MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, DUAL PATIENT CONNECT; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number LIBERTY CYCLER SET, DUAL PATIENT CONNECT

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

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

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.Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Method, result and conclusion codes are unknown at this time.

Event Description

During the follow up of a separate event addressed in (b)(4) 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.

Manufacturer Narrative

Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius liberty cycler sets shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

Event Description

During the follow up of a separate 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: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 7658371
• MDR Text Key: 113014755
• Report Number: 8030665-2018-00985
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100736
• UDI-Public: 00840861100736
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• Device Catalogue Number: 050-87212
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: MO
• Date Manufacturer Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD SOLUTION; LIBERTY CYCLER; DELFLEX PD SOLUTION; LIBERTY CYCLER