BD PYXIS¿ MEDSTATION¿ ES
Report
- Report Number
- 2016493-2025-104503
- Event Type
- Malfunction
- Date Received
- August 12, 2025
- Date of Event
- July 15, 2025
- Report Date
- June 4, 2026
- Manufacturer
- CAREFUSION 303, INC.
- Product Code
- BRY
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: SECTION H MANUFACTURER NARRATIVE, SECTION B DESCRIBE EVENT OR PROBLEM, SECTION D DEVICE AVAILABLE FOR EVAL AND RETURNED TO MANUFACTURER. CORRECTION: SECTION D UNIQUE IDENTIFIER (UDI). PART ANALYSIS: THE REPORTED CONDITION OF SMART REMOTE MANAGER, LATCH WAS CONFIRMED BY FSE, HOWEVER, THE COMPONENTS ASSOCIATED WITH THE FAILURE REPORTED WERE NOT RECEIVED BY THE DCHU, THEREFORE, NO TESTING OR INSPECTION COULD BE PERFORMED. ACCORDING TO WORK ORDER (B)(4), THE FIELD SERVICE ENGINEER (FSE) REPORTED THAT REPLACED THE LATCH AND CHECKED CONNECTIONS, TIGHTENED THE VOLTAGE TO BOARD AND GOOD TEMPERATURE AND THEN CUSTOMER RECOVERED. THE SYSTEM FUNCTIONED AS EXPECTED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE WITH NO ISSUES OBSERVED. DURING DCHU VISUAL INSPECTION: PN 353844-01: A VISUAL INSPECTION WAS PERFORMED ON THE TWO ASSY RETRACTOR DWR HH CUBIE UNITS. BOTH PARTS ARRIVED WITH PHYSICAL DAMAGE, PRESENTING LOOSE COMPONENTS, STAINS, BLACK MARKS, BENDS, AND CUTS ALONG THE FLAT FLEX CABLE. A VISUAL INSPECTION UNDER THE MICROSCOPE (MICROSCOPE, C1531-62; CALIBRATION DUE DATE ON 25-APR-26) REVEALED COPPER STRANDS SHOWING SIGNS OF THERMAL DAMAGE ON THE TWO RETRACTOR BANDS. DURING DCHU TESTING: PN 353844-01: NO FURTHER TESTING WAS PERFORMED DUE TO SEVERE PHYSICAL DAMAGE, INCLUDING LOOSE COMPONENTS, STAINS, AND BENDS AND CUTS ALONG THE FLAT FLEX CABLE. ADDITIONALLY, SIGNS OF THERMAL DAMAGE WERE OBSERVED ON THE COPPER STRANDS OF BOTH ASSY RETRACTOR DWR HH CUBIE UNITS. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D). ROOT CAUSE: ROOT CAUSE DETERMINATION COULD NOT BE PERFORMED BECAUSE THE COMPONENTS RECEIVED FOR EVALUATION ARE NOT ASSOCIATED WITH COMPLAINT SMART REMOTE MANAGER, LATCH.
ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINTS WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 28-SEP-2022 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE SMART REMOTE MANAGER LATCH ON THE REFRIGERATOR CLICKED TO RELEASE, THEN RELEASED AND RELOCKED. A FIELD SERVICE ENGINEER REPLACED THE LATCH AND CHECKED CONNECTIONS, TIGHTENED THE VOLTAGE TO BOARD AND GOOD TEMPERATURE AND THEN CUSTOMER RECOVERED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT A BD PYXIS¿ MEDSTATION¿ ES SMART REMOTE MANAGER LATCH ON THE FRIDGE WAS CLICKING. THE CUSTOMER REPORTED THAT THEY HAD TO ACCESS THE MEDICATIONS FROM ANOTHER STATION THAT CAUSED A DELAY IN PATIENT CARE. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THE ROOT CAUSE COULD NOT BE IDENTIFIED, AS THE RETURNED COMPONENTS WERE NOT ASSOCIATED WITH THE REPORTED FAILURE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.
IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ MEDSTATION¿ ES SMART REMOTE MANAGER LATCH ON THE FRIDGE WAS CLICKING. THE CUSTOMER REPORTED THAT THEY HAD TO ACCESS THE MEDICATIONS FROM ANOTHER STATION THAT CAUSED A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.
IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ MEDSTATION¿ ES SMART REMOTE MANAGER LATCH ON THE FRIDGE WAS CLICKING. THE CUSTOMER REPORTED THAT THEY HAD TO ACCESS THE MEDICATIONS FROM ANOTHER STATION THAT CAUSED A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1099695 | BD PYXIS¿ MEDSTATION¿ ES | AUTOMATED DISPENSING CABINET | BRY | CAREFUSION 303, INC. | 500001002500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |