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 Myocardial Infarction (1969); Peritonitis (2252)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: it is unknown if a temporal relationship exists between ccpd therapy utilizing the liberty select cycler, liberty cycler set and the serious adverse events of an stemi (requiring hospitalization) and peritonitis, which reportedly required the patient to transition to another form of rrt.The etiology and timeline of events is unknown; therefore, causality cannot be established.However, the pdrn¿s response did not indicate a fresenius device(s) and/or product(s) malfunctioned or was deficient in any way.Myocardial infarctions are a widespread complication for patients undergoing maintenance dialysis due to their underlying and often complex cardiovascular and endocrine status.Additionally, those individuals undergoing pd therapy (manual or cycler based) are at high risk for infections of the peritoneum.Based on the information available, the 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 device(s) and/or product(s) caused and/or contributed to the serious adverse events.Furthermore, there was no report a fresenius product(s) and/or device(s) failed to meet the users¿ expectations or manufacturers¿ specifications.

Event Description

On 08/08/2023, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized.During intake, the pd registered nurse (pdrn) reported the patient contracted peritonitis while hospitalized and is no longer able to perform pd therapy.A written response from the patient¿s pdrn revealed the patient was hospitalized (admission date not provided, >30-day hospitalization) due to a st elevation myocardial infarction (stemi).It was reported the patient developed peritonitis while admitted and required transition to alternate form of rrt (modality type not provided).As of (b)(6) 2023, the patient remained hospitalized and is recovering from the serious adverse events.Additional information (e.G., hospital records, medication records, treatment records) was requested, however the patient¿s medical record was closed.The patient was discharged from the outpatient home program after being hospitalized for >30 days.Additional information was requested however the request could not be fulfilled as the patient¿s electronic medical record was closed.

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 08/08/2023, fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized.During intake, the pd registered nurse (pdrn) reported the patient contracted peritonitis while hospitalized and is no longer able to perform pd therapy.A written response from the patient¿s pdrn revealed the patient was hospitalized (admission date not provided, >30-day hospitalization) due to a st elevation myocardial infarction (stemi).It was reported the patient developed peritonitis while admitted and required transition to alternate form of rrt (modality type not provided).As of (b)(6) 2023, the patient remained hospitalized and is recovering from the serious adverse events.Additional information (e.G., hospital records, medication records, treatment records) was requested, however the patient¿s medical record was closed.The patient was discharged from the outpatient home program after being hospitalized for >30 days.Additional information was requested however the request could not be fulfilled as the patient¿s electronic medical record was closed.

• 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: 17625135
• MDR Text Key: 321971892
• Report Number: 0002937457-2023-01284
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2018
• 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; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 62 KG