2008T HD SYS. CDX W/BIBAG BLUE STAR
Report
- Report Number
- 0002937457-2022-01475
- Event Type
- Injury
- Date Received
- September 7, 2022
- Date of Event
- August 17, 2022
- Report Date
- September 16, 2022
- Manufacturer
- CONCORD MANUFACTURING
- Product Code
- KDI
- UDI-DI
- 00840861102099
- PMA / PMN Number
- K173972
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
PLANT INVESTIGATION: THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY. CLINICAL INVESTIGATION: THERE IS A TEMPORAL RELATIONSHIP BETWEEN HEMODIALYSIS THERAPY UTILIZING THE 2008T HD SYS. CDX W/BIBAG BLUE STAR AND THE PATIENT EVENT OF AN UNSPECIFIED ADVERSE EVENT DUE TO CARDIAC ISSUES. HOWEVER, THERE IS NO DOCUMENTATION IN THE COMPLAINT FILE TO SHOW A CAUSAL RELATIONSHIP BETWEEN THE ADVERSE EVENT AND USE OF THE HD MACHINE. THE REPORTED EVENT WAS SAID TO HAVE BEEN CAUSED BY CARDIAC ISSUES (UNSPECIFIED). PATIENTS WITH CHRONIC KIDNEY DISEASE (CKD) EXHIBIT AN ELEVATED CARDIOVASCULAR RISK MANIFESTING AS CORONARY ARTERY DISEASE, HEART FAILURE, ARRHYTHMIAS, AND SUDDEN CARDIAC DEATH. BASED ON THE LIMITED INFORMATION AND NO EVIDENCE OF A MALFUNCTION OR DEFICIENCY, THE 2008T HD SYS. CDX W/BIBAG BLUE STAR CAN BE EXCLUDED AS THE CAUSE OF THE PATIENT¿S ADVERSE EVENT.
ADDITIONAL INFORMATION: A1, A2, A3, A4, A5, B3, B5, B7, G2, H6 HEALTH EFFECT - CLINICAL CODE SECTION, H10 CLINICAL INVESTIGATION CLINICAL INVESTIGATION: THERE IS A TEMPORAL RELATIONSHIP BETWEEN HEMODIALYSIS THERAPY UTILIZING THE 2008T HD SYS. CDX W/BIBAG BLUE STAR AND THE PATIENT EVENT OF CHEST PAIN WITH TRANSPORT TO THE ER AND HOSPITALIZATION. HOWEVER, THERE IS NO DOCUMENTATION IN THE COMPLAINT FILE TO SHOW A CAUSAL RELATIONSHIP BETWEEN THE ADVERSE EVENT AND USE OF THE HD MACHINE. PRIOR TO THE START OF TREATMENT, THE PATIENT COMPLAINED OF HEARTBURN WHICH LATER ESCALATED TO CHEST PAIN AND GASPING BREATH. NITROGLYCERIN RESOLVED THE PAIN SUGGESTING THE ISSUE WAS CARDIAC IN NATURE AS NITROGLYCERIN IS USED FOR CHEST PAIN. THE DRUG OPENS UP THE BLOOD VESSELS AND ALLOWS BLOOD TO FLOW. IN ADDITION, THE PATIENT HAS A COMORBID CONDITION OF HYPERKALEMIA WHICH CAN ALSO CAUSE CHEST PAIN AND SHORTNESS OF BREATH. PATIENTS WITH CHRONIC KIDNEY DISEASE (CKD) EXHIBIT AN ELEVATED CARDIOVASCULAR RISK MANIFESTING AS CORONARY ARTERY DISEASE, HEART FAILURE, ARRHYTHMIAS, AND SUDDEN CARDIAC DEATH. BASED ON THE AVAILABLE INFORMATION AND NO EVIDENCE OF A MALFUNCTION OR DEFICIENCY, THE 2008T HD SYS. CDX W/BIBAG BLUE STAR CAN BE EXCLUDED AS THE CAUSE OF THE PATIENT¿S ADVERSE EVENT.
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 INTO THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO BE CONFIRMED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.
IT WAS REPORTED THAT A HEMODIALYSIS (HD) PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT DUE TO CARDIAC ISSUES WHILE DIALYZING ON A 2008T HD SYS. CDX W/BIBAG BLUE STAR. THE PATIENT WAS SENT TO THE HOSPITAL AND WAS RECOVERING. THE BIOMEDICAL TECHNICIAN (BMT) STATED THAT THEY CHECKED ULTRAFILTRATION (UF) CALIBRATION AND FOUND THAT AT 24 STROKES THE MACHINE DELIVERED 24.3ML OF FLUID. ALL OF THE HYDRAULIC PRESSURES, CONDUCTIVITY, TEMPERATURE, ARTERIAL, DIALYSATE, AND VENOUS PRESSURES WERE WITHIN SPECIFICATIONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.
IT WAS REPORTED THAT A HEMODIALYSIS (HD) PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT DUE TO CARDIAC ISSUES WHILE DIALYZING ON A 2008T HD SYS. CDX W/BIBAG BLUE STAR. THE PATIENT WAS SENT TO THE HOSPITAL AND WAS RECOVERING. THE BIOMEDICAL TECHNICIAN (BMT) STATED THAT THEY CHECKED ULTRAFILTRATION (UF) CALIBRATION AND FOUND THAT AT 24 STROKES THE MACHINE DELIVERED 24.3ML OF FLUID. ALL OF THE HYDRAULIC PRESSURES, CONDUCTIVITY, TEMPERATURE, ARTERIAL, DIALYSATE, AND VENOUS PRESSURES WERE WITHIN SPECIFICATIONS. ADDITIONAL INFORMATION WAS PROVIDED THROUGH THE FACILITY ADMINISTRATOR ON (B)(6) 2022. ON (B)(6) 2022 THIS FEMALE PATIENT ARRIVED FOR A REGULARLY SCHEDULED HD TREATMENT. THE PATIENT COMPLAINED OF HEARTBURN. THE TREATMENT WAS INITIATED ON A 2008T HD SYS. CDX W/BIBAG BLUE STAR WITH A 180NRE OPTIFLUX DIALYZER. THE BLOOD FLOW RATE WAS 400 AND THE DIALYSATE FLOW RATE WAS 500ML/MIN. APPROXIMATELY 40 MINUTES INTO THE TREATMENT AT 1305 HOURS, THE PATIENT COMPLAINED OF CHEST PAIN UNDER THE LOWER PAT OF THE STERNUM WITH A RATING OF 8/10. THE PATIENT STATED THAT SHE WAS GASPING. THE PATIENT WAS ALERT AND ORIENTED TIMES THREE (TO PEOPLE, PLACE, AND TIME). THERE WAS NO DIAPHORESIS, AND NO CYANOSIS NOTED. THE PATIENT¿S BLOOD PRESSURE (BP) WAS 155/86, HEART RATE (HR) 89, RESPIRATORY RATE (RR) 18. THIS INFORMATION WAS COMMUNICATED TO THE DOCTOR WHO SUGGESTED THE PATIENT BE TAKEN OFF THE DIALYSIS TREATMENT AND SENT TO THE EMERGENCY ROOM (ER) FOR EVALUATION. THE PATIENT WAS GIVEN 0.4MG NITROGLYCERIN SUBLINGUAL PER THE DOCTOR¿S SUGGESTION. ADDITIONALLY, THE PATIENT WAS ADMINISTERED OXYGEN AND AT DISCONNECT WAS GIVEN 250ML NORMAL SALINE RINSE BACK. THE PATIENT WAS INFORMED OF THE DOCTOR¿S RECOMMENDATION AND INITIALLY DECLINED TRANSPORT TO THE ER STATING IT WAS JUST HEARTBURN AND THAT THE PAIN HAD RESOLVED AFTER TAKING THE NITROGLYCERIN. THE PATIENT EVENTUALLY AGREED TO GO TO THE ER AFTER BEING TOLD THE IMPORTANCE OF AN EVALUATION AND FINDING THE CAUSE OF THE CHEST PAIN. 911 WAS CALLED. THE PATENT WAS TRANSPORTED TO THE ER AT APPROXIMATELY 1330 HOURS AND ADMITTED TO THE HOSPITAL FOR CHEST PAIN. THE PATIENT UNDERWENT A STRESS TEST AND LABS WERE DRAWN FOR TROPONIN LEVELS (VALUES NOT PROVIDED). ALL TESTS WERE NORMAL. THE CAUSE OF THE PATIENT¿S CHEST PAIN WAS NOT CONFIRMED. IT IS UNKNOWN IF THE PATIENT'S ADVERSE EVENT WAS RELATED TO ANY FRESENIUS DEVICE(S) OR PRODUCT(S) AND/OR THEIR DIALYSIS THERAPY. THE PATIENT WAS DISCHARGED ON (B)(6) 2022 AND RETURNED TO REGULARLY SCHEDULED HD TREATMENTS ON (B)(6) 2022. NO FURTHER INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT A HEMODIALYSIS (HD) PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT DUE TO CARDIAC ISSUES WHILE DIALYZING ON A 2008T HD SYS. CDX W/BIBAG BLUE STAR. THE PATIENT WAS SENT TO THE HOSPITAL AND WAS RECOVERING. THE BIOMEDICAL TECHNICIAN (BMT) STATED THAT THEY CHECKED ULTRAFILTRATION (UF) CALIBRATION AND FOUND THAT AT 24 STROKES THE MACHINE DELIVERED 24.3ML OF FLUID. ALL OF THE HYDRAULIC PRESSURES, CONDUCTIVITY, TEMPERATURE, ARTERIAL, DIALYSATE, AND VENOUS PRESSURES WERE WITHIN SPECIFICATIONS. ADDITIONAL INFORMATION WAS PROVIDED THROUGH THE FACILITY ADMINISTRATOR ON (B)(6) 2022. ON (B)(6) 2022 THIS FEMALE PATIENT ARRIVED FOR A REGULARLY SCHEDULED HD TREATMENT. THE PATIENT COMPLAINED OF HEARTBURN. THE TREATMENT WAS INITIATED ON A 2008T HD SYS. CDX W/BIBAG BLUE STAR WITH A 180NRE OPTIFLUX DIALYZER. THE BLOOD FLOW RATE WAS 400 AND THE DIALYSATE FLOW RATE WAS 500ML/MIN. APPROXIMATELY 40 MINUTES INTO THE TREATMENT AT 1305 HOURS, THE PATIENT COMPLAINED OF CHEST PAIN UNDER THE LOWER PAT OF THE STERNUM WITH A RATING OF 8/10. THE PATIENT STATED THAT SHE WAS GASPING. THE PATIENT WAS ALERT AND ORIENTED TIMES THREE (TO PEOPLE, PLACE, AND TIME). THERE WAS NO DIAPHORESIS, AND NO CYANOSIS NOTED. THE PATIENT¿S BLOOD PRESSURE (BP) WAS 155/86, HEART RATE (HR) 89, RESPIRATORY RATE (RR) 18. THIS INFORMATION WAS COMMUNICATED TO THE DOCTOR WHO SUGGESTED THE PATIENT BE TAKEN OFF THE DIALYSIS TREATMENT AND SENT TO THE EMERGENCY ROOM (ER) FOR EVALUATION. THE PATIENT WAS GIVEN 0.4MG NITROGLYCERIN SUBLINGUAL PER THE DOCTOR¿S SUGGESTION. ADDITIONALLY, THE PATIENT WAS ADMINISTERED OXYGEN AND AT DISCONNECT WAS GIVEN 250ML NORMAL SALINE RINSE BACK. THE PATIENT WAS INFORMED OF THE DOCTOR¿S RECOMMENDATION AND INITIALLY DECLINED TRANSPORT TO THE ER STATING IT WAS JUST HEARTBURN AND THAT THE PAIN HAD RESOLVED AFTER TAKING THE NITROGLYCERIN. THE PATIENT EVENTUALLY AGREED TO GO TO THE ER AFTER BEING TOLD THE IMPORTANCE OF AN EVALUATION AND FINDING THE CAUSE OF THE CHEST PAIN. 911 WAS CALLED. THE PATENT WAS TRANSPORTED TO THE ER AT APPROXIMATELY 1330 HOURS AND ADMITTED TO THE HOSPITAL FOR CHEST PAIN. THE PATIENT UNDERWENT A STRESS TEST AND LABS WERE DRAWN FOR TROPONIN LEVELS (VALUES NOT PROVIDED). ALL TESTS WERE NORMAL. THE CAUSE OF THE PATIENT¿S CHEST PAIN WAS NOT CONFIRMED. IT IS UNKNOWN IF THE PATIENT'S ADVERSE EVENT WAS RELATED TO ANY FRESENIUS DEVICE(S) OR PRODUCT(S) AND/OR THEIR DIALYSIS THERAPY. THE PATIENT WAS DISCHARGED ON (B)(6) 2022 AND RETURNED TO REGULARLY SCHEDULED HD TREATMENTS ON (B)(6) 2022. NO FURTHER INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT A HEMODIALYSIS (HD) PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT DUE TO CARDIAC ISSUES WHILE DIALYZING ON A 2008T HD SYS. CDX W/BIBAG BLUE STAR. THE PATIENT WAS SENT TO THE HOSPITAL AND WAS RECOVERING. THE BIOMEDICAL TECHNICIAN (BMT) STATED THAT THEY CHECKED ULTRAFILTRATION (UF) CALIBRATION AND FOUND THAT AT 24 STROKES THE MACHINE DELIVERED 24.3ML OF FLUID. ALL OF THE HYDRAULIC PRESSURES, CONDUCTIVITY, TEMPERATURE, ARTERIAL, DIALYSATE, AND VENOUS PRESSURES WERE WITHIN SPECIFICATIONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1232206 | 2008T HD SYS. CDX W/BIBAG BLUE STAR | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | CONCORD MANUFACTURING | 191126 | 00840861102099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Female | Hospitalization| R | FRESENIUS BLOODLINES| FRESENIUS BLOODLINES| FRESENIUS BLOODLINES| FRESENIUS BLOODLINES| FRESENIUS DIALYZER| FRESENIUS DIALYZER| FRESENIUS DIALYZER| FRESENIUS DIALYZER |