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

Catalog Number RTLR180343

Device Problem Overfill (2404)

Patient Problems Dyspnea (1816); Abdominal Distention (2601)

Event Date 04/16/2019

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

This is a report of a patient who experienced an increased intraperitoneal volume (iipv) event coincident with peritoneal dialysis (pd) therapy.The event was discovered while reviewing the patient¿s treatment records following a report of a patient not being able to breathe and feeling bloated.The patient stated that the cycler would not stop draining and no alarms were reported.The patient discontinued treatment during drain 3 of 5 due to the large drain.A review of the patient¿s treatment records identified that the patient drained 4800 ml during drain 3 of the treatment.This drain volume is 240% the patient's prescribed fill volume of 2000 ml.As a result of the iipv event, the technical support representative advised the patient to notify their peritoneal dialysis registered nurse (pdrn) of the event.The patient stated they would finish treatment on the cycler.Upon follow up with the pdrn, it was confirmed that the patient did not experience any additional symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The pdrn stated that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and stated the patient was able to complete the peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd).Subsequently, the patient missed two days of treatment.The patient has received a new cycler which is working well and continuing with pd therapy without issue.The cycler was reported to be returned to the manufacturer for physical evaluation.

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; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8559979
• MDR Text Key: 143411767
• Report Number: 2937457-2019-01227
• 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
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 04/29/2019
• 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