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 01/01/2023

Event Type  Injury  

Manufacturer Narrative

Clinical review: there is a potential temporal relationship between pd therapy utilizing the liberty select cycler and the patient event of hernia.However, it is unknown if the hernia was pre-existing prior to the patient being initiated on pd therapy or if the hernia developed during pd therapy.Only 4.9% of pd patients develop hernia after the initiation of dialysis.The type and location of the hernia are unknown.Patients on pd therapy are at risk of developing a hernia for several reasons including increased stress on the muscles of the abdomen.It is unknown if pd therapy exacerbated the patient¿s hernia.There is no allegation of a device malfunction or deficiency causing the patient¿s hernia.Based on the available information and no allegation or evidence of a malfunction or deficiency related to the hernia, the liberty select cycler can be excluded as the cause of the hernia.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A peritoneal dialysis (pd) patient contacted fresenius technical support for a drain complication and to request a cycler replacement.Upon following up with the pd program manager, it was documented that the patient has a hernia.No additional information was provided.Attempts to obtain additional information were unsuccessful.

Manufacturer Narrative

Additional information: d9, h3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed with no physical damage noted.A simulated therapy was initiated and completed on the cycler without complication.The cycler underwent system air leak and valve actuation testing and was found to meet product specifications.An internal inspection found no discrepancies.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.

Event Description

A peritoneal dialysis (pd) patient contacted fresenius technical support for a drain complication and to request a cycler replacement.Upon following up with the pd program manager, it was documented that the patient has a hernia.No additional information was provided.Attempts to obtain additional information were unsuccessful.

Event Description

A peritoneal dialysis (pd) patient contacted fresenius technical support for a drain complication and to request a cycler replacement.Upon following up with the pd program manager, it was documented that the patient has a hernia.No additional information was provided.Attempts to obtain additional information were unsuccessful.

Manufacturer Narrative

Correction: a3 (patient gender), b1 (type of report).

Event Description

A peritoneal dialysis (pd) patient contacted fresenius technical support for a drain complication and to request a cycler replacement.Upon following up with the pd program manager, it was documented that the patient has a hernia.No additional information was provided.Attempts to obtain additional information were unsuccessful.

Manufacturer Narrative

Correction: b2 (outcomes attributed to adverse 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: 18451638
• MDR Text Key: 332180084
• Report Number: 0002937457-2024-00022
• 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,Followup,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Device Age: MO
• Date Manufacturer Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2009
• 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; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET
• Patient Outcome(s): Required Intervention
• Patient Sex: Male