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 Problem Hypervolemia (2664)

Event Date 05/22/2021

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: it is unknown if a temporal relationship exists between ccpd therapy utilizing the liberty select cycler and the adverse event of fluid retention as no definitive diagnosis or exact relationship to the cycler was reported.It is well established pd patients are at high risk for fluid retention and/or fluid volume overload due to multiple factors including inappropriate prescription, noncompliance, loss of residual renal function, mechanical problems, and peritoneal membrane dysfunction.In the absence of a confirmed diagnosis and exact cause of this event, the source of the patient¿s fluid retention cannot be determined as of this reporting; however, as stated before, the root cause of fluid retention in pd patient¿s is multifactorial and can be contributed by both mechanical and/or patient physiological complications.Therefore, the liberty select cycler cannot be excluded as a potential source of this event.Based on the available information, though an allegation exists stating this event was related to the use of the liberty select cycler, there is no objective evidence any fresenius product(s) or device(s) deficiency or malfunction caused or contributed to this patient¿s adverse event.

Event Description

It was reported that a peritoneal dialysis (pd) patient was hospitalized.There was an inferred allegation stating this event was related to the use of the liberty select cycler in the initial reporting.The patient was hospitalized on (b)(6) 2021 for feeling sick due to too much fluid in her.The patient believed this issue was cycler related; however, the exact diagnosis, the specific relationship between this event and the use of the liberty select cycler, medical interventions required to alleviate the patient¿s symptoms and the patient¿s current status were not reported.Multiple attempts were made to the outpatient clinic and patient to obtain further information concerning this hospitalization; however, no additional information was obtained.

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 that a peritoneal dialysis (pd) patient was hospitalized.There was an inferred allegation stating this event was related to the use of the liberty select cycler in the initial reporting.The patient was hospitalized on (b)(6) 2021 for feeling sick due to too much fluid in her.The patient believed this issue was cycler related; however, the exact diagnosis, the specific relationship between this event and the use of the liberty select cycler, medical interventions required to alleviate the patient¿s symptoms and the patient¿s current status were not reported.Multiple attempts were made to the outpatient clinic and patient to obtain further information concerning this hospitalization; however, no additional information was obtained.

• 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
• MDR Report Key: 11975655
• MDR Text Key: 255408410
• Report Number: 2937457-2021-01220
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

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: 05/25/2021
• Initial Date FDA Received: 06/10/2021
• Supplement Dates Manufacturer Received: 06/16/2021
• Supplement Dates FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID.; DELFLEX PD FLUID.; LIBERTY CYCLER SET.; LIBERTY CYCLER SET.; DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention