COMBISET SMARTECH BLOODLINE (NO HEPARIN)
Report
- Report Number
- 0008030665-2025-01024
- Event Type
- Death
- Date Received
- May 5, 2025
- Date of Event
- March 26, 2025
- Report Date
- May 13, 2025
- Manufacturer
- ERIKA DE REYNOSA, S.A. DE C.V.
- Product Code
- KOC
- PMA / PMN Number
- K201207
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
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 HD THERAPY UTILIZING THE COMBISET SMARTECH BLOODLINES AND THE PATIENT EVENT OF BLOOD LOSS WITH SUBSEQUENT DEATH. ALTHOUGH IT WAS REPORTED THAT A BLOOD LEAK OCCURRED FROM THE CONNECTION OF THE CATHETER LUMEN AND THE COMBISET VENOUS BLOOD LINE, THERE IS NO DOCUMENTATION OF ANY DEFECTS OR DAMAGE NOTED AT THE CONNECTION SITE PRIOR TO THE START OF TREATMENT. ADDITIONALLY, THERE WERE NO OTHER REPORTED ISSUES LEADING UP TO THE EVENT THAT WOULD CAUSE THE REPORTED LOOSE CONNECTION. IT WAS REPORTED THAT THE CONNECTION WAS SECURE PRIOR TO THE START OF TREATMENT. IN ADDITION, THERE ARE SEVERAL DOCUMENTED CHECKS THROUGHOUT THE TREATMENT THAT INDICATE THE PATIENT ACCESS, AND THE PATIENT CONNECTOR CLIP WERE CHECKED. THE COMBISET SMARTECH BLOODLINE IFU STATES TO ¿ENSURE ALL CONNECTIONS ARE SECURE BEFORE USE AND MONITOR FOR LEAKS REGULARLY DURING PATIENT USE. BLOOD LEAKS CAN RESULT IF CONNECTIONS ARE NOT SECURE.¿ ALTHOUGH IT WAS REPORTED THAT THE PATIENT CONNECTOR CLIP WAS PLACED PRIOR TO THE INITIATION OF TREATMENT AND DOCUMENTED AS STILL BEING CONNECTED AT THE TIME OF THE EVENT, IT COULD NOT BE CONFIRMED IF THE CLIP WAS STILL ATTACHED POST EVENT. THE COMBISET SMARTECH BLOODLINES IFU ADDITIONALLY STATES ¿USE OF CATHETERS, AVF NEEDLE SETS OR OTHER DEVICES NOT COMPATIBLE WITH THIS SET MAY RESULT IN BLOOD/AIR LEAKAGE OR ACCIDENTAL DISCONNECTION, AIR EMBOLUS, SIGNIFICANT BLOOD LOSS, PATIENT INJURY OR DEATH.¿ IT WAS ALSO DOCUMENTED SEVERAL TIMES THAT THE PATIENT¿S ACCESS SITE WAS UNCOVERED AND VISIBLE DURING TREATMENT.
ADDITIONAL INFORMATION: D4, D9, H3, H4 PLANT INVESTIGATION: THE COMPLAINT SAMPLE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE DEVICE WAS NOT RETURNED IN ITS ORIGINAL PACKAGING. THE RETURNED SAMPLE INCLUDED BOTH AN ARTERIAL AND A VENOUS LINE. THE PATIENT CONNECTOR CLIP WAS NOT ATTACHED OR INCLUDED. THE SAMPLE UNDERWENT FUNCTIONAL TESTING AND WAS DISINFECTED ACCORDING TO PLANT PROCEDURES. NO LEAKS, KINKS, OR OTHER FAILURES WERE OBSERVED DURING DISINFECTION OF THE SAMPLE. NO IRREGULARITIES WERE FOUND DURING VISUAL INSPECTION OF THE RETURNED DEVICE. THE ARTERIAL AND VENOUS PATIENT END-CONNECTORS WERE CLOSELY INSPECTED FOR DAMAGE (INCLUDING COLLAR AND TAPER DAMAGE), AND NO DEFECTS WERE FOUND. SINCE THE PATIENT CONNECTOR CLIP WAS NOT RETURNED WITH THE SAMPLE, THE DEVICE WAS TESTED WITHOUT IT. THERE WERE NO DISCONNECTIONS OR LEAKS DURING TESTING. NO AIR BUBBLES WERE NOTED IN THE CIRCUIT, AND THERE WERE NO NOTED LEVEL VARIATIONS OF THE VENOUS OR ARTERIAL CHAMBERS. THERE WERE NO ALARMS EITHER. THE DIMENSIONS OF THE MALE CONICAL FITTINGS ON THE ARTERIAL AND VENOUS PATIENT CONNECTORS WERE INSPECTED AND FOUND TO BE ACCEPTABLE. THE DEVICE WORKED AS INTENDED, WITHOUT ANY PROBLEMS OR FAILURES. UPON COMPLETION OF THE EVALUATION, THERE WERE NO MALFUNCTIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE COMBISET WORKED AS INTENDED AND AN ASSOCIATED CAUSE COULD NOT BE DETERMINED.
IT WAS REPORTED TO FRESENIUS THAT A BLOOD LEAK OCCURRED DURING A HEMODIALYSIS (HD) PATIENT¿S TREATMENT, WHICH SUBSEQUENTLY RESULTED IN THEIR DEATH. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP AND REVIEW OF THE PATIENT¿S TREATMENT SHEET. THE PATIENT¿S PRE-TREATMENT VITAL SIGNS AT 10:33AM WERE CONFIRMED AS BLOOD PRESSURE (BP) 115/80, PULSE (P) 73, RESPIRATIONS (R) 16, TEMPERATURE (T) 96.6°. THE TREATMENT WAS INITIATED UTILIZING A CENTRAL VENOUS CATHETER (CVC) IN THE CHEST, ALONG WITH FRESENIUS COMBISET SMARTECH BLOODLINES, 2008T HD MACHINE, AND PATIENT CONNECTOR CLIP (NON-STERILE). THE CVC WAS REPORTEDLY WIPED WITH ALCOHOL PRIOR TO CONNECTING THE BLOODLINES. THE TREATMENT SHEET INDICATED THAT THE CVC CATHETER DRESSING WAS GAUZE WITH A SOLUTION OF 2% CHLORHEXIDINE GLUCONATE AND 70% ISOPROPYL ALCOHOL. THE ARTERIAL PRESSURE SETTING ON THE 2008T MACHINE WAS 160MMHG AND THE VENOUS PRESSURE WAS 100 ASYMMETRICAL. THE PATIENT DID NOT REPORT ANY CONCERNS PRIOR TO THE START OF TREATMENT. THE TREATMENT SHEET DOCUMENTED THE ULTRAFILTRATION RATE (UFR) 760, FLUID REMOVED 38, FLUID GIVEN 300, THE ACCESS AND CONNECTOR CLIP WERE CHECKED, THE PATIENT WAS RESTING COMFORTABLY, THE PATIENT WAS ALERT, THE ACCESS WAS VISIBLE, AND TREATMENT WAS INITIATED WITHOUT PROBLEMS. THE GREEN AMP LIGHT WAS ON. THE FOLLOWING VITAL SIGNS AND NOTES WERE RECORDED DURING THE TREATMENT: 11:00AM BP 144/54, P 64, ACCESS AND CONNECTOR CLIP CHECKED; 11:02AM BP 114/64, P 64, ACCESS AND CONNECTOR CLIP CHECKED, PATIENT WAS ALERT WITH NO COMPLAINTS, THE GREEN AMP LIGHT WAS ON; 11:31AM BP 154/71, P 66, ARTERIAL PRESSURE 182, VENOUS PRESSURE 125, GREEN AMP LIGHT ON, ACCESS VISIBLE, PATIENT DENIES COMPLAINTS, ACCESS AND CONNECTOR CLIP CHECKED, UFR 760, FLUID REMOVED 723. AT 11:45AM THE MACHINE ALARMED WITH AN UNSPECIFIED MACHINE ALARM (INITIALLY REPORTED AS AN ARTERIAL PRESSURE ALARM). THE PATIENT¿S BP WAS DOCUMENTED AS BP 87/31, P 125. THE TREATMENT SHEET DOCUMENTED THAT THE ACCESS WAS CHECKED, AND THE GREEN AMP LIGHT WAS ON. AT THIS TIME, IT WAS NOTED THERE WAS A BLOOD LEAK. THE LEAK WAS REPORTEDLY COMING FROM THE CONNECTION OF THE CATHETER LUMEN TO THE COMBISET VENOUS BLOOD LINE. THE CONNECTION WAS LOOSE, BUT NOT COMPLETELY DISCONNECTED. THE PATIENT CONNECTOR CLIP WAS REPORTEDLY STILL CONNECTED TO THE BLOOD LINE AND CATHETER. WHEN THE BLOOD LEAK WAS DETECTED, THE PATIENT WENT UNRESPONSIVE. A PULSE WAS NOT PALPABLE. TREATMENT WAS DISCONTINUED AND THE PATIENT¿S BLOOD FROM THE EXTRACORPOREAL CIRCUIT WAS IMMEDIATELY RETURNED WITH NORMAL SALINE (NS). CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. ANOTHER STAFF MEMBER ACTIVATED 911. THE PATIENT WAS ADMINISTERED OXYGEN VIA AMBU MASK. 3L OF NS WERE ADMINISTERED WHILE WAITING FOR EMERGENCY MEDICAL SERVICES (EMS). NO PATIENT VITALS WERE DOCUMENTED AFTER BECOMING UNRESPONSIVE. EMS ARRIVED AND IMMEDIATELY TRANSPORTED THE PATIENT TO THE HOSPITAL. AT THE HOSPITAL, THE PATIENT RECEIVED CPR, MULTIPLE MEDICATIONS (UNKNOWN), AND WAS INTUBATED. THE PATIENT EXPIRED AT 4:00PM. THE CAUSE OF DEATH DOCUMENTED IN THE MEDICAL RECORD DISCHARGE IS CARDIAC ARREST, ANEMIA, AND END STAGE RENAL DISEASE (ESRD). NO ESRD DEATH NOTIFICATION FORM CMS-2746-U2 WAS AVAILABLE. THE MEDICAL RECORD DOCUMENTED THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) AT 2L. IT WAS DOCUMENTED THAT PRIOR TO THE START OF THE PATIENT¿S TREATMENT, THE CONNECTION AT THE COMBISET VENOUS BLOODLINE AND CATHETER WAS SECURE. THE PATIENT CONNECTOR CLIP WAS REPORTEDLY ON AT THE START OF TREATMENT AND AT THE TIME OF THE BLOOD LEAK, HOWEVER; IT COULD NOT BE CONFIRMED IF THE CLIP REMAINED ON THE BLOODLINE POST EVENT. THE PATIENT DID NOT COMPLAIN OF ANY SYMPTOMS AT ANY TIME PRIOR TO THE ADVERSE EVENT. THERE WERE NO ADDITIONAL ALARMS OR TREATMENT ISSUES DOCUMENTED PRIOR TO THE UNKNOWN MACHINE ALARM. THE PATIENT¿S ACCESS SITE WAS REPORTED TO BE VISIBLE DURING THE TREATMENT. NO FURTHER INFORMATION WAS PROVIDED. THE SAMPLE WAS REPORTED TO BE AVAILABLE FOR MANUFACTURER EVALUATION.
IT WAS REPORTED TO FRESENIUS THAT A BLOOD LEAK OCCURRED DURING A HEMODIALYSIS (HD) PATIENT¿S TREATMENT, WHICH SUBSEQUENTLY RESULTED IN THEIR DEATH. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP AND REVIEW OF THE PATIENT¿S TREATMENT SHEET. THE PATIENT¿S PRE-TREATMENT VITAL SIGNS AT 10:33AM WERE CONFIRMED AS BLOOD PRESSURE (BP) 115/80, PULSE (P) 73, RESPIRATIONS (R) 16, TEMPERATURE (T) 96.6°. THE TREATMENT WAS INITIATED UTILIZING A CENTRAL VENOUS CATHETER (CVC) IN THE CHEST, ALONG WITH FRESENIUS COMBISET SMARTECH BLOODLINES, 2008T HD MACHINE, AND PATIENT CONNECTOR CLIP (NON-STERILE). THE CVC WAS REPORTEDLY WIPED WITH ALCOHOL PRIOR TO CONNECTING THE BLOODLINES. THE TREATMENT SHEET INDICATED THAT THE CVC CATHETER DRESSING WAS GAUZE WITH A SOLUTION OF 2% CHLORHEXIDINE GLUCONATE AND 70% ISOPROPYL ALCOHOL. THE ARTERIAL PRESSURE SETTING ON THE 2008T MACHINE WAS 160MMHG AND THE VENOUS PRESSURE WAS 100 ASYMMETRICAL. THE PATIENT DID NOT REPORT ANY CONCERNS PRIOR TO THE START OF TREATMENT. THE TREATMENT SHEET DOCUMENTED THE ULTRAFILTRATION RATE (UFR) 760, FLUID REMOVED 38, FLUID GIVEN 300, THE ACCESS AND CONNECTOR CLIP WERE CHECKED, THE PATIENT WAS RESTING COMFORTABLY, THE PATIENT WAS ALERT, THE ACCESS WAS VISIBLE, AND TREATMENT WAS INITIATED WITHOUT PROBLEMS. THE GREEN AMP LIGHT WAS ON. THE FOLLOWING VITAL SIGNS AND NOTES WERE RECORDED DURING THE TREATMENT: 11:00AM BP 144/54, P 64, ACCESS AND CONNECTOR CLIP CHECKED; 11:02AM BP 114/64, P 64, ACCESS AND CONNECTOR CLIP CHECKED, PATIENT WAS ALERT WITH NO COMPLAINTS, THE GREEN AMP LIGHT WAS ON; 11:31AM BP 154/71, P 66, ARTERIAL PRESSURE 182, VENOUS PRESSURE 125, GREEN AMP LIGHT ON, ACCESS VISIBLE, PATIENT DENIES COMPLAINTS, ACCESS AND CONNECTOR CLIP CHECKED, UFR 760, FLUID REMOVED 723. AT 11:45AM THE MACHINE ALARMED WITH AN UNSPECIFIED MACHINE ALARM (INITIALLY REPORTED AS AN ARTERIAL PRESSURE ALARM). THE PATIENT¿S BP WAS DOCUMENTED AS BP 87/31, P 125. THE TREATMENT SHEET DOCUMENTED THAT THE ACCESS WAS CHECKED, AND THE GREEN AMP LIGHT WAS ON. AT THIS TIME, IT WAS NOTED THERE WAS A BLOOD LEAK. THE LEAK WAS REPORTEDLY COMING FROM THE CONNECTION OF THE CATHETER LUMEN TO THE COMBISET VENOUS BLOOD LINE. THE CONNECTION WAS LOOSE, BUT NOT COMPLETELY DISCONNECTED. THE PATIENT CONNECTOR CLIP WAS REPORTEDLY STILL CONNECTED TO THE BLOOD LINE AND CATHETER. WHEN THE BLOOD LEAK WAS DETECTED, THE PATIENT WENT UNRESPONSIVE. A PULSE WAS NOT PALPABLE. TREATMENT WAS DISCONTINUED AND THE PATIENT¿S BLOOD FROM THE EXTRACORPOREAL CIRCUIT WAS IMMEDIATELY RETURNED WITH NORMAL SALINE (NS). CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. ANOTHER STAFF MEMBER ACTIVATED 911. THE PATIENT WAS ADMINISTERED OXYGEN VIA AMBU MASK. 3L OF NS WERE ADMINISTERED WHILE WAITING FOR EMERGENCY MEDICAL SERVICES (EMS). NO PATIENT VITALS WERE DOCUMENTED AFTER BECOMING UNRESPONSIVE. EMS ARRIVED AND IMMEDIATELY TRANSPORTED THE PATIENT TO THE HOSPITAL. AT THE HOSPITAL, THE PATIENT RECEIVED CPR, MULTIPLE MEDICATIONS (UNKNOWN), AND WAS INTUBATED. THE PATIENT EXPIRED AT 4:00PM. THE CAUSE OF DEATH DOCUMENTED IN THE MEDICAL RECORD DISCHARGE IS CARDIAC ARREST, ANEMIA, AND END STAGE RENAL DISEASE (ESRD). NO ESRD DEATH NOTIFICATION FORM CMS-2746-U2 WAS AVAILABLE. THE MEDICAL RECORD DOCUMENTED THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) AT 2L. IT WAS DOCUMENTED THAT PRIOR TO THE START OF THE PATIENT¿S TREATMENT, THE CONNECTION AT THE COMBISET VENOUS BLOODLINE AND CATHETER WAS SECURE. THE PATIENT CONNECTOR CLIP WAS REPORTEDLY ON AT THE START OF TREATMENT AND AT THE TIME OF THE BLOOD LEAK, HOWEVER; IT COULD NOT BE CONFIRMED IF THE CLIP REMAINED ON THE BLOODLINE POST EVENT. THE PATIENT DID NOT COMPLAIN OF ANY SYMPTOMS AT ANY TIME PRIOR TO THE ADVERSE EVENT. THERE WERE NO ADDITIONAL ALARMS OR TREATMENT ISSUES DOCUMENTED PRIOR TO THE UNKNOWN MACHINE ALARM. THE PATIENT¿S ACCESS SITE WAS REPORTED TO BE VISIBLE DURING THE TREATMENT. NO FURTHER INFORMATION WAS PROVIDED. THE SAMPLE WAS REPORTED TO BE AVAILABLE FOR MANUFACTURER EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1895355 | COMBISET SMARTECH BLOODLINE (NO HEPARIN) | ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS | KOC | ERIKA DE REYNOSA, S.A. DE C.V. | 25AR01015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Female | Required Intervention| D | FRESENIUS 2008T MACHINE.| FRESENIUS 2008T MACHINE.| FRESENIUS OPTIFLUX DIALYZER.| FRESENIUS OPTIFLUX DIALYZER.| PATIENT CONNECTOR CLIP.| PATIENT CONNECTOR CLIP. |