CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
|
Back to Search Results |
|
Model Number 180343 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
No Information (3190)
|
Event Date 10/01/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical review: there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.Additionally, there is no allegation of a liberty select cycler malfunction or deficiency related to the hospitalization.
|
|
Event Description
|
A peritoneal dialysis (pd) patient contacted technical support (ts) to report an m31 air detected in cassette alarm which occurred during dwell 2 of 4.According to the patient, no fluid leak was found and there were no air bubbles seen.The patient reported that the nurse set up the treatment for them.The patient was in the hospital and utilizing a cycler that belonged to the inpatient unit.Attempts to obtain additional information were unsuccessful and the reason for the patient¿s admission to the hospital was unknown.However, there is no documentation in the complaint file or allegation that the hospitalization was related to any liberty select cycler malfunction or deficiency or that it was pd related.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|
|
|