MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180343

Device Problems Use of Device Problem (1670); Overfill (2404)

Patient Problem Weight Changes (2607)

Event Date 12/26/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental mdr will be submitted upon device evaluation.

Event Description

A peritoneal dialysis patient reported his cycler alarmed for a supply bag event during dwell 4 of 5.While troubleshooting the patient reported his treatment history.During drain 0 the patient had bypassed the drain and went directly to fill 1.During fill 1 the patient filled with 1499 ml.During drain 1 the patient drained 3788 ml.The technician suggested replacing the cycler due to the large drain but the patient declined.He reported he had bypassed drain 0 intentionally and was aware that he should have drained before filling.The patient also reported that he had gained a lot of weight recently.The patient was advised to contact his nurse.During follow up the patient's nurse reported the patient had advised the on call nurse that he had gained greater than 10 lbs.Due to not draining dialysate adequately.The reported large drain of 3788 ml was 253% over the expected drain volume which resulted in a reportable device malfunction.

Manufacturer Narrative

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
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7207623
• MDR Text Key: 98047736
• Report Number: 2937457-2018-00208
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K171652
• 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: 05/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• 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: 01/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER SET; PD FLUID
• Patient Age: 71 YR
• Patient Weight: 84