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 Nausea (1970); Vomiting (2144); Hernia (2240); Obstruction/Occlusion (2422)

Event Date 10/11/2017

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a probable temporal association exists between the liberty cycler and the patient¿s nausea/vomiting with hospitalization for small bowel obstruction and incarcerated umbilical hernia requiring small bowel resection and subsequent transition to hemodialysis (hd) therapy.Reportedly, the patient¿s umbilical hernia was pre-existing for at least 1 year prior to event.There have not been any reported allegations of a liberty cycler device malfunction that may have caused or contributed to the exacerbation of the patient¿s pre-existing umbilical hernia.The etiology of the patient¿s small bowel obstruction and incarcerated umbilical hernia is unknown.Increased intra-abdominal pressure during peritoneal dialysis due to the dialysate can create or exacerbate pre-existing weaknesses in the supporting abdominal wall structures.Therefore, no conclusion can be made that there was or was not any causal relationship between the liberty cycler and patient¿s incarcerated umbilical hernia event.Plant investigation: the device was not 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 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.

Event Description

A peritoneal dialysis (pd) patient had an umbilical hernia that the patient¿s pd medical team had reportedly been monitoring for approximately 1 year.On (b)(6) 2017, the patient was experiencing nausea and vomiting during a home visit with the pd nurse and was medically advised to go to the emergency room (er).Subsequently, the patient was admitted to the hospital with a small bowel obstruction and an incarcerated umbilical hernia.Per the patient¿s pd nurse, the patient underwent a small bowel resection without colostomy and a hemodialysis (hd) tunneled central venous catheter (cvc) placement while hospitalized.The patient has since transitioned to hd therapy.The patient remains hospitalized with a plan to transfer to a long-term care facility for hd and rehabilitation.The patient and pd medical team plan to resume pd therapy at some time in the future.There have been no known instances of increased intra-peritoneal volume (iipv) during continuous cyclic peritoneal dialysis (ccpd) therapy or any reported liberty cycler malfunction associated with the patient¿s umbilical hernia.

• 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: 7033866
• MDR Text Key: 92097586
• Report Number: 2937457-2017-01188
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• 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?: Yes
• Device Age: MO
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2012
• 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; PERITONEAL DIALYSIS (PD) FLUID
• Patient Outcome(s): Hospitalization; Required Intervention