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 06/04/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 fresenius became aware that this (b)(6) male patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized on (b)(6) 2022, allegedly due to receiving the incorrect prescription.During additional follow-up, the patient¿s pd registered nurse (pdrn) confirmed the patient was hospitalized on (b)(6) 2022 due to worsening dyspnea.Radiological studies revealed the patient was in fluid overload, and the patient was placed on ccpd utilizing a 4.25% dextrose solution to promote increased fluid removal.No other diagnostic testing or procedures were performed, however the patient remained hospitalized until on (b)(6) 2022.The patient has reportedly recovered from the events and continues to perform continuous cyclic peritoneal dialysis (ccpd) at home without issue.The peritoneal dialysis registered nurse (pdrn) attributed causality to the patient not adding a last fill and daytime exchange to his prescription as ordered.The patient is non-compliant with fluid intake which required the patient to perform a last fill and daytime exchange, however the patient purposefully did not perform the additional exchanges, which led to fluid overload.The patient¿s prescription has been updated and education was provided.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: a temporal relationship exists between continuous cyclic peritoneal dialysis (ccpd) therapy utilizing the liberty select cycler, and the serious adverse events of fluid overload (characterized by dyspnea), which required hospitalization.The peritoneal dialysis registered nurse (pdrn) attributed causality to the patient¿s non-adherence to the pd prescription.The patient reportedly failed to perform a last fill and daytime exchange as ordered, which led to fluid overload.The pdrn reported the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.Fluid overload is a well-known potential complication of the end stage renal dialysis (esrd) process.Furthermore, causality can often be attributed to several different internal and external factors such as, physiological changes, mechanical issues, membrane/transport failure.Additionally, patient related factors such as non-compliance (unintentional or otherwise) can be a significant contributing factor, thus limiting the efficacy of rrt.Based on the available information, the patient¿s liberty select cycler is disassociated from the events.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction occurred.

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

On (b)(6) 2022 fresenius became aware this 67-year-old male patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized on (b)(6) 2022, allegedly due to receiving the incorrect prescription.During additional follow-up, the patient¿s pd registered nurse (pdrn) confirmed the patient was hospitalized on (b)(6) 2022 due to worsening dyspnea.Radiological studies revealed the patient was in fluid overload, and the patient was placed on ccpd utilizing a 4.25% dextrose solution to promote increased fluid removal.No other diagnostic testing or procedures were performed, however the patient remained hospitalized until (b)(6) 2022.The patient has reportedly recovered from the events and continues to perform continuous cyclic peritoneal dialysis (ccpd) at home without issue.The peritoneal dialysis registered nurse (pdrn) attributed causality to the patient not adding a last fill and daytime exchange to his prescription as ordered.The patient is non-compliant with fluid intake which required the patient to perform a last fill and daytime exchange, however the patient purposefully did not perform the additional exchanges, which led to fluid overload.The patient¿s prescription has been updated and education was provided.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.

• 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
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 14873856
• MDR Text Key: 295036150
• Report Number: 0002937457-2022-01089
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

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: 06/09/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 07/13/2022
• Supplement Dates FDA Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID.; DELFLEX PD FLUID.; LIBERTY CYCLER SET .; LIBERTY CYCLER SET .
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male