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

Model Number LIBERTY SELECT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Arrhythmia (1721); High Blood Pressure/ Hypertension (1908); Tachycardia (2095); Abdominal Distention (2601)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

The reported complaint symptom (iipv (dv > 180% to 200% of fv) was not confirmed.The reported complaint symptom (m65 scale reading error warning) was not confirmed.A visual inspection of the returned cycler exterior showed no signs of physical damage.An (as-received) simulated treatment was performed and completed without failures.The cycler weighed fill volume values were within tolerance for a liberty cycler.The system air leak test passed.The valve actuation test passed.The load cell verification was within tolerance.There were no discrepancies encountered in the internal inspection of the cycler.

Event Description

Peritoneal dialysis nurse reported to technical support during a request for a replacement liberty select that the patient is in the hospital.Patient treatment details were provided and assessed for 150% and 180% iipv and did reveal an episode of increased intraperitoneal volume (iipv).The largest drain volume from this treatment occurred during drain (manual stat drain) where 4000ml drained.This drain is 190% of the prescribed fill volume.In order to be a reportable malfunction, at least 180% of the prescribed fill volume would have to have been drained.A 180% of fill volume 2100ml is 3780ml.Therefore, a reportable malfunction has occurred.Follow up with the peritoneal dialysis nurse indicates that the patient experienced an irregular heart rhythm.Additional information was solicited.

Manufacturer Narrative

There is a temporal relationship between ccpd treatment with the liberty select cycler and the pt¿s reported overfill event, most likely characterized by a large drain volume (> 180% of the pt¿s fill volume) with abdominal distention and concurrent rapid/ irregular heart rate (unknown reading), hypertension (unknown reading) warranting hospitalization.Based on the available information, it cannot be fully determined what may have led to the pt¿s overfill event.While there was an allegation the pt.Received the m65 ¿scale reading error¿ it is unknown why the m65 ¿scale reading error¿ occurred and whether or not this contributed to an overfill.The liberty select cycler was returned to the manufacturer for further investigation and no failure was detected (device operated within specification) during a simulated cycler assisted pd treatment with pt.Settings as received.Ccpd treatment details are not available for evaluation of other potential causes for the pt¿s overfill event.

Event Description

Details surrounding the patient¿s hospital course are unknown as the hospital discharge summary is unavailable.Per the nurse, the pt.Was discharged on (b)(6) 2018 continuing on pd therapy.Reportedly, the patient¿s symptoms have since resolved.Additional information has been solicited.

• 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: 7535240
• MDR Text Key: 108998186
• Report Number: 2937457-2018-01424
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY SELECT
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Device Age: MO
• Date Manufacturer Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER SET; PD SOLUTION
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR