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

Model Number 180343

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

Patient Problem No Information (3190)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: on 7/17/2020, a registered nurse contacted customer support on behalf of this patient on peritoneal dialysis (pd) therapy who was experiencing a patient line is blocked message and subsequent m65 scale alarm with the liberty select cycler.During the call, it was reported the patient was using the cycler in a hospital setting.There no reported adverse effects from the reported alarms nor any allegations that the patient being in the hospital was related to any fresenius device or product.No further information is known despite multiple due diligence attempts.Based on the available information, there is no allegation or indication that a fresenius device or product issue caused or contributed to a serious patient harm or injury.

Event Description

A registered nurse (rn) reported that a peritoneal dialysis (pd) patient was receiving patient line is blocked messages during fill 2 of 5 of their pd treatment.The rn reported that the patient was putting their arm over the patient line.Once the patient line is blocked alarm was cleared, a scale reading error was received during fill 2 of 5 of their pd treatment.The heater bag was positioned correctly and there was one bag on the heater tray.The load cell reading without the heater bag was 796.The rn stated that they were not a peritoneal dialysis registered nurse (pdrn); therefore they were going to call in a pdrn for assistance with calibrating the cycler at the hospital.The rn stated that they would give technical support a call once the pdrn came to the hospital.Additional information was requested, however; to date has not been provided.

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; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 10356185
• MDR Text Key: 201541612
• Report Number: 2937457-2020-01381
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/03/2020
• Supplement Dates Manufacturer Received: 08/06/2020
• Supplement Dates FDA Received: 08/11/2020
• 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