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 Myocardial Infarction (1969); Sepsis (2067)

Event Date 08/11/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A peritoneal dialysis (pd) patient's clinic registered nurse (rn) reported the pd patient had been hospitalized (b)(6) 2017 due to a heart attack and sepsis.As of (b)(6) 2017 the patient remained hospitalized and was receiving hemodialysis treatments.Medical records were requested.

Manufacturer Narrative

Conclusion: there is no documentation indicating a temporal relationship between the liberty cycler and the patient hospitalization for heart attack/sepsis.Additionally, a possible causal relationship cannot be determined based on the available information in the complaint file.The etiology and treatment of the patient¿s heart attack/sepsis events are unknown to date.However, there is a possible association between the patient¿s pre-existing extensive cardiac history and diabetes mellitus to the hospitalization event.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-conformance 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.

Event Description

Information in the complaint file was reviewed by a post market surveillance clinician.On (b)(6) 2017, this peritoneal dialysis (pd) patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis (ccpd) therapy was admitted to the hospital for myocardial infarction and sepsis (precipitating signs and symptoms unknown).During follow up call on (b)(6) 2017, the pd nurse disclosed the patient was receiving hemodialysis (hd) treatments while hospitalized.It is unknown why the patient was transitioned to hd therapy and hd products were unknown.Hospitalization course was unknown.Additional information was requested but was not made available at this time.

• 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: 6797515
• MDR Text Key: 82793277
• Report Number: 2937457-2017-00735
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Initial Date Manufacturer Received: 08/09/2017
• Initial Date FDA Received: 08/16/2017
• Supplement Dates Manufacturer Received: 08/21/2017
• Supplement Dates FDA Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2008
• 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): Hospitalization; Life Threatening; Required Intervention