NURSE ASSIST, LLC
Report
- Report Number
- 3002695476-2024-00051
- Event Type
- Death
- Date Received
- November 26, 2024
- Date of Event
- November 12, 2023
- Report Date
- November 22, 2024
- Manufacturer
- NURSE ASSIST, LLC
- Product Code
- FRO
- PMA / PMN Number
- K083042
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
THIS REPORT IS BASED ON AN EVENT FROM (B)(6) 2023. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. AN ANALYSIS OF THE DEVICE LOT RECORDS INDICATES THAT THE PRODUCT MET ALL SPECIFICATIONS AND RELEASE REQUIREMENTS. BASED ON THE AVAILABLE INFORMATION IN THE COMPLAINT FILE AND INVESTIGATION CONDUCTED BY NURSE ASSIST AND OUR MEDICAL DIRECTOR, THERE IS NO CLEAR EVIDENCE TO REASONABLY SUGGEST THAT STERICARE 0.9% SODIUM CHLORIDE SALINE SOLUTION MAY HAVE BEEN A CAUSE OF THE REPORTED EVENT AND RESULTING HARM (SEPSIS). OTHER MOST LIKELY FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT INCLUDE (MAY NOT BE LIMITED TO) PATIENT SPECIFIC CONDITIONS (EG: LYMPHODEMA OR GRAFT-VERSUS-HOST-DISEASE OR THE UNDERLYING CONDITION OF LYMPHOMA AND THE RESULTANT TREATMENT WITH HIGH DOSE CHEMOTHERAPY AND BONE MARROW TRANSPLANT WOULD HAVE LEFT THE PATIENT IN A PERSISTENT IMMUNE-COMPROMISED STATE).
THIS REPORT IS BASED ON AN EVENT FROM (B)(6) 2023. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. AN ANALYSIS OF THE DEVICE LOT RECORDS INDICATES THAT THE PRODUCT MET ALL SPECIFICATIONS AND RELEASE REQUIREMENTS. BASED ON THE AVAILABLE INFORMATION IN THE COMPLAINT FILE AND INVESTIGATION CONDUCTED BY NURSE ASSIST AND OUR MEDICAL DIRECTOR, THERE IS NO CLEAR EVIDENCE TO REASONABLY SUGGEST THAT STERICARE 0.9% SODIUM CHLORIDE SALINE SOLUTION MAY HAVE BEEN A CAUSE OF THE REPORTED EVENT AND RESULTING HARM (SEPSIS). OTHER MOST LIKELY FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT INCLUDE (MAY NOT BE LIMITED TO) PATIENT SPECIFIC CONDITIONS (EG: LYMPHODEMA OR GRAFT-VERSUS-HOST-DISEASE OR THE UNDERLYING CONDITION OF LYMPHOMA AND THE RESULTANT TREATMENT WITH HIGH DOSE CHEMOTHERAPY AND BONE MARROW TRANSPLANT WOULD HAVE LEFT THE PATIENT IN A PERSISTENT IMMUNE-COMPROMISED STATE).
THE DECEDENT WAS DIAGNOSED WITH LYMPHOMA ON OR AROUND 2016 AND RECEIVED A BONE MARROW TRANSPLANT IN 2016. THE DECEDENT DEVELOPED LYMPHEDEMA IN 2021. ON OR AROUND (B)(6) 2023, HE DEVELOPED GRAFT-VERSUS-HOST DISEASE, AND THE LYMPHEDEMA WORSENED. THE REPORT INDICATED THE DECEDENT USED 1 BOTTLE OF SOLUTION ON HIS OPEN WOUNDS AND CUTS FOR A FEW WEEKS. THE DECEDENT SUFFERED FROM LYMPHEDEMA, A CONDITION WHICH CAUSED HIM TO EXPERIENCE WOUNDS AND INFECTIONS AROUND HIS LEGS. THE DECEDENT WAS PRESCRIBED 4 BOTTLES OF 0.9% SODIUM CHLORIDE SALINE SOLUTION ON OR AROUND (B)(6) 2023 BY CITY OF HOPE HOSPITAL IN DUARTE, CALIFORNIA TO CLEAN HIS WOUNDS AND INFECTIONS. THE DECEDENT WAS SUPPLIED 4 BOTTLES OF NURSE ASSIST, LLC 0.9% SODIUM CHLORIDE SALINE SOLUTION BY BRYAM HEALTHCARE CENTERS, INC ON OR AROUND (B)(6) 2023. AFTER USING 1 OF THE 4 BOTTLES, THE DECEDENT BEGAN SUFFERING FROM EXTREME PAIN, ABNORMAL SWELLING, A CHANGE IN SKIN COLOR AND PAIN ON HIS WOUNDS AND INFECTIONS. THE DECEDENT WAS TRANSPORTED TO A LOCAL HOSPITAL ON OR AROUND (B)(6) 2023, AFTER ARRIVING HE WENT INTO SEPTIC SHOCK AND CARDIAC ARREST AND PASSED AWAY.
THE DECEDENT WAS DIAGNOSED WITH LYMPHOMA ON OR AROUND 2016 AND RECEIVED A BONE MARROW TRANSPLANT IN 2016. THE DECEDENT DEVELOPED LYMPHEDEMA IN 2021. ON OR AROUND (B)(6) 2023, HE DEVELOPED GRAFT-VERSUS-HOST DISEASE, AND THE LYMPHEDEMA WORSENED. THE REPORT INDICATED THE DECEDENT USED 1 BOTTLE OF SOLUTION ON HIS OPEN WOUNDS AND CUTS FOR A FEW WEEKS. THE DECEDENT SUFFERED FROM LYMPHEDEMA, A CONDITION WHICH CAUSED HIM TO EXPERIENCE WOUNDS AND INFECTIONS AROUND HIS LEGS. THE DECEDENT WAS PRESCRIBED 4 BOTTLES OF 0.9% SODIUM CHLORIDE SALINE SOLUTION ON OR AROUND (B)(6) 2023 BY (B)(6) HOSPITAL IN (B)(6), CALIFORNIA TO CLEAN HIS WOUNDS AND INFECTIONS. THE DECEDENT WAS SUPPLIED 4 BOTTLES OF NURSE ASSIST, LLC 0.9% SODIUM CHLORIDE SALINE SOLUTION BY (B)(6) CENTERS, INC ON OR AROUND (B)(6) 2023. AFTER USING 1 OF THE 4 BOTTLES, THE DECEDENT BEGAN SUFFERING FROM EXTREME PAIN, ABNORMAL SWELLING, A CHANGE IN SKIN COLOR AND PAIN ON HIS WOUNDS AND INFECTIONS. THE DECEDENT WAS TRANSPORTED TO A LOCAL HOSPITAL ON OR AROUND (B)(6) 2023, AFTER ARRIVING HE WENT INTO SEPTIC SHOCK AND CARDIAC ARREST AND PASSED AWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2360218 | NURSE ASSIST, LLC | 0.9% NORMAL SALINE FOR IRRIGATION USP IN SCREW BOTTLE TOP | FRO | NURSE ASSIST, LLC | 6270 | 23076070 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization| D |