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

Catalog Number RTLR180111

Device Problem Overfill (2404)

Patient Problems Chest Pain (1776); Dyspnea (1816); Hypervolemia (2664)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be filed upon completion of the manufacturer's investigation.

Event Description

A peritoneal dialysis nurse reported the patient's scale stopped working.The nurse stated that the patient was not able to properly monitor weight.The patient was admitted to the hospital due to fluid overload.The nurse confirmed that the patient was hospitalized for fluid overload characterized by shortness of breath and chest pain from (b)(6) 2018.The patient continued peritoneal dialysis throughout the hospitalization.

Manufacturer Narrative

Clinical investigation: there is a temporal relationship between the event of fluid overload and subsequent hospitalization and treatment completion of ccpd therapy on the liberty cycler.However, the liberty cycler performed as expected and there is no allegation against the cycler or documentation in the file related to a malfunction of the cycler.Due to the broken scale, the patient could not enter his accurate weight at the end of treatment as required.Weight at end of treatment needs to be entered into patient data per liberty cycler user guide.Plant investigation: the alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.The serial number of the alleged device is unknown, therefore a device history review could not be performed.

• 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: 7437314
• MDR Text Key: 105706926
• Report Number: 2937457-2018-01081
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 04/17/2018
• Supplement Dates Manufacturer Received: 04/20/2018
• Supplement Dates FDA Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 FLUID
• Patient Age: 45 YR
• Patient Weight: 138