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

Catalog Number 03-2622-3

Device Problem Filtration Problem (2941)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2013

Event Type  malfunction  

Event Description

A biomedical technician (bmt) called regarding a question for requirements for an uninterrupted power supply for the hemodialysis machine.According to the bmt, during a pt's continuous renal replacement therapy treatment, the hemodialysis machine experienced a short power-down due to the hospital performing a back up generator test.He added that the intensive care unit nurses were not aware that the hemodialysis machine was alarming and that the blood pump had stopped.By the time the problem was discovered, the blood in the tubing had coagulated and the tubing needed to be replaced.The blood was not able to be returned to the pt.Estimated blood loss experienced by the pt was approximately 200ml which was confined to the extracorporeal circuit.There was no report that medical intervention was required or if the pt was able to complete treatment.There was no info provided if the pt was receiving the blood thinner heparin.No sample is a available for return to the mfr.

Manufacturer Narrative

Based on the info provided, it is unknown how the device may have caused or contributed to the event.There was no info provided by the reporter re:treatment details.Although requested, treatment info and medical records have not been provided.There is no indication a serious injury had occurred.The plant investigation is in progress.A supplemental medwatch report will be submitted upon completion of the investigation.

• Brand Name: COMBI SET
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; cd, reynosa, tamps ; MX
• Manufacturer (Section G): REYNOSA PLANT, ERIKA DE REYNOSA, S.A. DE C.V.; mike allen 1331; cd, reynosa, tamps ; MX
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 4927997
• MDR Text Key: 6032742
• Report Number: 8030665-2015-00328
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2622-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2013
• 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: 2008K HEMODIALYSIS MACHINE