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

Catalog Number 050-87216

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

Patient Problem Myocardial Infarction (1969)

Event Date 10/05/2015

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 5 lot numbers 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 specifications.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

A peritoneal dialysis (pd) patient reported she was hospitalized.Subsequent follow up with the peritoneal dialysis registered nurse (pdrn) revealed on (b)(6) 2015 the patient experienced chest pains prior to commencement of pd treatment.The pdrn reported the patient was seen in a local emergency room and was discharged home.The patient spent less than 23 hours in the local hospital.The patient returned home and connected to the liberty cycler to begin pd therapy.The patient then reported worsening of chest pains and disconnected from pd therapy and returned to the local hospital.Upon return to local hospital, the patient was found to have experienced a myocardial infarction.The patient subsequently underwent triple bypass surgery on an unknown date and was discharged from hospital on (b)(6) 2015.

Manufacturer Narrative

Medical records were reviewed and do not contain any dialysis treatment records.There was no documentation that indicates a causal relationship between the liberty cycler cassette and the patient's chest pain or cardiac disease.Medical records reveal the patient's chronic cardiac history and coronary artery disease were the cause of patient's chest pain and subsequent coronary artery bypass graft.

Event Description

The following is from medical records provided by the patient's treatment facility.The patient presented to the hospital initially with chest pain and was diagnosed with anemia that was treated with two units of packed red blood cells and discharged home.The patient returned to the hospital again a few days later and was diagnosed with an acute myocardial infarction.Multi-vessel disease was found and a triple coronary artery bypass graft was performed.The patient developed postoperative thrombocytopenia and anemia.The patient improved and eleven days after admission was discharged to a long term nursing facility.Discharge diagnosis included acute coronary syndrome with symptomatic critical left main disease, status post triple coronary artery bypass graft.

• Brand Name: LIBERTY CYCLER CASSETTE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; parque industrial reynosa; reynosa, tamaulipas CP 88 780; MX CP 88780
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 5332014
• MDR Text Key: 34677060
• Report Number: 8030665-2015-00609
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 12/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2016
• 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: 73 YR