MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number 180343

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pneumonia (2011); Pulmonary Edema (2020)

Event Date 01/13/2021

Event Type  Injury  

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.Clinical investigation: a temporal relationship exists between continuous cyclic peritoneal dialysis (ccpd) therapy utilizing the liberty select cycler, and the patient¿s serious adverse event of pulmonary edema and pneumonia, which warranted hospitalization.The etiology of the events is unknown; therefore, causality cannot fully be established.Pulmonary edema is a common and often preventable process in the end stage renal disease (esrd) community.Factors such as an inappropriate peritoneal dialysis (pd) prescription, dietary indiscretion, peritoneal membrane failure, and/or mechanical issues can all be contributing factors in the patient¿s development of pulmonary edema.While there is no objective evidence indicating a fresenius device(s) or product(s) deficiency or malfunction caused the serious adverse events; limited information precluded an extensive and thorough investigation.Therefore, given the lack of treatment data, event(s) causality, discharge summary, current patient disposition, and no manufacturer evaluation of the suspect device; the liberty select cycler cannot be excluded from having a causal or contributory role in the serious adverse events.

Event Description

A patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis (ccpd) for renal replacement therapy (rrt) presented to the hospital with solution in their abdomen.Follow-up with the patient¿s peritoneal dialysis registered nurse (pdrn) revealed the patient was admitted for pneumonia and fluid in the lungs (pulmonary edema).Subsequent attempts to obtaining additional information (e.G., discharge summary, past medical history) have thus far been unsuccessful.

• 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 11259930
• MDR Text Key: 229838301
• Report Number: 2937457-2021-00161
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention