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

Model Number 180343

Device Problems Thermal Decomposition of Device (1071); Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported that the screen of a patient¿s liberty select cycler went blank while powering up prior to the patient¿s peritoneal dialysis (pd) treatment.The ok and stop keys were on, however the screen remained blank.The patient¿s contact indicated that when plugging in the power cord at the back of the cycler there were sparks observed.At that point in time, the technical support representative advised them to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event.A replacement cycler was issued to the patient.It was reported that an alternate treatment option was available.Upon follow up with the pdrn, the reported event was confirmed, however, specific details regarding the malfunction were not available.The pdrn indicated there were no flames, smoke, nor any thermal damage during the event.The cycler was plugged in directly to an outlet, however, it is unknown if it was a hospital grade ground-fault circuit interrupter (gfci) outlet.There were no recent power outages or surges reported.It was confirmed that there were no adverse events or medical intervention required as a result of the reported event.The patient completed treatment on the date of the event.The cycler replacement was received and it is working as expected.The reported cycler was returned for physical evaluation.

Event Description

It was reported that the screen of a patient¿s liberty select cycler went blank while powering up prior to the patient¿s peritoneal dialysis (pd) treatment.The ok and stop keys were on, however the screen remained blank.The patient¿s contact indicated that when plugging in the power cord at the back of the cycler there were sparks observed.At that point in time, the technical support representative advised them to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event.A replacement cycler was issued to the patient.It was reported that an alternate treatment option was available.Upon follow up with the pdrn, the reported event was confirmed, however, specific details regarding the malfunction were not available.The pdrn indicated there were no flames, smoke, nor any thermal damage during the event.The cycler was plugged in directly to an outlet, however, it is unknown if it was a hospital grade ground-fault circuit interrupter (gfci) outlet.There were no recent power outages or surges reported.It was confirmed that there were no adverse events or medical intervention required as a result of the reported event.The patient completed treatment on the date of the event.The cycler replacement was received and it is working as expected.The reported cycler was returned for physical evaluation.

Manufacturer Narrative

Additional information: d9.H3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.An exterior visual inspection of the returned cycler showed no signs of physical damage.Upon power up, the cycler touch screen test failed.When powering on the cycler, the ok, stop and up/down arrow push buttons illuminated, however the front panel touch screen remained blank.It was identified that the cause for the blank screen was due to an internal short and scorch marks present on the transformer (t1) of the inverter board.The inverter board is located on the rear of the front panel assembly.A known good inverter board was installed and the display became fully operational.There were no other discrepancies during the internal inspection of the returned cycler.A pre- accelerated stress test (ast) simulated treatment was initiated and completed without failures.The cycler underwent and passed the following tests: catch post hipot test, patient hipot test, safety analyzer test, voltage check.All electrical testing passed, no evidence an electrical spark was reproduced during the investigation.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, the reported issue was confirmed and the cause was determined to be an internal short of the transformer on the inverter board.The cycler was refurbished following the evaluation.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 12657454
• MDR Text Key: 277193652
• Report Number: 2937457-2021-02085
• 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: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

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: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Device Age: MO
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/19/2021
• Supplement Dates Manufacturer Received: 10/28/2021
• Supplement Dates FDA Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2014
• 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