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 Anemia (1706); Diarrhea (1811); Unspecified Infection (1930); Uremia (2188)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical review: based on the available information, there was no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.Additionally, there was no allegation of a liberty select cycler or liberty cycler set malfunction related to the reported event.

Event Description

A peritoneal dialysis (pd) patient reported to fresenius technical support (ts) that they had been hospitalized.Ts followed up with the patient's peritoneal dialysis registered nurse (pdrn) for more information.There was no specific allegation the event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon additional follow-up, the patient's pdrn revealed the patient was hospitalized for an elevated white blood cell count, anemia, diarrhea and uremic symptoms.It was reported the patient had an infection, yet the nature of the infection and diagnosis were not reported to the outpatient clinic.The patient was ruled out for peritonitis and it was suspected the infection may have been gastrointestinal in nature.The patient was able to undergo ccpd therapy on a hospital provided cycler (brand and model unknown) during the admission.The patient had an uneventful hospital course and was discharged the following day.It was confirmed the patient's symptoms, unspecified infection and the associated hospitalization were unrelated to pd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues ccpd therapy on a newly received 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.

Manufacturer Narrative

Additional information: a2 and a4; this information was omitted from the initial report.

• 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
• MDR Report Key: 11067088
• MDR Text Key: 223460710
• Report Number: 2937457-2020-02315
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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
• Device Age: MO
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET; DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 90