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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 11/28/2015

Event Type  Injury  

Manufacturer Narrative

The patient's medical records were requested and have been received.A clinical investigation will be completed, and a supplemental report will be submitted.A supplemental report will be submitted upon completion of plant's investigation.

Event Description

A follow up letter received from peritoneal dialysis (pd) patient's clinic reported the patient was currently in the hospital.During a follow-up, the pd registered nurse (rn) stated the patient was hospitalized due to a bloodstream infection caused by streptococcal sepsis.The patient was hospitalized on (b)(6) 2015 and discharged on (b)(6) 2015.The patient continued pd treatment without any reported problems.The pdrn stated the hospitalization was not related to the patient's pd therapy or liberty cycler.Medical records provided from the patient's treatment facility: presented at the hospital with a four day history of headache, runny nose, chills, body aches, night sweats and febrile for two days.She was positive for nausea after eating her main complaint was "head congestion".She was treated with iv antibiotics.She was discharged home in improved and stable condition.

Manufacturer Narrative

The patient's medical records were received and a clinical investigation was completed.The source of the patient's streptococcus bacteremia was not definitely determined but, the medical records reveal the source of infection was suspected to be an infected av fistula.However, the patient was transitioned from hemodialysis to peritoneal dialysis approximately 2 month prior to this event.Medical records state that the main complaint of sinus headache was presumed to be a viral sinusitis.Patient was experiencing diarrhea that negative for clostridium difficile and suspected to be antibiotic related.Patient also received venofer on (b)(6) 2015 during hospitalization for macrocytic anemia but, there is no documentation in the medical records that reveals patient received venofer prior to this event or contributed to this event.Patient is a heart transplant recipient on immunosuppression.This and the patient's medical history put the patient at high risk for infection of any type.Medical records reveal that the patient was not positive for peritonitis, clostridium difficile, influenza, pneumonia or respirator virus.There is no documentation in the medical record that indicates a causal relationship between the patient 's liberty cycler and the patient's blood infection.There is no documentation in the medical records that indicates a causal relationship between the patient 's peritoneal dialysis solution and the patient's blood infection.The 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 nonconformances during he manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.

• 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, cnor ; 920 winter st. ; waltham , MA 02451-1457 ; 7816999000
• MDR Report Key: 5346677
• MDR Text Key: 35215716
• Report Number: 2937457-2015-01764
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2009
• 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
• Patient Age: 48 YR
• Patient Weight: 50