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

Catalog Number RTLR180111

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Pain (1994); Peritonitis (2252)

Event Date 04/23/2017

Event Type  Injury  

Manufacturer Narrative

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.The clinical review of all information currently available concluded the following: although a temporal relationship between the diagnosis of gram positive coccobacilli peritonitis and the fresenius products exists, there was no documentation supporting a causal relationship between the fresenius products and the event of gram positive coccobacilli peritonitis and subsequent hospitalization.The cause of the episode of peritonitis appears to be related to the nurses performing the patient¿s pd treatments during patient¿s rehabilitation for subdural hematoma.There appears to have been a breach in sterile technique in not placing the staysafe cap on the pd catheter resulting in the necessity to remove the patient¿s pd catheter (not a fresenius product) while hospitalized and transitioning patient to hemodialysis (hd) treatments.Additionally, there was no allegation of device malfunction and the association of peritonitis and subsequent patient hospitalization.

Event Description

A peritoneal dialysis (pd) patient reported that he had previously presented to the hospital with abdominal pain approximately one week prior, and had been treated for an infection.The patient further reported that the cause of the infection was a result of not replacing the staysafe cap on his pd catheter after treatment.The patient reported that he had temporarily changed modality of dialysis treatment to hemodialysis pending the resolution of the infection.The patient admitted the infection was a result of use error.Additional information received from the patient¿s pd nurse discovered that the patient had been in a rehabilitation facility for a subdermal hematoma (details unknown) and the patient had acquired peritonitis while in the rehabilitation facility.Additionally the pd nurse stated the patient was not conscious (unknown level of consciousness and cognitive ability) therefore the rehabilitation nurses were performing or assisting patient in performing the patient¿s dialysis treatments.Furthermore it was revealed by the pd nurse that the patient reported ¿having difficulty remembering things¿.The pd nurse reported that there were no issues with the patient¿s pd catheter or the fresenius staysafe cap.The pd nurse reported that the patient was admitted to the hospital due to peritonitis on (b)(6) 2017.The patient was treated with antibiotics: vancomycin, every treatment course at 500 mg for two weeks via iv route, from (b)(6) 2017 through (b)(6) 2017.The pd nurse confirmed that the patient underwent removal of the pd catheter (not a fresenius product) and placed on hemodialysis for renal replacement therapy.The patient was discharged on (b)(6) 2017 back to rehabilitation facility.The pd nurse reported that the patient will continue on temporary in-center hemodialysis and ultimately have a new pd catheter placed (no procedure scheduled to date).

• 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: 6603642
• MDR Text Key: 76377306
• Report Number: 2937457-2017-00412
• 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: Patient
• Type of Report: Initial
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• 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?: No
• Device Age: MO
• Date Manufacturer Received: 05/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2012
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 99