N
Patient 1
(B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON THE COMPLETION OF THIS ACTIVITY.
MAUDE MDR 5413566
- MDR report key
- 5413566
- Report number
- 8030665-2016-00050
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-01-08
- Date received
- 2016-02-05
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- TANYA TAFT
- 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 | FRESENIUS HOME HEMO WITH PRIME BAG | HIGH PERMEABILITY HEMODIALYSIS SYSTEM FOR AT HOME USE | FRESENIUS MEDICAL CARE NORTH AMERICA | ONW | 03-2962-3 | 15KR01074 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-02-05 | 0 | 1. H |
Event Narratives#
D
Patient 1
A USER FACILITY REPORTED THAT APPROXIMATELY 2.5 HOURS INTO THE HOME HEMODIALYSIS TREATMENT, THE PATIENT BECAME AWARE OF A BLOOD LEAK. THE PATIENT CALLED THE HOME HEMODIALYSIS NURSE (RN) TO INFORM HER OF THE INCIDENT, AND SUBSEQUENTLY REPORTED FEELING DIZZY AND HAVING LOW BLOOD PRESSURE. THE NURSE ALERTED THE AUTHORITIES FOR A MEDICAL EMERGENCY, AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL VIA AMBULANCE FOR AN ASSESSMENT AND BLOOD WORK. THE PATIENT WAS DISCHARGED HOME. NO MEDICAL INTERVENTION WAS REPORTED. THE ESTIMATED BLOOD LOSS (EBL) WAS NOT KNOWN. FOLLOW-UP INFORMATION WAS PROVIDED BY THE AT-HOME NURSE WHO REVEALED THAT THE BLOODLINE WAS BROUGHT INTO THE CLINIC ON (B)(6) 2016 WHERE IT WAS INSPECTED BY BOTH THE PATIENT AND STAFF. REPORTEDLY, THE VENOUS TUBING WAS MISALIGNED WHEN ATTACHED TO THE DIALYZER. NO DAMAGE TO THE TUBING WAS VISIBLE. THE BLOOD LEAK OCCURRED AT THE DIALYZER AND VENOUS CONNECTION SITE. ADDITIONALLY, THE PATIENT WAS PREVIOUSLY INSTRUCTED ON THE PROPER USE OF MOISTURE SENSORS, BUT NO SENSORS WERE PLACED ON THE FLOOR DURING THE TREATMENT. FOLLOWING THIS EVENT, THE PATIENT WAS SCHEDULED TO RETURN TO THE CLINIC FOR A ONE WEEK REVIEW OF AT HOME SAFETY PROTOCOLS. FURTHER INFORMATION HAS BEEN REQUESTED.
N
Patient 1
THE COMPLAINT DEVICE WAS NOT RETURNED AND NO COMPANION SAMPLE WAS AVAILABLE TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ALTERNATE SAMPLES WERE AVAILABLE FOR ANALYSIS AS ALL RELATED LOTS HAVE BEEN SOLD AND DISTRIBUTED. A MANUFACTURING REVIEW WAS PERFORMED OF THE PRODUCTS SHIPPED TO THE DIALYSIS CENTER FOR THE THREE (3) MONTH TIME FRAME WHICH IMMEDIATELY PRECEDED THE EVENT OCCURRENCE DATE. THIS REVIEW INCLUDED THE LOT NUMBERS FOR ALL BLOODLINE TUBING SETS SHIPPED TO THIS ACCOUNT WITHIN THE SELECTED TIME FRAME. A RECORDS REVIEW WAS PERFORMED ON EACH IDENTIFIED LOT. 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 BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.
D
Patient 1
FOLLOW-UP INFORMATION WAS PROVIDED BY THE HOME HEMODIALYSIS MRN. THE PATIENT'S ESTIMATED BLOOD LOSS WAS NOT KNOWN. HOWEVER, ON (B)(6) 2016, THE PATIENT'S HEMOGLOBIN WAS 106. A FEW DAYS AFTER THE EVENT, ON (B)(6) 2016, THE PATIENT'S HEMOGLOBIN WAS ONCE AGAIN TESTED AND WAS FOUND TO BE DOWN TO 88. THE PATIENT SPENT THE NIGHT IN THE HOSPITAL'S EMERGENCY DEPARTMENT, HAD BLOOD WORK COMPLETED, AND WAS DISCHARGED THE FOLLOWING DAY ((B)(6) 2016). THE PATIENT'S CURRENT CONDITION WAS REPORTED AS BEING FINE. THE PATIENT HAS COMPLETELY RECOVERED AND IS DOING WELL.
N
Patient 1
MANUFACTURING EVALUATION: THE COMPLAINT DEVICE WAS NOT RETURNED AND NO COMPANION SAMPLE WAS AVAILABLE TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ALTERNATE SAMPLES WERE AVAILABLE FOR ANALYSIS AS ALL RELATED LOTS HAVE BEEN SOLD AND DISTRIBUTED. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOT. 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 BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. CLINICAL INVESTIGATION: THE PATIENT MEDICAL RECORDS WERE PROVIDED BY THE FACILITY ON APRIL 6, 2016. A CLINICAL INVESTIGATION WAS PERFORMED TO IDENTIFY A CAUSAL RELATIONSHIP BETWEEN THE HEMODIALYSIS TREATMENT AND THE ADVERSE EVENT. ON (B)(6) 2016, THE PATIENT CALLED THE HOME HEALTH REGISTERED NURSE (RN) APPROXIMATELY 2 HOURS INTO THE HEMODIALYSIS TREATMENT AFTER OBSERVING A MODERATELY SIZED ?PUDDLE OF BLOOD? DRIPPING TO THE FLOOR FROM THE VENOUS END OF THE DIALYZER. REPORTEDLY, THE PATIENT FAILED TO PLACE A LEAK ALERT SENSOR BELOW THE DIALYZER AS INSTRUCTED TO DO DURING THE HOME HEALTH TRAINING. EMERGENCY SERVICES WERE CONTACTED AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL FOR ASSESSMENT. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ((B)(6) 2016), AND THEN SCHEDULED TO RETURN TO THE CLINIC FOR A ONE WEEK REVIEW OF SAFETY PROTOCOLS AT HOME. THE PATIENT INITIALLY INDICATED THAT THE VENOUS BLOODLINE TUBING WAS DEFECTIVE AND CRACKED WHICH RESULTED IN THE BLOOD LEAK. HOWEVER, UPON EXAMINATION OF THE DEVICE AT THE HOME HEALTH CLINIC, THE HOME HEALTH RN DETERMINED THAT THE VENOUS BLOODLINE WAS NOT THREADED (CONNECTED) PROPERLY OR CORRECTLY SECURED TO THE REVACLEAR DIALYZER AT THE VENOUS END. NO CRACK WAS VISIBLE IN THE TUBING; THE BLOOD APPEARED TO HAVE LEAKED AROUND THE DIALYZER AND VENOUS CONNECTION SITE. ADDITIONALLY, THE PATIENT ADMITTED NOT BEING ABLE TO RETURN THE BLOOD WITHIN THE CIRCUIT. FURTHERMORE, THE PATIENT FAILED TO USE MOISTURE SENSORS ON THE FLOOR, BENEATH THE DIALYZER, AS SHE HAD BEEN PREVIOUSLY INSTRUCTED TO DO DURING HOME HD TRAINING. THE PATIENT WAS SCHEDULED TO RETURN TO THE CLINIC FOR A ONE WEEK REVIEW OF HOME HEMODIALYSIS SAFETY PROTOCOLS. MEDICAL RECORDS CONFIRM THAT NO DEVICE MALFUNCTION OCCURRED. BASED ON THE DOCUMENTATION PROVIDED WITHIN THE PATIENT?S MEDICAL RECORDS, THE ADVERSE EVENT LIKELY OCCURRED AS A RESULT OF USER ERROR.