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

Device Problem Insufficient Information (3190)

Patient Problems Sepsis (2067); Peritonitis (2252)

Event Type  Injury  

Event Description

The following is based on medical records received from the pt's clinic: on (b)(6) 2014 the pt developed diffuse abdominal pain, fever, diarrhea, and nausea and vomiting.On (b)(6)2014 he was hospitalized with peritonitis.The pt had a ct scan done and it showed the presence of a small bowel obstruction, on (b)(6) 2014, the pt was transferred to another hosp for a higher level of care and was admitted to the intensive care unit.The pt was diagnosed with sepsis and was treated with vancomycin and levaquin.He was npo and had a nasogastric tube inserted due to the presence of a small bowel obstruction.The pt's pd catheter was removed surgically on (b)(6) 2014 due to the peritonitis and he was treated with merrem intravenously for a 14 day course.He was placed on hemodialysis 3 times per week and continued to show improvement.On (b)(6) 2014, he was discharged to a long term acute care facility with his nasogastric tube still present.Upon discharge he was in stable condition.

Manufacturer Narrative

This report is being submitted as part of a system level review; which will include an investigation of all potential fresenius products being used at the time of the event.A supplemental report will be submitted upon final review and completion of the plant's investigation.Clinical info review: this event has been reported as a serious injury, although it is undetermined if there is a reasonable suspected causal relationship between the products and the events of peritonitis and small bowel obstruction.Peritonitis is a known risk for peritoneal dialysis, usually caused by a break in aseptic technique.The fact that the culture grew multiple organisms, indicate the source is likely a break in aseptic technique, as well as, the presence of a small bowel obstruction, where bacteria could have been transferred.The pt had 3 episodes of peritonitis prior to this admission.There is no history of specific malfunction, or the products being out of specs.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: corie vazquez, mgr ; 920 winter st; waltham, MA 02451-1457 ; 7816999071
• MDR Report Key: 4128690
• MDR Text Key: 4790280
• Report Number: 2937457-2014-02708
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/15/2014
• Initial Date FDA Received: 09/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 SOLUTION; LIBERTY CYCLER,
• Patient Weight: 49