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 Syncope (1610); Low Blood Pressure/ Hypotension (1914); Urinary Tract Infection (2120)

Event Date 08/22/2017

Event Type  Injury  

Manufacturer Narrative

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 patient's contact reported when the patient completed treatment the patient was assisted to the restroom.While in the restroom the patient lost consciousness and patient contact called for an ambulance.The loss of consciousness was a few minuted.The patient was hospitalized.The patient could not stand without syncope due to blood pressure dropping.The patient was already on midodrine for the low blood pressure.During the hospitalization a urinary tract infection (uti) was also found and treated.During last follow up the patient had transferred to a rehabilitation facility for treatment of the uti and syncope on going.

Manufacturer Narrative

Clinical review: there is a temporal association between ccpd treatment with the liberty cycler and the patient's syncopal episode requiring subsequent hospitalization on (b)(6) 2017.Although there is no documentation to support a causal association between the liberty cycler and the patient's syncopal event.Moreover, there have been no reported allegation against a liberty cycler malfunction that may have caused or contributed to the patient event.While the etiology of the patient's syncope is unknown, the possibility exists that the syncopal event is associated with the patient's pre-existing hypotension episodes for which the patient is prescribed midodrine.Furthermore, syncopal episodes may occur in the elderly during illness.Therefore the possibility also exists that the patient's uti infection (discovered during hospitalization) could also be related to the syncopal event experienced by the patient.

Event Description

".".

• 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: 6878096
• MDR Text Key: 86703828
• Report Number: 2937457-2017-00917
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• 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?: No
• Device Age: MO
• Date Manufacturer Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2013
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 55