DIALOG A + 1 BLOOD PUMP 120V
Report
- Report Number
- 3002879653-2016-00036
- Event Type
- Death
- Date Received
- December 14, 2016
- Date of Event
- December 6, 2016
- Report Date
- March 24, 2025
- Manufacturer
- B. BRAUN AVITUM AG - MELSUNGEN
- Product Code
- FKJ
- UDI-DI
- 04046963816483
- PMA / PMN Number
- K963440
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
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). CUSTOMER REPORTED THAT, THE NEEDLE DISLODGED FROM THE PATIENT DURING A DIALYSIS THERAPY ON THE DIALOG HEMODIALYSIS MACHINE (B)(6). THE PATIENT WAS SET TO RUN FOR 4 HOURS, BUT AFTER 3 HOURS AND 15 MIN, IT WAS DISCOVERED THAT THE NEEDLE DISLODGED FROM THE PATIENT AND WAS SHOOTING BLOOD INTO THE COAT THAT THE PATIENT HAD ON. ACCORDING TO THE SAME REPORT, THE DIALYSIS MACHINE DID NOT TRIGGER AN ALARM. WHEN THE DISLODGEMENT OF THE VENOUS NEEDLE WAS DETECTED, THE THERAPY WAS STOPPED, SALINE WAS ADMINISTERED, CPR WAS INITIATED AND OXYGEN WAS APPLIED. THE PATIENT WAS TRANSFERRED TO THE EMERGENCY ROOM. AFTER FOLLOW UP CALLS WITH THE FACILITY, B. BRAUN AVITUM LEARNED THE FOLLOWING INFORMATION: 1. THE PATIENT PASSED AWAY TWO DAYS LATER AFTER SEVERAL HEART ATTACKS. 2. THE FACILITY MEDICAL DOCTOR DETERMINED THAT THE CAUSE OF DEATH WAS CARDIAC ARREST. 3. THE PATIENT WAS A 79 YEAR OLD MALE. 4. VITAL SIGNS OF PATIENT WERE: A) PRE-DIALYSIS: BLOOD PRESSURE 112/80, PULSE 78 AND TEMPERATURE 98.7. B) DURING DIALYSIS: BLOOD PRESSURE 82/43 TO 98/46, PULSE 85 TO 79. C) POST-DIALYSIS: BLOOD PRESSURE 69/30, PULSE WAS THREADY AND WEAK. 5. VITAL SIGNS WERE CHECKED EVERY 30 MINUTES DURING DIALYSIS. 6. NEEDLE INSERTION SITE WAS CHECKED EVERY 30 MINUTES. A B. BRAUN AVITUM SERVICE TECHNICIAN WAS SENT TO THE FACILITY TO SERVICE THE MACHINE. BASED ON HIS REPORT, HE CHECKED THE VENOUS PRESSURE FUNCTIONALITY, AS WELL AS, THE OVERALL FUNCTIONALITY OF THE DEVICE. HE PERFORMED ALL SAFETY CHECKS AND VALIDATED THAT THE PV WAS WITHIN TOLERANCE, FUNCTIONAL AND ALARMING. NO MALFUNCTIONS WERE IDENTIFIED WITH THE DIALOG MACHINE. HE RAN A MOCK THERAPY, DISINFECTED THE MACHINE AND RELEASED THE MACHINE FOR USE. ALL INFORMATION AND MACHINE TREND FILES ASSOCIATED WITH THIS EVENT WERE FORWARDED TO THE EQUIPMENT MANUFACTURER B. BRAUN AVITUM GERMANY. ACCORDING TO THEIR INVESTIGATION, THE TREND DATA RECORD OF THE DESCRIBED THERAPY SHOWS A DROP OF THE VENOUS PRESSURE ABOUT 2 HOURS 45 MIN INTO THERAPY. THIS WAS MOST PROBABLY THE TIME WHEN THE VENOUS NEEDLE DISLODGED. THE VENOUS PRESSURE REMAINED ABOVE THE LOWER VENOUS PRESSURE LIMIT FOR THE FOLLOWING 4 MINUTES. THEREFORE, THE DIALOG+ MACHINE DID NOT TRIGGER AN ALARM. EVENTUALLY, THE VENOUS PRESSURE FELL BELOW THIS THRESHOLD AND THE MACHINE DID TRIGGER THE ALARM "VENOUS PRESSURE LOWER LIMIT (SUP)". CONSEQUENTLY, THE DIALOG+ MACHINE SWITCHED INTO PATIENT-SAFE MODE, THE BLOOD PUMP STOPPED AND THE VENOUS SAFETY AIR CLAMP CLOSED. THE ANALYSIS OF THE TREND DATA RECORD DOES NOT GIVE ANY EVIDENCE OF A MALFUNCTION OF THE DIALOG+ DIALYSIS MACHINE. BASED ON THE TREND DATA RECORD, THE POSSIBLE BLOOD LOSS WAS CALCULATED. FROM THE TIME OF THE POSSIBLE NEEDLE DISLODGEMENT UNTIL THE TIME WHEN THE ALARM WAS TRIGGERED, THE POTENTIAL BLOOD LOSS OF THE PATIENT WAS CALCULATED TO BE ABOUT 1700 ML AT AN ACTUAL BLOOD FLOW OF 400 ML/MIN. ACCORDING TO THE MEDICAL ASSESSMENT A BLOOD LOSS CAUSED BY A NEEDLE DISLODGEMENT MIGHT LEAD TO A BLOOD PRESSURE DROP FOLLOWED BY MYOCARDIAL ISCHEMIA AND HEART ATTACK. AS STATED IN THE GUIDELINE IEC/TR 62653 (ED. 1.0,2012-06 - GUIDELINE FOR SAFE OPERATION OF MEDICAL EQUIPMENT USED FOR HEMODIALYSIS TREATMENTS, THE VENOUS PRESSURE MONITOR OF ANY DIALYSIS MACHINE MAY NOT RELIABLY DETECT LEAKS, BLOOD TUBING SEPARATION FROM THE BLOOD ACCESS DEVICE, OR NEEDLE DISLODGEMENT. LITTLE OR NO PRESSURE CHANGE MAY OCCUR DEPENDING ON THE CIRCUMSTANCE. IT IS UNLIKELY BUT POSSIBLE FOR A LEAK TO OCCUR, THE BLOOD TUBING TO SEPARATE, OR ACCESS NEEDLE TO DISLODGE WITHOUT VENOUS PRESSURE ALARM. THIS CURRENT STATE-OF-THE-ART OF DIALYSIS MACHINES IS REFLECTED IN THE INSTRUCTIONS FOR USE OF THE DIALOG+ DIALYSIS MACHINE IN THE FOLLOWING WARNING: RISK TO PATIENT DUE TO BLOOD LOSS IF CANNULAS GET DISCONNECTED OR SLIP OUT! STANDARD MONITORING FUNCTION OF THE DIALYSIS MACHINE CANNOT SAFELY DETECT THAT SUCH A SITUATION HAS ARISEN! ENSURE THAT THE ACCESS TO THE PATIENT ALWAYS REMAINS FULLY VISIBLE DURING THERAPY. ENSURE THAT CANNULAS ARE ADEQUATELY FIXED. REGULARLY CHECK PATIENT ACCESS. VENOUS LOWER LIMIT SHOULD PREFERABLY BE > 0 MMHG. IN SUMMARY, THE INVESTIGATION SHOWED THAT THE DIALOG+ DIALYSIS MACHINE DID NOT SHOW ANY PRODUCT DEVIATION. THE RISK OF NEEDLE DISLODGEMENT AND THE RESPECTIVE MEASURES ARE DESCRIBED IN THE INSTRUCTIONS FOR USE OF THE DIALYSIS MACHINE. ALL INFORMATION CONCERNING THIS INCIDENT HAS BEEN INCLUDED IN OUR TREND ANALYSIS OF THE PRODUCT LINE. A HISTORICAL REVIEW OF THE CUSTOMER COMPLAINT DATABASE, REVEALED NO ADVERSE TRENDS REGARDING THIS ISSUE. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.
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). CUSTOMER REPORTED THAT, THE NEEDLE DISLODGED FROM THE PATIENT DURING A DIALYSIS THERAPY ON THE DIALOG HEMODIALYSIS MACHINE (B)(6). THE PATIENT WAS SET TO RUN FOR 4 HOURS, BUT AFTER 3 HOURS AND 15 MIN, IT WAS DISCOVERED THAT THE NEEDLE DISLODGED FROM THE PATIENT AND WAS SHOOTING BLOOD INTO THE COAT THAT THE PATIENT HAD ON. ACCORDING TO THE SAME REPORT, THE DIALYSIS MACHINE DID NOT TRIGGER AN ALARM. WHEN THE DISLODGEMENT OF THE VENOUS NEEDLE WAS DETECTED, THE THERAPY WAS STOPPED, SALINE WAS ADMINISTERED, CPR WAS INITIATED AND OXYGEN WAS APPLIED. THE PATIENT WAS TRANSFERRED TO THE EMERGENCY ROOM. AFTER FOLLOW UP CALLS WITH THE FACILITY, B. BRAUN AVITUM LEARNED THE FOLLOWING INFORMATION: 1. THE PATIENT PASSED AWAY TWO DAYS LATER AFTER SEVERAL HEART ATTACKS. 2. THE FACILITY MEDICAL DOCTOR DETERMINED THAT THE CAUSE OF DEATH WAS CARDIAC ARREST. 3. THE PATIENT WAS A 79 YEAR OLD MALE. 4. VITAL SIGNS OF PATIENT WERE: A) PRE-DIALYSIS: BLOOD PRESSURE 112/80, PULSE 78 AND TEMPERATURE 98.7. B) DURING DIALYSIS: BLOOD PRESSURE 82/43 TO 98/46, PULSE 85 TO 79. C) POST-DIALYSIS: BLOOD PRESSURE 69/30, PULSE WAS THREADY AND WEAK. 5. VITAL SIGNS WERE CHECKED EVERY 30 MINUTES DURING DIALYSIS. 6. NEEDLE INSERTION SITE WAS CHECKED EVERY 30 MINUTES. A B. BRAUN AVITUM SERVICE TECHNICIAN WAS SENT TO THE FACILITY TO SERVICE THE MACHINE. BASED ON HIS REPORT, HE CHECKED THE VENOUS PRESSURE FUNCTIONALITY, AS WELL AS, THE OVERALL FUNCTIONALITY OF THE DEVICE. HE PERFORMED ALL SAFETY CHECKS AND VALIDATED THAT THE PV WAS WITHIN TOLERANCE, FUNCTIONAL AND ALARMING. NO MALFUNCTIONS WERE IDENTIFIED WITH THE DIALOG MACHINE. HE RAN A MOCK THERAPY, DISINFECTED THE MACHINE AND RELEASED THE MACHINE FOR USE. ALL INFORMATION AND MACHINE TREND FILES ASSOCIATED WITH THIS EVENT WERE FORWARDED TO THE EQUIPMENT MANUFACTURER B. BRAUN AVITUM GERMANY. ACCORDING TO THEIR INVESTIGATION, THE TREND DATA RECORD OF THE DESCRIBED THERAPY SHOWS A DROP OF THE VENOUS PRESSURE ABOUT 2 HOURS 45 MIN INTO THERAPY. THIS WAS MOST PROBABLY THE TIME WHEN THE VENOUS NEEDLE DISLODGED. THE VENOUS PRESSURE REMAINED ABOVE THE LOWER VENOUS PRESSURE LIMIT FOR THE FOLLOWING 4 MINUTES. THEREFORE, THE DIALOG+ MACHINE DID NOT TRIGGER AN ALARM. EVENTUALLY, THE VENOUS PRESSURE FELL BELOW THIS THRESHOLD AND THE MACHINE DID TRIGGER THE ALARM "VENOUS PRESSURE LOWER LIMIT (SUP)". CONSEQUENTLY, THE DIALOG+ MACHINE SWITCHED INTO PATIENT-SAFE MODE, THE BLOOD PUMP STOPPED AND THE VENOUS SAFETY AIR CLAMP CLOSED. THE ANALYSIS OF THE TREND DATA RECORD DOES NOT GIVE ANY EVIDENCE OF A MALFUNCTION OF THE DIALOG+ DIALYSIS MACHINE. BASED ON THE TREND DATA RECORD, THE POSSIBLE BLOOD LOSS WAS CALCULATED. FROM THE TIME OF THE POSSIBLE NEEDLE DISLODGEMENT UNTIL THE TIME WHEN THE ALARM WAS TRIGGERED, THE POTENTIAL BLOOD LOSS OF THE PATIENT WAS CALCULATED TO BE ABOUT 1700 ML AT AN ACTUAL BLOOD FLOW OF 400 ML/MIN. ACCORDING TO THE MEDICAL ASSESSMENT A BLOOD LOSS CAUSED BY A NEEDLE DISLODGEMENT MIGHT LEAD TO A BLOOD PRESSURE DROP FOLLOWED BY MYOCARDIAL ISCHEMIA AND HEART ATTACK. AS STATED IN THE GUIDELINE IEC/TR 62653 (ED. 1.0,2012-06 - GUIDELINE FOR SAFE OPERATION OF MEDICAL EQUIPMENT USED FOR HEMODIALYSIS TREATMENTS, THE VENOUS PRESSURE MONITOR OF ANY DIALYSIS MACHINE MAY NOT RELIABLY DETECT LEAKS, BLOOD TUBING SEPARATION FROM THE BLOOD ACCESS DEVICE, OR NEEDLE DISLODGEMENT. LITTLE OR NO PRESSURE CHANGE MAY OCCUR DEPENDING ON THE CIRCUMSTANCE. IT IS UNLIKELY BUT POSSIBLE FOR A LEAK TO OCCUR, THE BLOOD TUBING TO SEPARATE, OR ACCESS NEEDLE TO DISLODGE WITHOUT VENOUS PRESSURE ALARM. THIS CURRENT STATE-OF-THE-ART OF DIALYSIS MACHINES IS REFLECTED IN THE INSTRUCTIONS FOR USE OF THE DIALOG+ DIALYSIS MACHINE IN THE FOLLOWING WARNING: RISK TO PATIENT DUE TO BLOOD LOSS IF CANNULAS GET DISCONNECTED OR SLIP OUT! STANDARD MONITORING FUNCTION OF THE DIALYSIS MACHINE CANNOT SAFELY DETECT THAT SUCH A SITUATION HAS ARISEN! ENSURE THAT THE ACCESS TO THE PATIENT ALWAYS REMAINS FULLY VISIBLE DURING THERAPY. ENSURE THAT CANNULAS ARE ADEQUATELY FIXED. REGULARLY CHECK PATIENT ACCESS. VENOUS LOWER LIMIT SHOULD PREFERABLY BE > 0 MMHG. IN SUMMARY, THE INVESTIGATION SHOWED THAT THE DIALOG+ DIALYSIS MACHINE DID NOT SHOW ANY PRODUCT DEVIATION. THE RISK OF NEEDLE DISLODGEMENT AND THE RESPECTIVE MEASURES ARE DESCRIBED IN THE INSTRUCTIONS FOR USE OF THE DIALYSIS MACHINE. ALL INFORMATION CONCERNING THIS INCIDENT HAS BEEN INCLUDED IN OUR TREND ANALYSIS OF THE PRODUCT LINE. A HISTORICAL REVIEW OF THE CUSTOMER COMPLAINT DATABASE, REVEALED NO ADVERSE TRENDS REGARDING THIS ISSUE. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED. PER EMAIL SENT FROM [email protected] TO B. BRAUN MEDICAL INC. ON 18.MAR.2025, MDR FUP1 FOR MANUFACTURER REPORT NUMBER 3002879653-2016-00036 WAS NEVER RECEIVED. THEREFORE, WE ARE SUBMITTING THE FUP1 WITHIN 14 DAYS OF EMAIL RECEIPT AS INSTRUCTED WITHIN THE EMAIL. PLEASE NOTE THAT FUP1 ORIGINALLY HAD FAILED ACKNOWLEDGEMENTS; HOWEVER, 3002879653-2016-00036 FUP2 WAS SUBMITTED WITH ALL INFORMATION WITH PASSING ACKNOWLEDGEMENTS ON 27.JAN.2017.
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). THE MACHINE TREND FILE AND ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE FACILITY AND THE INVESTIGATION IS ON-GOING AT THIS TIME. A FOLLOW UP REPORT WILL BE PROVIDED WHEN THE EVALUATION RESULTS ARE AVAILABLE.
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED THE NEEDLE DISLODGED FROM THE PATIENT AND THE MACHINE DID NOT ALARM. THE PATIENT WAS SET TO RUN ON THE MACHINE FOR 4 HRS AND AT 3:15, IT WAS DISCOVERED THAT THE NEEDLE DISLODGED FROM THE PATIENT AND WAS SHOOTING BLOOD INTO THE COAT THAT THE PATIENT HAD ON. THE NURSES STOPPED THE THERAPY AFTER NOTICING SOMETHING WAS WRONG WITH THE PATIENT. MEDICAL INTERVENTION WAS NECESSARY. CLINICIANS ADMINISTERED NORMAL SALINE SOLUTION. THE PATIENT WAS SENT TO THE EMERGENCY ROOM, HAD SEVERAL HEART ATTACKS, AND PASSED AWAY TWO DAYS LATER IN THE HOSPITAL. " NO ALARM WAS TRIGGERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 824783 | DIALOG A + 1 BLOOD PUMP 120V | HEMODIALYSIS SYSTEM | FKJ | B. BRAUN AVITUM AG - MELSUNGEN | 710500K | 04046963816483 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male | Hospitalization| R| O| D |