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

Catalog Number RTLR180343

Device Problem Sparking (2595)

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

Event Date 04/07/2018

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be filed upon completion of the manufacturer's investigation.Evaluation in progress, not yet complete.

Event Description

A peritoneal dialysis patient reported that upon powering on the cycler, the power outlet emitted sparks.The patient confirmed that the house breakers were then the reset.At this point, the cycler would not power on.The power cord was secured at both ends.The patient was not connected to the cycler.The patient completed treatment with manuals.The cycler was replaced.

Manufacturer Narrative

Device evaluation: the actual device was returned for investigation.The visual exterior inspection showed no physical damage.The cycler turned on successfully and operated as intended.The cycler passed the voltage verification check.The cycler passed the 1000ml treatment.An internal visual inspection of the returned cycler encountered no discrepancies.The device history record did not reveal any issues or problems related to the reported symptom code(s).There were no non-conformance's found.

Event Description

A peritoneal dialysis patient reported that upon powering on the cycler, the power outlet emitted sparks.The patient confirmed that the house breakers were then the reset.At this point, the cycler would not power on.The power cord was secured at both ends.The patient was not connected to the cycler.The patient completed treatment with manuals.The cycler was replaced.

• Brand Name: LIBERTY SELECT 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: 7444780
• MDR Text Key: 106043761
• Report Number: 2937457-2018-01097
• 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
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• 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: 04/12/2018
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2017
• 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