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

Catalog Number RTLR180111

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

Patient Problems Death (1802); Myocardial Infarction (1969)

Event Date 02/14/2018

Event Type  Death  

Manufacturer Narrative

Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.An investigation of the device manufacturing records was conducted and verified that there were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.In addition, a device history records (dhr) review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.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.Should additional relevant information become available, a supplemental report will be submitted.A clinical investigation was performed to identify a causal relationship between the patient's peritoneal dialysis (pd) treatment and the patient's passing.Based on the provided information, it is currently unknown if a causal relationship exists between this event and the use of the liberty cycler or any fresenius product.As the cycler was not returned, it could not be confirmed if the cycler malfunctioned in a way that could have caused or contributed to the death.Although a direct causal relationship could not be confirmed, a temporal relationship between the patient's pd treatment and the adverse event remains.Should additional new information be made available this clinical investigation will be reevaluated.

Event Description

It was reported that a patient passed away coincident with peritoneal dialysis therapy.The cause of death was stated to be a myocardial infarction.Follow up with the nurse verified that the patient was connected to the cycler at the time of their passing.The patient¿s cycler was displaying an unspecified alarm when the patient was found unresponsive in their home.Emergency services were contacted and resuscitation efforts were attempted by ems.The patient was pronounced at their home.Treatment records for the time of the incident were not available for review.It was unknown if there were any additional issues or alarms that had occurred around the time of the incident.Additional information was requested but was not available.

• Brand Name: LIBERTY CYCLER UL
• 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: 7344839
• MDR Text Key: 102598181
• Report Number: 2937457-2018-00790
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2011
• 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
• Treatment: DELFLEX PD SOLUTION; LIBERTY CYCLER SET
• Patient Outcome(s): Death
• Patient Age: 82 YR