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

Model Number LIBERTY CYCLER UL ASSEMBLY (NEW

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2018

Event Type  malfunction  

Manufacturer Narrative

The alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.A serial number search in the complaint system found one prior complaint with the issues of iipv ((dv > 180% to 200% of fv) and m65 scale reading error warning within 90 days of the notified date.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.

Event Description

Peritoneal dialysis nurse reported liberty cycler overfilled patient on his initial fill.Patient reported the fill took 2 hours and cycler would not allow a stat drain.Patient was getting scale alarms and performed a manual drain for 5 liters.Treatment details was requested and there was no treatment data for the date of the alleged event.However clinic notes indicate the patient manually drained 5000ml after completing a treatment on that date.Treatment data was 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 (drain unknown) where 5000ml drained.This drain is 209% 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 the prescribed fill volume of 2397ml is 4315ml.Therefore, a reportable malfunction has occurred.The liberty cycler was not replaced.

Manufacturer Narrative

Correction: the reported symptom iipv (dv > 180% to 200% of fv) was not confirmed.The reported symptom (filling slowly) was not confirmed.The reported symptom (stat drain question) was not confirmed.The reported symptom (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.Go/no go check passed.Weighed fill volume verification passed.System air leak test passed.Valve actuation test passed.Patient sensor calibration check passed.Load cell verification was within tolerance.There were no discrepancies encountered during the internal inspection of the cycler.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.

Event Description

".".

• Brand Name: LIBERTY CYCLER UL ASSEMBLY (NEW)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7489514
• MDR Text Key: 107470038
• Report Number: 2937457-2018-01246
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY CYCLER UL ASSEMBLY (NEW
• Device Catalogue Number: 180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Device Age: MO
• Date Manufacturer Received: 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER SET; PD SOLUTION