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

Catalog Number RTLR180111

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

Patient Problems Fever (1858); Pneumonia (2011)

Event Date 05/13/2017

Event Type  Injury  

Manufacturer Narrative

The liberty cycler was not returned to the plant for investigation.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 record review confirmed the labeling, material, and process controls were within specification.A supplemental report will be submitted upon completion of the clinical investigation.

Event Description

Peritoneal dialysis nurse reported that a peritoneal dialysis patient was hospitalized on (b)(6) 2017 with a fever.Follow up with the patient's peritoneal dialysis nurse indicated that the patient was diagnosed and treated for pneumonia.The source of the infection is unknown.The patient continues to performed peritoneal dialysis at the hospital.Additional information was solicited.

Manufacturer Narrative

The liberty cycler was not returned to the plant for investigation.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 record review confirmed the labeling, material, and process controls were within specification.A supplemental report will be submitted upon completion of the clinical investigation.Conclusion: although a temporal relationship exists between the liberty cycler/fresenius products and the patient¿s probable respiratory symptoms, fever episodes and subsequent development of pneumonia requiring hospitalization, there is no allegation against any fresenius products and the association of the patient¿s pneumonia and subsequent hospitalization.

Event Description

Review of the complaint file was completed by a post market surveillance clinician.It was reported this peritoneal dialysis (pd) patient reported drain complications from fibrin present in the pd catheter, which were resolved with heparin instillation.On (b)(6) 2017 during a follow up call to the pd patient¿s clinic registered nurse (rn), it was revealed the patient was performing pd treatments and started experiencing fevers of unknown etiology requiring the patient to be admitted on (b)(6) 2017.Additionally, the patient continued to perform pd treatments during febrile episode.On (b)(6) 2017 during a follow up call to the service center the patient contact stated the patient was experiencing drain complications during drain 0 of 4 with 111/1500ml drained.The patient contact stated stat drained the patient but the drain was very slow.The patient contact opted to cancel treatment and followed up with pd clinic in the morning.The pd patient stated he had no problems with ccpd treatment on night of (b)(6) 2017 and the patient decided to cancel treatment for night of (b)(6) 2017 and go to pd clinic for a schedule appointment on (b)(6) 2017.The issue of the drain complications was resolved with standard of care heparin secondary to fibrin issues in the pd catheter.During the hospitalization the patient continued to perform pd treatments, as yet peritonitis is not confirmed.On (b)(6) 2017, during a follow up call the pdrn revealed the patient continued to be hospitalized (currently 9 days length of stay) for pneumonia with fever episodes.

• Brand Name: LIBETY 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: 6614371
• MDR Text Key: 76745530
• Report Number: 2937457-2017-00432
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• 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?: Yes
• Device Age: MO
• Date Manufacturer Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2013
• 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: PD SOLUTION
• Patient Outcome(s): Hospitalization; Required Intervention