Hospira Blood Sets Tied to One DeathAug 20, 2013
Device maker Hospira, Inc. issued an Important Safety Information Letter over specific blood kits concerning reports that, in some cases, the outer walls of the blood bags were punctured with the piercing pin during insertion of the pin into the blood bag, according to the U.S. Food and Drug Administration (FDA).
The action has been deemed a Class I by the agency, which means that there is a reasonable probability that the use of or exposure to a damaged blood kit will cause serious adverse health consequences or death. The FDA designated that matter a Class I recall following a report of at least one patient death that was due, in part to a treatment delay caused by a punctured blood bag, according to MassDevice.com.
The cause of the problem involves the design of the new International Organization for Standardization (ISO)-compliant pin. The pin has a sharp point that can sometimes pierce the walls of blood bags considered non-ISO-compliant.
Hospira blood sets are used for the administration of blood and blood products. If the piercing pin on this product were to puncture the blood bag’s outer wall, which may cause blood and blood products stored in the bag to spill, it could then lead to an interruption in therapy. Also, blood product spillage can potentially lead to the healthcare professional being exposed to the spilled blood.
According to Hospira, a “delay in therapy has a worst-case potential to result in significant injury or death.” The seriousness of that delay or interruption depends on the patient’s underlying condition and could potentially cause significant injury and death. In fact, this problem has been found to be a contributing factor in a report of one patient’s death over a therapy delay or interruption. The sets were distributed from July 2011 through February 2013 and include the following Impacted List Numbers products:
- 14200-04-28 Secondary Blood Set
- 14203-04-28 Blood Set
- 14206-04-28 Y-type Blood Set
- 14207-04-28 Blood Set
- 14210-04-28 Plum™ Blood Set
- 14211-04-28 Plum Blood Set
- 14212-04-28 Plum Y-type Blood Set
- 14217-04-28 Y-type Blood Set
- 14219-04-28 Y-type Blood Set
According to the FDA’s release, customers need not discontinue use of the recalled Hospira blood sets and need not return the products; however, Hospira recommends that users exercise extreme caution when piercing blood bags with a recalled Hospira blood set. Also Hospira recommends that all instructions for use included with the blood bag and health care facility protocol for spiking blood bags be completely followed to minimize the possibility of puncturing the blood bag’s outer wall. Around March 2013 Hospira began distributing sets with a blunter piercing pin shorter than the pins in the recalled sets.
Hospira indicated that it is not initiating a recall of the Impacted List Numbers products and advised customers contact Hospira for information about these sets. A copy of the Important Safety Information Letter can be obtained from Stericycle at 1-866-608-3936 from 8:00 a.m. to 5:00 p.m. Eastern Time, Monday through Friday. Facilities may contact Hospira at 1-800-441-4100 from 8:00 a.m. to 5:00 p.m. Central Time, Monday through Friday or by email to ProductComplaints@hospira.com. Hospira Medical Communications may be reached at 1-800-615-0187 anytime, 24 hours a day, seven days a week.