The manufacturer of our 2-liter bags of Belzer UW Cold Storage Solution (Preservation Solutions, Inc.), has informed us that two (2) units, one distributed and one in production, have been confirmed to have a pinhole leak at the base of the injection port (the point at which the port is sonically welded into the body of the bag). Such a leak, if present, compromises sterility and could lead to contamination of the solution and contamination of any organs flushed with or placed in the cold storage solution. Fortunately, neither unit was used in a transplant procedure. Preservation Solutions has since conducted an inspection of approximately 1,500 2-liter units in inventory, and no further units with the sonic-weld defect were found.
Based on available information, the incidence of the defect appears to be extremely low; but out of an abundance of caution, Bridge to Life, in concert with Preservation Solutions, has initiated a Field Correction of all 2-liter bags currently in distribution. The Field Correction process allows inspection of the product at a location other than the manufacturing facility by a qualified individual, and the product, when it has been confirmed not to exhibit the defect, can be returned to inventory. A Field Correction is distinguishable from a product recall, in that products are corrected in the field, i.e., not at the place of manufacture. We believe that this is an important distinction in this matter.
If your organization purchased 2-liter bags of Belzer UW Cold Storage Solution from Bridge to Life, you will receive a registered letter with instructions on how to implement the Field Correction. These Field Correction activities are being undertaken with the agreement and concurrence of the FDA. In addition, the United Network for Organ Sharing (UNOS), is aware of this matter and Bridge to Life is in contact with that organization.
Please note that this notice DOES NOT APPLY to Belzer UW® Cold Storage Solution in 1-liter bag, or to any other product forms. There have been NO reports of a leak or any other defects in the 1-liter bags. Thermo-Fisher, the manufacturer of the bags, has confirmed to PSI that different tooling is used to perform the sonic weld of the injection port in the 1-liter bag than that used in the 2-liter bag.
Field Correction Question & Answer
Q: What is a Field Correction?
A: It is typically a situation in which the Manufacturer (or another party in the distribution chain) undertakes an activity or activities to correct an error or defect in devices when they are “in the field,” as opposed to bringing all the devices subject to the Field Correction back to the place of manufacture.
Q: Why is the defect in the 2-liter Belzer UW® Cold Storage Solution bag able to be corrected in the field?
The defect is a potential for the 2-liter bag to have a pinhole leak at the base of the injection port. The manufacturer tells us that based on its ongoing investigation of the situation, only a very small proportion of units subject to the withdrawal will be found to have a leak. Because a unit exhibiting the defect is readily observable by a trained inspector, the units with the defect can be culled from those that have no leak. After inspection a product confirmed to be free of the defect will be able to be returned to the field for use.
Q: Why is the Field Correction Inspection not being done at my facility?
A: Bridge to Life has hundreds of customers, and only a few of our largest customers are expected to have more than a case or two of the 2-liter product in inventory. Therefore, to avoid the cost of and time for the manufacturer’s Field Correction Inspector to travel to hundreds of facilities around the country to inspect only a few devices at each one, the manufacturer asked if we would have the 2-liter products brought back to our distribution center in South Carolina for a single inspection of all returned units. Realizing the efficiencies of this process, and the time that would be saved, we agreed.
Q: Can we do our own inspections?
The interests of public health requires that the Field Correction inspections be consistent and have the highest likelihood of not missing a 2-liter bag with a defect. An inspector who has seen the defect in units will be more likely to find bags exhibiting the defect.
Q: Is this Field Correction a recall?
FDA deems a correction of this nature to be a Recall, and will so classify it. But the nature of the corrective activity allows it to be termed a “Field Correction” under FDA policy and practice.