MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE REYNOSA MANUFACTURING LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 050-87216

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

Patient Problem Myocardial Infarction (1969)

Event Date 07/18/2016

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.A supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

A peritoneal dialysis (pd) patient reported he experienced a heart attack while connected to the cycler and was subsequently hospitalized.Follow-up with the patient's pd nurse confirmed the patient experienced chest pain during treatment and disconnected and brought to the hospital where he was admitted on (b)(6) 2016.The patient was discharged on (b)(6) 2016.

Manufacturer Narrative

Clinical review of the medical records do not reveal any documentation of a cause for the patient¿s heart attack.The lack of information, including the patient¿s comorbidities, do not allow for assessment of a causal relationship between peritoneal dialysis with fresenius products and the patient¿s heart attack.Complaint sample was not available, and the lot number of product involved in this incident was unknown.However, sales and shipping search to the client within the time frame of three months before the date of occurrence was performed.According to our records no product is available from these lots on distribution centers to be analyzed.The entire lots have been sold and distributed.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the record review confirmed the labeling, material, and process controls were within specification.The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): FRESENIUS MEDICAL CARE REYNOSA MANUFACTURING; erika de reynosa; reynosa
• Manufacturer (Section G): REYNOSA; erika de reynosa, s.a.; parque industrial reynosa; reynosa, tamaulipas. cp 88780 ; MX 88780
• Manufacturer Contact: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5856359
• MDR Text Key: 51467113
• Report Number: 8030665-2016-00401
• 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
• Type of Report: Initial,Followup
• Report Date: 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• 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: UDI: 00840861100750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2016
• 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: DELFLEX PD SOLUTION
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention