MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180111

Device Problems Use of Device Problem (1670); Overfill (2404)

Patient Problems Vomiting (2144); Discomfort (2330)

Event Date 05/31/2017

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned to the manufacturer for physical evaluation.A visual inspection of the returned cycler exterior showed no sign of physical damage.The simulated treatment was performed and completed without any failures or problems.The cycler weighed fill volume values were within tolerance.Mechanical testing of components all passed.There were no discrepancies encountered in the internal inspection of the cycler.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device manufacturing review confirmed the labeling, material, and process controls were within specification.

Event Description

A peritoneal dialysis patient reported that his cycler was not draining him as expected.The patient reported that during the day he does a manual fill of 2,500 ml.During fill 1 the fill volume was 2,300 ml.The patient was uncomfortable and a stat drain was initiated where the patient drained 6,142 ml.This is 246% of the patient's largest prescribed fill.During the stat drain the patient reported he felt tired and vomited.He did not require any medical intervention.Treatment records were reviewed with technical support and it was discovered that the patient was intentionally bypassing drain 0.The patient reported he was bypassing drain 0 due to a potential misunderstanding of his pd nurse.The reported large drain of 6.142 ml was 246% over the expected drain volume which resulted in a reportable device malfunction.During follow up the patient's nurse reported that the patient did not require any medical intervention and continued dialysis as prescribed with a replacement cycler.

• Brand Name: LIBERTY CYCLER
• 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: 6675632
• MDR Text Key: 78711242
• Report Number: 2937457-2017-00522
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• 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: 06/07/2017
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2015
• 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: 84 YR
• Patient Weight: 67