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 Problem Death (1802)

Event Date 12/06/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).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

A peritoneal dialysis (pd) patient's clinic registered nurse (rn), reported the patient passed away on the cycler on (b)(6) 2016.Additional follow-up was made with another clinic pdrn, who confirmed the patient's death and stated the patient had passed away at home, while connected to the cycler undergoing treatment.Per pdrn she did not believe any pd products were related to the event.She indicated the coroner had informed her that the patient had passed away from complications related to coronary artery disease.The patient had been on dialysis approximately 3 years.Per the nurse, the patient had been transitioned to hemodialysis from (b)(6) 2016 due to low albumin.The patient had just resumed pd therapy following this.She indicated there were no other concomitant medications or co-morbid condition information available.Medical records were requested.

Manufacturer Narrative

Conclusions: there is no documentation supporting a possible association between the liberty cycler and the patient's expiration.However, there is a probable association between the coroner¿s findings/evaluation of patient expiring due to complications related to preexisting coronary artery disease and patient expiration.

Event Description

Source documents in complaint file were reviewed by a post market surveillance clinician.There is limited clinical information available.It was reported that this patient with end stage renal disease (esrd) expired on (b)(6) 2016 during a continuous cyclic peritoneal dialysis (ccpd) treatment on the liberty cycler.The patient had a dialysis vintage of approximately 3 years of renal replacement therapy.During the period of time ((b)(6) 2016) the patient transitioned from ccpd to hemodialysis (hd) due to reportedly low albumin levels (values unknown).The patient then resumed ccpd therapy.According to the peritoneal dialysis registered nurse (pdrn) the patient¿s death was not related to the any fresenius products.The pdrn reported that the coroner had informed her that the patient passed away from complications related to coronary artery disease (cad).

• 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: 6213827
• MDR Text Key: 63559228
• Report Number: 2937457-2016-01267
• 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,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• 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: 01/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2016
• 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 CASSETTE
• Patient Outcome(s): Death
• Patient Age: 73 YR