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 Chest Pain (1776); Pleural Effusion (2010); Lethargy (2560); Pericardial Effusion (3271)

Event Date 11/12/2021

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 events of pleural effusion, pericarditis (characterized by prolonged weakness and chest pain), which required hospitalization and surgical intervention.Causality was attributed to the patient¿s worsening renal function, inadequate dialysis, and their usage of anticoagulants.The medical records did not indicate the serious adverse events were related to a fresenius device(s) and/or product(s).The prevalence of dialysis-associated pericarditis is increasing in the esrd community for patients on maintenance peritoneal dialysis.At least three factors are known to contribute to pericarditis: inadequate dialysis, anticoagulation therapy, and/or fluid overload.Based on the information available, the patient¿s liberty select cycler is excluded from having caused or contributed to the patient¿s serious adverse events and subsequent hospitalization.There is no objective evidence indicating a fresenius product(s) and/or device(s) deficiency or malfunction occurred triggering the patient¿s serious adverse event(s).Furthermore, there is no report a fresenius device(s) and/or product(s) failed to meet user expectations or manufacturer specifications.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported to fresenius on (b)(6) 2022 that this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was admitted to the intensive care unit (icu) on (b)(6) 2021.The patient¿s spouse reported the patient was diagnosed with a pericardial effusion due to ¿bad dialysis¿, and a chest catheter (a non-fresenius product) was placed for hemodialysis (hd).The discharge summary was obtained on (b)(6) 2022.The documents state the patient presented to the emergency room (er) on (b)(6) 2021 with complaints of chest discomfort, lightheadedness (due to atrial fibrillation), and generalized weakness which has grown progressively worse over the last two weeks.The patient¿s admission vitals included: blood pressure = 130/65, heart rate = 80 bpm, temperature = 98.0, respirations = 20, weight = 95.4 kgs, oxygen saturation = 95% on room air.While in the er, the patient experienced several episodes of hypotension and was formally admitted.Radiological testing performed on (b)(6) 2021 revealed a large pericardial effusion, as well as a left-sided pleural effusion.On (b)(6) 2021 the patient underwent a cardiac catheterization, which included a pericardiocentesis (drain left in place) removing 780 cc of bloody fluid from around the heart, as well as ultrasound guided thoracentesis removing 1200 ml of bloody drainage.Following the procedures, the patient was admitted to the icu and a hd catheter was placed for rrt.A transthoracic echocardiogram (tte) was performed following the pericardiocentesis which showed a substantial persistent pericardial effusion, with concern of a loculated effusion which could not be drained during the pericardiocentesis.As a result, thoracic surgery was consulted, and the patient underwent surgery to place a pericardial window on (b)(6) 2021 to address the located fluid.The etiology of the pericarditis and pleural effusion were identified as worsening renal function, inadequate pd therapy, and anticoagulation therapy (patient on eliquis).The patient responded well to the procedures as well as hd therapy, and the patient¿s bun decreased from 100¿s to 70¿s while hospitalized.On (b)(6) 2021, the cardiology and thoracic surgery departments cleared the patient for discharge after undergoing a final hd treatment.The patient was discharged home in stable condition and started outpatient hd on (b)(6) 2022.

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.As a serial number could not be determined, device history and manufacturing records could not be reviewed.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

Event Description

It was reported to fresenius on 1/dec/2022 that this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was admitted to the intensive care unit (icu) on (b)(6) 2021.The patient¿s spouse reported the patient was diagnosed with a pericardial effusion due to ¿bad dialysis¿, and a chest catheter (a non-fresenius product) was placed for hemodialysis (hd).The discharge summary was obtained on 7/dec/2022.The documents state the patient presented to the emergency room (er) on (b)(6) 2021 with complaints of chest discomfort, lightheadedness (due to atrial fibrillation), and generalized weakness which has grown progressively worse over the last two weeks.The patient¿s admission vitals included: blood pressure = 130/65, heart rate = 80 bpm, temperature = 98.0, respirations = 20, weight = 95.4 kgs, oxygen saturation = 95% on room air.While in the er, the patient experienced several episodes of hypotension and was formally admitted.Radiological testing performed on (b)(6) 2021 revealed a large pericardial effusion, as well as a left-sided pleural effusion.On (b)(6) 2021 the patient underwent a cardiac catheterization, which included a pericardiocentesis (drain left in place) removing 780 cc of bloody fluid from around the heart, as well as ultrasound guided thoracentesis removing 1200 ml of bloody drainage.Following the procedures, the patient was admitted to the icu and a hd catheter was placed for rrt.A transthoracic echocardiogram (tte) was performed following the pericardiocentesis which showed a substantial persistent pericardial effusion, with concern of a loculated effusion which could not be drained during the pericardiocentesis.As a result, thoracic surgery was consulted, and the patient underwent surgery to place a pericardial window on (b)(6) 2021 to address the located fluid.The etiology of the pericarditis and pleural effusion were identified as worsening renal function, inadequate pd therapy, and anticoagulation therapy (patient on eliquis).The patient responded well to the procedures as well as hd therapy, and the patient¿s bun decreased from 100¿s to 70¿s while hospitalized.On (b)(6) 2021, the cardiology and thoracic surgery departments cleared the patient for discharge after undergoing a final hd treatment.The patient was discharged home in stable condition and started outpatient hd on (b)(6) 2022.

• 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: 16033119
• MDR Text Key: 305977663
• Report Number: 0002937457-2022-02183
• 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: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• 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: 12/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 73 YR
• Patient Sex: Male