| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP | HIGH PERMEABILITY HEMODIALYSIS SYSTEM FOR AT HOME USE | FRESENIUS MEDICAL CARE NORTH AMERICA | ONW | 190395 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-04-06 | 0 | 1. H; 2. L; 3. R |
Patient 1
(B)(4). NO PARTS WERE NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE POST MARKET SURVEILLANCE DEPARTMENT IS IN THE PROCESS OF REVIEWING PATIENT MEDICAL RECORDS AND TREATMENT SHEETS. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED AT THE COMPLETION OF THESE ACTIVITIES.
Patient 1
A NURSE FROM A HOME HEMODIALYSIS FACILITY HAD REPORTED A PATIENT BEING ADMITTED TO THE HOSPITAL DUE TO ADVERSE SYMPTOMS EXHIBITED DURING A HOME HEMODIALYSIS TREATMENT. ADVERSE SYMPTOMS INCLUDE CHEST PAINS, SHORTNESS OF BREATH, AND FEELING OF FULLNESS. IT SHOULD BE NOTED THAT ON (B)(6) 2016, THE PATIENT ATTEMPTED HEMODIALYSIS TREATMENT AND WAS UNSUCCESSFUL DUE TO SEVERAL TRANSMEMBRANE PRESSURE ALARMS ON THIS MACHINE. THE PATIENT WAS UNABLE TO RECEIVE ADEQUATE TREATMENT DUE TO ALARMS FOR LOW TRANSMEMBRANE PRESSURE. THE MACHINE WAS ASSESSED BY A FRESENIUS TECHNICIAN AND PASSED ALL FUNCTIONAL TESTS, SO THE PATIENT'S TREATMENT WAS DISCONTINUED AND A PHYSICIAN ORDERED A FISTULOGRAM BE DONE ON (B)(6) 2016. A PHYSICIAN EXAMINED THE PATIENT'S FISTULA AND FOUND NO PROBLEMS, THUS, NO INTERVENTION WAS NEEDED. DURING TREATMENT ON (B)(6) 2016, THERE WERE CONTINUED ALARMS EMITTING FROM THE MACHINE FOR LOW TRANSMEMBRANE PRESSURE. THE PATIENT HALTED TREATMENT AND CONTACTED THE HOME HEMO NURSE, WHO PROMPTLY VISITED THE PATIENT'S HOME. THE HOME HEMO NURSE WAS ABLE TO GET THIS MACHINE TO PASS FUNCTIONAL TESTING AND PLACED THE PATIENT BACK ON THE MACHINE. APPROXIMATELY 1 HOUR INTO TREATMENT, THE PATIENT HAD REPORTED SYMPTOMS INDICATED ABOVE. THE PATIENT WAS RUSHED TO THE HOSPITAL WHERE THEY WERE ADMITTED FOR PULMONARY ADEMA WITH HYPOTENSION AS A RESULT OF FLUID OVERLOAD. THE PATIENT WAS TREATED AT THE HOSPITAL AND RELEASED. THE PATIENT WAS ABLE TO SUCCESSFULLY COMPLETE IN CENTER DIALYSIS ON (B)(6) 2016 AND COMPLETED A SUCCESSFUL HOME HEMODIALYSIS TREATMENT THEREAFTER ON (B)(6) 2016. MEDICAL RECORDS HAVE BEEN REQUESTED AND RECEIVED FOR REVIEW.
Patient 1
CLINICAL INVESTIGATION: THE PATIENT MEDICAL RECORDS WERE PROVIDED BY THE FACILITY ON MARCH 16, 2016. A CLINICAL INVESTIGATION WAS PERFORMED TO IDENTIFY A CAUSAL RELATIONSHIP BETWEEN THE HEMODIALYSIS TREATMENT AND THE ADVERSE EVENT. THE MEDICAL RECORDS DO NOT CONTAIN A MEDICATION LIST FOR REVIEW. MEDICAL RECORDS CLEARLY REVEAL THE PATIENT WAS HOSPITALIZED FOR VOLUME OVERLOAD DUE TO MISSING HEMODIALYSIS TREATMENTS. IN ADDITION, THE PATIENT HAS A HISTORY OF HYPERTENSION AND WAS CLEARLY HYPERTENSIVE PRIOR TO STARTING HEMODIALYSIS ON (B)(6) 2016. THERE IS NO DOCUMENTATION IN THE MEDICAL RECORD THAT INDICATES A CAUSAL RELATIONSHIP BETWEEN THE PATIENT?S HOSPITALIZATION FOR VOLUME OVERLOAD AND THE SALINE. IT IS EVIDENT THAT THE PATIENT HAD A SUCCESSFUL HEMODIALYSIS ON (B)(6) 2016. IT APPEARS THE PATIENT HAD NO HEMODIALYSIS TREATMENT ON (B)(6) 2016, AN UNSUCCESSFUL TREATMENT ON (B)(6) 2016, NO TREATMENTS ON (B)(6) 2016 AND ANOTHER UNSUCCESSFUL HEMODIALYSIS TREATMENT ON (B)(6) 2016. MEDICAL RECORDS DO NOT CONTAIN A SCHEDULE FOR HEMODIALYSIS TREATMENTS. IT SHOULD BE NOTED THERE IS NO DOCUMENTATION IN THE MEDICAL RECORD THAT INDICATES PATIENT WAS SCHEDULED FOR IN-CLINIC HEMODIALYSIS DUE TO HEMODIALYSIS MACHINE MALFUNCTION. THERE IS NO DOCUMENTATION IN THE MEDICAL RECORD THAT INDICATES PATIENT WAS INSTRUCTED TO COME TO THE CLINIC FOR HEMODIALYSIS TREATMENTS DUE TO MISSING SEVERAL DAYS EVEN THOUGH PATIENT WAS ABLE TO BE TRANSPORTED VIA CAR. ALTHOUGH THE MEDICAL RECORDS DO INDICATE THERE WAS A PROBLEM WITH THE MACHINE, THE PATIENT?S HOSPITALIZATION FOR FLUID OVERLOAD WAS SECONDARY TO MISSED HEMODIALYSIS WHICH WAS NOT COMPLETED OR HOME OR IN-CLINIC.
Patient 1
PATIENT MISSED SEVERAL CONSECUTIVE DAYS OF HOME HEMODIALYSIS (HD) TREATMENTS. DURING THE HOME HD TREATMENT PERFORMED ON (B)(6) 2016, THE PATIENT EXPERIENCED CHEST PRESSURE AND DYSPNEA, AND THEN WENT TO THE EMERGENCY ROOM. AT THE EMERGENCY ROOM (ER), THE PATIENT WAS FOUND TO HAVE AN ELEVATED SYSTOLIC BLOOD PRESSURE OF 251. THE PATIENT WAS ADMITTED INTO THE HOSPITAL AND WAS ADMINISTERED HEMODIALYSIS FOR SEVERAL CONSECUTIVE DAYS. THE PATIENT'S WEIGHT AND BLOOD PRESSURE IMPROVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2016.
Patient 1
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED BY A FRESENIUS REGIONAL EQUIPMENT SPECIALIST (RES) AND NO PARTS WERE RETURNED FOR FAILURE ANALYSIS. FOLLOW-UP INFORMATION WAS PROVIDED BY THE BIOMEDICAL ENGINEER WHO REVEALED THAT TESTING WAS PERFORMED PER THE ADVERSE EVENT CHECKLIST AND NO PROBLEMS WERE IDENTIFIED. HOWEVER, THE DIALYSATE PRESSURE TRANSDUCER WAS REPLACED DURING PREVENTIVE MAINTENANCE (PM) AS THE UNIT WOULD NOT HOLD A CALIBRATION. THE CALIBRATION ISSUE WAS RESOLVED AFTER REPLACEMENT OF THE TRANSDUCER. FUNCTIONAL TESTING PERFORMED BY THE BIOMED CONFIRMED THE UNIT WAS OPERATING PROPERLY. THE UNIT REMAINS AT THE USER FACILITY AS A RESERVE BACK-UP. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.