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 Problem Peritonitis (2252)

Event Date 09/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).There was no information provided that indicated a causal relationship between the peritoneal dialysis and use of fresenius products and the peritonitis.The most common cause of peritonitis is a breach in technique or biofilm on the peritoneal dialysis catheter.The plant investigation has not yet been completed.A follow up report will be filed upon completion of the investigation.

Event Description

Peritoneal dialysis patient's nurse (pdrn) reported the patient was diagnosed with staphylococcus peritonitis.Follow up with the patient's pdrn indicated that the patient was hospitalized on (b)(6) 2016 and released on (b)(6) 2016 for the staph infection.Pdrn attributed the infection to the patient not following aseptic technique when performing peritoneal dialysis treatments.Patient was treated with vancomycin, 1000mg x 3 doses.

Manufacturer Narrative

The device was not repaired or replaced against this complaint.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.

Event Description

Peritoneal dialysis patient's nurse (pdrn) reported the patient was diagnosed with staphylococcus peritonitis.Follow up with the patient's pdrn indicated that the patient was hospitalized on (b)(6) 2016 and released on (b)(6) 2016 for the staph infection.Pdrn attributed the infection to the patient not following aseptic technique when performing peritoneal dialysis treatments.Patient was treated with vancomycin, 1000mg x 3 doses.

• 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: 6083742
• MDR Text Key: 59329971
• Report Number: 2937457-2016-01137
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043363
• 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: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• 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: 12/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2011
• 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: 61 YR