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 12/07/2016

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 reported to the clinic registered nurse (rn) she developed peritonitis from cloudy solution.A sample was brought into the clinic and looked visibly cloudy.Follow-up was made with the pdrn, who confirmed the pd patient was diagnosed and hospitalized with peritonitis on (b)(6) 2016, shortly after using a cloudy solution bag.The exact date of use was unknown.The culture came back positive for e.Coli and klebsiella.The patient was given ceftazidime and gentamicin for treatment.The exact dose was unknown.The patient was discharged from the hospital on (b)(6) 2016 and was currently feeling much better.The pdrn does not believe the pd solution to be related to the diagnosis of peritonitis.The pdrn reports the cause of the peritonitis as the patient's history of chronic constipation.Medical records were requested.

Manufacturer Narrative

Additional information: 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.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.

Event Description

The file information was reviewed by a post market surveillance cilician.The peritoneal dialysis patient presented to the hospital on (b)(6) 2016 due to peritonitis.The patient reported that the peritonitis was caused by cloudy peritoneal dialysis solution.The peritoneal dialysis (pd) nurse confirmed that the solution bag appeared cloudy and solution was drawn up in a syringe and was cloudy.The pd nurse stated that two bags out of the patient supplies were cloudy.The peritoneal dialysis fluid culture was positive for the organism escherichia coli and klebsiella.The patient was treated with ceftazidime and gentamicin.The patient was discharged from the hospital on (b)(6) 2016 and the pd nurse reported the patient was feeling ¿much better¿.The patient first stated the peritonitis was due to the cloudy peritoneal dialysis solution however later attributed the peritonitis to a ¿bad batch of green tea¿.The pd nurse did not believe the solution was related to the peritonitis and related to the peritonitis to the patient¿s past history with chronic constipation.The pd nurse stated that the patient was good at following aseptic technique.

Event Description

Hospital records received indicated that the peritoneal dialysis patient presented to the emergency room with acute abdominal pain with bowel urgency.The abdominal pain was described as involving the entire abdomen intermittently with the right and left lower quadrants.The patient was afebrile.Physical examination of the patient¿s abdomen revealed that the abdomen was distended and soft with light pressure causing discomfort.The examination revealed active bowel sounds.The patient was diagnosed with peritonitis secondary to the peritoneal dialysis catheter following a positive culture with the organisms escherichia coli and klebsiella oxytocia.The patient was treated with vancomycin and gentamicin.The patient was discharged home in stable condition.

• 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: 6215577
• MDR Text Key: 63636229
• Report Number: 2937457-2016-01270
• 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: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• 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?: No
• Device Age: MO
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2013
• 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: 41 YR
• Patient Weight: 60