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

Model Number 180343

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

Patient Problem Hypervolemia (2664)

Event Date 04/12/2021

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between drain complications during pd with the liberty select cycler and the patient¿s subsequent hospitalization for fluid volume overload.Fluid volume overload is not uncommon as those with kidney disease struggle to maintain fluid balance in the body.Manufacturer product investigation is pending, therefore it has not been determined if the cycler was performing as intended and cannot be excluded as a causal/contributory factor in this event.However, the patient¿s pd catheter (not a fresenius product) also cannot be excluded as a causal/contributory factor in this event.The patient¿s missed pd treatment is also clinically significant in the development of fluid volume overload and concern for functionality of the pd catheter.Moreover, the patient required thrombolytic and anticoagulant treatment to the pd catheter for potential fibrin (often associated with drain complications) prior to and during hospitalization.The patient has since been transitioned to hd until the pd catheter can be further evaluated.Therefore, there is reasonable concern that a malfunctioning pd catheter may be associated with the patient¿s fluid volume overload event.Plant investigation: no parts were returned to the manufacturer for physical evaluation.An investigation of the device manufacturing records was conducted by the manufacturer.A review of records using the reported serial number did not indicate there were any non-conformances or 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.

Event Description

It was reported to fresenius that this peritoneal dialysis (pd) patient was hospitalized for fluid volume overload.The patient had been experiencing drain complications while using the liberty select cycler.The pd nurse stated the patient was seen in the outpatient pd clinic and given the medication activase (thrombolytic) to mitigate any potential fibrin in the pd catheter (not a fresenius product).Additionally, the nurse stated the patient was using heparin (anticoagulant), per standing orders.It was reported the patient also underwent an x-ray which showed the pd catheter was in good position.The patient went home that same day but the drain complications continued.The patient was not able to fully drain using the cycler or during manual exchange.The patient returned to the clinic where their catheter was flushed and it was confirmed that their pd cathteter was working.The nurse reported the patient returned home and continued pd treatments manually and was not able to drain.The patient re-attempted pd treatment on the fresenius cycler and continued to encounter drain complications.Per the nurse, the patient did not do a pd treatment.Subsequently, the patient was hospitalized for fluid volume overload.The nurse stated during the patient¿s hospitalization they received two hemodialysis (hd) treatments.The patient was also given a second course of activase (thrombylotic) and was able to drain on the hospital-provided cycler.The patient was discharged home and continued experiencing issues with draining on the home cycler.The patient contacted fresenius technical support and a replacement cycler was issued.The patient continues pd treatment via manual exchange.The patient was also transitioned to hemodialysis (hd) therapy until the pd catheter can be further evaluated by the surgeon.The nurse confirmed the patient did not have any further adverse events.The nurse indicated the patient¿s hospitalization for fluid volume overload event may have been related to the pd catheter (required 2 interventions and needs further evaluation for placement/function) or may be related to the cycler.

Event Description

It was reported to fresenius that this peritoneal dialysis (pd) patient was hospitalized for fluid volume overload.The patient had been experiencing drain complications while using the liberty select cycler.The pd nurse stated the patient was seen in the outpatient pd clinic and given the medication activase (thrombolytic) to mitigate any potential fibrin in the pd catheter (not a fresenius product).Additionally, the nurse stated the patient was using heparin (anticoagulant), per standing orders.It was reported the patient also underwent an x-ray which showed the pd catheter was in good position.The patient went home that same day but the drain complications continued.The patient was not able to fully drain using the cycler or during manual exchange.The patient returned to the clinic where their catheter was flushed and it was confirmed that their pd cathteter was working.The nurse reported the patient returned home and continued pd treatments manually and was not able to drain.The patient re-attempted pd treatment on the fresenius cycler and continued to encounter drain complications.Per the nurse, the patient did not do a pd treatment.Subsequently, the patient was hospitalized for fluid volume overload.The nurse stated during the patient¿s hospitalization they received two hemodialysis (hd) treatments.The patient was also given a second course of activase (thrombylotic) and was able to drain on the hospital-provided cycler.The patient was discharged home and continued experiencing issues with draining on the home cycler.The patient contacted fresenius technical support and a replacement cycler was issued.The patient continues pd treatment via manual exchange.The patient was also transitioned to hemodialysis (hd) therapy until the pd catheter can be further evaluated by the surgeon.The nurse confirmed the patient did not have any further adverse events.The nurse indicated the patient¿s hospitalization for fluid volume overload event may have been related to the pd catheter (required 2 interventions and needs further evaluation for placement/function) or may be related to the cycler.

Manufacturer Narrative

Correction: d9, h3, h6.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 11753481
• MDR Text Key: 248219929
• Report Number: 2937457-2021-00912
• 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
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR