MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA CUSTOM COMBI SET

Catalog Number 03-2722-9

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

Patient Problem Death (1802)

Event Date 12/15/2014

Event Type  Death  

Event Description

A biomedical technician called technical support and reported a pt incident of cardiac arrest.Upon follow up with the inpatient acute dialysis manager, the following was reported: a female pt was admitted to the hospital for complaints of shortness of breath, weakness, nausea and vomiting on (b)(6) 2014.She had missed he dialysis treatment and was dialyzed in the hospital on (b)(6) 2014 without incident.It was reported by the acutes inpatient manager that the pt had a cardiopulmonary arrest on (b)(6) 2014 in her hospital room greater than four hours later after dialysis.The pt was resuscitated and transferred to the intensive care unit (icu).She underwent hemodialysis in her room on (b)(6) 2014 and had a second cardiopulmonary arrest after a rhythm changed was noted approximately three minutes into her treatment.Her blood was returned and she was resuscitated.She had a subsequent cardiopulmonary arrest a short time later and expired.There was no allegation of malfunction made against the product.There was no sample available.

Manufacturer Narrative

Based on the information provided, it is unk how the device may have caused or contributed to the event.The post market clinical department is in the process of reviewing pt medical records and treatment data information regarding the reported expiration after cardiopulmonary arrest during and subsequent to hemodialysis treatment.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.The device was not returned to the manufacturer for analysis.A post dialysis adverse event evaluation was reportedly performed by the clinic biomedical technician.According to the initial reporter, there was no malfunction found.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

• Brand Name: CUSTOM COMBI SET
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; mike allen 1331; parque industrial reynosa
• Manufacturer Contact: tanya taft, rn ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 4454236
• MDR Text Key: 5423498
• Report Number: 8030665-2015-00029
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2014

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: Health Professional
• Device Expiration Date: 02/01/2017
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 14BR01233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/23/2014
• Initial Date FDA Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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: CITALOPRAM; LEVOTHYROXINE; METOCLOPRAMIDE; 2008K HEMODIALYSIS MACHINE; AMLODIPINE; LISINOPRIL; OXYCODONE; CARVEDILOL; CLONIDINE; BICARBONATE; 2K2CA NATURALYTE; F160 DIALYZER
• Patient Outcome(s): Death
• Patient Age: 52 YR
• Patient Weight: 69