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 Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Dizziness (2194); Hypervolemia (2664)

Event Date 02/01/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, fresenius became aware this 69-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) 2023 due to hypotension and lactic acidosis.Medical records indicated the patient presented to the emergency room (er) on (b)(6) 2023 due to dizziness, vomiting, and fatigue.The patient reported his ccpd treatment time increased on (b)(6) 2023 from 7.5 hours to 12.5 hours.The patient was assessed and found to be significantly volume depleted (hypovolemic) and hypotensive.The initial workup discovered the patient was in ¿severe¿ lactic acidosis with an elevated troponin (within normal limits for esrd patients).The patient was treated with intravenous (iv) fluid replacement (normal saline, volume unknown), and nephrology was consulted.The patient significantly improved with iv fluid replacement, and the nephrologist ordered ccpd therapy to be withheld for 24 hours.The patient resumed ccpd therapy on (b)(6) 2023 without issues and by (b)(6) 2023 the patient¿s fatigue had abated.The patient was discharged on (b)(6) 2023 in stable condition and recovered from the event.During the hospitalization, the patient's blood pressure remained on the low side; therefore, the patient was instructed to hold his carvedilol and lasix until his nephrology appointment.Prior to discharge the nephrologist returned the patient to a 7.5-hour treatment.

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 patient¿s serious adverse events of fatigue, vomiting, dizziness, hypovolemia and hypotension.Causality was attributed to a recent increase in treatment time from 7.5 hours to 12.5 hours.The medical records did not indicate a fresenius device(s) and or product(s) was involved in the serious adverse events.Hypotension remains a common complication of pd therapy and occurs in approximately >12% of all treatments.Very often, the cause of the hypotension is multifactorial; however, hypovolemia appears to be the most predominant cause.Based on the information available, the liberty select cycler can be disassociated from the serious adverse events.There was no allegation or objective evidence indicating a fresenius device(s) and/or product(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 user expectations or 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 28/feb/2023, fresenius became aware this 69-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) 2023 due to hypotension and lactic acidosis.Medical records indicated the patient presented to the emergency room (er) on (b)(6) 2023 due to dizziness, vomiting, and fatigue.The patient reported his ccpd treatment time increased on (b)(6) 2023 from 7.5 hours to 12.5 hours.The patient was assessed and found to be significantly volume depleted (hypovolemic) and hypotensive.The initial workup discovered the patient was in ¿severe¿ lactic acidosis with an elevated troponin (within normal limits for esrd patients).The patient was treated with intravenous (iv) fluid replacement (normal saline, volume unknown), and nephrology was consulted.The patient significantly improved with iv fluid replacement, and the nephrologist ordered ccpd therapy to be withheld for 24 hours.The patient resumed ccpd therapy on (b)(6) 2023 without issues and by(b)(6) 2023 the patient¿s fatigue had abated.The patient was discharged on (b)(6) 2023 in stable condition and recovered from the event.During the hospitalization, the patient's blood pressure remained on the low side; therefore, the patient was instructed to hold his carvedilol and lasix until his nephrology appointment.Prior to discharge the nephrologist returned the patient to a 7.5-hour treatment.

• 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: 16550675
• MDR Text Key: 311372188
• Report Number: 0002937457-2023-00377
• 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: 04/12/2023

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: 02/28/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2019
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 58 KG