493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON AUGUST 2, 2010, B)(6) FROM B)(6) DIALYSIS CENTER CONTACTED MAR COR PURIFICATION (MCP) ASKING FOR ASSISTANCE IN DETERMINING THE ROOT CAUSE(S) OF A PYROGENIC OUTBREAK AT B)(6). BURKHOLDERIA CEPACIA COMPLEX (BCC) WAS THE IDENTIFIED BACTERIA. MCP WENT TO B)(6)I AND EVALUATED THE SITUATION. THE CONCLUSION WAS THE FACILITY WAS NOT PERFORMING REQUIRED DISINFECTIONS OF THE RO WATER SYSTEM AS INDICATED BY THE TEST RESULTS OF COLONY COUNTS AND LAL ENDOTOXIN TESTING AND DISINFECTION RECORDS. MCP'S ADULT OF THE RO WATER SYSTEM AND B)(6) PROCEDURES ALSO REVEALED A DISCONNECT BETWEEN THE PEOPLE TAKING READINGS/RECORDING TEST RESULTS AND THE PEOPLE WHO WOULD ANALYZE THE RESULTS AND TAKE APPROPRIATE CORRECTIVE ACTION. MCP GAVE TRAINING TO B)(6) PERSONNEL ON APPROPRIATELY MONITORING THE RO WATER SYSTEM. MCP IS ALSO WORKING WITH THE FACILITY TO CONTINUE THE EDUCATION OF THEIR PERSONNEL RELATIVE TO PROPER MAINTENANCE OF THE RO WATER SYSTEM AND TREND ANALYSIS OF DATA FROM THE RO WATER SYSTEM. B)(6) IS COMMITTED TO ENSURING THEY HAVE AN ON-GOING, COMPLAINT RO WATER SYSTEM. MCP IS COMMITTED TO OFFERING ASSISTANCE AND SERVICES TO THE FACILITY TO ENSURE APPROPRIATE MAINTENANCE OF THEIR RO WATER SYSTEM TO PREVENT A REOCCURRENCE OF THIS TYPE OF SITUATION.

    Description of Event or Problem · 1

    DURING THE LAST 30 MINUTES OF HEMODIALYSIS TREATMENT, SEVEN PATIENTS DEVELOPED SYMPTOMS OF INFECTION. TWO OF THESE PATIENTS WERE TREATED AT THE DIALYSIS CLINIC AND RELEASED AND FIVE OF THESE PATIENTS WERE HOSPITALIZED, TREATED AND RELEASED FROM THE HOSPITAL.

    Additional Manufacturer Narrative · 2

    ON AUGUST 2, 2010, (B)(6) FROM (B)(6) CONTACTED MAR COR PURIFICATION (MCP) ASKING FOR ASSISTANCE IN DETERMINING THE ROOT CAUSE(S) OF A PYROGENIC OUTBREAK AT (B)(6). BURKHOLDERIA CEPACIA COMPLEX (BCC) WAS THE IDENTIFIED BACTERIA. MCP WENT TO (B)(6) AND EVALUATED THE SITUATION. THE CONCLUSION WAS THE FACILITY WAS NOT PERFORMING REQUIRED DISINFECTIONS OF THE RO WATER SYSTEM AS INDICATED BY THE TEST RESULTS OF COLONY COUNTS AND LAL ENDOTOXIN TESTING AND DISINFECTION RECORDS. MCP'S ADULT OF THE RO WATER SYSTEM AND (B)(6) PROCEDURES ALSO REVEALED A DISCONNECT BETWEEN THE PEOPLE TAKING READINGS/RECORDING TEST RESULTS AND THE PEOPLE WHO WOULD ANALYZE THE RESULTS AND TAKE APPROPRIATE CORRECTIVE ACTION. MCP GAVE TRAINING TO (B)(6) PERSONNEL ON APPROPRIATELY MONITORING THE RO WATER SYSTEM. MCP IS ALSO WORKING WITH THE RELATIVE TO CONTINUE THE EDUCATION OF THEIR PERSONNEL RELATIVE TO PROPER MAINTENANCE OF THE RO WATER SYSTEM AND TREND ANALYSIS OF DATA FROM THE RO WATER SYSTEM. (B)(6) IS COMMITTED TO ENSURING THEY HAVE AN ON-GOING, COMPLAINT RO WATER SYSTEM. MCP IS COMMITTED TO OFFERING ASSISTANCE AND SERVICES TO THE FACILITY TO ENSURE APPROPRIATE MAINTENANCE OF THEIR RO WATER SYSTEM TO PREVENT A REOCCURRENCE OF THIS TYPE OF SITUATION.

    Description of Event or Problem · 2

    DURING THE LAST 30 MINUTES OF HEMODIALYSIS TREATMENT, SEVEN PATIENTS DEVELOPED SYMPTOMS OF INFECTION. TWO OF THESE PATIENTS WERE TREATED AT THE DIALYSIS CLINIC AND RELEASED AND FIVE OF THESE PATIENTS WERE HOSPITALIZED, TREATED AND RELEASED FROM THE HOSPITAL. DATE OF OCCURRENCE: B)(6)2010.

    Additional Manufacturer Narrative · 3

    ON AUGUST 2, 2010, (B)(6) FROM (B)(6) CONTACTED MAR COR PURIFICATION (MCP) ASKING FOR ASSISTANCE IN DETERMINING THE ROOT CAUSE(S) OF A PYROGENIC OUTBREAK AT (B)(6). BURKHOLDERIA CEPACIA COMPLEX (BCC) WAS THE IDENTIFIED BACTERIA. MCP WENT TO (B)(6) AND EVALUATED THE SITUATION. THE CONCLUSION WAS THE FACILITY WAS NOT PERFORMING REQUIRED DISINFECTIONS OF THE RO WATER SYSTEM AS INDICATED BY THE TEST RESULTS OF COLONY COUNTS AND LAL ENDOTOXIN TESTING AND DISINFECTION RECORDS. MCP'S ADULT OF THE RO WATER SYSTEM AND (B)(6) PROCEDURES ALSO REVEALED A DISCONNECT BETWEEN THE PEOPLE TAKING READINGS/RECORDING TEST RESULTS AND THE PEOPLE WHO WOULD ANALYZE THE RESULTS AND TAKE APPROPRIATE CORRECTIVE ACTION. MCP GAVE TRAINING TO (B)(6) PERSONNEL ON APPROPRIATELY MONITORING THE RO WATER SYSTEM. MCP IS ALSO WORKING WITH THE RELATIVE TO CONTINUE THE EDUCATION OF THEIR PERSONNEL RELATIVE TO PROPER MAINTENANCE OF THE RO WATER SYSTEM AND TREND ANALYSIS OF DATA FROM THE RO WATER SYSTEM. (B)(6) IS COMMITTED TO ENSURING THEY HAVE AN ON-GOING, COMPLAINT RO WATER SYSTEM. MCP IS COMMITTED TO OFFERING ASSISTANCE AND SERVICES TO THE FACILITY TO ENSURE APPROPRIATE MAINTENANCE OF THEIR RO WATER SYSTEM TO PREVENT A REOCCURRENCE OF THIS TYPE OF SITUATION.

    Description of Event or Problem · 3

    DURING THE LAST 30 MINUTES OF HEMODIALYSIS TREATMENT, SEVEN PATIENTS DEVELOPED SYMPTOMS OF INFECTION. TWO OF THESE PATIENTS WERE TREATED AT THE DIALYSIS CLINIC AND RELEASED AND FIVE OF THESE PATIENTS WERE HOSPITALIZED, TREATED AND RELEASED FROM THE HOSPITAL. DATE OF OCCURRENCE: (B)(6)2010.

    Additional Manufacturer Narrative · 4

    ON AUGUST 2, 2010, (B)(6) FROM (B)(6) CONTACTED MAR COR PURIFICATION (MCP) ASKING FOR ASSISTANCE IN DETERMINING THE ROOT CAUSE(S) OF A PYROGENIC OUTBREAK AT (B)(6). BURKHOLDERIA CEPACIA COMPLEX (BCC) WAS THE IDENTIFIED BACTERIA. MCP WENT TO (B)(6)AND EVALUATED THE SITUATION. THE CONCLUSION WAS THE FACILITY WAS NOT PERFORMING REQUIRED DISINFECTIONS OF THE RO WATER SYSTEM AS INDICATED BY THE TEST RESULTS OF COLONY COUNTS AND LAL ENDOTOXIN TESTING AND DISINFECTION RECORDS. MCP'S ADULT OF THE RO WATER SYSTEM AND (B)(6) PROCEDURES ALSO REVEALED A DISCONNECT BETWEEN THE PEOPLE TAKING READINGS/RECORDING TEST RESULTS AND THE PEOPLE WHO WOULD ANALYZE THE RESULTS AND TAKE APPROPRIATE CORRECTIVE ACTION. MCP GAVE TRAINING TO (B)(6) PERSONNEL ON APPROPRIATELY MONITORING THE RO WATER SYSTEM. MCP IS ALSO WORKING WITH THE RELATIVE TO CONTINUE THE EDUCATION OF THEIR PERSONNEL RELATIVE TO PROPER MAINTENANCE OF THE RO WATER SYSTEM AND TREND ANALYSIS OF DATA FROM THE RO WATER SYSTEM. (B)(6) IS COMMITTED TO ENSURING THEY HAVE AN ON-GOING, COMPLAINT RO WATER SYSTEM. MCP IS COMMITTED TO OFFERING ASSISTANCE AND SERVICES TO THE FACILITY TO ENSURE APPROPRIATE MAINTENANCE OF THEIR RO WATER SYSTEM TO PREVENT A REOCCURRENCE OF THIS TYPE OF SITUATION.

    Description of Event or Problem · 4

    DURING THE LAST 30 MINUTES OF HEMODIALYSIS TREATMENT, SEVEN PATIENTS DEVELOPED SYMPTOMS OF INFECTION. TWO OF THESE PATIENTS WERE TREATED AT THE DIALYSIS CLINIC AND RELEASED AND FIVE OF THESE PATIENTS WERE HOSPITALIZED, TREATED AND RELEASED FROM THE HOSPITAL. DATE OF OCCURRENCE: (B)(6)2010.

    Additional Manufacturer Narrative · 5

    ON AUGUST 2, 2010, (B)(6) FROM (B)(6) CONTACTED MAR COR PURIFICATION (MCP) ASKING FOR ASSISTANCE IN DETERMINING THE ROOT CAUSE(S) OF A PYROGENIC OUTBREAK AT (B)(6). BURKHOLDERIA CEPACIA COMPLEX (BCC) WAS THE IDENTIFIED BACTERIA. MCP WENT TO (B)(6) AND EVALUATED THE SITUATION. THE CONCLUSION WAS THE FACILITY WAS NOT PERFORMING REQUIRED DISINFECTIONS OF THE RO WATER SYSTEM AS INDICATED BY THE TEST RESULTS OF COLONY COUNTS AND LAL ENDOTOXIN TESTING AND DISINFECTION RECORDS. MCP'S ADULT OF THE RO WATER SYSTEM AND (B)(6) PROCEDURES ALSO REVEALED A DISCONNECT BETWEEN THE PEOPLE TAKING READINGS/RECORDING TEST RESULTS AND THE PEOPLE WHO WOULD ANALYZE THE RESULTS AND TAKE APPROPRIATE CORRECTIVE ACTION. MCP GAVE TRAINING TO (B)(6) PERSONNEL ON APPROPRIATELY MONITORING THE RO WATER SYSTEM. MCP IS ALSO WORKING WITH THE RELATIVE TO CONTINUE THE EDUCATION OF THEIR PERSONNEL RELATIVE TO PROPER MAINTENANCE OF THE RO WATER SYSTEM AND TREND ANALYSIS OF DATA FROM THE RO WATER SYSTEM. (B)(6) IS COMMITTED TO ENSURING THEY HAVE AN ON-GOING, COMPLAINT RO WATER SYSTEM. MCP IS COMMITTED TO OFFERING ASSISTANCE AND SERVICES TO THE FACILITY TO ENSURE APPROPRIATE MAINTENANCE OF THEIR RO WATER SYSTEM TO PREVENT A REOCCURRENCE OF THIS TYPE OF SITUATION.

    Description of Event or Problem · 5

    DURING THE LAST 30 MINUTES OF HEMODIALYSIS TREATMENT, SEVEN PATIENTS DEVELOPED SYMPTOMS OF INFECTION. TWO OF THESE PATIENTS WERE TREATED AT THE DIALYSIS CLINIC AND RELEASED AND FIVE OF THESE PATIENTS WERE HOSPITALIZED, TREATED AND RELEASED FROM THE HOSPITAL. DATE OF OCCURRENCE: (B)(6)2010.

    Additional Manufacturer Narrative · 6

    ON AUGUST 2, 2010, (B)(6) FROM (B)(6) CONTACTED MAR COR PURIFICATION (MCP) ASKING FOR ASSISTANCE IN DETERMINING THE ROOT CAUSE(S) OF A PYROGENIC OUTBREAK AT (B)(6). BURKHOLDERIA CEPACIA COMPLEX (BCC) WAS THE IDENTIFIED BACTERIA. MCP WENT TO (B)(6) AND EVALUATED THE SITUATION. THE CONCLUSION WAS THE FACILITY WAS NOT PERFORMING REQUIRED DISINFECTIONS OF THE RO WATER SYSTEM AS INDICATED BY THE TEST RESULTS OF COLONY COUNTS AND LAL ENDOTOXIN TESTING AND DISINFECTION RECORDS. MCP'S ADULT OF THE RO WATER SYSTEM AND (B)(6) PROCEDURES ALSO REVEALED A DISCONNECT BETWEEN THE PEOPLE TAKING READINGS/RECORDING TEST RESULTS AND THE PEOPLE WHO WOULD ANALYZE THE RESULTS AND TAKE APPROPRIATE CORRECTIVE ACTION. MCP GAVE TRAINING TO (B)(6) PERSONNEL ON APPROPRIATELY MONITORING THE RO WATER SYSTEM. MCP IS ALSO WORKING WITH THE RELATIVE TO CONTINUE THE EDUCATION OF THEIR PERSONNEL RELATIVE TO PROPER MAINTENANCE OF THE RO WATER SYSTEM AND TREND ANALYSIS OF DATA FROM THE RO WATER SYSTEM. (B)(6) IS COMMITTED TO ENSURING THEY HAVE AN ON-GOING, COMPLAINT RO WATER SYSTEM. MCP IS COMMITTED TO OFFERING ASSISTANCE AND SERVICES TO THE FACILITY TO ENSURE APPROPRIATE MAINTENANCE OF THEIR RO WATER SYSTEM TO PREVENT A REOCCURRENCE OF THIS TYPE OF SITUATION.

    Description of Event or Problem · 6

    DURING THE LAST 30 MINUTES OF HEMODIALYSIS TREATMENT, SEVEN PATIENTS DEVELOPED SYMPTOMS OF INFECTION. TWO OF THESE PATIENTS WERE TREATED AT THE DIALYSIS CLINIC AND RELEASED AND FIVE OF THESE PATIENTS WERE HOSPITALIZED, TREATED AND RELEASED FROM THE HOSPITAL. DATE OF OCCURRENCE: (B)(6)2010.

    Additional Manufacturer Narrative · 7

    ON AUGUST 2, 2010, (B)(6) FROM (B)(6) CONTACTED MAR COR PURIFICATION (MCP) ASKING FOR ASSISTANCE IN DETERMINING THE ROOT CAUSE(S) OF A PYROGENIC OUTBREAK AT (B)(6). BURKHOLDERIA CEPACIA COMPLEX (BCC) WAS THE IDENTIFIED BACTERIA. MCP WENT TO (B)(6) AND EVALUATED THE SITUATION. THE CONCLUSION WAS THE FACILITY WAS NOT PERFORMING REQUIRED DISINFECTIONS OF THE RO WATER SYSTEM AS INDICATED BY THE TEST RESULTS OF COLONY COUNTS AND LAL ENDOTOXIN TESTING AND DISINFECTION RECORDS. MCP'S ADULT OF THE RO WATER SYSTEM AND (B)(6) PROCEDURES ALSO REVEALED A DISCONNECT BETWEEN THE PEOPLE TAKING READINGS/RECORDING TEST RESULTS AND THE PEOPLE WHO WOULD ANALYZE THE RESULTS AND TAKE APPROPRIATE CORRECTIVE ACTION. MCP GAVE TRAINING TO (B)(6) PERSONNEL ON APPROPRIATELY MONITORING THE RO WATER SYSTEM. MCP IS ALSO WORKING WITH THE RELATIVE TO CONTINUE THE EDUCATION OF THEIR PERSONNEL RELATIVE TO PROPER MAINTENANCE OF THE RO WATER SYSTEM AND TREND ANALYSIS OF DATA FROM THE RO WATER SYSTEM. (B)(6) IS COMMITTED TO ENSURING THEY HAVE AN ON-GOING, COMPLAINT RO WATER SYSTEM. MCP IS COMMITTED TO OFFERING ASSISTANCE AND SERVICES TO THE FACILITY TO ENSURE APPROPRIATE MAINTENANCE OF THEIR RO WATER SYSTEM TO PREVENT A REOCCURRENCE OF THIS TYPE OF SITUATION.

    Description of Event or Problem · 7

    DURING THE LAST 30 MINUTES OF HEMODIALYSIS TREATMENT, SEVEN PATIENTS DEVELOPED SYMPTOMS OF INFECTION. TWO OF THESE PATIENTS WERE TREATED AT THE DIALYSIS CLINIC AND RELEASED AND FIVE OF THESE PATIENTS WERE HOSPITALIZED, TREATED AND RELEASED FROM THE HOSPITAL. DATE OF OCCURRENCE: (B)(6)2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FR-4 REVERSE OSMOSIS SYSTEM FIP G.E.M. WATER SYSTEMS INT'L LLC 12 GPM, 7.5 HP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization
    2
    3
    4
    5
    6
    7