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); Pulmonary Edema (2020); Hypervolemia (2664)

Event Date 11/27/2021

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient had fluid around their lungs due to too much 1.5% solution.The patient was hospitalized and used a 1.5% and a 2.5% solution bag for treatment.The patient needed to order additional 2.5% solution bags to take fluid off and the clinic is aware.Per the pd nurse, the patient was not using the solution properly and has a mental illness causing the patient to be confused on how and what solutions to use.The patient has had some home visits and is being monitored.2.5% solution has been ordered.Upon follow-up, the patient¿s pd registered nurse (pdrn) confirmed the patient was hospitalized for dyspnea, fluid overload and pulmonary edema.It was reported the patient was utilizing only 1.5% dextrose-based solution, when the patient should have been using of 2.5% dextrose-based solution as trained.The pdrn confirmed the patient suffers from mental/behavioral health issues.The patient is forgetful and unintentionally non-compliant at times.The patient spent many years homeless, living under a bridge and received no medical or mental health care.The patient requires extra training and monitoring, which has been part of the plan-of-care since beginning renal replacement therapy (rrt).The patient received ccpd while hospitalized, utilizing a 2.5% delflex solution with good improvement of the patient¿s dyspnea, pulmonary edema, and fluid overload.The patient was discharged home on (b)(6) 2021, and resumed utilizing the same liberty select cycler as before the events.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.

Manufacturer Narrative

A temporal relationship exists between ccpd therapy utilizing the liberty select cycler, and the patient¿s serious adverse events of fluid overload (characterized by dyspnea), which progressed into pulmonary edema and required hospitalization.The patient¿s pdrn attributed causality to the patient¿s usage of 1.5% dextrose solution, when a 2.5% dextrose solution was needed to increase uf.The pdrn reported the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.Pulmonary edema is a well-known potential complication of the esrd process and can be attributed to a wide-range of causes (e.G., non-compliance, physiological changes, mechanical issues, health status changes).Additionally, patient related factors such as non-compliance are significant contributing factors, limiting the efficacy of rrt.Based on the available information, the patient¿s liberty select cycler is disassociated from the events.There is no objective evidence indicating a serious injury, patient death, or other serious adverse event related to a fresenius device(s) or product(s) occurred warranting further investigation.Furthermore, the patient resumed utilizing the same liberty select cycler at home, without any reported issues of machine malfunction or deficiency.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported that a peritoneal dialysis (pd) patient had fluid around their lungs due to too much 1.5% solution.The patient was hospitalized and used a 1.5% and a 2.5% solution bag for treatment.The patient needed to order additional 2.5% solution bags to take fluid off and the clinic is aware.Per the pd nurse, the patient was not using the solution properly and has a mental illness causing the patient to be confused on how and what solutions to use.The patient has had some home visits and is being monitored.2.5% solution has been ordered.Upon follow-up, the patient¿s pd registered nurse (pdrn) confirmed the patient was hospitalized for dyspnea, fluid overload and pulmonary edema.It was reported the patient was utilizing only 1.5% dextrose-based solution, when the patient should have been using of 2.5% dextrose-based solution as trained.The pdrn confirmed the patient suffers from mental/behavioral health issues.The patient is forgetful and unintentionally non-compliant at times.The patient spent many years homeless, living under a bridge and received no medical or mental health care.The patient requires extra training and monitoring, which has been part of the plan-of-care since beginning renal replacement therapy (rrt).The patient received ccpd while hospitalized, utilizing a 2.5% delflex solution with good improvement of the patient¿s dyspnea, pulmonary edema, and fluid overload.The patient was discharged home on (b)(6) 2021, and resumed utilizing the same liberty select cycler as before the events.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.

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.

• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13078928
• MDR Text Key: 282733705
• Report Number: 2937457-2021-02501
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• 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: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2020
• 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): Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 64 KG