SAPPHIRE M.T INFUSION PUMP - GERMAN
Report
- Report Number
- 3010293992-2025-00055
- Event Type
- Malfunction
- Date Received
- September 2, 2025
- Report Date
- November 20, 2025
- Manufacturer
- EITAN MEDICAL LTD.
- Product Code
- FRN
- UDI-DI
- 7290109150802
- PMA / PMN Number
- K192860
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
INVESTIGATION TYPE: EITAN MEDICAL INVESTIGATED THE PUMP AND ITS EVENT LOG. INVESTIGATION FINDINGS: THE MINOR DEVIATIONS OBSERVED IN THE EVENT LOG ARE WITHIN THE SAPPHIRE PUMP'S ACCURACY SPECIFICATIONS. THEREFORE, NO OVER DELIVERY WAS OBSERVED IN THE TREATMENTS PERFORMED BY THE CUSTOMER. CONCLUSION: NO OVER DELIVERY WAS OBSERVED IN THE TREATMENTS PERFORMED BY THE CUSTOMER. THIS REPORTED EVENT OCCURRED OUTSIDE OF THE US ON A DEVICE THAT IS SIMILAR TO THE ONE MARKETED IN THE US AND FOR WHICH THERE IS NO DATA IN GUDID. DEVICE'S PREMARKET SUBMISSION NUMBER: K192860.
INVESTIGATION TYPE: EITAN MEDICAL INVESTIGATED THE PUMP AND ITS EVENT LOG. INVESTIGATION FINDINGS: THE PUMP'S ACCURACY WAS TESTED AND FOUND TO MEET SPECIFICATIONS. HOWEVER, A SMALL DEVIATION WAS OBSERVED IN 2 OF THE 3 TREATMENTS FOUND IN THE EVENT LOG. CONCLUSION: NO INVESTIGATION CONCLUSION IS AVAILABLE YET. EITAN MEDICAL CONTINUES TO INVESTIGATE THIS COMPLAINT. THIS REPORTED EVENT OCCURRED OUTSIDE OF THE US ON A DEVICE THAT IS SIMILAR TO THE ONE MARKETED IN THE US AND FOR WHICH THERE IS NO DATA IN GUDID. DEVICE'S PREMARKET SUBMISSION NUMBER: K192860.
EVENT LOG HAS BEEN RECEIVED AND IS CURRENTLY UNDER INVESTIGATION. INVESTIGATION FINDINGS WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORTED EVENT OCCURRED OUTSIDE OF THE US ON A DEVICE THAT IS SIMILAR TO THE ONE MARKETED IN THE US AND FOR WHICH THERE IS NO DATA IN GUDID. DEVICE'S PREMARKET SUBMISSION NUMBER: K192860.
THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM GERMANY. A DELIVERY ISSUE WAS REPORTED. NO HUMAN HARM AND NO MEDICAL INTERVENTION OCCURRED AS A RESULT OF THIS COMPLAINT.
THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM GERMANY. A DELIVERY ISSUE WAS REPORTED. NO HUMAN HARM AND NO MEDICAL INTERVENTION OCCURRED AS A RESULT OF THIS COMPLAINT.
THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM GERMANY. A DELIVERY ISSUE WAS REPORTED. NO HUMAN HARM AND NO MEDICAL INTERVENTION WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2865142 | SAPPHIRE M.T INFUSION PUMP - GERMAN | INFUSION PUMP | FRN | EITAN MEDICAL LTD. | 7290109150802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |