AN UNSPECIFIED CLOSED SYSTEM ART LINE TRANSUDUCER
Report
- Report Number
- 9617594-2025-00501
- Event Type
- Malfunction
- Date Received
- March 18, 2025
- Date of Event
- January 2, 2025
- Report Date
- May 5, 2025
- Manufacturer
- ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
- Product Code
- DRS
- PMA / PMN Number
- K061573
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. THEREFORE, A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED. A MANUFACTURING RECORD REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER.
A2 - DATE OF BIRTH - THE PATIENTS AGE WAS USED TO APPROXIMATE THE DATE OF BIRTH AS (B)(6) 2019. . THE DEVICE WAS NOT SPECIFIED, AND THE 510K WAS ASSUMED TO BE K061573. THE INVESTIGATION IS PENDING COMPLETION. UPON COMPLETION OF THE INVESTIGATION A SUPPLEMENTAL MDR WILL BE SUBMITTED.
A COMPLAINT WAS RECEIVED REGARDING AN UNSPECIFIED CLOSED SYSTEM ART LINE TRANSDUCER THAT EXPERIENCED DEVICE INACCURACY. THE REPORTER STATED THAT PATIENT'S ART LINE WAS NOT READING ACCURATELY. THE PATIENT INVOLVED WAS 6.14 YEARS OLD AND MALE. THE AFFECTED AREA OR UNIT LOCATION WAS H2B. THERE WERE NO OTHER DEVICES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THUS, THERE WAS PATIENT INVOLVEMENT, NO HUMAN HARM AND UNKNOWN DELAY IN THERAPY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1592419 | AN UNSPECIFIED CLOSED SYSTEM ART LINE TRANSUDUCER | TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR | DRS | ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR | Male |