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 Abdominal Pain (1685); Hernia (2240)

Event Date 01/01/2024

Event Type  Injury  

Event Description

On 29/feb/2024, this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler reported to fresenius technical services he experienced a hernia.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 pd registered nurse, it was reported this patient experienced a right-sided inguinal hernia prior to his start on pd therapy (exact date of diagnosis unknown).The cause of this patient¿s adverse event is unknown, but it was affirmed the patient¿s hernia was unrelated to pd therapy or cycler use since it preceded his start on pd therapy in (b)(6) 2022.It was explained the use of any fresenius product(s) or device(s) has not exacerbated the patient¿s hernia or any perceived symptoms; however, the patient recently began to feel pain throughout the day (on and off the cycler) and it was decided to schedule corrective surgery for this patient¿s long-standing issue which will be performed in (b)(6) 2024.It was affirmed the patient has not missed or deviated from his pd therapy as a result of the hernia.Additionally, it was confirmed the initial diagnosis of the patient¿s hernia was unrelated to pd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient remains on ccpd therapy on the same liberty select cycler at home throughout and following this event.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: a temporal relationship does not exist between ccpd therapy utilizing the liberty select cycler and the initial diagnosis of this patient¿s hernia.It is well established that 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 cannot be determined; however, the source of this patient¿s hernia does not have relevance to the use of any fresenius product(s) or device(s) as this adverse event preceded his start on pd therapy as reported by a medical professional.It is well known a majority of hernias occur prior to the start of pd therapy.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.

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 (b)(6) 2024 this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler reported to fresenius technical services he experienced a hernia.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 pd registered nurse, it was reported this patient experienced a right-sided inguinal hernia prior to his start on pd therapy (exact date of diagnosis unknown).The cause of this patient¿s adverse event is unknown, but it was affirmed the patient¿s hernia was unrelated to pd therapy or cycler use since it preceded his start on pd therapy in (b)(6) 2022.It was explained the use of any fresenius product(s) or device(s) has not exacerbated the patient¿s hernia or any perceived symptoms; however, the patient recently began to feel pain throughout the day (on and off the cycler) and it was decided to schedule corrective surgery for this patient¿s long-standing issue which will be performed in (b)(6) 2024.It was affirmed the patient has not missed or deviated from his pd therapy as a result of the hernia.Additionally, it was confirmed the initial diagnosis of the patient¿s hernia was unrelated to pd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient remains on ccpd therapy on the same liberty select cycler at home throughout and 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: 18876461
• MDR Text Key: 337343538
• Report Number: 0002937457-2024-00416
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• 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: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2020
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 80 KG