| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | U1104 1550 SINGLE PATIENTSYSTEM | SYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT | BAXTER HEALTHCARE - LARGO | FKP | 5M5538 | R | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2010-03-15 | 0 | 1. R |
Patient 1
THE CUSTOMER STATES THAT ONE PATIENT GENERATED AN AXSYM TOXO IGG ASSAY FALSE NEGATIVE RESULT OF LESS THAN 2.0 IU/ML. THE SAME PATIENT CAME BACK TO THE LAB ABOUT ONE MONTH LATER AND WAS REDRAWN AND GENERATED AN AXSYM TOXO IGG ASSAY RESULT OF POSITIVE (28 IU/ML). THE CUSTOMER THEN RETESTED THE ORIGINAL SAMPLE AND GENERATED A POSITIVE RESULT OF 26 IU/ML. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB AND NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. A SERVICE CALL WAS INITIATED.
Patient 1
(B)(4). THE DEVICE WAS EVALUATED IN THE CLINIC FACILITY ON (B)(6) 2010 BY THE FIELD SERVICE TECHNICIAN. THE ALARM (B)(6) IS RELATED TO A FAILURE IN THE BYPASS VALVE OR IN THE ISOLATION VALVE. THE EVALUATION OF THE TECHNICIAN CONFIRMED THE THREE WAY VALVE WAS NOT IN GOOD CONDITION. THE EVALUATION PERFORMED BY THE TECHNICIAN DEMONSTRATES THE THREE WAY VALVE WAS FILLED WITH HEAVY METAL DUE TO THE USE OF INADEQUATE (UNPURE) WATER. THE THREE WAY VALVE WAS CLEANED AND INSTALLED INTO THE MACHINE. THE DEVICE WAS CONSIDERED READY FOR USE.
Patient 1
ON (B) (6) 2010 A REPORT WAS RECEIVED FROM A FACILITY NURSE STATING THAT THE 1550 SINGLE PATIENT SYSTEM MACHINE HAD ULTRAFILTRATION DURING PATIENT HEMODIALYSIS THERAPY RESULTING IN THE PATIENT EXPERIENCING HYPOTENSION AND DIAPHORESIS. THE DEVICE WAS PROGRAMMED TO FILTRATE 3.3 BUT THE MACHINE ACTUALLY FILTRATED 4.4. THE NURSE STATED THE DEVICE SHOWED A FAILURE CODE "FL06". 1000ML SALINE SOLUTION INTRAVENOUS (IV) WAS ADMINISTERED TO THE PATIENT. THE PATIENT WAS OBSERVED FOR 40 MINUTES AND THE PATIENT IMPROVED. THE PHYSICIAN WAS NOTIFIED OF THE EVENT. THE NURSE FOLLOWED UP WITH THE PATIENT LATER THAT DAY AND HE FELT GOOD. THIS IS A MALE PATIENT, (B) (6). THE FAILURE CODE (FL06) THAT OCCURRED ON THE HEMODIALYSIS MACHINE INVOLVED INDICATES A FAILURE IN THE THREE-WAY BYPASS/ISOLATION VALVE. REPORTEDLY, THE DEVICE HAD PREVENTIVE MAINTENANCE ON (B) (6) 2010 PRIOR TO THE EVENT AND ON (B) (6) 2010, AFTER THE EVENT. THE TECHNICIAN EVALUATED THE DEVICE AT THE FACILITY. RESULTS OF EVALUATION INDICATES THERAPY WAS PERFORMED ON THIS MACHINE USING ACUEDUCT WATER (THIS MEANS UNTREATED WATER). THE TECHNICIAN ALSO INDICATED THAT THE WATER USED IN THIS BAXTER RENAL CLINIC IS PROPER (TREATED) WATER, BUT THE MACHINE IS ALSO USED IN OTHER CLINICS WHERE UNTREATED WATER IS USED. THE ACUEDUCT (UNTREATED) WATER RESULTS IN THE THREE-WAY VALVE HAVING A BUILD-UP OF HEAVY METAL RESIDUE.
Patient 1
(B) (4). THE FIELD SERVICE TECHNICIAN WENT TO THE CLINIC AND EVALUATED THE DEVICE. CURRENTLY, THE DATE OF THE EVALUATION IS UNKNOWN AND THE FINAL RESULTS OF THE EVALUATION HAVE NOT YET BEEN RECEIVED.