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

Model Number LIBERTY CYCLER

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

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Peritonitis (2252); Abdominal Distention (2601)

Event Date 05/26/2018

Event Type  Injury  

Manufacturer Narrative

Clinical review: there is no documentation that supports a causal association between the liberty select cycler/ liberty cycler set and the pt¿s chest pain with loss of consciousness that led to pt.Hospitalization.The etiology for the pt¿s chest pain cannot be determined with the information at hand; however cardiac etiology was not suspected.The pt.Had ongoing low blood pressure and previous history of syncopal episodes which was likely associated with use of hypertensive medications.Additionally, it was suspected, and the pt.Was empirically treated for discitis/osteomyelitis of the thoracic spine which may have also been confounding factor in the pt¿s ongoing chest pain.During hospitalization it was discovered the pt.Had peritonitis.Although a temporal relationship exists between the liberty select cycler/liberty cycler set and the pt¿s peritonitis event; there is no documentation that indicates a liberty select cycler/liberty cycler set malfunction caused or contributed to this peritonitis event.Based on the available information, the source for the pt¿s peritonitis cannot be determined.Peritonitis is a well-known complication of pd therapy.Should additional information become available, this clinical investigation will be updated accordingly.Plant investigation: a supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

On (b)(6) 2018, (b)(6) patient (pt.) with end stage renal disease (esrd) on continuous cycling peritoneal dialysis (ccpd) presented to the emergency room (er) via ambulance with complaints of substernal chest pain that began 1 day prior.The pt¿s chest pain radiated to her back and stomach and approximately 1 hour prior to hospital arrival the pt.Felt nauseated with epigastric abdominal pain and lost consciousness temporarily.Moreover, the pt¿s pd effluent yielded a high white blood cell (wbc) count, red blood cell (rbc) count and growth of gram positive cocci in clusters suggestive of bacterial peritonitis.Renal consult completed during hospital course and recorded pt.Euvolemic.The pt.Was initially continued on ccpd treatment however the pt.Was unable to tolerate pd treatment due to abdominal pain.Further details surrounding management of the pt¿s renal replacement therapy while hospitalized is unknown.A review of medical records pertinent to planned re-admission on 29/may/2018 indicates the pt.Was continued on the antibiotics zosyn and daptomycin initially.The pt.Still had symptoms of abdominal fullness but denied frank abdominal pain; no fever or chills on exam.During hospital course, the pt¿s vital signs recorded were stable; lab values stable.It was recorded the pt.Continued pd therapy while hospitalized (treatment details are unknown).The pt¿s ongoing chest pain was not suspected to be cardiac in nature.No further untoward events recorded.Infectious disease was consulted, and it was indicated the pt.Was treated empirically for vertebral infection/ osteomyelitis with a change from the antibiotic zosyn to cefepime and continued with cubicin every 48 hours ordered until (b)(6) 2018.The pt.Required placement of a peripherally inserted central catheter (picc) for continued antibiotics at home after hospital discharge on (b)(6) 2018.

Manufacturer Narrative

The alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.

• Brand Name: UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED)
• 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: 7642624
• MDR Text Key: 112497446
• Report Number: 2937457-2018-01814
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY CYCLER
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: MO
• Date Manufacturer Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2010
• 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: ALLOPURINOL; AMLODIPINE; CALCITRIOL; CLONIDINE; CUBICIN; HEPARIN; LABETALOL; LASIX; LIBERTY CYCLER SET; MEDROL; PAXIL; PD SOLUTION; ZOSYN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR