LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
Report
- Report Number
- 0002937457-2023-01398
- Event Type
- Malfunction
- Date Received
- September 8, 2023
- Date of Event
- August 31, 2023
- Report Date
- September 19, 2023
- Manufacturer
- CONCORD MANUFACTURING
- Product Code
- FKX
- UDI-DI
- 00840861102068
- PMA / PMN Number
- K181108
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO BE CONFIRMED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
A LICENSED PRACTICAL NURSE (LPN) FROM A LONG-TERM CARE (LTC) FACILITY REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT A FLUID LEAK OCCURRED DURING A PATIENT'S PERITONEAL DIALYSIS (PD) TREATMENT. PRIOR TO DISCOVERY OF THE FLUID LEAK, IT WAS REPORTED THAT AN ¿M31 AIR DETECTED IN CASSETTE¿ ALARM OCCURRED DURING DRAIN 3 OF 6. THE LPN CONTACTED TS FOR ASSISTANCE IN BYPASSING THE ALARM. AFTER FAILING TO MOVE PAST THE ALARM, THE LPN WAS ADVISED TO RESETUP THE CYCLER WITH NEW SUPPLIES. WHEN THE LPN OPENED THE CYCLER DOOR, THE FLUID LEAK WAS DISCOVERED. THE LPN CONFIRMED THERE WAS NO VISIBLE DAMAGE ON THE BACK OF THE CASSETTE. THE ORIGIN OF THE LEAK WAS NOT KNOWN. THE PATIENT DID NOT COMPLETE THEIR TREATMENT. THE LPN SAID THE STAFF AT THE FACILITY WERE NEVER TRAINED TO PERFORM MANUAL PD EXCHANGES AS AN ALTERNATIVE TO USING THE CYCLER. THE LPN WAS ADVISED BY TS TO LET THE CYCLER DRY OUT AND WAIT A FULL 24-HOURS BEFORE USING IT AGAIN. IN ORDER TO DO THIS, THE PATIENT HAD TO MISS TREATMENT THE FOLLOWING DAY AS WELL. HOWEVER, THE LPN CONFIRMED THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, EXPERIENCE ANY ADVERSE EFFECTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE LPN CONFIRMED THE PATIENT¿S DOCTOR WAS NOTIFIED, AND PROPHYLACTIC ANTIBIOTICS WERE NOT PRESCRIBED. THE PATIENT WAS SAID TO BE CONTINUING PD THERAPY ON THE SAME CYCLER WITHOUT ANY FURTHER ISSUES.
A LICENSED PRACTICAL NURSE (LPN) FROM A LONG-TERM CARE (LTC) FACILITY REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT A FLUID LEAK OCCURRED DURING A PATIENT'S PERITONEAL DIALYSIS (PD) TREATMENT. PRIOR TO DISCOVERY OF THE FLUID LEAK, IT WAS REPORTED THAT AN ¿M31 AIR DETECTED IN CASSETTE¿ ALARM OCCURRED DURING DRAIN 3 OF 6. THE LPN CONTACTED TS FOR ASSISTANCE IN BYPASSING THE ALARM. AFTER FAILING TO MOVE PAST THE ALARM, THE LPN WAS ADVISED TO RESETUP THE CYCLER WITH NEW SUPPLIES. WHEN THE LPN OPENED THE CYCLER DOOR, THE FLUID LEAK WAS DISCOVERED. THE LPN CONFIRMED THERE WAS NO VISIBLE DAMAGE ON THE BACK OF THE CASSETTE. THE ORIGIN OF THE LEAK WAS NOT KNOWN. THE PATIENT DID NOT COMPLETE THEIR TREATMENT. THE LPN SAID THE STAFF AT THE FACILITY WERE NEVER TRAINED TO PERFORM MANUAL PD EXCHANGES AS AN ALTERNATIVE TO USING THE CYCLER. THE LPN WAS ADVISED BY TS TO LET THE CYCLER DRY OUT AND WAIT A FULL 24-HOURS BEFORE USING IT AGAIN. IN ORDER TO DO THIS, THE PATIENT HAD TO MISS TREATMENT THE FOLLOWING DAY AS WELL. HOWEVER, THE LPN CONFIRMED THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, EXPERIENCE ANY ADVERSE EFFECTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE LPN CONFIRMED THE PATIENT¿S DOCTOR WAS NOTIFIED, AND PROPHYLACTIC ANTIBIOTICS WERE NOT PRESCRIBED. THE PATIENT WAS SAID TO BE CONTINUING PD THERAPY ON THE SAME CYCLER WITHOUT ANY FURTHER ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1113697 | LIBERTY SELECT CYCLER ASSY(NON-VALUATED) | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | CONCORD MANUFACTURING | 00840861102068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Female | DELFLEX PD FLUID| DELFLEX PD FLUID| LIBERTY CYCLER SET| LIBERTY CYCLER SET |