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

Catalog Number RTLR180111

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

Patient Problems Death (1802); Dyspnea (1816); Pneumonia (2011); Sepsis (2067); Hypervolemia (2664)

Event Date 10/27/2017

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted following evaluation.

Event Description

A peritoneal dialysis (pd) nurse reported that a patient expired while receiving treatment on a liberty cycler and wanted to know if the cycler was acceptable to use again without service.The nurse reported the cycler was working properly and in dwell 1 when the patient passed away.There were no alarms or messages per the nurse.The nurse reported the patient had been in the hospital for 24 hours for pneumonia and sepsis.The cycler was replaced as a precaution.During follow up the facility¿s clinical director reported the patient was a hemodialysis and peritoneal dialysis patient with non-fresenius devices prior to hospital admission.The patient presented in intensive care unit with severe dyspnea, suspected pneumonia, and sepsis.The patient came in with hypervolemia.The patient's nephrologist ordered peritoneal dialysis treatment with the facility's liberty cycler and pd set with a fill volume of 2000 ml for 5 fills of delflex 2.5% with 5000 units of heparin per 5 liter bag for 10,000 ml total.The patient proceeded through drain 0 and fill 1 and expired during dwell 1.Drain 1 is not recorded.The facility nephrologist was consulted after the event and stated the patient should not have been placed on pd upon admission but instead should have had hemodialysis due to the existing dyspnea and fluid overload.The clinical manager noted that the patient's first fill was an exacerbating condition that affected the patient's breathing further and was a contributing factor to the patient's death.She also reported that the clinic's nephrologist noted the patient was not a good candidate for pd in general due to patient's comorbidities (not disclosed).The patient was noted to reject hemodialysis upon admission.The pd set in use (unknown type) was not considered as a contributing factor and was discarded.Additional information has been solicited.

Manufacturer Narrative

The simulated treatment was performed, completed without any failures or problems.The reported symptom operation questions was not confirmed.Information has been documented.The system air leak passed.The voltage check passed.The load cell value and verification was within tolerance.Passed mushroom head check.Test positive for glucose.A visual inspection of the returned cycler exterior showed no sign of physical damage.The cycler received as infested machine.There were several sign of dried cockroaches¿ egg within cycler.Device history record did not reveal any issues or problems related to the reported symptom code(s).

Event Description

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• 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: 7057915
• MDR Text Key: 92882816
• Report Number: 2937457-2017-01238
• 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
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2010
• 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
• Treatment: DELFLEX 2.5% PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 33 YR