MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER

Catalog Number RTLR180111

Device Problem Invalid Sensing (2293)

Patient Problem Peritonitis (2252)

Event Date 05/20/2015

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) pt reported that his effluent was more yellow that it usually was.Upon follow-up with the pd nurse, she confirmed that the pt came to the clinic on (b)(6) 2015 and a pd fluid culture was done and he was started on antibiotics due to elevated white blood cell count (wbc).The culture did not grow any organisms.After three additional treatments of antibiotics another culture was taken and the wbc was higher, the effluent was cloudy, however no organisms grew.A third culture was taken and was negative but the wbc's were decreased significantly.Culture reports have been requested.

Manufacturer Narrative

This report is being submitted as part of a system level review; which will include an investigation of all potential fresenius product being used at the time of the event.A supplemental report will be submitted upon completion of plant's investigation.

Manufacturer Narrative

Based on medical records information it appears that on (b)(6) 2015, this patient was diagnosed with peritonitis and started on intraperitoneal antibiotics.According to the peritoneal dialysis registered nurse (pdrn), the patient was in the clinic on (b)(6) 2015 and had his peritoneal fluid cultured and was placed on antibiotics due to escalated white blood cell count (wbc).The patient was not hospitalized.According to the pdrn, the culture did not grow and organisms.Per the pdrn, after three additional treatments of antibiotics another culture was taken and the wbc was higher than effluent was cloudy but again did not grow any organisms.A third culture was taken and was negative for organisms but the wbcs finally came down significantly.Medical records reveal patient continued to have elevated white blood cell counts on (b)(6) 2015 but, cultures continued to be negative.Medical records show patient's peritonitis never resolved and not new episodes of peritonitis.Medical records do not contain any dialysis treatment records, progress notes, medication records, physician's orders or flow sheets for review.There is no documentation in the medical record that indicates the cause of the peritonitis.There is no documentation in the medical record that indicates there is a causal relationship between the patient's liberty cycler and concomitant products and the patient's peritonitis.The reported complaint is not confirmed.The device was not provided for evaluation.The device records confirmed that released product met specifications; and documented manufacturing process controls were within specification.Per the documented product investigation, there was no indication that the fresenius product caused, contributed to or was a factor in the reported event.

Event Description

Additional information: follow-up received.Patient had a peritoneal dialysis fluid culture on (b)(6) 2015 that had an elevated white cell count of 653.Culture returned negative.Patient had repeat culture negative peritoneal dialysis fluid specimens with eleated white blood cell counts on (b)(6) 2015.Patient was diagnosed with peritonitis and treated with intraperitoneal antibiotics.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft, rn ; 920 winter st; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4861427
• MDR Text Key: 5861002
• Report Number: 2937457-2015-01210
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,consumer,health prof
• Type of Report: Initial,Followup
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• 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
• Date Manufacturer Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2010
• 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: LIBERTY CYCLER CASSETTE
• Patient Outcome(s): Required Intervention