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 Problem Peritonitis (2252)

Event Date 12/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) - the actual device was not returned to the manufacturer for physical evaluation.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device manufacturing review confirmed the labeling, material, and process controls were within specification.

Event Description

A peritoneal dialysis (pd) patient's daughter reported the patient was hospitalized on (b)(6) 2016 due to peritonitis.Follow-up was made with the pd patient's clinic registered nurse (rn), who stated on (b)(6) 2016 the patient came into the clinic reporting of abdominal pain and cloudy effluent, and was advised to go to the emergency room and was later admitted on (b)(6) 2016 due to peritonitis.Per pdrn it was unknown what may have attributed to the infection.Per pdrn no fluid leaks were reported during treatments or prior to infection, and as of (b)(6) 2016 the patient remained hospitalized and was receiving unspecified antibiotics.Medical records were requested.

Manufacturer Narrative

Medical records were reviewed by post market surveillance staff.There was no information reported that indicated a causal relationship between the peritoneal dialysis and use of fresenius products and the patient¿s hospitalization.No conclusion of a causal relationship between the peritoneal dialysis and fresenius products and the patient¿s hospitalization can be drawn with the provided information without a reported reason for the hospital admission.No further information is available.

Event Description

Medical records were provided by the patient's dialysis center.The peritoneal dialysis (pd) nurse reported that the peritoneal dialysis patient presented to the clinic with abdominal pain and cloudy effluent.The pd nurse confirmed that there were no fluid leaks during peritoneal dialysis treatment prior to the infection.The patient was advised to go to the emergency room by the clinic staff.The peritoneal dialysis patient presented to the emergency room with abdominal pain, fatigue, nausea, poor appetite and abdominal pain with eating.The patient denied fever, chills, changes in bowel or bladder habits or diarrhea.The patient was admitted to the hospital on (b)(6) 2016 for further evaluation and treatment.The peritoneal dialysis fluid was positive for the organism staphylococcus aureus.The patient was afebrile upon admission.The patient reported while in the hospital that there had been a hole in the extension set and her daughter changed it prior to the infection.The patient was treated with the antibiotics vancomycin 1.5 grams and ceftazidime 1 gram.The patient and family member were re-educated to never change the extension set and to allow the change to be completed by trained staff.During the education in the hospital is was discovered that the patient was not completing the hand washing process as taught and was reeducated on washing hands for two minutes.The patient was discharged from the hospital on (b)(6) 2016.

• 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: 6206832
• MDR Text Key: 63340470
• Report Number: 2937457-2016-01258
• Device Sequence Number: 1
• Product Code: FKX
• 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 Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 01/20/2017

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 Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Initial Date Manufacturer Received: 12/15/2016
• Initial Date FDA Received: 12/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2009
• 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: DELFLEX PD SOLUTION; LIBERTY CYCLER CASSETTE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 48