AVOSET INFUSION PUMP ROW
Report
- Report Number
- 3010293992-2026-00001
- Event Type
- Malfunction
- Date Received
- January 5, 2026
- Report Date
- April 6, 2026
- Manufacturer
- EITAN MEDICAL LTD.
- Product Code
- FRN
- UDI-DI
- 7290109152097
- PMA / PMN Number
- K213744
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 003
Narratives
EITAN MEDICAL HAS CONDUCTED ATTEMPTS TO RECEIVE THE PUMP ITSELF INVESTIGATION. HOWEVER, IT WAS NOT PROVIDED BY THE CUSTOMER. AS A RESULT, A COMPREHENSIVE INVESTIGATION OF THIS EVENT COULD NOT BE CONDUCTED. IF THE PUMP IS PROVIDED BY THE CUSTOMER, AN INVESTIGATION WILL BE CONDUCTED, AND THE INVESTIGATION'S FINDINGS WILL BE PRESENTED IN A 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: K213744.
THE FOLLOWING TESTS AND INSPECTIONS WERE PERFORMED BY EITAN MEDICAL: INVESTIGATION TYPE: EITAN MEDICAL INVESTIGATED THE PUMP. INVESTIGATION FINDINGS: NO INDICATION OF ANY FAILURE THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT WAS OBSERVED. THE PUMP'S ACCURACY WAS TESTED AND FOUND TO MEET SPECIFICATIONS. CONCLUSION: THE PUMP'S ACCURACY MEETS SPECIFICATIONS. NO FAILURE WAS FOUND. 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: K213744.
THE FOLLOWING TESTS AND INSPECTIONS WERE PERFORMED BY EITAN MEDICAL: INVESTIGATION TYPE: EITAN MEDICAL INVESTIGATED THE PUMP'S EVENT LOG. INVESTIGATION FINDINGS: THE ACCURACY OF THE DEVICE CANNOT BE DETERMINED SOLELY BY THE EVENT LOG. CONCLUSION: THE ACCURACY OF THE DEVICE CANNOT BE DETERMINED SOLELY BY THE EVENT LOG. EITAN MEDICAL HAS REQUESTED THE PUMP TO BE RECEIVED FOR INVESTIGATION. WHEN RECEIVED, THE PUMP WILL BE TESTED, AND THE TEST RESULTS WILL BE PRESENTED IN A 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: K213744.
THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM FRANCE. A DELIVERY ISSUE WAS REPORTED. NO HUMAN HARM AND NO MEDICAL INTERVENTION WAS REPORTED. THE TYPE OF DRUG DURING THE EVENT WAS NOT REPORTED. SINCE THE LIKELIHOOD OF CAUSING OR CONTRIBUTING TO DEATH OR SERIOUS INJURY COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION ABOUT THE TYPE OF DRUG INVOLVED, THE COMPLAINT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.
THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM FRANCE. A DELIVERY ISSUE WAS REPORTED. NO HUMAN HARM AND NO MEDICAL INTERVENTION WAS REPORTED.
THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM FRANCE. A DELIVERY ISSUE WAS REPORTED. NO HUMAN HARM AND NO MEDICAL INTERVENTION WAS REPORTED. THE TYPE OF DRUG DURING THE EVENT WAS NOT REPORTED. SINCE THE LIKELIHOOD OF CAUSING OR CONTRIBUTING TO DEATH OR SERIOUS INJURY COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION ABOUT THE TYPE OF DRUG INVOLVED, THE COMPLAINT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 540398 | AVOSET INFUSION PUMP ROW | INFUSION PUMP | FRN | EITAN MEDICAL LTD. | 7290109152097 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |