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); Bacterial Infection (1735); Diarrhea (1811); Fever (1858); Nausea (1970); Sepsis (2067); Tachycardia (2095); Vomiting (2144); Peritonitis (2252); Malaise (2359)

Event Date 06/06/2018

Event Type  Injury  

Manufacturer Narrative

Plant investigation: the alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.A serial number search in the complaint system found no complaint issues with the same symptom code within 90 days of the notified date of the alleged event.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.

Event Description

During follow up on a separate event the peritoneal dialysis nurse stated the patient was hospitalized from (b)(6) 2018 for a foot infection (sepsis).The peritoneal dialysis nurse stated that while at the hospital the patient was diagnosed with peritonitis.Additional information was solicited, but unavailable.

Manufacturer Narrative

Clinical investigation: there is a temporal relationship between ccpd therapy with the liberty select cycler/liberty cycler set and the patient¿s peritonitis.All dialysis treatments include a certain risk of infection because of the decreased immune defenses of patients in established renal failure (erf) and because dialysis techniques increase the potential of microbial contamination.Peritoneal dialysis (pd), and in particular continuous ambulatory pd (capd), is associated with a high risk of infection of the peritoneum.Based on the available information, it is not possible to determine the source of the patient¿s peritonitis.No device malfunction or deficiency was alleged; the liberty select cycler/liberty cycler set was not returned for evaluation and a device history record review conducted showed no non-conformances.There is no documentation on file suggesting a causal relationship with the liberty select cycler/liberty cycler set.

Event Description

During the follow up of a separate event it was reported the patient was hospitalized.According to the discharge notes, the patient presented with fever (102.8) tachycardia, and leukocytosis.The patient admitted having nausea, vomiting, abdominal pain, general malaise and poor appetite.The patient reported diarrhea which resolved prior to hospitalization and redness, drainage and foul smell from foot wound for the last 1 to 2 days was reported.The discharge notes revealed a diverse microbiology history which included gas, enterococcus, (b)(6), pseudomonas, multi drug resistant organism (mdro) klebsiella, haemophilus, chronic osteomyelitis in 2017, 4th and 5th metatarsal amputation in 2016 and extensive antibiotics treatment in early 2017 for worsening left foot wound.Peritoneal fluid culture was positive for gram positive cocci, blood culture positive for alpha streptococcus and drainage from left foot culture was positive for staphylococcus aureus.Chest x-ray conducted for chronic cough showed no infiltrates.The patient was started on empiric vancomycin, fluconazole and rifampin.The patient was given maalox for heart burn.On (b)(6) 2018, the patient was discharged to home on fluconazole 100 mg by mouth daily for 6 weeks, rifampin 600mg by mouth daily for 7 days and vancomycin 1.5 gm intra peritoneal weekly for six weeks.

• 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
• MDR Report Key: 7658239
• MDR Text Key: 113011293
• Report Number: 2937457-2018-01863
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/18/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 06/22/2018
• Supplement Dates FDA Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD SOLUTION; LIBERTY CYCLER SET; DELFLEX PD SOLUTION; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention