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

Catalog Number RTLR180343

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

Patient Problems Edema (1820); Pneumonia (2011)

Event Date 11/23/2018

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: there is a probable temporal relationship between pd therapy on the liberty select cycler and the patient event of hydrocele.Pd dialysate fluid can leak from the peritoneal cavity causing genital edema due to body structure abnormalities.Communicating hydroceles can occur following increased intra-abdominal fluid or pressure such as that in dialysis.There is no documentation to show a causal relationship between the liberty select cycler and the hydrocele.There is no documentation to show a temporal or causal relationship between pd therapy with the liberty select cycler and the event of pneumonia.The cause of the pneumonia is unknown, however, there is no indication that any fresenius device(s) caused or contributed to the patient being hospitalized on (b)(6) 2018 with pneumonia.

Event Description

A peritoneal dialysis (pd) patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) contacted technical support for assistance.Upon follow up, the clinical secretary reported that the patient was hospitalized for pneumonia (signs and symptoms unknown) and hydrocele (genital edema).The patient was admitted to the hospital on (b)(6) 2018.The cause of the patient¿s pneumonia and hydrocele is unknown.The patient remains hospitalized.It is unknown if pd therapy was continued in the hospital or if any fresenius device(s) or product(s) were utilized during hospitalization.Additional details surrounding the patient¿s hospital course and condition were requested, however, not provided.

Manufacturer Narrative

No parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.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: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8124566
• MDR Text Key: 129044276
• Report Number: 2937457-2018-03542
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K171652
• 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: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET ; DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention