MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180343

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dehydration (1807); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Dizziness (2194)

Event Date 08/16/2023

Event Type  Injury  

Event Description

On 18/aug/2023 during follow-up for file (b)(4), fresenius became aware this 88-year-old male patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler for renal replacement therapy (rrt) was hospitalized due to dehydration.The patient was reportedly injected with ¿serum¿ for fluid replacement.No additional information was provided during intake.Medical records from the patient¿s pd registered nurse [(pd)rn] revealed the patient presented to the emergency room on (b)(6) 2023 with complaints of dizziness, near syncope when standing (2-3 days), and hypotension [systolic blood pressure (sbp) = 60¿s].The patient (corroborated by spouse) reported experiencing drain complications and larger than expected ultrafiltration (uf) volumes (>3000 ml) over the past 48 hours despite treatment compliance.The patient was attempting to replace the increased uf with fluids and ¿salty snacks,¿ however it was unsuccessful.The patient was admitted and treated with 1500 ml of normal saline (ns) over the next 24 hours and a single dose of intravenous (iv) cefepime was administered, despite the patient¿s lack of infectious symptoms.The patient¿s tachycardia (value not provided) and sbp improved (100¿s) following the administration of iv fluids, and the patient resumed ccpd therapy on (b)(6) 2023 utilizing a 1.5% dialysate (heparin added, no rationale provided) without reported difficulty.On 18/aug/2023, the patient experienced an unexpected drop (causality not provided) in hgb (9.3 to 7.9), however it does not appear the patient required medical intervention for the event.On (b)(6) 2023, the patient was prescribed midodrine (likely long term) and received a 250 ml ns bolus for hypotension.The remainder of the patient¿s hospitalization was unremarkable, and the patient was discharged on (b)(6) 2023.Per the pdrn and discharge summary, the patient¿s dehydration, tachycardia, and orthostatic dizziness/hypotension were caused by the patient¿s reduced cardiac output/function (e.G., cardiomyopathy, worsening heart failure, low ejection fraction).Once discharged, the patient resumed utilizing the same liberty select cycler at home without any reported issue(s).The pdrn reported the patient will be transitioning to hospice care due to their worsening heart failure and will continue ccpd therapy until they are ready to enter hospice.

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 ccpd therapy utilizing the liberty select cycler and the serious adverse events of dehydration, orthostatic hypotension/dizziness, near syncope and tachycardia, which required hospitalization.Per the pdrn¿s response (including medical records), the serious adverse events were attributed to the patient¿s reduced/worsening cardiac output/function (e.G., cardiomyopathy, worsening heart failure, low ejection fraction).Additionally, there was no reported fresenius device(s) and/or product(s) deficiency or malfunction.Hypotension remains a common complication among esrd patients and is frequently multifactorial in origin.Based on the information available, the liberty select cycler can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating a fresenius product(s) and/or device(s) caused and/or contributed to the serious adverse events.Furthermore, there was no report a fresenius product(s) and/or device(s) failed to meet the users¿ expectations or manufacturers¿ 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 18/aug/2023 during follow-up for file (b)(4), fresenius became aware this 88-year-old male patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler for renal replacement therapy (rrt) was hospitalized due to dehydration.The patient was reportedly injected with ¿serum¿ for fluid replacement.No additional information was provided during intake.Medical records from the patient¿s pd registered nurse [(pd)rn] revealed the patient presented to the emergency room on (b)(6) 2023 with complaints of dizziness, near syncope when standing (2-3 days), and hypotension [systolic blood pressure (sbp) = 60¿s].The patient (corroborated by spouse) reported experiencing drain complications and larger than expected ultrafiltration (uf) volumes (>3000 ml) over the past 48 hours despite treatment compliance.The patient was attempting to replace the increased uf with fluids and ¿salty snacks,¿ however it was unsuccessful.The patient was admitted and treated with 1500 ml of normal saline (ns) over the next 24 hours and a single dose of intravenous (iv) cefepime was administered, despite the patient¿s lack of infectious symptoms.The patient¿s tachycardia (value not provided) and sbp improved (100¿s) following the administration of iv fluids, and the patient resumed ccpd therapy on (b)(6) 2023 utilizing a 1.5% dialysate (heparin added, no rationale provided) without reported difficulty.On (b)(6) 2023, the patient experienced an unexpected drop (causality not provided) in hgb (9.3 to 7.9), however it does not appear the patient required medical intervention for the event.On (b)(6) 2023, the patient was prescribed midodrine (likely long term) and received a 250 ml ns bolus for hypotension.The remainder of the patient¿s hospitalization was unremarkable, and the patient was discharged on (b)(6) 2023.Per the pdrn and discharge summary, the patient¿s dehydration, tachycardia, and orthostatic dizziness/hypotension were caused by the patient¿s reduced cardiac output/function (e.G., cardiomyopathy, worsening heart failure, low ejection fraction).Once discharged, the patient resumed utilizing the same liberty select cycler at home without any reported issue(s).The pdrn reported the patient will be transitioning to hospice care due to their worsening heart failure and will continue ccpd therapy until they are ready to enter hospice.

Manufacturer Narrative

Correction provided in b6 and b7.

Event Description

On 18/aug/2023 during follow-up for file (b)(6), fresenius became aware this 88-year-old male patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler for renal replacement therapy (rrt) was hospitalized due to dehydration.The patient was reportedly injected with ¿serum¿ for fluid replacement.No additional information was provided during intake.Medical records from the patient¿s pd registered nurse [(pd)rn] revealed the patient presented to the emergency room on 16/aug/2023 with complaints of dizziness, near syncope when standing (2-3 days), and hypotension [systolic blood pressure (sbp) = 60¿s].The patient (corroborated by spouse) reported experiencing drain complications and larger than expected ultrafiltration (uf) volumes (>3000 ml) over the past 48 hours despite treatment compliance.The patient was attempting to replace the increased uf with fluids and ¿salty snacks,¿ however it was unsuccessful.The patient was admitted and treated with 1500 ml of normal saline (ns) over the next 24 hours and a single dose of intravenous (iv) cefepime was administered, despite the patient¿s lack of infectious symptoms.The patient¿s tachycardia (value not provided) and sbp improved (100¿s) following the administration of iv fluids, and the patient resumed ccpd therapy on (b)(6) 2023 utilizing a 1.5% dialysate (heparin added, no rationale provided) without reported difficulty.On (b)(6) 2023, the patient experienced an unexpected drop (causality not provided) in hgb (9.3 to 7.9), however it does not appear the patient required medical intervention for the event.On (b)(6) 2023, the patient was prescribed midodrine (likely long term) and received a 250 ml ns bolus for hypotension.The remainder of the patient¿s hospitalization was unremarkable, and the patient was discharged on (b)(6) 2023.Per the pdrn and discharge summary, the patient¿s dehydration, tachycardia, and orthostatic dizziness/hypotension were caused by the patient¿s reduced cardiac output/function (e.G., cardiomyopathy, worsening heart failure, low ejection fraction).Once discharged, the patient resumed utilizing the same liberty select cycler at home without any reported issue(s).The pdrn reported the patient will be transitioning to hospice care due to their worsening heart failure and will continue ccpd therapy until they are ready to enter hospice.

• 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: 17632189
• MDR Text Key: 322064740
• Report Number: 0002937457-2023-01292
• 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
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2016
• 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; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 88 KG