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

Catalog Number RTLR180111

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

Patient Problems Dehydration (1807); Diarrhea (1811); Dysphagia/ Odynophagia (1815); Nausea (1970); Vomiting (2144)

Event Date 04/18/2018

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: it is possible a temporal relationship exists between continuous cyclic peritoneal dialysis (ccpd) therapy utilizing the liberty cycler and the patient¿s adverse event(s) of nausea, vomiting, dehydration and diarrhea which warranted hospitalization.Based on the information available, the etiology for the patient¿s nausea, vomiting, dehydration and diarrhea is unknown, therefore causality cannot be determined.However, it is known that patients with renal failure commonly experience gastrointestinal complications.At the time of this clinical investigation, there have been no reported allegations or documentation indicating the liberty cycler caused or contributed to a serious adverse event(s).Additionally there is no evidence the machine malfunctioned or failed to perform as expected.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A peritoneal dialysis (pd) patient's contact reported that the pd patient was hospitalized for stomach issues such as vomiting and difficulty swallowing.Upon follow up with the patient's peritoneal dialysis nurse (pdrn), it was confirmed that the patient was hospitalized for non-specific stomach issues and difficulty swallowing.The pdrn stated that the patient is still hospitalized and admitting diagnosis was dehydration, diarrhea, and unspecified nausea and vomiting.The pdrn stated that it was not believed to be related to the patient's peritoneal dialysis therapy.Additional information was unable to be obtained.

Manufacturer Narrative

 plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• 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
• MDR Report Key: 7512738
• MDR Text Key: 108226057
• Report Number: 2937457-2018-01338
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

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
• Device Age: MO
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/14/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 05/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention