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

Catalog Number RTLR180111

Device Problem Insufficient Information (3190)

Patient Problems Aneurysm (1708); Low Blood Pressure/ Hypotension (1914); Urinary Tract Infection (2120); Weakness (2145); Confusion/ Disorientation (2553)

Event Date 08/06/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A peritoneal dialysis (pd) patient reported he set up the and then had to go to the hospital.He had not connected.Follow-up was made with the pd patient's wife, who stated her husband had originally been taken to the emergency room on (b)(6) 2017 reporting of weakness, nervousness and had low blood pressure and was determined to have a urinary tract infection, and was prescribed antibiotics and not admitted to the hospital.The contact stated her husband had not yet begun his peritoneal dialysis treatment that evening and confirmed there was no issue with overfill and no injury occurred as a result of the reported drain alarm.The contact stated her husband was able to resume and complete his peritoneal dialysis treatment without issue.The contact stated on (b)(6) 2017 her husband again began reporting weakness, nervousness and had low blood pressure, and took her husband back to the emergency room.The contact stated she was going to bring manual supplies for her husband to continue completing peritoneal dialysis treatments while at the hospital.The contact stated the hospital was going to perform a cat scan on her husband, and that he was likely going to be admitted.Additional follow-up was made with the pd patient's clinic registered nurse (rn), who stated the patient was admitted to the hospital on (b)(6) 2017 and discharged on (b)(6) 2017 for a leaking abdominal aortic aneurysm (aaa).The aaa leak was repaired, and the patient was now at home.Per pdrn, the patient experienced abdominal pain due to the aaa, but denied any sort of infection.Medical records were requested.

Manufacturer Narrative

Conclusion: although a temporal relationship exists between peritoneal dialysis (pd) and the events of weakness, hypotension and abdominal pain, there is no documentation supporting a possible association between the liberty cycler and the aaa.The patient has a highly complex past medical history significant for anemia, protein disorder, atrial fibrillation, encephalopathy, nephrotic syndrome, phosphorus disorder, anxiety, coagulation defect, angina, hyperparathyroidism and aaa with stent placement.Pdrn stated that in terms of causality, it is ¿not related to delflex.¿ during the hospitalization the patient continued to perform continuous ambulatory peritoneal dialysis (capd); although it is unknown if fresenius products were utilized.There is no documentation or indication to show a relationship between the patient's admitting diagnoses and any fresenius products.There was no allegation against any fresenius products.If additional information becomes available, the need for a clinical investigation will be re-evaluated accordingly.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-conformance 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

A peritoneal dialysis (pd) patient reported he set up the and then had to go to the hospital.He had not connected.Follow-up was made with the pd patient's wife, who stated her husband had originally been taken to the emergency room on (b)(6) 2017 reporting of weakness, nervousness and had low blood pressure and was determined to have a urinary tract infection, and was prescribed antibiotics and not admitted to the hospital.The contact stated her husband had not yet begun his peritoneal dialysis treatment that evening and confirmed there was no issue with overfill and no injury occurred as a result of the reported drain alarm.The contact stated her husband was able to resume and complete his peritoneal dialysis treatment without issue.The contact stated on (b)(6) 2017 her husband again began reporting weakness, nervousness and had low blood pressure, and took her husband back to the emergency room.The contact stated she was going to bring manual supplies for her husband to continue completing peritoneal dialysis treatments while at the hospital.The contact stated the hospital was going to perform a cat scan on her husband, and that he was likely going to be admitted.Additional follow-up was made with the pd patient's clinic registered nurse (rn), who stated the patient was admitted to the hospital on (b)(6) 2017 and discharged on (b)(6) 2017 for a leaking abdominal aortic aneurysm (aaa).The aaa leak was repaired, and the patient was now at home.Per pdrn, the patient experienced abdominal pain due to the aaa, but denied any sort of infection.Medical records were requested.

• 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: 6811040
• MDR Text Key: 83257430
• Report Number: 2937457-2017-00764
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2011
• 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