MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 050-87216

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

Patient Problem Peritonitis (2252)

Event Date 08/11/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Additional medical records have been requested.Follow up will be submitted if additional information is received and upon completion of the plant's investigation.

Event Description

During review of the patient's medical records, it was revealed the patient was diagnosed with peritonitis in (b)(6) 2015.No additional information available.

Manufacturer Narrative

Additional information: other relevant history; model and lot #.Corrected data: date of event.The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.The complaint device lot number was not reported, however the sales and shipping records for the patient were reviewed for three months prior to the date of occurrence.No product was available from these lots in distribution centers to be analyzed, as the entirety of the lots have been sold and distributed.Device history review was performed on the potential related lots.No non-conformance reports or other abnormalities during the manufacturing process were found for these lots.The product involved met current specifications.In addition, the device record review confirmed the labeling, material, and process controls were within specification.The system level review of the liberty cycler and concomitant products found no indication that the products caused or contributed in any way to the clinical event.Clinical review of the medical record reveals no indication for the source of peritonitis.Medical records do not state the patient contacted peritonitis during dialysis treatment.There was no documentation in the medical record that states a causal relationship between the liberty cycler set and the patient¿s peritonitis.

Event Description

Review of medical records provided by the patient's treatment facility.The patient was admitted into the hospital on (b)(6) 2015 with citrobacter peritonitis.The patient was diagnosed the week before and failed oral ciprofloxin therapy.Patient was started on intraperitoneal ceftazidime.Patient improved and was discharged (b)(6) 2015.Medical records reveal the patient does not have good vision and does her peritoneal dialysis at home by herself.Patient's son was educated on peritoneal dialysis administration.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; erika de reynosa; reynosa
• Manufacturer (Section G): REYNOSA; erika de reynosa, s. a. de c.; mike allen 1331 parque; reynosa, tamaulipas. cp
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5471027
• MDR Text Key: 39381182
• Report Number: 8030665-2016-00098
• Device Sequence Number: 1
• Product Code: FJK
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Device Lot Number: UNKNOWN
• Other Device ID Number: 00840861100750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR