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

Catalog Number UNKNOWN- LIBERTY CYCLER UL

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

Patient Problem No Information (3190)

Event Date 01/23/2020

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A peritoneal dialysis (pd) patient reported experiencing excessive alarms on a hospital¿s liberty cyclers.The patient reported that the alarms occurred due to the pd machines being outdated.The patient reportedly requested the hospital staff get new machines, but it has not yet happened.There was no information pertaining to the hospitalization of the patient.In addition, there was no indication that a device malfunction or deficiency attributed to the reported hospitalization.The patient did not report if the hospital was utilizing fresenius cyclers or another manufacturer¿s device.Multiple attempts have been made to obtain additional information, and at this time no additional information has been provided.

Manufacturer Narrative

Additional information: the below clinical review was inadvertently omitted from the previous reports.Clinical review: there was no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.Therefore, the completion of a clinical investigation is not warranted at this time.

Manufacturer Narrative

Concomitant products were inadvertently omitted from the initial report.Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.As a serial number could not be determined, device history and manufacturing records could not be reviewed.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

• Brand Name: LIBERTY CYCLER UL
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 9703945
• MDR Text Key: 179234955
• Report Number: 2937457-2020-00310
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2020

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 Catalogue Number: UNKNOWN- LIBERTY CYCLER UL
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/13/2020
• Supplement Dates Manufacturer Received: 02/17/2020; 02/27/2020
• Supplement Dates FDA Received: 02/26/2020; 02/27/2020
• 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