MAUDE Adverse Event Report: CONCORD MANUFACTURING UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number LIB CYC

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

Patient Problems Dehydration (1807); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Hernia (2240)

Event Date 04/03/2018

Event Type  Injury  

Manufacturer Narrative

There is no documentation in the complaint file to show a causal relationship between the event of dehydration, nausea, hypotension and hiatal hernia diagnosis and the liberty cycler.Additionally there is no reported allegation of a machine malfunction related to this event.There is a possible temporal relationship between the patient¿s hiatal hernia and pd therapy on the liberty cycler, although it is unknown when the hernia developed.The symptoms of the hernia could have been exacerbated by the intra-abdominal pressure of pd therapy.The alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.

Event Description

During routine follow up with a peritoneal dialysis patient on an unrelated customer experience, it was reported the patient was hospitalized on (b)(6) 2018 due to low blood pressure, dehydration, and nausea.Additional details were reported in a call to the pdrn on (b)(6) 2018 which clarified that the patient was admitted to the hospital with a diagnosis of hiatal hernia.The patient was experiencing esophageal issues (unspecified) which subsequently led to poor fluid intake resulting in dehydration, hypotension and nausea.Hospital course is unknown.The patient continued pd therapy during hospitalization although it is unknown if any fresenius products were utilized.The cause of the hiatal hernia is unknown although the pdrn states that it is not related to dialysis.It is unknown when the hernia occurred.Patient disposition is unknown.Additional information was solicited.

• Brand Name: UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED)
• 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: 7455959
• MDR Text Key: 106358695
• Report Number: 2937457-2018-01139
• 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: Patient
• Type of Report: Initial
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIB CYC
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 04/05/2018
• 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 SOLUTION
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 59