STAY SAFE/LUER LOCK CATHETER EXT. 18 IN.
Report
- Report Number
- 8030665-2022-00206
- Event Type
- Malfunction
- Date Received
- March 2, 2022
- Date of Event
- February 14, 2022
- Report Date
- April 7, 2022
- Manufacturer
- ERIKA DE REYNOSA, S.A. DE C.V.
- Product Code
- KDI
- UDI-DI
- 00840861100798
- PMA / PMN Number
- K904806
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 SAMPLE WAS NOT RETURNED TO THE MANUFACTURER AND THE LOT NUMBER WAS NOT PROVIDED. THE CATHETER EXTENSION WAS NOT RECEIVED HOWEVER A CYCLER SET CASSETTE WAS RETURNED. THE SAMPLE RECEIVED WAS VISUALLY INSPECTED AND WAS FOUND THAT THE CYCLER SET IS ACCEPTABLE NO DAMAGE WAS OBSERVED ON THE PATIENT CONNECTOR. NO INFORMATION WAS FOUND IN THE SYSTEM FROM THIS CUSTOMER REGARDING THE PRODUCT. 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.
CORRECTION: H.6.
IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED FLUID LEAKING BETWEEN THE CATHETER AND TRANSFER SET. THE PATIENT REPORTED RECEIVING AN M31 AIR DETECTED IN CASSETTE ALARM DURING AN UNKNOWN FILL STAGE OF TREATMENT. THE CYCLER WAS REBOOTED AND PATIENT RECEIVED THE MWD WATCHDOG TIMER ERROR. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. UPON FOLLOW UP, THE PDRN REPORTED THE LEAK WAS DUE TO A LOOSE TRANSFER SET. THE PATIENT REPORTED THE LEAK WAS FROM THE CATHETER NOT THE CYCLER SET CASSETTE. IT WAS CONFIRMED THAT THE PATIENT WAS ABLE TO COMPLETE PERITONEAL DIALYSIS TREATMENT. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS PRESCRIBED 1750 MG VANCOMYCIN AND 2000 MG CEFTAZIDIME ONE TIME ORDERS AS A PRECAUTION. THE PATIENT IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES.
IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED FLUID LEAKING BETWEEN THE CATHETER AND TRANSFER SET. THE PATIENT REPORTED RECEIVING AN M31 AIR DETECTED IN CASSETTE ALARM DURING AN UNKNOWN FILL STAGE OF TREATMENT. THE CYCLER WAS REBOOTED AND PATIENT RECEIVED THE MWD WATCHDOG TIMER ERROR. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. UPON FOLLOW UP, THE PDRN REPORTED THE LEAK WAS DUE TO A LOOSE TRANSFER SET. THE PATIENT REPORTED THE LEAK WAS FROM THE CATHETER NOT THE CYCLER SET CASSETTE. IT WAS CONFIRMED THAT THE PATIENT WAS ABLE TO COMPLETE PERITONEAL DIALYSIS TREATMENT. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS PRESCRIBED 1750 MG VANCOMYCIN AND 2000 MG CEFTAZIDIME ONE TIME ORDERS AS A PRECAUTION. THE PATIENT IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES.
IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED FLUID LEAKING BETWEEN THE CATHETER AND TRANSFER SET. THE PATIENT REPORTED RECEIVING AN M31 AIR DETECTED IN CASSETTE ALARM DURING AN UNKNOWN FILL STAGE OF TREATMENT. THE CYCLER WAS REBOOTED AND PATIENT RECEIVED THE MWD WATCHDOG TIMER ERROR. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. UPON FOLLOW UP, THE PDRN REPORTED THE LEAK WAS DUE TO A LOOSE TRANSFER SET. THE PATIENT REPORTED THE LEAK WAS FROM THE CATHETER NOT THE CYCLER SET CASSETTE. IT WAS CONFIRMED THAT THE PATIENT WAS ABLE TO COMPLETE PERITONEAL DIALYSIS TREATMENT. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS PRESCRIBED 1750 MG VANCOMYCIN AND 2000 MG CEFTAZIDIME ONE TIME ORDERS AS A PRECAUTION. THE PATIENT IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1989887 | STAY SAFE/LUER LOCK CATHETER EXT. 18 IN. | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | ERIKA DE REYNOSA, S.A. DE C.V. | 050-95005 | 00840861100798 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | DELFLEX PD FLUID| DELFLEX PD FLUID| DELFLEX PD FLUID| LIBERTY CYCLER SET| LIBERTY CYCLER SET| LIBERTY CYCLER SET| LIBERTY SELECT CYCLER| LIBERTY SELECT CYCLER| LIBERTY SELECT CYCLER |