MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE CUSTOM COMBI SET

Catalog Number 03-2722-9

Device Problem Insufficient Information (3190)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 04/10/2014

Event Type  Death  

Event Description

It was reported by the dialysis clinic that the pt was on dialysis for about 3 hours and he was found unresponsive.Cpr was initiated and the emergency medical services ems, was called.The pt was given 500cc of saline, and cardioverted x2 prior to ems arriving.Pt wife was present and the decision to end the life support effort was made.

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.A supplemental report will be submitted upon completion of the plant's investigation.Clinical info reviewed.This event has been reported as a serious injury, although it is undetermined if there is a reasonable suspected causal relationship between the product(s) and the event.This pt expired during treatment, and incidentally, the machine failed the uf pump test by 0.006 ml per stroke.This will total approximately 87 cc additional uf from the prescribed volume in the 3 hours of treatment.This is not clinically significant and did not cause or contributed to this event.The accepted margin of error in uf is 50 cc plus or minus per hour; technically, the ultrafiltration achieved by this machine was still within specifications.This event report is related to four separate products and associated with mdrs # 1713747-2014-99974, 2937457-2014-00898, 8030665-2014-00453, 1713747-2014-00265, 3005162618-2014-00006, and 3005162618-2014-00007.

• Brand Name: CUSTOM COMBI SET
• Manufacturer (Section D): FRESENIUS MEDICAL CARE
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; parque industrial reynosa; cd, reynosa, tamps 8878 0; MX 88780
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 3877223
• MDR Text Key: 21244407
• Report Number: 8030665-2014-00453
• 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,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2014
• 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: SALINE 0.9%; CUSTOM COMBI SET; OPTIFLUX DIALYZER; 2008T HEMODIALYSIS SYSTEM; GRANUFLO; NATURALYTE
• Patient Outcome(s): Death
• Patient Age: 85 YR
• Patient Weight: 74