AURORA - BASE TINA MACHINEWITH ARM OPTION (+N100ARM)
Report
- Report Number
- 1423500-2010-00932
- Event Type
- Death
- Date Received
- May 28, 2010
- Date of Event
- April 6, 2010
- Report Date
- May 7, 2010
- Manufacturer
- BAXTER HEALTHCARE - LARGO
- Product Code
- KDI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
(B)(4). THE DEVICE HISTORY COULD NOT BE OBTAINED BECAUSE THE UNIT WAS USED AFTER THE INCIDENT. IT IS UNKNOWN WHAT THE HOSPITAL'S STANDARD OPERATING PROCEDURES (SOPS) ARE REGARDING TRAINING. TRAINING WAS NOT OFFERED DURING THE VISIT AS THE HOSPITAL HAD INDICATED THEY HAVE SWITCHED TO A NEW PRODUCT. THE IDENTITY OF THE NURSE IS UNKNOWN, AND IT IS UNKNOWN WHETHER OR NOT THE NURSE INVOLVED IN THE EVENT WAS NEW.
(B) (4). AN ON SITE VISIT IS SCHEDULED FOR JUNE 1, 2010 AND THE BAXTER FIELD SERVICE TECHNICIAN WILL EVALUATE THE DEVICE AT THAT TIME. THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S.
(B) (4). AN ON SITE VISIT WAS COMPLETED ON 06/01/10. RESULTS OF THE EVALUATION ARE NOTED IN THE ON SITE SUMMARY UNDER THE ATTACHMENT TAB. THE SUMMARY INDICATES: FUNCTION CHECKS WERE COMPLETED ON THE DEVICE. THE ALARMS REPORTEDLY FUNCTIONED PROPERLY. THE FACILITY STAFF WERE UNABLE TO ADVISE WHERE THE DEVICE OPERATOR MANUAL WAS MAINTAINED AND WERE UNAWARE OF ADDENDUM (B) (4) REGARDING "INADVERTENT ACCESS DISLODGEMENT". IT IS UNCLEAR IF ADDITIONAL TRAINING WAS OFFERED TO THE FACILITY, HOWEVER, A COPY OF THE ADDENDUM WAS OFFERED AND DECLINED AS THE CURRENT SYSTEM IS TO BE REPLACED BY THE FACILITY. THE FACILITY IS CONDUCTING A ROOT CAUSE ANALYSIS, HOWEVER, THEY DECLINE TO PROVIDE A COPY OF THE INVESTIGATION. PER (B) (4), A REPRESENTATIVE OF (B) (4) HAD CONTACTED HER ON 6-15-10 REGARDING A COPY OF THE CORONER'S REPORT WHICH THE FACILITY HAS DECLINED TO PROVIDE.
ON MAY 7TH, 2010 BAXTER (B) (4) WAS NOTIFIED OF A COMPLAINT FROM A CUSTOMER REPORTING THAT THEIR AURORA HEMODIALYSIS MACHINE MAY HAVE MALFUNCTIONED RESULTING IN BLOOD LOSS TO A PATIENT AND TO THE PATIENT EXPIRATION. IT IS UNKNOWN IF THE DEVICE ALARMED. THIS AURORA MACHINE HAS BEEN USED ON OTHER PATIENTS AFTER THE INCIDENT ADDRESSED IN (B) (4)) ((B) (4) BLOODLINES). THE FACILITY THE TECHNICAL MANAGER REQUESTED BAXTER ASSESSES THE MACHINE (AS A THIRD PARTY) AND ADVISE WHETHER THE DEVICE IS PERFORMING CORRECTLY. THE PATIENT'S DEATH HAS BEEN IDENTIFIED AS A CORONER'S CASE AND INQUIRY IS BEING PERFORMED AND HAS BEEN REPORTED TO HEALTH (B) (4). ALL INFORMATION REQUIRED FROM THE CUSTOMER MUST BE REQUESTED IN WRITING. THE PROCESS STEP IS DURING USE, AND THERE IS A REPORT OF PATIENT DEATH. AS PART OF A CORONER'S CASE, A THIRD PARTY ASSESSMENT OF THE INSTRUMENT IS REQUIRED TO DETERMINE IF THE DEVICE FUNCTIONED AS DESIGNED. THE ASSESSMENT IS SCHEDULED FOR TUESDAY JUNE 1, 2010 PER REQUEST OF THE CORONER. FUNCTIONAL CHECKS HAVE BEEN REQUESTED. THE DEVICE WILL BE EVALUATED BY A BAXTER TECHNICIAN ON JUNE 1ST, 2010. INITIALLY, ON APRIL 24TH 2010, BAXTER (B) (4) PRODUCT SURVEILLANCE RECEIVED A REPORT FROM THE CUSTOMER THAT (B) (4) BLOODLINES (THE VENOUS BLOOD TUBING) BECAME DISCONNECTED DURING TREATMENT RESULTING IN BLOOD LOSS AND PATIENT EXPIRATION. THIS EVENT OCCURRED DURING A HEMODIALYSIS TREATMENT ON (B) (6) 2010 ON AN AURORA MACHINE. THE EVENT INVOLVING THE BLOOD LINES IS ADDRESSED IN (B) (4) AND RELATED TO THE (B) (4) BLOODLINES. THE BLOODLINE SAMPLE IS NOT AVAILABLE FOR EVALUATION. REPORTEDLY, A BLANKET HAD BEEN PLACED OVER THE PATIENT AND POSSIBLY OVER THE CATHETER SITE. THE CUSTOMER INDICATED THEY WERE NOT SURE WHERE THE BLOODLINE LEAK OCCURRED, ALTHOUGH IT IS POSSIBLE THAT THE V LINE AND V PORT BECAME DISCONNECTED. THE EVENT OF BLOOD LOSS OCCURRED NEAR THE END OF THE PATIENT'S TREATMENT. IT IS UNCLEAR AS TO WHETHER OR NOT THE MACHINE ALARMED. THE PATIENT LOST A LARGE AMOUNT OF BLOOD (AMOUNT UNKNOWN). BLOOD WAS UNABLE TO BE RETURNED TO THE PATIENT. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) ON (B) (6) 2010 AND SUBSEQUENTLY EXPIRED ON (B) (6) 2010. A COPY OF THE CORONER'S REPORT WILL NOT BE AVAILABLE AS IT IS CONSIDERED CONFIDENTIAL UNDER THE (B) (6) CORONER'S ACT AND IS NOT PROVIDED TO THE HOSPITAL EXCEPT AS IT RELATES TO QUALITY OF CARE REVIEWS. ADDITIONAL INFORMATION WAS RECEIVED ON 05/26/2010: REPORTEDLY THE FACILITY ADVISED A BAXTER SALES REPRESENTATIVE OF THE COMPLAINT A MONTH AFTER THE EVENT DATE. THE LOCAL COMPLAINT COORDINATOR (LCC) ATTEMPTED TO CONTACT THE FACILITY NURSE IDENTIFIED AS THE PRIMARY CONTACT FOR THREE WEEKS BEFORE MAKING CONTACT. DURING THE DISCUSSION OF THE EVENT WITH THE FACILITY NURSE, THE NURSE INDICATED THE FACILITY FELT THAT THERE WAS A LEAK IN THE BLOODLINES WHICH RESULTED IN LOSS OF AN UNKNOWN QUANTITY OF BLOOD FROM THE PATIENT NEAR THE END OF THE DIALYSIS THERAPY ON (B) (6) 2010. THE PATIENT WAS TRANSFERRED TO THE ICU AND EXPIRED LATER THAT NIGHT. THE NURSE INDICATED THE FACILITY FELT THAT THE BLOODLINE LEAK CONTRIBUTED TO THE PATIENT'S DEATH. THE FACILITY DISCARDED THE BLOODLINES AND THE LOT NUMBER WAS UNAVAILABLE. THE LCC WAS ABLE TO DETERMINE THE LAST THREE LOT NUMBERS OF BLOODLINES SENT TO THE FACILITY. (B) (4) WAS NOTIFIED AND EVALUATED THE RETAINED SAMPLES OF THE THREE LOT NUMBERS WITH NO ISSUES NOTED. THE NURSE DECLINED TO PROVIDE A LISTED CAUSE OF DEATH, PATIENT DIAGNOSIS, PATIENT MEDICAL HISTORY OR ADDITIONAL DETAILS RELATED TO THE EVENT. THE LCC CONFIRMED THAT THE FACILITY HAS RECEIVED A COPY OF THE BAXTER INADVERTENT ACCESS DISLODGEMENT ADDENDUM DATE MARCH 2006 FOR THE AURORA OPERATOR'S MANUAL.
THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LFS CUSTOMER SERVICE. THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6) 2010 ALLEGING THAT THE ONETOUCH® ULTRAMINI METER IS GIVING AN ERROR MESSAGE. THE PATIENT'S DIABETES IS MANAGED WITH SELF ADJUSTING INSULIN. THE PRODUCT ISSUE BEGAN DURING (B)(6) 2010. THE PATIENT CLAIMED THAT ONE WEEK PRIOR TO CONTACTING LFS, SHE RAN OUT OF TEST STRIPS DUE TO THE ERROR MESSAGES. AT THE SAME TIME, THE PATIENT DEVELOPED SYMPTOMS OF FEELING WEAK AND SHAKY. IT IS NOT CLEAR HOW SHE MANAGED HER DIABETES ON THE DAY OF CONCERN AND WHAT TREATMENT SHE TOOK TO ABATE THE SYMPTOMS. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE PATIENT WAS UNABLE TO IDENTIFY THE ERROR MESSAGE. THE PRODUCT ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE HAD SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPOGLYCEMIA AFTER THE PRODUCT ISSUE BEGAN.
IT WAS REPORTED THAT ON THREE DIFFERENT OCCASSIONS THE VENTILATOR SHUT DOWN/REBOOTED WITH AN AUDIBLE ALARM WHILE ON A PATIENT. THE VENTILATOR DISPLAYED RESET AFTER EACH OCCURRANCE. THE PATIENT CONTINUED TO USE THE VENTILATOR AFTER REBOOT OCCURRED. AFTER THE LAST OCCURANCE, THE PATIENT WAS PLACED ON ANOTHER VENTILATOR. NO PATIENT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AURORA - BASE TINA MACHINEWITH ARM OPTION (+N100ARM) | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | BAXTER HEALTHCARE - LARGO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| R |