N
Patient 1
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
MAUDE MDR 6212333
- MDR report key
- 6212333
- Report number
- 2937457-2016-01265
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-12-02
- Date received
- 2016-12-29
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- THOMAS C. JOHNSON
- Address
- 920 WINTER ST. WALTHAM MA 02451 US
- Phone
- 781-781-7816
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP | HEMODIALYSIS SYSTEM FOR HOME USE | CONCORD MANUFACTURING | ONW | 190395 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-12-29 | 0 |
Event Narratives#
D
Patient 1
THE DIALYSIS CHARGE NURSE AT THE USER FACILITY REPORTED A BLOOD LOSS EVENT THAT OCCURRED APPROXIMATELY 2 HOURS AFTER INITIATION OF THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE CHARGE NURSE DESCRIBED WHAT APPEARED AS A NEGATIVE DRAINING SOUND COMING FROM THE 2008K@HOME HEMODIALYSIS (HD) MACHINE. AIR, PRESENT IN THE ARTERIAL CHAMBER OF THE BLOODLINE, REPORTEDLY TRAVELED TO THE BLOOD PUMP, HOWEVER, NO AIR ALARM WAS GENERATED BY THE 2008K@HOME HD MACHINE. THE PATIENT?S TREATMENT WAS STOPPED, AND THE EXTRACORPOREAL CIRCUIT WAS DISCARDED. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS NOTED AS BEING APPROXIMATELY 300ML. , THE PATIENT WAS RE-SETUP ON ANOTHER MACHINE, AND THEN THE TREATMENT WAS CONTINUED AND SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES BEING REPORTED. FOLLOWING THE EVENT, THE 2008K@HOME HD MACHINE WAS REMOVED FROM SERVICE FOR EVALUATION. ADDITIONALLY, FOLLOWING THE BLOOD LOSS, THE PATIENT'S HEMOGLOBIN (HGB) WAS NOTED AS BEING LOW. HOWEVER, NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. THE BLOODLINE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT WAS DISCARDED BY THE USER FACILITY.
N
Patient 1
ALTHOUGH REQUESTED, NO FURTHER EVENT RELATED DETAILS HAVE BEEN RECEIVED. THEREFORE, IT IS NOT CURRENTLY KNOWN IF ANY SERVICE RELATED REPAIR ACTIVITIES HAVE BEEN PERFORMED OR IF THE UNIT HAS BEEN RETURNED TO SERVICE AT THE USER FACILITY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED. 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. 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 WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE 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.
D
Patient 1