MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER SET, SINGLE CONN./EXT.DL

Catalog Number 050-87216

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

Patient Problem Peritonitis (2252)

Event Date 11/13/2015

Event Type  Injury  

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.Device review: the device was not returned to the manufacturer for physical evaluation.The customer was unable to provide the manufacturer with the lot number of the product used in the reported event.As no lot number was provided by the complainant, a record review was performed on each of the lot numbers shipped to the complainant in the three months leading up to the reported event.The record review found three lot number shipped to the customer during that time period.The batch production records for these lots were reviewed.The batch 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

Peritoneal dialysis (pd) patient initial reported that he experienced abdominal pains but he thinks it could be related to the food that he was eating in new mexico.Follow up with peritoneal dialysis registered nurse (pdrn) reported that the patient returned from his trip with peritonitis.The pdrn did not have culture results or information about the event as he was treated in a hospital.The exact date of diagnosis was not known, but it was following his trip but it was approximately (b)(6) 2015.The patient's catheter was removed and he was transitioned to hemodialysis.The cause of the peritonitis was undetermined.

Manufacturer Narrative

Additional information: five sections.(b)(4).Medical records were provided and have been reviewed and found there was no documentation for the cause of the patient's peritonitis.Medical records did not contain dialysis treatment sheets or progress notes for review or hospital progress notes for review.Lab results were not legible.Medical records revealed the patient's peritoneal dialysis catheter malfunctioned for an unknown cause.The catheter is not a fresenius product.There was no documentation that indicated a causal relationship between the liberty cycler set and the patient's peritonitis.

Event Description

The following is from medical records received from the patient's treatment facility.The patient presented to the hospital on (b)(6) 2015 with abdominal pain and was diagnosed with staphylococcus aureus peritonitis.The patient was treated with vancomycin and cefepime.On (b)(6) 2015 his peritoneal dialysis catheter was removed and he transitioned to hemodialysis with a planned start date of (b)(6) 2015.The patient's catheter was found to be malfunctioning.The patient also experienced hyperkalemia that resolved and worsening edema that was treated with peritoneal dialysis.He was discharged on (b)(6) 2015.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT.DL
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT, ERIKA DE REYNOSA, S.A. DE C.V.; parque industrial reynosa; reynosa, tamaulipas, cp 88780 ; MX 88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter street; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 5346740
• MDR Text Key: 35242355
• Report Number: 8030665-2015-00622
• 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
• Type of Report: Initial,Followup
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Other Device ID Number: 00840861100750
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 87 YR