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

Catalog Number RTLR180343

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 10/05/2019

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: the file has been assessed for the necessity of performing a clinical investigation.On (b)(6) 2019 this patient on peritoneal dialysis (pd) contacted customer support and reported a ¿supply bag line is blocked¿ alarm with the liberty select cycler during dwell 2 of pd treatment.After trouble shooting, the patient asked for assistance with stat drain and cancelling the treatment stating she wanted to go to the hospital.During follow-up the patient stated the hospitalization was not related to any fresenius products.The patient is continuing use of the cycler without any further issues.At this time, there is no allegation or documentation that indicates any fresenius device(s) caused or contributed to a serious adverse patient outcome.The completion of a clinical investigation is not warranted at this time.

Event Description

It was reported that the liberty cycler is alarming with a supply bag lines are blocked message during dwell 2.The alarm occurred once.The fresenius technical support representative assisted the patient with checking for a broken supply bag cone, clamps open, and the number of bags connected are correct.The patient wanted to go to the hospital, so the cycler was rebooted, treatment cancelled and stat drain entered.During follow-up, the patient stated the hospitalization was not related to any fresenius products.The patient stated she is continuing use of the cycler without any further issues.At this time, there is no allegation or documentation that indicates any fresenius device(s) caused or contributed to a serious adverse patient outcome.

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: 9241472
• MDR Text Key: 163911634
• Report Number: 2937457-2019-03250
• 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: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization