MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number UNKNOWN

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

Patient Problems Anemia (1706); Dyspnea (1816); Myocardial Infarction (1969)

Event Date 04/15/2016

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.

Event Description

A peritoneal dialysis patient's caregiver reported the patient experienced a myocardial infarction while connected to the cycler and was hospitalized for one week.The following is from medical records provided by the patient's treatment facility.The patient was transferred for anemia without a source of bleeding from another hospital.Her hemoglobin and hematocrit were stable upon arrival.She was found to be dyspneic and wheezing with pneumonia and chronic obstructive disease exacerbation.She was found to have left groin ecchymoses extending to her flank from a previous cardiac catheterization.She was also found to have an acute stemi (st elevation myocardial infarction).The patient was made a do not resuscitate on (b)(6) 2016.Follow-up with the patient¿s peritoneal dialysis registered nurse indicated the patient¿s myocardial infarction was due to the patient¿s health conditions and not related to use with fresenius products.

Manufacturer Narrative

(b)(4).The complaint sample was not available and the lot number was unknown, thus a search of the lots delivered to the customer was conducted, with a time frame of three months before of the occurrence day.According to the sap system no product was available from these lots on distribution centers to be analyzed.The entire lots had been sold and distributed.Device history record review was performed on potential related lots.No nonconformance reports or other abnormalities during the assembly of these lots were found.The product involved met current specifications.Clinical review reveals there was no documentation in the medical record supporting a possible association between the fresenius dialysis products, the event of myocardial infarction, pneumonia, copd exacerbation, and the outcome of hospitalization.However, there is a certain association between the patient¿s co-morbid diseases of coronary artery disease, dyslipidemia, chronic diastolic congestive heart failure, hypertension, atrial fibrillation, copd, the events, and the outcome.

Event Description

The following is from review of medical records provided.On (b)(6) 2016, the patient experienced a ¿heart attack¿ while performing pd therapy, presented to a hospital, was admitted, and was diagnosed with an inferior wall st elevated myocardial infarction (stemi).On an unknown date during the admission, the patient underwent percutaneous coronary intervention with drug-eluting stent (des) of svg to rca and posterior descending artery (pda).On an unknown date during the admission post cardiac catheterization, the patient experienced left groin ecchymosis extending to the flank, was anemic, and was transfused; blood product type or units not reported.On an unknown date during the admission, the patient underwent an echocardiogram that showed an ejection fraction of 40-45% with moderate hypokinesis of the entire septum.On an unknown date during the admission, the patient was found to be dyspneic with wheezing, pneumonia, and copd exacerbation.On (b)(6) 2016, the patient was transferred and admitted to another hospital.As of (b)(6) 2016, the patient was discharged from the hospital, the event of acute inferior wall stemi improved, it is unknown if the pneumonia, dyspnea, wheezing, pneumonia, or copd exacerbation resolved, and the patient continues ccpd therapy.

• Brand Name: LIBERTY CYCLER SET
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; erika de reynosa; reynosa
• Manufacturer (Section G): REYNOSA; erika de reynosa, s.a.; parque industrial reynosa; reynosa, tamaulipas. cp 88780 ; MX 88780
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999751
• MDR Report Key: 5663223
• MDR Text Key: 45405936
• Report Number: 8030665-2016-00235
• 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: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 06/08/2016

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: Nurse
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 05/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2016
• 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: Initial
• Patient Sequence Number: 1
• Treatment: ISOSORBIDE MONONITRATE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 72