The recall was initiated after reports of arterial line kinks in the CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors, which are used with the Blood Volume Monitor (BVM),
The kinking may develop prior to or during use and may not be apparent until after the blood tubing warms, according to Fresenius. The most commonly affected location is in the pre- or post-cuvette tubing segments, entering or leaving the BVM module. The kinks are not always visible because they may occur in the tubing behind the BVM module door.
Kinked tubing occurred on specific lots of Part Number 03-2695-9 distributed between August 2010 and November 2010 and specific lots of Part Number 03-2795-7 distributed between August 2010 and November 2010.
Kinking is a partial obstruction of the bloodline caused by a bend or narrowing of the tubing that results in a restriction of blood flow. Kinks may manifest as arterial pressure alarms or be mistaken as access problems.
Kinking is likely to result in inadequate or incomplete hemodialysis treatment which may result in the need for medical intervention, lengthening of the dialysis treatment and/or additional dialysis, Fresenius said in a news release.
Fresenius said has not received any reports of hemolysis associated with the defective devices. However, kinking can cause hemolysis. Hemolysis is the breakdown of red blood cells, which may result in serious injury and or death.
There have been reports of re-needling when operators mistakenly concluded that an access problem existed, according to the news release. There is also the possibility for the inappropriate administration of tissue plasminogen activator (tPA) if operators mistakenly conclude there is an access problem.
“Customers who have the affected lots of CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for use with the BVM which are being recalled should discontinue their use immediately and return product to Fresenius Medical Care,” the company said in the release.
The recall started on Nov. 19, 2010 after Fresenius received complaints of kinked tubing. The FDA has classified this action as a Class I recall.
The recall includes the following part numbers and lot numbers which were sold in the U.S. and Canada.
Part Number: 03-2695-9 Lot Numbers: 10HR01065, 10HR01083, 10HR01197, 10HR01259, 10JR01019, 10JR01031, 10JR01040, 10JR01058, 10JR01067, 10JR01077, 10JR01239, 10LR01041, 10LR01053, 10LR01061, 10LR01070, 10LR01102,10LR01111, 10LR01123, 10LR01269, 10LR01282, 10LR01283, 10LR01284, 10LR01285, 10NR01020, 10NR01031, 10NR01041, 10NR01050, 10NR01146, 10NR01157, 10NR01169, 10NR01180
Part Number: 03-2795-7 Lot Numbers: 09JR01174, 09JR01229, 09NR01139,10KR01801
Fresenius said it has provided written notification of the recall with confirmation of receipt to all U.S. and Canadian customers and is arranging for the return of affected products. Customers with questions may contact Fresenius Medical Care Customer Service Team at (800) 323-5188 in the United States and (888) 709-4411 in Canada.
Fresenius has also notified the U.S. Food and Drug Administration (FDA) and Health Canada, and is working with them to coordinate recall activities.
