| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FRESENIUS 2008K@HOME | HIGH PERMEABILITY HEMODIALYSIS SYSTEM FOR AT HOME USE | FRESENIUS MEDICAL CARE NORTH AMERICA | ONW | 2008K@HOME | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-07-15 | 0 | 1. D |
Patient 1
(B)(4). NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE POST MARKET SURVEILLANCE IS IN THE PROCESS OF REQUESTING MEDICAL RECORDS AND TREATMENT DATA IN RELATION TO THIS EVENT. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED AT THE COMPLETION OF THIS ACTIVITY.
Patient 1
THE PATIENT'S SPOUSE REPORTED THAT THE PATIENT WAS EXPIRED DURING A ROUTINE EFFECTIVENESS CHECK. THE CLINIC ASSOCIATED WITH THE PATIENT'S HOME TREATMENTS WAS CONTACTED TO GATHER FURTHER INFORMATION RELATED TO THE EXACT CIRCUMSTANCES WHICH LED TO THE PATIENT'S DEATH. THE REGISTERED NURSE (RN) AT THE USER FACILITY, RESPONSIBLE FOR THIS PATIENT'S CARE, INDICATED THAT THE PATIENT WENT INTO CARDIAC ARREST AND PASSED ON (B)(6) 2016. THE PATIENT'S LAST KNOWN HOME TREATMENT WAS ON (B)(6) 2016 WHICH WAS SUCCESSFULLY COMPLETED WITHOUT ISSUE. SEVERAL DAYS LATER, WHILE TRAVELING, THE PATIENT EXPERIENCED A HEART ATTACK, AND WAS HOSPITALIZED. WHILE HOSPITALIZED, THE PATIENT CONTINUED TO UNDERGO HEMODIALYSIS TREATMENTS, WITH THE LAST KNOWN TREATMENT BEING PERFORMED ON (B)(6) 2016. FURTHERMORE, THE RN STATED THAT THE PATIENT HAD CHRONIC ISCHEMIC HEART DISEASE AND CONTINUED TO HAVE HEART ISSUES WHILE HOSPITALIZED. REPORTEDLY, THE PHYSICIANS TREATING THE PATIENT WERE ABLE TO SEE ON-GOING HEART PROBLEMS DURING MEDICAL TESTING. A SECOND ATTEMPT TO GATHER SPECIFIC DETAILS RELATED TO THIS EVENT WAS MADE BY FOLLOWING UP WITH THE HOSPITAL. A HEMODIALYSIS NURSE REVEALED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2016, BUT REFUSED TO PROVIDE ANY FURTHER PATIENT OR EVENT DETAILS. NO FURTHER INFORMATION WAS MADE AVAILABLE BY THE HOSPITAL OR USER FACILITY IN REGARDS TO THE SEQUENCE OF EVENTS LEADING UP TO THE PATIENT'S DEATH. NO MALFUNCTIONS OF ANY FRESENIUS PRODUCTS WERE ALLEGED DURING THE FOLLOW-UP ATTEMPTS PERFORMED TO GATHER INFORMATION SURROUNDING THIS PATIENT'S EXPIRATION. THE PATIENT MEDICAL RECORDS HAVE BEEN REQUESTED.
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. THEREFORE, THE INVESTIGATION WAS NOT ABLE TO CONFIRM A DEVICE ISSUE THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS NOT ABLE TO BE CONDUCTED BY THE MANUFACTURER AS THE 2008K@HOME HEMODIALYSIS (HD) MACHINE IN QUESTION WAS NOT KNOWN, THEREFORE, THE SERIAL NUMBER WAS NOT ABLE TO BE PROVIDED. HOWEVER, ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO THE "DHR REVIEW CHECKLIST & RELEASE PROCEDURE." P/N 500658; A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.