MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE, REYNOSA PLANT COMBI SET

Catalog Number 03-2622-3

Device Problem Use of Device Problem (1670)

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

Event Date 09/25/2014

Event Type  malfunction  

Event Description

A hemodialysis inpatient user facility has reported that during treatment the blood pump stopped and alarmed arterial pressure.The machine was "re-set." the blood pump stopped a second time.Issue was addressed before machine could alarm a second time.It was then noticed that air was inside the bloodline tubing.A blood clot was also noted in the venous line.The blood in the arterial line was returned to the pt, the venous line was not returned resulting in an estimated blood loss that was 200 ml.The pt had no adverse effects and no med intervention was required.The pt completed treatment on the same machine with a new set-up with no further issues.The pt was asymptomatic and no intervention was required.The issue could not be duplicated when the machine was tested and no repairs were made.The machine has been returned to service with no further issues.

Manufacturer Narrative

Plant investigation has not yet been completed.A follow up report will be filed upon completion of the investigation.It is unclear how this event could have occurred as it has been reported.The initial follow up from the rn alleges "arterial pressure alarm" which indicates the machine sensed insufficient pressure from the blood coming from the pt which would typically occur if the fistula needle was impeded in some way.This can cause turbulence in the lines leading to the occurrence of air bubbles.The air detector alarmed appropriately to indicate the level of blood in the venous chamber had dropped and the venous clamp below that chamber is designed to clamp off the contents of the venous chamber before it enters the venous portion of the pt line (the blood return portion) making it unlikely any air would be present in this area.The presence of a "clot" in the venous chamber is not an unusual occurrence and is dependent on adequate heparinization of the blood and blood flow from the fistula.The machine was used again after the second system set up without issue and the issue could not be duplicated by the res.No repairs were made to the machine.

• Brand Name: COMBI SET
• Manufacturer (Section D): FRESENIUS MEDICAL CARE, REYNOSA PLANT; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; parque; industrial reynosa; reynosa, tamps 8878 0; MX 88780
• Manufacturer Contact: tanya taft ; 920 winter st; waltham, MA 02451 ; 7816999000
• MDR Report Key: 4230798
• MDR Text Key: 4976404
• Report Number: 8030665-2014-00827
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• 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: 09/25/2014
• 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: FRESENIUS 2008K2 HEMODIALYSIS MACHINE