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); High Blood Pressure/ Hypertension (1908); Hypoxia (1918); Tachycardia (2095); Electrolyte Imbalance (2196); Hypovolemia (2243); Hypervolemia (2664)

Event Date 07/21/2022

Event Type  Injury  

Event Description

On 26/jul/2022, 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 on (b)(6) 2022, due to shortness of breath (dyspnea) and fluid overload.No additional information was provided during intake.The discharge summary was received on 28/jul/2022, which revealed the patient presented to the emergency room (er) on (b)(6) 2022 for shortness of breath (dyspnea).The patient reported undergoing intermittent hd therapy but is currently performing ccpd at home.While in the er, the patient was found to be hypertensive (value not provided), tachypneic (rate not provided), hyperkalemic (6.4 mmol/l), and mildly hypoxic.Radiological studies showed bilateral increasing pulmonary infiltrates, felt to be congestive heart failure (chf) and chronic obstructive pulmonary disease (copd).The patient¿s hyperkalemia was treated with lokelma.The patient was severely fluid overloaded and was treated with multiple rounds of hd.Additionally the patient¿s copd was successfully treated with supplemental oxygen (3-5 liters), solu-medrol and multiple nebulizers.The patient was discharged home on (b)(6) 2022 in stable conditioning and has recovered from the events.The patient¿s pd registered nurse (pdrn) confirmed the events were unrelated to the patient¿s utilization of a fresenius product(s) and/or device(s).

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: a temporal relationship exists between ccpd therapy utilizing a liberty select cycler, and the patient¿s serious adverse events of dyspnea, hypertension, tachypnea, mild hypoxia, hyperkalemia, chf, copd, and fluid overload, which warranted hospitalization and supplementary hd.The definitive etiology of the events is unknown; therefore, causality cannot be established.However, the patient¿s pdrn reported the events were unrelated to the patient¿s utilization of any fresenius device(s) and/or product(s).Fluid overload is a well-known potential complication of the esrd process.Causality can often be attributed to several different internal and external factors such as, physiological changes, mechanical issues, membrane/transport failure, non-compliance.Additionally, hyperkalemia is a common finding regarding electrolyte imbalances in esrd patients, as the patients¿ lack of urinary output predisposes them to imbalances.Based on the information available, the patient¿s liberty select cycler can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating the liberty select cycler caused or contributed to the serious adverse events.Furthermore, there is no report the device failed to meet manufacturer specifications.

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 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 through (b)(6) 2022, due to shortness of breath (dyspnea) and fluid overload.No additional information was provided during intake.The discharge summary was received on (b)(6) 2022, which revealed the patient presented to the emergency room (er) on (b)(6) 2022 for shortness of breath (dyspnea).The patient reported undergoing intermittent hd therapy but is currently performing ccpd at home.While in the er, the patient was found to be hypertensive (value not provided), tachypneic (rate not provided), hyperkalemic (6.4 mmol/l), and mildly hypoxic.Radiological studies showed bilateral increasing pulmonary infiltrates, felt to be congestive heart failure (chf) and chronic obstructive pulmonary disease (copd).The patient¿s hyperkalemia was treated with lokelma.The patient was severely fluid overloaded and was treated with multiple rounds of hd.Additionally the patient¿s copd was successfully treated with supplemental oxygen (3-5 liters), solu-medrol and multiple nebulizers.The patient was discharged home on (b)(6) 2022 in stable conditioning and has recovered from the events.The patient¿s pd registered nurse (pdrn) confirmed the events were unrelated to the patient¿s utilization of a fresenius product(s) and/or device(s).

Manufacturer Narrative

Correction provided in h6.

Event Description

On (b)(6) 2022, 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 on (b)(6) 2022 through (b)(6) 2022, due to shortness of breath (dyspnea) and fluid overload.No additional information was provided during intake.The discharge summary was received on (b)(6) 2022, which revealed the patient presented to the emergency room (er) on (b)(6) 2022 for shortness of breath (dyspnea).The patient reported undergoing intermittent hd therapy but is currently performing ccpd at home.While in the er, the patient was found to be hypertensive (value not provided), tachypneic (rate not provided), hyperkalemic (6.4 mmol/l), and mildly hypoxic.Radiological studies showed bilateral increasing pulmonary infiltrates, felt to be congestive heart failure (chf) and chronic obstructive pulmonary disease (copd).The patient¿s hyperkalemia was treated with lokelma.The patient was severely fluid overloaded and was treated with multiple rounds of hd.Additionally the patient¿s copd was successfully treated with supplemental oxygen (3-5 liters), solu-medrol and multiple nebulizers.The patient was discharged home on 25/jul/2022 in stable conditioning and has recovered from the events.The patient¿s pd registered nurse (pdrn) confirmed the events were unrelated to the patient¿s utilization of a fresenius product(s) and/or device(s).

Manufacturer Narrative

Correction provided in h6.

Event Description

On (b)(6) 2022, 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 on (b)(6) 2022 through (b)(6) 2022, due to shortness of breath (dyspnea) and fluid overload.No additional information was provided during intake.The discharge summary was received on (b)(6) 2022, which revealed the patient presented to the emergency room (er) on (b)(6) 2022 for shortness of breath (dyspnea).The patient reported undergoing intermittent hd therapy but is currently performing ccpd at home.While in the er, the patient was found to be hypertensive (value not provided), tachypneic (rate not provided), hyperkalemic (6.4 mmol/l), and mildly hypoxic.Radiological studies showed bilateral increasing pulmonary infiltrates, felt to be congestive heart failure (chf) and chronic obstructive pulmonary disease (copd).The patient¿s hyperkalemia was treated with lokelma.The patient was severely fluid overloaded and was treated with multiple rounds of hd.Additionally the patient¿s copd was successfully treated with supplemental oxygen (3-5 liters), solu-medrol and multiple nebulizers.The patient was discharged home on (b)(6) 2022 in stable conditioning and has recovered from the events.The patient¿s pd registered nurse (pdrn) confirmed the events were unrelated to the patient¿s utilization of a fresenius product(s) and/or device(s).

• 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: 15176433
• MDR Text Key: 297353340
• Report Number: 0002937457-2022-01307
• 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,Followup,Followup
• Report Date: 08/18/2022

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: 07/26/2022
• Initial Date FDA Received: 08/05/2022
• Supplement Dates Manufacturer Received: 08/11/2022; 08/17/2022; 08/17/2022
• Supplement Dates FDA Received: 08/12/2022; 08/17/2022; 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2011
• 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; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male