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 Problem No Information (3190)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: the file was assessed to determine whether a clinical investigation is warranted.On 24/jun/2020, an acute hospital registered nurse (rn) contacted fresenius technical support for assistance with an overfill on cycle 2 of 4 with a hospitalized patient.The rn was contacted multiple times to acquire the patient¿s name and outpatient dialysis clinic; however, no additional information was obtained.Due to the lack of patient and hospital information, further follow-up and/or written correspondence is not feasible.Based on the limited information available, there is no specific allegation or objective evidence indicating the patient¿s hospitalization, a serious injury, patient death, or other adverse event(s) requiring medical intervention related to a fresenius product(s) or device(s) occurred warranting further investigation.Therefore, the completion of a clinical investigation is not warranted at this time.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported that a peritoneal dialysis (pd) patient was hospitalized for unspecified reasons.Fresenius technical services received a call from a hospital registered nurse (rn) inquiring on the patient's positive ultrafiltration value from their pd treatment.The patient was using a liberty select cycler leased to the hospital (unspecified name) by a fresenius affiliated acute dialysis program.Upon review of the patient's treatment data it was determined that an increased intraperitoneal volume (iipv) incident had occurred after identifying that the patient had a drain volume of 3101 ml which is 155% of the patient's fill volume of 2002 ml.The iipv is not considered a reportable malfunction, however, a replacement cycler was offered but the rn declined.The date of the hospitalization, patient identifiable information, reason for hospitalization, diagnosis, and outcome were never provided.There was no allegation that the iipv resulted in an adverse event, injury, or medical intervention.Multiple follow up attempts were performed to inquire on the reason for the patient's hospitalization, however, a response was not received.No products are expected to be returned for physical evaluations.

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.

• 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: 10257871
• MDR Text Key: 198348973
• Report Number: 2937457-2020-01244
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• 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: 07/24/2020
• 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