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 Anemia (1706); Atrial Fibrillation (1729); Atrial Tachycardia (1731); Chest Pain (1776); Dyspnea (1816); Ischemia (1942); Myocardial Infarction (1969); Nausea (1970); Electrolyte Imbalance (2196); Peritonitis (2252); ST Segment Depression (2487)

Event Date 05/28/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A peritoneal dialysis (pd) patient stated she was calling from the hospital and stated she had a heart attack.Follow-up was made with the pd patient's clinic registered nurse (rn), who stated the patient had chest pain during her continuous cycler-assisted peritoneal dialysis (ccpd) therapy on (b)(6) 2017.The patient completed the therapy session and was later admitted to a hospital with a diagnosis of myocardial infarction.The patient continued ccpd therapy while in hospital.

Manufacturer Narrative

Corrected date of event: (b)(6) 2017.Removed patient code: (b)(4) myocardial infarction conclusion: although a temporal relationship may exist between the last ccpd treatment at home prior to patient experiencing chest pain, tightness in palate back throat, nausea with dry heaves, rapid breathing and elevated heart rate with subsequent prolonged hospitalization, there is no documentation supporting a possible causal association between fresenius products and the adverse events experienced by the patient.Therefore, actual causality was unable to be determined.Furthermore, the patient has a known complex medical history (including an extensive cardiac history with recent cardiac related hospitalizations) which predisposes the patient to subsequent cardiac complications and possibly a contributory factor in this ischemic event.Additionally, the patient was ordered to continue with pd therapy (own liberty cycler) in the hospital.However, due to coronary bypass post-operative complications (anemia, electrolyte imbalance and fluid overload) the patient subsequently transitioned to hd therapy in the hospital with a plan to continue hd in a rehabilitative facility upon discharge.It was noted in the medical records the goal is to have the patient resume pd therapy when medically suitable.A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

Information in the complaint file and medical records were reviewed.On (b)(6) 2017 the peritoneal dialysis (pd) patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis (ccpd) therapy stated that she was currently in the hospital for heart attack and reported the event was not related to the cycler machine.Follow-up was made with the pd patient¿s clinic registered nurse (rn), who stated the patient was experiencing chest pain during her ccpd therapy on (b)(6) 2017 and was subsequently admitted to the hospital for myocardial infarction (mi).The pd nurse affirmed the pt.Completed her ccpd treatment on the night of the event and continues ccpd therapy in the hospital with the replacement cycler.Review of the medical records revealed this patient presented to the emergency room (er) on (b)(6) 2017 experiencing mid-sternal chest pain, tightness in her palate in back throat, nausea with dry heaves, rapid breathing and elevated heart rate.The patient also reported the chest pain and tightness in her palate in back throat began early morning at home and she proceeded to self-administered nitroglycerin which eased the pain she was experiencing.The patient reported self- measurement of blood pressure (bp) initially 130/80; subsequently 85/38 (significant change)15 minutes later with a heart rate (hr) range 36-150 beats per minute at home.Hospital evaluation on (b)(6) 2017 included a 10 point review of systems.The patient¿s pd catheter was in good position with no evidence of infection at the site.The patient reported chest pain resolved since presenting to the hospital (after self-administration of nitroglycerin).The patient was subsequently admitted to the hospital for further cardiac evaluation and management with telemetry monitoring due to unstable angina and continued on her pd therapy while hospitalized with her home a liberty cycler.On (b)(6) 2017, it was noted that the patient¿s troponin level went from being initially undetectable on (b)(6) 2017 to a subsequent rise, and it was noted the patient had a true mild ischemic event.On (b)(6) 2017 the patient underwent cardiac catheterization revealing severe multi-vessel coronary artery disease consequently not susceptible to percutaneous repair; and ejection fraction of 55%.On (b)(6) 2017 the patient had coronary bypass surgery off pump with subsequent post-operative atrial dysrhythmia with prolonged pauses requiring placement of temporary pace maker on (b)(6) 2017.The patient continued to exhibit sinoatrial node dysfunction with episodes of pauses and therefore placement of a permanent pacemaker occurred on (b)(6) 2017.The patient was extubated on (b)(6) 2017 and had a hemodialysis (hd) catheter placed and was transitioned to hd therapy due to post-operative fluid overload and electrolyte imbalance.The patient received a blood transfusion without noted issues (unknown date) for post-operative hemorrhagic anemia /thrombocytopenia.On (b)(6) 2017 the patient was evaluated for rehabilitative services.Evaluation noted the patient exhibited a decrease in baseline independence with activities of daily living and mobility since being hospitalized and plan of care included physical and occupational rehabilitative service for an estimated 2 weeks post hospitalization.At the time of evaluation the patient was stable and continuing hd therapy in the hospital on thrice weekly schedule with a plan to eventually return to pd therapy when appropriate.On (b)(6) 2017, ongoing evaluation and management during the patient hospitalization by medical, cardiology and nephrology services with periodic trending of patient laboratory and diagnostic testing was noted in the patient medical record.Furthermore, a discharge date was not identified in the patient medical records.However, on (b)(6) 2017 it was noted the patient was accepted into rehabilitative services with continued hd therapy.

Manufacturer Narrative

An investigation of the device was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.A visual inspection of the returned cycler exterior showed no sign of physical damage.Simulated treatment was performed and completed without any unexpected alarms or problems occurring.The valve actuation test, system air leak test and mushroom head check passed.There were no discrepancies encountered in the internal inspection of the cycler.The record review confirmed the labeling, material, and process controls were within specification.There were no reported device malfunctions that would have caused the reported event.

Event Description

Information in the complaint file and medical records were reviewed.On (b)(6) 2017 the peritoneal dialysis (pd) patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis (ccpd) therapy stated that she was currently in the hospital for heart attack and reported the event was not related to the cycler machine.Follow-up was made with the pd patient¿s clinic registered nurse (rn), who stated the patient was experiencing chest pain during her ccpd therapy on(b)(6) 2017 and was subsequently admitted to the hospital for myocardial infarction (mi).The pd nurse affirmed the pt.Completed her ccpd treatment on the night of the event and continues ccpd therapy in the hospital with the replacement cycler.Review of the medical records revealed this patient presented to the emergency room (er) on (b)(6) 2017 experiencing mid-sternal chest pain, tightness in her palate in back throat, nausea with dry heaves, rapid breathing and elevated heart rate.The patient also reported the chest pain and tightness in her palate in back throat began early morning at home and she proceeded to self-administered nitroglycerin which eased the pain she was experiencing.The patient reported self- measurement of blood pressure (bp) initially 130/80; subsequently 85/38 (significant change)15 minutes later with a heart rate (hr) range 36-150 beats per minute at home.Hospital evaluation on (b)(6) 2017 included a 10 point review of systems.The patient¿s pd catheter was in good position with no evidence of infection at the site.The patient reported chest pain resolved since presenting to the hospital (after self-administration of nitroglycerin).The patient was subsequently admitted to the hospital for further cardiac evaluation and management with telemetry monitoring due to unstable angina and continued on her pd therapy while hospitalized with her home a liberty cycler.On (b)(6) 2017, it was noted that the patient¿s troponin level went from being initially undetectable on (b)(6) 2017 to a subsequent rise, and it was noted the patient had a true mild ischemic event.On (b)(6) 2017 the patient underwent cardiac catheterization revealing severe multi-vessel coronary artery disease consequently not susceptible to percutaneous repair; and ejection fraction of 55%.On (b)(6) 2017 the patient had coronary bypass surgery off pump with subsequent post-operative atrial dysrhythmia with prolonged pauses requiring placement of temporary pace maker on (b)(6) 2017.The patient continued to exhibit sinoatrial node dysfunction with episodes of pauses and therefore placement of a permanent pacemaker occurred on (b)(6) 2017.The patient was extubated on (b)(6) 2017 and had a hemodialysis (hd) catheter placed and was transitioned to hd therapy due to post-operative fluid overload and electrolyte imbalance.The patient received a blood transfusion without noted issues (unknown date) for post-operative hemorrhagic anemia /thrombocytopenia.On (b)(6) 2017 the patient was evaluated for rehabilitative services.Evaluation noted the patient exhibited a decrease in baseline independence with activities of daily living and mobility since being hospitalized and plan of care included physical and occupational rehabilitative service for an estimated 2 weeks post hospitalization.At the time of evaluation the patient was stable and continuing hd therapy in the hospital on thrice weekly schedule with a plan to eventually return to pd therapy when appropriate.On (b)(6) 2017, ongoing evaluation and management during the patient hospitalization by medical, cardiology and nephrology services with periodic trending of patient laboratory and diagnostic testing was noted in the patient medical record.Furthermore, a discharge date was not identified in the patient medical records.However, on (b(6) 2017 it was noted the patient was accepted into rehabilitative services with continued hd therapy.

• 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: 6654784
• MDR Text Key: 78016311
• Report Number: 2937457-2017-00488
• 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: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• 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: 06/21/2017
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2014
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 61