LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
Report
- Report Number
- 0008030665-2024-00385
- Event Type
- Malfunction
- Date Received
- April 19, 2024
- Date of Event
- April 6, 2024
- Report Date
- May 3, 2024
- Manufacturer
- ERIKA DE REYNOSA, S.A. DE C.V.
- Product Code
- FKX
- UDI-DI
- 00840861100750
- PMA / PMN Number
- K173718
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- 003
Narratives
PLANT INVESTIGATION: AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER, A PHYSICAL EVALUATION COULD NOT BE PERFORMED. A BATCH RECORDS REVIEW WAS CONDUCTED BY THE MANUFACTURER FOR THE REPORTED LOT. THERE WERE NO NON-CONFORMANCES OR ABNORMALITIES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE ENTIRE LOT HAS BEEN SOLD AND DISTRIBUTED. IN ADDITION, A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE LOT MET ALL SPECIFICATIONS FOR RELEASE. A PRODUCT HISTORY REVIEW DID NOT REVEAL A PROBABLE CAUSE FOR THE CUSTOMER COMPLAINT. AS A PHYSICAL EVALUATION COULD NOT BE PERFORMED, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED.
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
ADDITIONAL INFORMATION: A.2.,A.3.,A.4. AND B.5.
A PERITONEAL DIALYSIS (PD) PATIENT REPORTED THAT DURING TREATMENT THE PIN CONNECTOR STARTED SPOUTING FLUID FROM IT. THE FLUID WAS DISCOVERED DURING DWELL 3 OF 4. THE PATIENT WAS CONNECTED DURING INCIDENT. THE FLUID LEAKED FROM THE BLUE PIN. A MWD WATCH-DOG TIMER ERROR HAD OCCURRED DURING THE SET-UP FOR TREATMENT. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED. THERE WAS NO PATIENT HARM INDICATED IN THE INITIAL REPORT. THERE ARE NO SAMPLES LISTED AS BEING AVAILABLE TO RETURN FOR ANALYSIS. A CLINICAL MANAGER CALLED BACK AND VERIFIED THE FLUID LEAK AND SAID THERE WAS NO HARM, INTERVENTION OR ADVERSE EVENT RELATED TO THE FLUID LEAK. THERE ARE NO SAMPLES TO RETURN.
A PERITONEAL DIALYSIS (PD) PATIENT REPORTED THAT DURING TREATMENT THE PIN CONNECTOR STARTED SPOUTING FLUID FROM IT. THE FLUID WAS DISCOVERED DURING DWELL 3 OF 4. THE PATIENT WAS CONNECTED DURING INCIDENT. THE FLUID LEAKED FROM THE BLUE PIN. A MWD WATCH-DOG TIMER ERROR HAD OCCURRED DURING THE SET-UP FOR TREATMENT. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED. THERE WAS NO PATIENT HARM INDICATED IN THE INITIAL REPORT. THERE ARE NO SAMPLES LISTED AS BEING AVAILABLE TO RETURN FOR ANALYSIS.
A PERITONEAL DIALYSIS (PD) PATIENT REPORTED THAT DURING TREATMENT THE PIN CONNECTOR STARTED SPOUTING FLUID FROM IT. THE FLUID WAS DISCOVERED DURING DWELL 3 OF 4. THE PATIENT WAS CONNECTED DURING INCIDENT. THE FLUID LEAKED FROM THE BLUE PIN. A MWD WATCH-DOG TIMER ERROR HAD OCCURRED DURING THE SET-UP FOR TREATMENT. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED. THERE WAS NO PATIENT HARM INDICATED IN THE INITIAL REPORT. THERE ARE NO SAMPLES LISTED AS BEING AVAILABLE TO RETURN FOR ANALYSIS. A CLINICAL MANAGER CALLED BACK AND VERIFIED THE FLUID LEAK AND SAID THERE WAS NO HARM, INTERVENTION OR ADVERSE EVENT RELATED TO THE FLUID LEAK. THERE ARE NO SAMPLES TO RETURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1408896 | LIBERTY CYCLER SET, SINGLE CONN./EXT. DL | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | ERIKA DE REYNOSA, S.A. DE C.V. | 23LR08059 | 00840861100750 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Male | DELFLEX PD FLUID| DELFLEX PD FLUID| DELFLEX PD FLUID| LIBERTY SELECT CYCLER| LIBERTY SELECT CYCLER| LIBERTY SELECT CYCLER |