LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
Report
- Report Number
- 0002937457-2022-01316
- Event Type
- Malfunction
- Date Received
- August 8, 2022
- Date of Event
- July 30, 2022
- Report Date
- September 28, 2022
- Manufacturer
- CONCORD MANUFACTURING
- Product Code
- FKX
- UDI-DI
- 00840861102068
- PMA / PMN Number
- K181108
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- 003
Narratives
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION A VISUAL INSPECTION OF THE RETURNED CYCLER EXTERIOR SHOWED NO SIGN OF PHYSICAL DAMAGE. PATIENT SENSOR CHECK PASSED. SYSTEM AIR LEAK TEST PASSED. VALVE ACTUATION TEST PASSED. A 3 HOUR ACCELERATED STRESS TEST (AST) WAS PERFORMED AND PASSED. THERE WERE NO FLUID LEAKS IN THE TEST CASSETTE. AN INVESTIGATION OF THE CYCLER MUSHROOM HEADS VERIFIED THAT THE SURFACE CONDITIONS AND ALIGNMENTS WERE WITHIN SPECIFICATION. THERE WERE NO VISUAL DISCREPANCIES FOUND DURING THE INTERNAL INSPECTION. IN ADDITION, A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND VERIFIED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. UPON COMPLETION OF THE EVALUATION, THERE WERE NO MALFUNCTIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CYCLER PERFORMED AS DESIGNED AND AN ASSOCIATED CAUSE COULD NOT BE DETERMINED.
A PERITONEAL DIALYSIS (PD) PATIENT'S CARETAKER REPORTED THAT FLUID WAS FOUND INSIDE THE CASSETTE DOOR OF THE CYCLER. TECHNICAL SERVICES ISSUED THE PATIENT A NEW CYCLER AND ADVISED FOR PATIENT NOT TO USE THE CYCLER. IN A FOLLOW UP CALL, THE CARETAKER CONFIRMED THE INITIAL REPORT OF FLUID IN THE CASSETTE DOOR. THE CARETAKER STATED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE CARETAKER EXPLAINED THAT THE NEW CYCLER ARRIVED LATER THE SAME DAY AS THE EVENT, THEREFORE THERE WAS NO NEED FOR ALTERNATIVE TREATMENT. THE CARETAKER CONFIRMED THAT THE PATIENT HAS RECEIVED THE REPLACEMENT CYCLER AND IS CONTINUING WITH PERITONEAL DIALYSIS ON THE NEW CYCLER WITHOUT ISSUE AND WITHOUT REOCCURRENCE OF THE REPORTED EVENT. THE CYCLER IS AVAILABLE TO BE RETURNED FOR ANALYSIS.
A PERITONEAL DIALYSIS (PD) PATIENT'S CARETAKER REPORTED THAT FLUID WAS FOUND INSIDE THE CASSETTE DOOR OF THE CYCLER. TECHNICAL SERVICES ISSUED THE PATIENT A NEW CYCLER AND ADVISED FOR PATIENT NOT TO USE THE CYCLER. IN A FOLLOW UP CALL, THE CARETAKER CONFIRMED THE INITIAL REPORT OF FLUID IN THE CASSETTE DOOR. THE CARETAKER STATED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE CARETAKER EXPLAINED THAT THE NEW CYCLER ARRIVED LATER THE SAME DAY AS THE EVENT, THEREFORE THERE WAS NO NEED FOR ALTERNATIVE TREATMENT. THE CARETAKER CONFIRMED THAT THE PATIENT HAS RECEIVED THE REPLACEMENT CYCLER AND IS CONTINUING WITH PERITONEAL DIALYSIS ON THE NEW CYCLER WITHOUT ISSUE AND WITHOUT REOCCURRENCE OF THE REPORTED EVENT. THE CYCLER IS AVAILABLE TO BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2103111 | LIBERTY SELECT CYCLER ASSY(NON-VALUATED) | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | CONCORD MANUFACTURING | 180343 | 00840861102068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female | DELFLEX PD FLUID| DELFLEX PD FLUID| LIBERTY CYCLER SET| LIBERTY CYCLER SET |