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

Catalog Number RTLR180111

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

Patient Problems Cardiac Arrest (1762); Death (1802); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969)

Event Date 05/25/2017

Event Type  Death  

Manufacturer Narrative

Source documents were reviewed in the complaint although a temporal relationship may exist between the last ccpd treatments occuring at home prior to the patient's experience of chest pain, termination of treatment and the events of a diagnosed fatal myocardial infarction during surgery for gastrointestinal hemorrhage, there is no documentation supporting a possible causal relationship between fresenius products and the patient's subsequent expiration.The actual device was not returned to the manufacturer for physical evaluation.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device manufacturing review confirmed the labeling, material, and process controls were within specification.

Event Description

Source documents and received end stage renal disease (esrd) death notification were reviewed in the complaint file.It was reported on (b)(6) 2017 on a service call by the patient contact that patient was experiencing a heart attack and was taken off the liberty cycler to go to the hospital for evaluation and treatment.On (b)(6) 2017 during a follow-up call to the peritoneal dialysis (pd) patient¿s clinic registered nurse (rn), it was revealed the patient had been admitted to the hospital on (b)(6) 2017 with a diagnosis of myocardial infarction, underwent surgery for acute gastrointestinal (gi) bleed and during surgery went into cardiac arrest and expired on (b)(6) 2017.The pdrn stated the patient¿s wife commented the patient had a tear in the gastro-intestinal wall.The patient did not perform pd treatment during hospitalization.Per rn, the gi bleed or ear had nothing to do with dialysis and cardiac arrest was not related to dialysis or pd solution.The esrd form received revealed the patient expired in the hospital, with primary cause as acute myocardial infarction and secondary cause as gastrointestinal hemorrhage.The modality of the patient at time of death was continuous cycler-assisted (ccpd) therapy.The patient had terminated therapy and cancelled treatment at home due to experiencing signs of myocardial infarction.Renal replacement therapy was not discontinued prior to death.The pdrn noted the patient was not dialyzing in the hospital prior to expiration, and was in hospice care prior to death.

• Brand Name: LIBERTY CYCLER
• Type of Device: SYSTEM, PERITONEAL DIALYSIS, 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: 6651122
• MDR Text Key: 77890257
• Report Number: 2937457-2017-00483
• 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: consumer,health professional
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Device Age: MO
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2008
• 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: LIBERTY CYCLER CASSETTE; PD SOLUTION
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 77