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 Problem Hernia (2240)

Event Date 01/04/2024

Event Type  Injury  

Event Description

On 14/feb/2024, during a follow up, a peritoneal dialysis registered nurse [(pd)rn] reported to fresenius this pd patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler underwent umbilical hernia surgery.There was no specific allegation this adverse event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with the patient¿s pdrn, it was reported this patient was diagnosed with an umbilical hernia on 4/jan/2024 via computed tomography.The reported cause of the hernia was described as undue force by the patient in his home with no indication of a relationship to pd therapy or the use of any fresenius product(s) or device(s).The patient underwent a laparoscopic umbilical hernia repair procedure on (b)(6) 2024.The patient recovered from this event as she continued ccpd therapy throughout recovery with reduced fill volumes.It was confirmed the patient¿s umbilical hernia, and the associated repair procedure were not due to a deficiency or malfunction of any fresenius product(s) or device(s).It is presumed the patient continues ccpd therapy on the same liberty select cycler following this event.

Manufacturer Narrative

Plant investigation: 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 adverse event of this patient¿s hernia.It is well established those patients undergoing pd therapy are at high risk for mechanical complication due to hernias of any etiology and may be safely repaired to continue successful pd therapy.The cause of this patient¿s hernia can be attributed to excessive strain (or ¿undue force¿ as described by the patient) in her home with no indication of pd therapy involvement as reported by a medical professional.This is further supported by multiple studies that have found no positive correlation between increased volumetric pressure during pd therapy and hernia occurrence.Therefore, the liberty select cycler can be excluded as a root cause of this patient¿s adverse event.Based on the required information, there was no allegation or objective evidence of any fresenius product(s) or device(s) deficiency or malfunction caused or contributed to this patient¿s adverse event.

Event Description

On (b)(6)2024, during a follow up, a peritoneal dialysis registered nurse [(pd)rn] reported to fresenius this pd patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler underwent umbilical hernia surgery.There was no specific allegation this adverse event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with the patient¿s pdrn, it was reported this patient was diagnosed with an umbilical hernia on (b)(6)2024 via computed tomography.The reported cause of the hernia was described as undue force by the patient in his home with no indication of a relationship to pd therapy or the use of any fresenius product(s) or device(s).The patient underwent an out-patient laparoscopic umbilical hernia repair procedure on (b)(6)2024.The patient recovered from this event as she continued ccpd therapy throughout recovery with reduced fill volumes.It was confirmed the patient¿s umbilical hernia, and the associated repair procedure were not due to a deficiency or malfunction of any fresenius product(s) or device(s).It is presumed the patient continues ccpd therapy on the same liberty select cycler following this event.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Complaint investigation did not find objective evidence indicating a product problem, thus the complaint is unconfirmed.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 (b)(6) 2024 during a follow up, a peritoneal dialysis registered nurse [(pd)rn] reported to fresenius this pd patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler underwent umbilical hernia surgery.There was no specific allegation this adverse event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with the patient¿s pdrn, it was reported this patient was diagnosed with an umbilical hernia on (b)(6) 2024 via computed tomography.The reported cause of the hernia was described as undue force by the patient in his home with no indication of a relationship to pd therapy or the use of any fresenius product(s) or device(s).The patient underwent an out-patient laparoscopic umbilical hernia repair procedure on (b)(6) 2024.The patient recovered from this event as she continued ccpd therapy throughout recovery with reduced fill volumes.It was confirmed the patient¿s umbilical hernia, and the associated repair procedure were not due to a deficiency or malfunction of any fresenius product(s) or device(s).It is presumed the patient continues ccpd therapy on the same liberty select cycler following this event.

• 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: 18758747
• MDR Text Key: 336003978
• Report Number: 0002937457-2024-00303
• Device Sequence Number: 1
• Product Code: FKX
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• 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: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2017
• 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: LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET; PD SOLUTION; PD SOLUTION; PD SOLUTION
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 33 KG