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); Device Handling Problem (3265)

Patient Problem Peritonitis (2252)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A peritoneal dialysis (pd) patient's contact reported the patient was being treated for peritonitis.The contact stated the patient was diagnosed with peritonitis at the beginning of the month (specific date couldn't be provided) and stated the last treatment with antibiotics was on (b)(6) 2017.The pd patient's contact indicated that the connection to the patient's catheter became loose and that patient reconnected back to the same supplies, and a "couple" of days later patient was diagnosed with peritonitis.The patient's wife stated that patient was currently doing fine and was completing his treatments on the cycler.Additional information is being solicited.

Manufacturer Narrative

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 device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.

Event Description

Medical records were received and reviewed by a post market surveillance clinician.During a follow up call the peritoneal dialysis patient reported being diagnosed with peritonitis.The patient reported the during peritoneal dialysis treatment the connection came loose and was reconnected with the same supplies a couple days prior to the diagnosis of peritonitis.The peritoneal dialysis (pd) nurse confirmed that the patient was diagnosed with bacterial peritonitis due to touch contamination.The pd nurse also reported that the patient had been utilizing peritoneal dialysis since (b)(6) 2013.Review of the medical records indicated that the peritoneal dialysis fluid was cultured and resulted in a positive culture result with the organism staphylococcus haemolyticus.The patient was treated with the antibiotic vancomycin.The last antibiotic treatment was reported to have occurred on (b)(6) 2017.The patient was reported as recovered.

• 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: 6447460
• MDR Text Key: 71323098
• Report Number: 2937457-2017-00217
• 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
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• 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: 04/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2013
• 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: DELFLEX PD SOLUTION; LIBERTY CYCLER CASSETTE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR