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 Cardiac Arrest (1762); Death (1802); Heart Failure (2206)

Event Date 03/15/2017

Event Type  Death  

Manufacturer Narrative

(b)(4) - the clinical evaluation determined that although a temporal relationship exist between the last ccpd treatment and the patient subsequent expiration, there is not enough information to consider potential causality.Prior to the event the patient had progressive increase of blood pressure and significant decrease of ultra filtration.This possibly contributed to the patient expiration.Additionally the patient's significant and highly complex comorbidities; including diabetes mellitus, hypertension, hyperphosphatemia and hypokalemia 3 put the patient at high risk for sudden death.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

On 03/17/2017, it was reported by the peritoneal dialysis registered nurse (pdrn), that a patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis (ccpd) therapy since (b)(6) 2017 expired on (b)(6) 2017 while connected to the liberty cycler, it appeared that the patient completed the ccpd treatment.A spontaneous fatal event of heart failure was attributed as the cause.Treatment records prior to the event showed an upward trend in the patient¿s blood pressure and a downward trend in the patient¿s pd ultrafiltration values.Esrd death notification was made available by the pdrn, which listed the primary cause of death as ¿cardiac arrest, cause unknown¿ with no secondary causes.Esrd death notification was made available by the pdrn, which lists the primary cause of death as ¿cardiac arrest, cause unknown¿ with no secondary causes.

• 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: 6492368
• MDR Text Key: 72776360
• Report Number: 2937457-2017-00256
• Device Sequence Number: 1
• Product Code: FKX
• 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,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• 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: 03/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2017
• 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 SET; PD DELFLEX SOLUTION
• Patient Outcome(s): Death
• Patient Age: 85 YR
• Patient Weight: 73