DIALOG+®
Report
- Report Number
- 3002879653-2018-00009
- Event Type
- Death
- Date Received
- October 16, 2018
- Date of Event
- October 12, 2018
- Report Date
- November 21, 2018
- Manufacturer
- B. BRAUN AVITUM AG - MELSUNGEN
- Product Code
- KDI
- UDI-DI
- 04046963686345
- PMA / PMN Number
- K963440
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 003
Narratives
EXEMPTION NUMBER E2015012. B. BRAUN MEDICAL INC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN AVITUM AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN AVITUM INTERNAL REPORT # (B)(4). NEITHER THE DEVICE INVOLVED NOR THE TREND DATE HAS BEEN RECEIVED FOR EVALUATION. THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.
EXEMPTION NUMBER E2015012. B. BRAUN MEDICAL INC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN AVITUM AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN AVITUM INTERNAL REPORT # (B)(4). UPON REQUEST, THE CUSTOMER CONFIRMED THAT NO B. BRAUN AVITUM PRODUCT IS SUSPECTED TO HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THE DIALOG+ DIALYSIS MACHINE WAS TECHNICALLY INSPECTED. IT OPERATED AS INTENDED. THE ANALYSIS OF THE TREND DATA RECORD SHOWED THAT THE SELF-TEST EQUALITY OF THE BLOOD PRESSURE SENSORS HAD TO BE REPEATED ONCE. THE CAUSE FOR THE FAILURE IS NOT KNOWN FROM THE TREND DATA. IT'S POSSIBLE A CLAMP OF THE EXTRACORPOREAL CIRCUIT WAS CLOSED DURING THE SELF-TEST. THE FAILED SELF-TEST IS NO INDICATION FOR A MALFUNCTION OF THE DIALOG+ MACHINE. THE SELF-TEST WAS FINALLY PASSED AND THE THERAPY COULD BE STARTED. AFTER THERAPY STARTED THE VENOUS PRESSURE INCREASED SLIGHTLY, BUT CONSTANTLY FOR ABOUT 10 MINUTES. THE ALARM "VENOUS PRESSURE - UPPER LIMIT" (ALARM CODE 1052) WAS TRIGGERED BY THE MACHINE. FOLLOWING THIS ALARM, THE BLOOD PUMP STOPPED AND THE DIALYSIS MACHINE SWITCHED INTO BYPASS. THIS ALARM DOES NOT INDICATE ANY MALFUNCTION OF THE DEVICE. THE ALARM WAS ACKNOWLEDGED ACTIVELY BY THE OPERATOR AND THE THERAPY WAS CONTINUED. ABOUT 1 MINUTE LATER, THE VENOUS PRESSURE (PV) INCREASED AND THE ARTERIAL PRESSURE (PA) DECREASED SUDDENLY AT THE SAME TIME. THE RESPECTIVE ALARMS, "ARTERIAL PRESSURE - LOWER LIMIT" (ALARM CODE 1051) AND "VENOUS PRESSURE - UPPER LIMIT" (ALARM CODE 1052) WERE TRIGGERED, THE BLOOD PUMP STOPPED AGAIN AND THE MACHINE SWITCHED INTO BYPASS MODE. THESE PRESSURE ALARMS COULD BE EXPLAINED BY A KINKING OF THE ARTERIAL AND VENOUS LINE AND COULD BE EXPLAINED BY THE PATIENT'S SEIZURE ACTIVITY DESCRIBED BY THE CUSTOMER. AFTER THE BLOOD PUMP WAS RESTARTED, THE ARTERIAL PRESSURE WAS SLIGHTLY POSITIVE AND THERE WAS NO RED DETECTED AT THE VENOUS RED DETECTOR (RDV). THE PATIENT WAS OBVIOUSLY DISCONNECTED FROM THE MACHINE AS DESCRIBED. ABOUT 6.5 MINUTES LATER, THE PATIENT WAS RECONNECTED TO THE MACHINE AND THERAPY WAS CONTINUED FOR SLIGHTLY MORE THAN 1 MINUTE, WHEN ANOTHER "VENOUS PRESSURE - UPPER LIMIT" ALARM STOPPED THE BLOOD PUMP. THIS ALARM WAS ACKNOWLEDGED AND THERAPY WAS FINISHED BY THE OPERATOR 32 SECONDS LATER, ABOUT 22 MINUTES AFTER THERAPY STARTED. THE EVENTS LOGGED IN THE DATA RECORDING OF THE DIALOG+ MACHINE MATCH THE DESCRIPTION OF THE EVENT BY THE CUSTOMER. THE ANALYSIS OF THE TREND DATA RECORD SHOWED THAT THE DIALOG+ MACHINE OPERATED AND REACTED AS INTENDED. THE INSPECTION OF THE DIALOG+ DIALYSIS MACHINE BY THE CUSTOMER'S TECHNICIAN AND THE ANALYSIS OF THE TREND DATA DO NOT SHOW ANY PRODUCT DEVIATION. THE MACHINE OPERATED AS INTENDED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED A PATIENT CODED 26 MINUTES INTO TREATMENT. THE PATIENT WAS VERY ILL PRIOR TO TREATMENT. PATIENT (B)(6) FEMALE WITH RENAL FAILURE ON HEMODIALYSIS FOR AT LEAST 15 YEARS. PATIENT HAD SPECIAL PROCEDURE FOR HERO CATHETER THIS SUMMER DUE TO NO OTHER ACCESS AVAILABLE FOR HEMODIALYSIS RELATED TO LONG TERM HISTORY OF TREATMENT. HISTORY OF DIABETES, HYPERTENSION, RIGHT BELOW KNEE AMPUTATION (B)(6) 2014, LEFT BELOW KNEE AMPUTATION IN 2018, COLOSTOMY FOR BOWEL ISCHEMIA, PARTIAL THYROIDECTOMY, ANEMIA, THROMBUS. PATIENT WAS ADMITTED TO HOSPITAL ICU (B)(6) 2018 DUE TO DECREASED BLOOD PRESSURE (BP) ONE (1) HOUR AFTER OUT PATIENT HEMODIALYSIS TREATMENT. THE PATIENT WAS PLACED ON SEVERAL PRESSORS INCLUDING LEVOPHED TO RAISE BP. THE PATIENT WAS OFF THE LEVOPHED PRIOR TO TREATMENT ON (B)(6) 2018. THE PATIENT DID ALSO HAVE IN-PATIENT TREATMENT PRIOR TO THE ONE ON (B)(6) 2018. THE PATIENT ARRIVED TO THE DIALYSIS UNIT ON (B)(6) 2018 ALERT AND ORIENTED PRIOR TO TREATMENT. THE TREATMENT STARTED AND 14 MINUTES INTO TREATMENT THE PATIENT HAD SEIZURE ACTIVITY. THE PATIENT WAS RINSED BACK AND DIALYSIS HELD, RAPID RESPONSE TEAM CALLED, BP 82/61. IT WAS DECIDED TO RESTART DIALYSIS BY THE RENAL PHYSICIAN AND PATIENT CARDIOPULMONARY ARRESTED A FEW MINUTES LATER. SEVERAL MEDS WERE GIVEN IN CODE. THE PATIENT OUTCOME WAS DEATH. PATIENT'S CURRENT MEDS AT TIME OF INCIDENT: ASPIRIN 81 MG DAILY, CRESTOR 20 MG DAILY, MIDODRINE 10 MG 3 TIMES PER DAY, NEURONTIN 20 MG 2 TIMES PER DAY, INSULIN HUMALOG 5UNITS SA 3 TIMES PER DAY, LANTUS 14 UNITS IN AM, ANTIVERT 20 MG DAILY, PAXIL 20 MG DAILY, NEPHRO-VITE DAILY, PHOSLO 657 3 CAPS, 3 TIMES DAILY. PATIENT LABS: SODIUM 126, POTASSIUM 5, CHLORIDE 97, CO2 19, BUN 53, CREATININE 7.7, GFR 6, CALCIUM 7, PHOSPHORUS 1.3, ALBUMIN 3.4. WHITE COUNT 8.0; HGB 10.8, HCT 34.4. THERE WERE NO ISSUES WITH DISCONNECTION OR BLOOD LEAKING FROM PATIENT. THE CATHETER WAS PATENT AND FLOWING AS EXPECTED DURING TREATMENT.
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED A PATIENT CODED 26 MINUTES INTO TREATMENT. THE PATIENT WAS VERY ILL PRIOR TO TREATMENT. PATIENT (B)(6) FEMALE WITH RENAL FAILURE ON HEMODIALYSIS FOR AT LEAST 15 YEARS. PATIENT HAD SPECIAL PROCEDURE FOR HERO CATHETER (B)(6) DUE TO NO OTHER ACCESS AVAILABLE FOR HEMODIALYSIS RELATED TO LONG TERM HISTORY OF TREATMENT. HISTORY OF DIABETES, HYPERTENSION, RIGHT BELOW KNEE AMPUTATION JUNE 2014, LEFT BELOW KNEE AMPUTATION IN 2018, COLOSTOMY FOR BOWEL ISCHEMIA, PARTIAL THYROIDECTOMY, ANEMIA, THROMBUS. PATIENT WAS ADMITTED TO HOSPITAL ICU (B)(6) 2018 DUE TO DECREASED BLOOD PRESSURE (BP) ONE (1) HOUR AFTER OUT PATIENT HEMODIALYSIS TREATMENT. THE PATIENT WAS PLACED ON SEVERAL PRESSORS INCLUDING LEVOPHED TO RAISE BP. THE PATIENT WAS OFF THE LEVOPHED PRIOR TO TREATMENT ON (B)(6) 2018. THE PATIENT DID ALSO HAVE IN-PATIENT TREATMENT PRIOR TO THE ONE ON (B)(6) 2018. THE PATIENT ARRIVED TO THE DIALYSIS UNIT ON (B)(6) 2018 ALERT AND ORIENTED PRIOR TO TREATMENT. THE TREATMENT STARTED AND 14 MINUTES INTO TREATMENT THE PATIENT HAD SEIZURE ACTIVITY. THE PATIENT WAS RINSED BACK AND DIALYSIS HELD, RAPID RESPONSE TEAM CALLED, BP 82/61. IT WAS DECIDED TO RESTART DIALYSIS BY THE RENAL PHYSICIAN AND PATIENT CARDIOPULMONARY ARRESTED A FEW MINUTES LATER. SEVERAL MEDS WERE GIVEN IN CODE. THE PATIENT OUTCOME WAS DEATH. PATIENT'S CURRENT MEDS AT TIME OF INCIDENT: ASPIRIN 81 MG DAILY. CRESTOR 20 MG DAILY. "MITODRINE" 10 MG 3 TIMES PER DAY. NEURONTIN 20 MG 2 TIMES PER DAY. INSULIN HUMALOG 5 UNITS SA 3 TIMES PER DAY. LANTUS 14 UNITS IN AM. ANTIVERT 20 MG DAILY. PAXIL 20 MG DAILY. NEPHRO-VITE DAILY. PHOSLO 657 3 CAPS, 3 TIMES DAILY. PATIENT LABS: SODIUM 126, POTASSIUM 5, CHLORIDE 97, CO2 19, BUN 53, CREATININE 7.7, GFR 6, CALCIUM 7, PHOSPHORUS 1.3, ALBUMIN 3.4, WHITE COUNT 8.0, HGB 10.8, HCT 34.4. THERE WERE NO ISSUES WITH DISCONNECTION OR BLOOD LEAKING FROM PATIENT. THE CATHETER WAS PATENT AND FLOWING AS EXPECTED DURING TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 809811 | DIALOG+® | HIGH PERMEABILIT | KDI | B. BRAUN AVITUM AG - MELSUNGEN | 710200L | 04046963686345 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR |