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

Catalog Number RTLR180343

Device Problem Overfill (2404)

Patient Problem Abdominal Distention (2601)

Event Date 07/14/2019

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 bypassing out of fill 5 and performing a stat drain.The patient contact stated that they wanted to make sure that the patient was empty as they were have surgery the next day.A review of the patient¿s treatment records identified that the patient drained 1596 ml during drain 5 and 2165 ml during drain 4 of the treatment.This drain volume is 188% the patient's maximum fill volume of 2002 ml.As a result of the iipv event, the technical support representative advised the patient contact that the patient was still carrying extra solution.The patient stopped draining at 1596 ml and switched to step 8.No further assistance was needed.Upon follow up, the patient contact confirmed the reported event and stated that they realized that the cycler was set at 70% and was reset to 85%.The patient contact stated that the patient needed to be empty for a knee replacement surgery.The patient contact stated that the patient¿s abdomen was distended, but they did not experience any other symptoms, injury, adverse event, or require medical intervention as a result of the reported event.The patient¿s distention subsided on its own after performing the stat drain.The patient has continued with peritoneal dialysis therapy on the same cycler without issue and without reoccurrence of the reported event.

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: 8821123
• MDR Text Key: 152029732
• Report Number: 2937457-2019-02288
• 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
• Type of Report: Initial,Followup
• Report Date: 08/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• 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: 08/01/2019
• 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
• Patient Age: 87 YR
• Patient Weight: 71