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 Electrolyte Imbalance (2196); Hypervolemia (2664)

Event Date 07/01/2022

Event Type  Injury  

Event Description

It was reported to fresenius that this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized due to high potassium levels (hyperkalemia) and retaining ¿a lot¿ of fluid (fluid retention).The patient reported they were discharged, after which they presented to the outpatient dialysis center to evaluate the functionality of their pd catheter (not a fresenius product).The pd catheter allegedly functioned as intended during manual testing (medical interpretation of evaluation unknown), thus the patient contacted fresenius technical support requesting a replacement liberty select cycler due to slow drains.Subsequent attempts to obtain additional information (e.G., discharge summary, hospital records, treatment data) have thus far proven unsuccessful.

Manufacturer Narrative

A temporal relationship exists between ccpd therapy utilizing the liberty select cycler and the serious adverse events of hyperkalemia and fluid retention, which required hospitalization (unknown duration).Multiple attempts were made to obtain additional information regarding the serious adverse events; however, no response was received.This lack of information precluded a more comprehensive investigation; therefore, limiting the possibility of establishing causality.Fluid retention and electrolyte imbalances are common and often preventable processes in esrd patients and are likely multifactorial in origin.Additionally, catheter related considerations, such as position, obstruction, omental wrapping, and fibrin can all be contributing factors.Based on the limited information available, the liberty select cycler cannot be disassociated from the events.There is currently no documentation or objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction occurred causing the serious adverse events.Nevertheless, due to the lack of follow-up information (e.G., hospital records, discharge summary, patient demographics, treatment data), the liberty select cycler cannot be excluded from having a possible contributory role in the events.However, it should be noted if the cycler is returned, a manufacturer evaluation may disassociate the liberty select cycler from having contributed to the serious adverse events.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

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

It was reported to fresenius that this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized due to high potassium levels (hyperkalemia) and retaining ¿a lot¿ of fluid (fluid retention).The patient reported they were discharged, after which they presented to the outpatient dialysis center to evaluate the functionality of their pd catheter (not a fresenius product).The pd catheter allegedly functioned as intended during manual testing (medical interpretation of evaluation unknown), thus the patient contacted fresenius technical support requesting a replacement liberty select cycler due to slow drains.Subsequent attempts to obtain additional information (e.G., discharge summary, hospital records, treatment data) have thus far proven unsuccessful.

• 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: 15182480
• MDR Text Key: 297414400
• Report Number: 0002937457-2022-01314
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

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: 07/18/2022
• Initial Date FDA Received: 08/08/2022
• Supplement Dates Manufacturer Received: 08/10/2022
• Supplement Dates FDA Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2019
• 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 Sex: Male