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

Catalog Number RTLR180343

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

Patient Problems Bacterial Infection (1735); Death (1802); Low Blood Pressure/ Hypotension (1914); Pneumonia (2011); Sepsis (2067); Peritonitis (2252)

Event Date 01/17/2018

Event Type  Death  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A peritoneal dialysis (pd) patient's contact reported the patient had passed away.Additional follow-up was made with the pd patient's clinic registered nurse (rn), who stated the patient had been hospitalized on an unknown date due to hypotension.The patient also developed pneumonia, clostridium difficile and peritonitis during the course of hospitalization the patient was performing hemodialysis as well as peritoneal dialysis during hospitalization and subsequently expired on an unknown date in (b)(6) 2018 due to sepsis.No additional information was available as the patient's medical records were placed in storage.The pd patient's treatment regimen included 1.55, 2.55, and 4.25% dextrose solution with 6 exchanges of 2.1 l and a last fill of 1.2 l since (b)(6) 2012.Additional information and medical records were requested.

Manufacturer Narrative

Plant investigation: 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.A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A peritoneal dialysis (pd) patient's contact reported the patient had passed away.Additional follow-up was made with the pd patient's clinic registered nurse (rn), who stated the patient had been hospitalized on an unknown date due to hypotension.The patient also developed pneumonia, clostridium difficile and peritonitis during the course of hospitalization the patient was performing hemodialysis as well as peritoneal dialysis during hospitalization and subsequently expired on an unknown date in (b)(6) 2018 due to sepsis.No additional information was available as the patient's medical records were placed in storage.The pd patient's treatment regimen included 1.55, 2.55, and 4.25% dextrose solution with 6 exchanges of 2.1l and a last fill of 1.2l since (b)(6) 2012.Additional information and medical records were requested.

Manufacturer Narrative

Date of death: (b)(6) 2018.Date of event: (b)(6) 2018.There is no documentation or indication a fresenius device(s) caused or contributed to a serious adverse patient outcome.Additionally, there is no allegation of the machine malfunctioning or the machine not performing as expected.

Event Description

The file and received medical records were reviewed by a post market surveillance clinician.On (b)(6) 2018 a peritoneal dialysis (pd) patient's contact reported the patient expired on (b)(6) 2018.On (b)(6) 2018 the peritoneal dialysis registered nurse (pdrn) faxed the discharge summary and esrd death notification to post market surveillance (pms).The discharge summary stated the patient was hospitalized on (b)(6) 2017 with multifocal pneumonia and despite aggressive medical intervention, the patient did not improve.During the course of the hospitalization, the patient was diagnosed with pancreatitis for unknown reasons, and a large pancreatic cyst growing candida glabrata.Despite antimicrobial and antifungal treatment, the patient continued to decline and become hypotensive.On (b)(6) 2018 the patient's status was changed to do not intubate (dnr) and do not intubate (dni), and a palliative care consult was obtained.On (b)(6) 2018 the family consented to inpatient hospice care, and the patient expired on (b)(6) 2018.The esrd death notification stated the primary cause of death was septicemia.The form states the patient discontinued rrt on (b)(6) 2018 per the family's request.

• Brand Name: LIBERTY SELECT 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: 7330282
• MDR Text Key: 102084685
• Report Number: 2937457-2018-00742
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2014
• 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: 82 YR