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

Catalog Number RTLR180111

Device Problems No Audible Alarm (1019); Overfill (2404)

Patient Problems Dyspnea (1816); Abdominal Distention (2601)

Event Date 11/13/2017

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: there is no documentation to show a causal relationship exists between the patient not draining well with symptoms of feeling full and short of breath and the liberty cycler.The cycler was evaluated by the manufacturer, and the issue could not be replicated.Additionally, there was no increased intraperitoneal volume (iipv) based on the treatment record provided.There is a temporal association with the patient¿s symptoms and the peritoneal dialysis (pd) therapy.The patient¿s exit site hernia and constipation were contributory factors to the symptoms and after prescribed treatment with lactulose the patient was feeling better and continuing pd therapy on the cycler.Plant investigation: the cycler was returned to the manufacturer for evaluation.A visual inspection of the exterior and interior showed no signs of physical damage or any discrepancies.The device was subjected to a simulated treatment test and was performed without any failures.During the test treatment, a ¿drain complication encountered¿ support warning had occurred, as expected, when the patient line was clamped during drain 1.This verified that the drain alarm properly occurs when the drain flow is intentionally restricted.The system air leak test, valve actuation test, and load cell verification test passed.An investigation of the device history (dhr) records was conducted by the manufacturer.There were no issues found during the manufacturing process which could be associated with the reported event.In addition, the dhr review confirmed the results of the in-progress and final quality control testing met all requirements.The investigation into the cause of the reported incident was not able to be confirmed.An evaluation of the returned device could not identify any malfunctions that would cause or contribute to drain problems.

Event Description

A peritoneal dialysis (pd) patient reported that the cycler was encountering ¿not draining no alarm¿ messages and is performing manual drains because he stated to be feeling full.The patient reported lower ultrafiltration at the end of treatment than what he has seen in the past.The patient¿s treatment information from the previous day did not show any increased intraperitoneal volume (iipv).The patient¿s pd nurse stated that the patient is manually draining 800 ml to 900 ml after completing treatment with the cycler and has experienced shortness of breath.The patient did not require any medical intervention or hospitalization.Per the pd nurse, the patient had recently developed an exit site hernia and has constipation which could be additional factors into why the patient is not draining well.The pd nurse had decreased the patient¿s fill volume from 2500 ml to 2000 ml, but he was still only draining 1500 ml.The patient received a new cycler and was able to drain 85% of fluid (utilizing liberty select cycler) compared to 70% drain previously.The patient has been taking lactulose for the constipation and feels much better and is continuing pd therapy on the liberty select cycler with no further reported issues.

• 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: 7107520
• MDR Text Key: 94475292
• Report Number: 2937457-2017-01322
• 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,consum
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/12/2017

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Initial Date Manufacturer Received: 11/16/2017
• Initial Date FDA Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2010
• 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): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 100