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

Catalog Number RTLR180343

Device Problem Overfill (2404)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/06/2019

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed with no physical damage noted.A simulated therapy was initiated and completed on the cycler without complication.The weighed fill volumes were found to be within tolerance and fill times were within specification.The cycler underwent and passed a system air leak test and valve actuation testing.Load cell verification testing was performed with no issues noted.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.

Event Description

A peritoneal dialysis (pd) patient reported that she observed the heater bag was empty during fill 1.The bag used was 5000ml and the patient¿s programmed first fill is 2000ml.The patient was also receiving the make sure heater bag is on the heater tray message multiple times during fill 1 of 4.The patient cancelled treatment after only filling 1766ml of the 2000ml of fill 1.At this point in time, the patient was advised to discontinue the use of the cycler and follow up with the peritoneal dialysis nurse (pdrn).A new cycler was issued to the patient due to a potential overfill based on the alleged empty heater bag.It was reported that an alternate treatment option was available.Upon follow up, the pdrn reported that treatment was completed.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The reported cycler has been returned to the manufacturer for physical evaluation.

• 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; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: amaral, matthew ; 920 winter st.; waltham, MA 02451 ; 7816999758
• MDR Report Key: 8834378
• MDR Text Key: 153232746
• Report Number: 2937457-2019-02326
• 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: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Device Age: MO
• Date Manufacturer Received: 07/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2017
• 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: 64 YR
• Patient Weight: 96