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

Model Number 180343

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Death (1802); Discomfort (2330)

Event Date 06/01/2020

Event Type  Death  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is a temporal relationship between peritoneal dialysis (pd) therapy on the liberty select cycler and the patient death as the patient was connected to the device at the time of the event.However, there is no documentation to show a causal relationship between the event and utilization of the device.Additionally, there is no allegation of a device malfunction or deficiency reported for this event.The patient had complained earlier in the day of chest pain and abdominal discomfort, but did not seek medical attention.It is unknown if those symptoms were indicative of an underlying medical issue causing or contributing to the death.The patient had a history of hypertension and diabetes mellitus type ii which both increase a patient¿s risk of mortality.Although the cause of the death is unknown, based on the available information and no allegation of a malfunction or deficiency, the liberty select cycler can be excluded as the cause of the patient death.

Event Description

A peritoneal dialysis registered nurse (pdrn) reported that a peritoneal dialysis (pd) patient passed away on the liberty select cycler in their sleep.The pdrn stated that the nature of the death is unknown.Upon follow up, the peritoneal dialysis registered nurse (pdrn) stated that the patient passed away on (b)(6) 2020.The patient¿s family member stated to the pdrn that the patient had been experiencing chest pain and abdominal discomfort earlier in the day prior to the start of peritoneal dialysis (pd) therapy.The pdrn stated that the family member found the patient unresponsive during the night and called 911.The pdrn stated that the paramedics arrived, but the patient was pronounced deceased.The pdrn stated that no resuscitative efforts were performed.The pdrn stated that the cause of death is unknown as no death code has been reported to the clinic.The pdrn was unsure if there was going to be an autopsy.The patient had not reported any issues with the liberty select cycler prior to their death.There were no reported issues on the night of the death.The pdrn stated that the patient mostly utilized 1.5% delflex solution, but would use 2.5% as needed.The pdrn stated that the liberty select cycler is available to be returned to the manufacture for evaluation, however; it was not confirmed if the final pickup of the liberty select cycler has been scheduled.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Manufacturer Narrative

Additional information: d10, h3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed on the cycler with no physical damage noted.The cycler underwent and passed a system air leak test, valve actuation test, go no go check, and load cell verification.A simulated treatment was performed and completed without failures.The cycler weighed fill volume values were within tolerance for a liberty cycler.The cycler was able to complete the treatment without issues.There were no visual discrepancies found during the internal inspection of the returned cycler.There were no visual discrepancies found during the internal inspection of the returned cycler.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.

• 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
• MDR Report Key: 10163925
• MDR Text Key: 195453947
• Report Number: 2937457-2020-01091
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K181108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event 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: 06/30/2020
• Device Age: MO
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 06/17/2020
• Supplement Dates Manufacturer Received: 06/17/2020; 07/08/2020
• Supplement Dates FDA Received: 06/22/2020; 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET ; DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Death
• Patient Age: 58 YR