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

Catalog Number RTLR180343

Device Problem Fluid/Blood Leak (1250)

Patient Problem Uremia (2188)

Event Date 08/26/2018

Event Type  Injury  

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.

Event Description

A peritoneal dialysis nurse (pdrn) reported a patient who was hospitalized on (b)(6) 2018 due to uremia caused by missed peritoneal dialysis treatments.Additional information was requested, but was not provided.

Manufacturer Narrative

Device evaluation: 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

It was reported this patient on peritoneal dialysis (ccpd) was hospitalized on (b)(6) 2018 due to uremia.Approximately 5 days prior to the hospitalization, on (b)(6) 2018, the patient reported ¿m31 air detected in cassette¿ alarm during pd treatment (unknown phase) with a reported observable fluid leak coming from the cassette door of the liberty select cycler.The patient reported he ended pd treatment on (b)(6) 2018 and was going to revert to manual pd therapy and the liberty select cycler was processed for replacement.According to the patient¿s pd nurse, the cause of the patient¿s uremia was related to missed pd treatments as the patient became frustrated with the fluid leak with the liberty select cycler and reportedly did not performing manual pd treatments correctly.The nurse stated the patient continued pd therapy (unknown products) while hospitalized.No further information surrounding the patient¿s hospitalization course, including patient disposition, are known despite multiple due diligence attempts.Based on the available information, the patient¿s uremia which resulted in hospitalization is most likely associated with missed/inadequate pd treatment.The patient reportedly was not adequately performing manual pd treatments (back up pd method) after experiencing a ¿m31 air detected in cassette¿ alarm and reported fluid leak approximately 5 days prior to hospitalization which led to replacement of the liberty select cycler.At this time, a possible contributory relationship between the liberty select cycler/ liberty cycler set and the patient¿s uremic event cannot be excluded; however, there is no documentation which indicates the liberty select cycler/liberty cycler set malfunctioned.Should additional information become available, please resubmit for a clinical review and this clinical investigation will be updated accordingly.

• 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: 7850263
• MDR Text Key: 119340637
• Report Number: 2937457-2018-02599
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization