MAUDE Adverse Event Report: FRESENIUS MED CARE CUSTOM COMBI SET

Catalog Number 03-2722-9

Device Problem Insufficient Information (3190)

Patient Problem Respiratory Failure (2484)

Event Date 08/06/2014

Event Type  Injury  

Event Description

It was reported by the clinic nurse that the pt was found unresponsive during hemodialysis, and was transported to the hosp and admitted to icu, pt required intubation and had continued hemodialysis while in hosp, the pt required a surgical procedure to remove a necrotic gallbladder during the admission.After some recovery the pt was transferred to a long term acute care hosp.

Manufacturer Narrative

This report is being submitted as part of a sys 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 final review of med records by post market clinical.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 demonstrated four lots have been shipped to the site in the three months prior to the event.According to the sap sys no product is available from these lots on distribution centers to be analyzed.All identified lots have been sold and distributed.A 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.The complaint record show that there was no alleged product malfunction or evidence that this device caused or contributed to pt incident.This report is related to five other product reports submitted on the same event.

• Brand Name: CUSTOM COMBI SET
• Manufacturer (Section D): FRESENIUS MED CARE; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; parque ind. reynosa; reynosa, tamaulipas CP 8 8780; MX CP 88780
• Manufacturer Contact: corie vazquez, mgr ; 920 winter st; waltham, MA 02451-1457 ; 7816999017
• MDR Report Key: 4129546
• MDR Text Key: 4938706
• Report Number: 8030665-2014-00716
• 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: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: No
• 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: 08/06/2014
• 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: OPTIFLUX DIALYZER FINISHED ASSY.; NATURALYTE DRY PACK; GRANUFLO 1; 0.9% NACL 1 L SALINE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention