Shortages of fluids for intravenous injection and for irrigation
This month Baxter voluntarily recalled two lots of sterile saline based on a customer complaint of particulate matter in the bags. The particulate matter was identified as insect parts. This is in addition to 600,000 bags of saline in April 2015, a recall which included other items on the list below which are in short supply. Hospira has received a record number of FDA warning letters, presently numbering somewhere in the forties, for the products it manufactures. The names of these two companies can be found again and again in the list of shortages below.
These shortages began in 2010, continue in the present, and will continue into the future. In order to cope, the FDA in 2012 asked for and received legislative authorization to import these most basic requirements of a well-functioning modern health system. They chose to import bags of sterile saline. You will find the names of these companies listed below as well. BBraun is importing saline from its Melsungen, Germany plant; Baxter, the same from its facility in Spain; Fresenius Kabi, the same from its factory in Norway. All of these passed FDA inspections.
The top three shortages in the list below reflect one of the means by which US healthcare providers are coping at the level of hospital pharmacies. Technicians there are injecting concentrated salt solutions into bags of sterile water to produce the 0.9% and 0.45% saline solutions that are in short supply despite the imports listed above. This is a source of error causing harm to patients. Some have been given sterile water without the sodium chloride; others have been given too much sodium chloride.
Wallcur is a company that makes simulated medical products for training. The most bizarre error to date has been the shipping of their simulated bags of saline for training, which are so labeled, to healthcare providers who then administered them intravenously to patients as if they were the real thing. The simulated bags of saline for training do not meet any of the standards for administration to humans, and more than forty patients are known to have been harmed.
The dextrose solutions listed below are required for patients, usually with high blood pressure, who are not to be given sodium. The Ringer’s lactate is most often used for replacement of high volumes of fluid lost during surgical procedures. The irrigation solutions are for washing away debris and blood when cleaning a wound or during surgery. They are made to different manufacturing standards and cannot be injected into a vein.
The following shortages are listed starting with the most recently updated bulletin as of 20150722.
Baxter had sterile water for injection on shortage due manufacturing delays. BBraun has sterile water for injection on…www.ashp.org
14.6% Sodium Chloride solution for injection, Fresenius Kabi 40 mL vial, 25 count (NDC 63323-0139-40) Hospira has 14.6…www.ashp.org
Fresenius Kabi has sodium chloride concentrated solution on shortage due to increased demand. Hospira has 23.4% sodium…www.ashp.org
Sterile water for irrigation, BBraun 2000 mL bag, 4 count (NDC 00264-7386-50) 3000 mL bag, 4 count (NDC 00264-7386-60…www.ashp.org
Amphastar has 50% dextrose injection on shortage due to increased demand. Hospira has 50% dextrose injection on…www.ashp.org
Baxter has lactated ringer's on shortage due manufacturing delays.1 BBraun has lactated ringer's irrigation on shortage…www.ashp.org
Baxter states the shortage is due to increased demand.1 BBraun had 5% dextrose on allocation due to increased demand.2…www.ashp.org
Baxter has lactated ringer's on shortage due to increased demand.1 BBraun has lactated ringer's on allocation due to…www.ashp.org
Baxter has 0.9% sodium chloride irrigation on shortage due manufacturing delays.1 aun has 0.9% sodium chloride…www.ashp.org
0.9 % Sodium Chloride, Baxter 250 mL bag (NDC 00338-0049-02) 500 mL bag (NDC 00338-0049-03) 1000 mL bag (NDC 00338-0049…www.ashp.org
Baxter discontinued 70% dextrose 500 mL in 1000 mL partial-fill bags in late-2014.1 Baxter and BBraun state the reason…www.ashp.org