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 04/01/2020

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. clinical investigation: the file was assessed to determine if a clinical investigation is warranted.A call was placed to customer support on behalf of the patient on peritoneal dialysis (pd) requesting operational assistance with set up of the liberty select cycler.It was reported the patient had a baxter pd connection (not a fresenius product) left on the pd catheter (not a fresenius product) after the patient left the hospital.The cause of the patient¿s hospitalization was not reported.However, there were no reported issues with any fresenius products in relation to the event.No further information about the hospitalization event 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

It was reported that a peritoneal dialysis (pd) patient discovered the hospital had left the baxter connector on their patient line during setup of their pd treatment after leaving the hospital.The baxter bag is not a fresenius product.The patient was confused on how to proceed with their pd treatment.The patient was advised to follow up with their peritoneal dialysis nurse (pdrn).Additional information regarding the hospitalization event 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: 10063029
• MDR Text Key: 191172246
• Report Number: 2937457-2020-00872
• 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: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• 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
• Date Manufacturer Received: 05/21/2020
• 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 Outcome(s): Hospitalization