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 Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

The reported symptom iipv ((dv > 180% to 200% of fv) was not confirmed.The reported symptom draining slowly was not confirmed.The reported complaint symptom (scale reading error warning) was not confirmed.The simulated treatment was performed, completed without any failures or problems.The cycler weighed fill volume values were within tolerance.The system air leak passed.The voltage check passed.The load cell value and verification was within tolerance.A visual inspection of the returned cycler exterior showed no sign of physical damage.There was no presence of visible liquid or evidence of past fluid within 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

Peritoneal dialysis patient reported during troubleshooting with technical support of scale reading errors.Patient treatment details was provided and assessed for 150% and 180% iipv and did reveal an episode of increased intraperitoneal volume (iipv) on (b)(6) 2018.The largest drain volume from this treatment occurred on during drain 2 where 4545ml drained.This drain is 181% 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 2499ml is 4498ml.Therefore, a reportable malfunction has occurred.The patient was advised to discontinue use of the cycler and to contact the clinic nurse.Follow up with the peritoneal dialysis nurse confirmed the patient did not experience any complications as a result of this incident.The patient peritoneal dialysis nurse indicated that the patient was being treated for constipation.No treatments were missed.The patient has resumed treatment with the replacement cycler.

• 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
• 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: 7496122
• MDR Text Key: 107701355
• Report Number: 2937457-2018-01277
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 04/26/2018
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2017
• 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
• Patient Age: 76 YR
• Patient Weight: 100