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 Peritonitis (2252)

Event Date 04/01/2024

Event Type  Injury  

Event Description

It was reported that a patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] was diagnosed with peritonitis.Attempts to obtain additional clinical information (e.G., discharge summary, organism, causality, patient demographics) were unsuccessful.

Manufacturer Narrative

Clinical review: a possible temporal relationship exists between ccpd therapy utilizing the liberty select cycler, liberty cycler set and the serious adverse event of peritonitis.The etiology of the peritonitis is currently unknown; therefore, causality cannot firmly be established.However, during intake the pdrn reported the peritonitis event did not require any fresenius device(s) and/or product(s) to be replaced.Additionally, the pdrn did not report the patient was experiencing any issues related to a fresenius device(s) and/or product(s).Those individuals undergoing pd therapy (manual or cycler based) are at high risk for infections of the peritoneum.Based on the information available, the patient¿s liberty select cycler and liberty cycler set can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating a fresenius product(s) and/or device(s) caused or contributed to the serious adverse events.Furthermore, there was no report a fresenius device(s) and/or product(s) failed to meet the users¿ expectations or manufacturers¿ specifications.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

• 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: 19140762
• MDR Text Key: 340560355
• Report Number: 0002937457-2024-00648
• 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
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• 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: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2017
• 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: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Required Intervention
• Patient Sex: Male