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 Problems Dyspnea (1816); Hypervolemia (2664)

Event Date 05/10/2021

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, and the patient¿s serious adverse event of fluid overload (characterized by dyspnea), which warranted hospitalization.Causality was attributed to the patient¿s non-adherence/compliance with prescribed fluid restrictions.Per the pdrn, the serious adverse events were unrelated to the patient¿s use of a fresenius device(s) or product(s).Fluid overload is a common and often preventable process.Patient related considerations such as non-compliance to a prescribed therapy, can be a significant contributing factor.Based on the information available, the patient¿s liberty select cycler is disassociated from the events.There is no allegation or objective evidence indicating a liberty select cycler deficiency or malfunction caused or contributed to the serious adverse events or hospitalization.Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

Fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized because they "couldn¿t breathe (dyspnea).¿ during follow-up, the patient¿s pd registered nurse (pdrn) reported the patient was hospitalized on (b)(6) 2021 due to fluid overload.The patient is reportedly non-compliant with fluid restrictions and is constantly over his estimated dry weight, despite frequent education.The pdrn reported the event was unrelated to any fresenius device(s) and/or product(s) deficiency or malfunction.The patient was discharged on (b)(6) 2021 and has recovered from the events.The patient received several ccpd treatments while hospitalized, utilizing a 4.25% dialysate to increase ultrafiltration with good effect.Additional information was requested (e.G., discharge summary, patient demographics), however the request was declined.

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.

Event Description

Fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized because they "couldn¿t breathe (dyspnea).¿ during follow-up, the patient¿s pd registered nurse (pdrn) reported the patient was hospitalized on (b)(6) 2021 due to fluid overload.The patient is reportedly non-compliant with fluid restrictions and is constantly over his estimated dry weight, despite frequent education.The pdrn reported the event was unrelated to any fresenius device(s) and/or product(s) deficiency or malfunction.The patient was discharged on (b)(6) 2021 and has recovered from the events.The patient received several ccpd treatments while hospitalized, utilizing a 4.25% dialysate to increase ultrafiltration with good effect.Additional information was requested (e.G., discharge summary, patient demographics), however the request was declined.

Event Description

Fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized because they "couldn¿t breathe (dyspnea).¿ during follow-up, the patient¿s pd registered nurse (pdrn) reported the patient was hospitalized on (b)(6) 2021 due to fluid overload.The patient is reportedly non-compliant with fluid restrictions and is constantly over his estimated dry weight, despite frequent education.The pdrn reported the event was unrelated to any fresenius device(s) and/or product(s) deficiency or malfunction.The patient was discharged on (b)(6) 2021 and has recovered from the events.The patient received several ccpd treatments while hospitalized, utilizing a 4.25% dialysate to increase ultrafiltration with good effect.Additional information was requested (e.G., discharge summary, patient demographics), however the request was declined.

Manufacturer Narrative

Correction.

Event Description

Fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized because they "couldn't breathe (dyspnea).¿ during follow-up, the patient¿s pd registered nurse (pdrn) reported the patient was hospitalized on (b)(6) 2021 due to fluid overload.The patient is reportedly non-compliant with fluid restrictions and is constantly over his estimated dry weight, despite frequent education.The pdrn reported the event was unrelated to any fresenius device(s) and/or product(s) deficiency or malfunction.The patient was discharged on (b)(6) 2021 and has recovered from the events.The patient received several ccpd treatments while hospitalized, utilizing a 4.25% dialysate to increase ultrafiltration with good effect.Additional information was requested (e.G., discharge summary, patient demographics), however the request was declined.

• 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: 11878975
• MDR Text Key: 254057363
• Report Number: 2937457-2021-01114
• 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: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 05/27/2021; 06/09/2021; 06/28/2021
• Supplement Dates FDA Received: 06/07/2021; 06/15/2021; 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID.; DELFLEX PD FLUID.; DELFLEX PD FLUID.; DELFLEX PD FLUID.; LIBERTY CYCLER SET.; LIBERTY CYCLER SET.; LIBERTY CYCLER SET.; LIBERTY CYCLER SET.
• Patient Outcome(s): Hospitalization; Required Intervention