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

Catalog Number RTLR180111

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

Patient Problems Death (1802); Uremia (2188)

Event Date 03/01/2018

Event Type  Death  

Manufacturer Narrative

Device evaluation: the device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.Clinical evaluation: the file was assessed for the need for clinical investigation completion.The reported information, which included a report that the patient expired, was reviewed.Per the end stage renal disease (esrd) death notification the cause of death was unknown with a secondary cause of hypokalemia and uremia from dialysis withdrawal.The date of withdrawal is unknown.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.The completion of a clinical investigation is not required.Should additional information become available, the need for a clinical investigation will be reassessed.

Event Description

A peritoneal dialysis nurse reported that a patient expired due to long-term cardiac illness.Due to no event date having been provided, (b)(6) 2018 will be used as the event date.

Manufacturer Narrative

Additional information: esrd death certificate received.

Event Description

A peritoneal dialysis nurse reported that a patient expired due to long-term cardiac illness.The date of death has been recorded as (b)(6) 2018.The patient had chosen to withdraw from dialysis on an unknown date.According to patient records, the secondary causes of death were hypokalemia and uremia due to dialysis withdrawl.

• Brand Name: LIBERTY CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7430672
• MDR Text Key: 105501466
• Report Number: 2937457-2018-01046
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 75 YR