MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE CUSTOM COMBI SET

Catalog Number 03-2742-9

Device Problem Insufficient Information (3190)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 06/26/2014

Event Type  Injury  

Event Description

It was reported by the clinic that the pt started her hemodialysis without difficulty, her vital signs were stable.A short time later, the pt stated that she was having difficulty breathing.The pt was started on oxygen via nasal cannula and then became pulseless.Cardiopulmonary resuscitation was initiated, the automated external defibrillator was applied, one cycle of cpr was performed and the pt regained consciousness.The pt was sent to the emergency room for further eval.

Manufacturer Narrative

This report is being submitted as part of a system level review.If any add'l info is obtained a supplemental report will be submitted.Clinical info reviewed: medica records info review indicates that on (b)(6) 2014, the pt experienced a cardiac arrest during hemodialysis.This event will be reported as a serious injury, although it is undetermined if there is a reasonable suspected causal relationship between the product (s) and the event of cardiac arrest.There is no history of specific malfunction or product being out of specification.The device investigation has not been completed.There were no products returned for investigation.Plant investigation: complaint sample is not available, and the lot number of product involved in this incident is unk.However, a three month sales and shipping search to the client site identified the lots shipped to the site.According to the sap system no product is available from these lots on distribution centers to be analyzed.The entire lots have been sold and distributed.Dhr 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.Complaint sample was not provided for eval and there is no device malfunction reported.The event reported on this pt involves six separate products.

• Brand Name: CUSTOM COMBI SET
• Manufacturer (Section D): FRESENIUS MEDICAL CARE; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; parque industrial reynosa; reynosa, tamaulipas, cp 8878 0; MX 88780
• Manufacturer Contact: corie vazquez ; 920 winter st; waltham, MA 02451 ; 7816999071
• MDR Report Key: 4012967
• MDR Text Key: 19762514
• Report Number: 8030665-2014-00580
• 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: 06/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03-2742-9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2014
• 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: 2008K2 DIALYSIS SYSTEM; NATURALYTE; FMC SALINE; GRANUFLO; FMC DIALYZER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 64 YR