MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180343

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Pleural Effusion (2010); Vomiting (2144); Uremia (2188); Hypervolemia (2664)

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

Clinical review; there is a temporal relationship between pd therapy on the liberty select cycler and the patient event of fluid volume overload, uremia, nausea and vomiting with subsequent hospitalization.However, there is no documentation to show a causal relationship between the liberty select cycler and the adverse event.Additionally, there is no reported malfunction or deficiency for this event.Per the pdrn, the patient is new to pd therapy and could be the reason for the fluid volume overload.The machine evaluation has not been completed at the time of this clinical investigation.Based on the available information the cause of the fluid overload leading to uremia, nausea and vomiting cannot be determined.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported that a patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) was hospitalized for fluid volume overload, nausea, vomiting and subsequent uremia.The peritoneal dialysis registered nurse (pdrn) stated that the patient was new to pd therapy which could have possibly contributed to the patient¿s adverse event.Hospital course in unknown.The patient was discharged after four days and has since recovered and continues pd therapy.The liberty select cycler was replaced by the patient¿s physician out of precaution.

Manufacturer Narrative

There is a temporal relationship between pd therapy on the liberty select cycler and the patient event of fluid volume overload (evidenced by pleural effusion and lung base consolidation), nausea and vomiting with subsequent hospitalization.However, despite the physician concern for machine issues there is no documentation to show a causal relationship between the liberty select cycler and the adverse event.Additionally, there is no reported malfunction or deficiency for this event.Per the pdrn, the patient is new to pd therapy and could be the reason for the fluid volume overload.The machine evaluation has not been completed at the time of this clinical investigation.Based on the available information the cause of the fluid overload, nausea and vomiting cannot be determined.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

Additional information was received through the discharge summary.The patient presented to the emergency department (ed) with complaints of vomiting for the past week.The patient was referred to the ed by nephrology after symptoms worsened.The patient did not complete peritoneal dialysis (pd) on the day of arrival to the ed.The patient was admitted to the hospital and diagnosed with fluid volume overload.It was initially suspected that the patient had a malfunctioning pd catheter (not a fresenius product) and therefore a right-sided non-tunneled dual-lumen temporary dialysis catheter was placed for hemodialysis (hd).Pd was resumed and it was noted that the therapy was working correctly.There was concern for a machine issue with the liberty select cycler at home which the nephrology department assisted in having replaced.A chest x-ray revealed a small right pleural effusion with right lung base consolidation.It was also seen that there was evidence of pulmonary hypertension.Lab results documented hyperkalemia and hyponatremia, however, there is no documentation of treatment during hospitalization.The patient¿s vomiting resolved.No further hospital course is documented and the patient was discharged to home in good condition.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed with no physical damage noted.A simulated therapy was initiated and completed on the cycler without complication.The weighed fill volumes were found to be within tolerance.The cycler underwent system air leak and valve actuation testing and was found to meet product specifications.Load cell verification testing was performed with no issues noted.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.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.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8236623
• MDR Text Key: 132775140
• Report Number: 2937457-2019-00104
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Device Age: MO
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 42