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

Catalog Number RTLR180343

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

Patient Problem Myocardial Infarction (1969)

Event Date 01/07/2018

Event Type  Injury  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A peritoneal dialysis (pd) patient reported he had been hospitalized on (b)(6) 2018 due to a heart attack.Follow-up was made with the pd patient's clinic registered nurse (rn), who confirmed the patient was admitted to the hospital on (b)(6) 2018 due to a heart attack.Per pdrn the patient was illiterate and often non-compliant with taking his medication and checking his blood sugar levels.Per pdrn the event occurred in the afternoon and the patient had not been dialyzing at the time of the occurrence or prior to hospitalization.Per pdrn the patient was assisted by his wife on completing pd therapy and stated the patient had not completed his peritoneal dialysis treatment the night prior.Per pdrn as of (b)(6) 2018 the patient was discharged and was able to continue continuous cycler-assisted peritoneal dialysis (ccpd) therapy without further issue.The pdrn was unable to provide the exact date the patient was discharged as the hospital records were not yet received in clinic.Medical records were requested.

Manufacturer Narrative

Conclusion: is unknown if a temporal relationship between the patient¿s myocardial infarction and the liberty select cycler.There is no documentation indicating a causal relationship between the liberty select cycler and the event of myocardial infarction.It should be noted, the patient was not performing ccpd at the time of the event.There is however a probable association between the myocardial infarction, reported medication non-compliance and multiple comorbid conditions such as; esrd, pre-existing cardiac issues (unspecified), diabetes mellitus type ii, hypertension, gout, hyperuricemia and hyperthyroidism, which most likely the caused or contributed to the adverse event.There is no documentation or allegation against any fresenius device(s) having malfunctioned or not perform as expected.Plant investigation: the device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.

Event Description

Information in the complaint file was reviewed by a post market surveillance clinician.On (b)(6) 2018 during a follow-up call for this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) reported he was hospitalized for a ¿heart attack¿ on (b)(6) 2018 (discharge date unknown).The patient reported he did not complete treatment on (b)(6) 2018, however he experienced no side-effects from the incomplete treatment and no medical intervention was required.During two separate follow-up calls on (b)(6) 2018, two peritoneal dialysis registered nurses (pdrn) from the same outpatient dialysis clinic confirmed the patient was admitted to the hospital due to a myocardial infarction on (b)(6) 2018.Neither pdrn had any details regarding the hospitalization, as the hospital records had not been received.However, both pdrn¿s reported the patient was discharged from the hospital (date unknown) and continued the same pd regimen for rrt.During a follow-up call on (b)(6) 2017 at 14:31, the pdrn reported the patient is ¿often¿ non-compliant with medication and blood glucose monitoring.The event occurred in the afternoon (exact time unknown), and the patient was not actively performing ccpd during the time of the event.Additionally the pdrn attributed the event to ¿possible cardiac issues.¿ it was determined during the customer service call on (b)(6) 2018, the patient¿s heater bag was empty and thus could not continue the fill cycle.No iipv was noted.

• 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: 7196146
• MDR Text Key: 97403031
• Report Number: 2937457-2018-00179
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2017
• 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
• Treatment: LIBERTY CYCLER CASSETTE; PD SOLUTION
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 93