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 Pain (1994); Hernia (2240); Constipation (3274)

Event Date 03/02/2024

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy reported experiencing a hernia, constipation and was hospitalized.There was no specific allegation these adverse events were 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 was diagnosed with a right-sided inguinal hernia on 4/mar/2024 while hospitalized.The patient was initially hospitalized on (b)(6) 2024 following right upper leg pain.It was affirmed the patient did not experience this symptom on or around the time of a pd treatment.Surgical intervention for the hernia was deferred by the patient during this hospitalization.The patient was able to undergo ccpd therapy on a hospital provided cycler (unknown brand and model) for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2024.The patient experienced constipation around the same time as this hospitalization that was attributed to poor diet and fluid intake by the patient.It was confirmed, though the cause of this patient¿s adverse event remains unknown, there was no indication the patient¿s hernia, constipation and the associated hospitalization were related to pd therapy or due to a deficiency or malfunction of nay fresenius product(s) or device(s).The patient is scheduled for a corrective procedure at the (b)(6) 2024 at which time his pd prescription will be changed to accommodate post-surgical recovery.The patient continues ccpd therapy on the same liberty select cycler at home post-discharge.

Manufacturer Narrative

Clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty select cycler and the diagnosis 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 adverse event cannot be determined; however, there was no indication this patient¿s hernia and constipation were related to pd therapy or due to a deficiency or malfunction of any fresenius product(s) or device(s) as reported by a medical professional.Therefore, the liberty select cycler can be excluded as a root cause or contributor 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.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy reported experiencing a hernia, constipation and was hospitalized.There was no specific allegation these adverse events were 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 was diagnosed with a right-sided inguinal hernia on (b)(6) 2024 while hospitalized.The patient was initially hospitalized on (b)(6) 2024 following right upper leg pain.It was affirmed the patient did not experience this symptom on or around the time of a pd treatment.Surgical intervention for the hernia was deferred by the patient during this hospitalization.The patient was able to undergo ccpd therapy on a hospital provided cycler (unknown brand and model) for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on(b)(6) 2024.The patient experienced constipation around the same time as this hospitalization that was attributed to poor diet and fluid intake by the patient.It was confirmed, though the cause of this patient¿s adverse event remains unknown, there was no indication the patient¿s hernia, constipation and the associated hospitalization were related to pd therapy or due to a deficiency or malfunction of nay fresenius product(s) or device(s).The patient is scheduled for a corrective procedure at the end of (b)(6) 2024 at which time his pd prescription will be changed to accommodate post-surgical recovery.The patient continues ccpd therapy on the same liberty select cycler at home post-discharge.

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.

• 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: 18976290
• MDR Text Key: 338558998
• Report Number: 0002937457-2024-00503
• 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: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2019
• 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): Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 90 KG