Contaminated Sierra Pre-Filled Heparin Syringes Cause Bacterial Infections in 40 People, CDC Investigating

Contaminated <"">Sierra Pre-filled syringes have made dozens of people in two states ill with a potentially serious bacterial infections.  The Centers for Disease Control and Prevention (CDC)  is investigating the illnesses, and the defective medical devices implicated in the infections have been pulled from the market.

Around 40 people have been sickened in Texas and Illinois, including 20 outpatients at Rush University Medical Center in Chicago.  So far, no deaths have been reported, but of the 20 Rush outpatients who fell ill, 14 required hospitalization.  Although all responded quickly to antibiotic treatment, one patient remains hospitalized as of Tuesday, said Dr. John Segreti, hospital epidemiologist.

Doctors at Rush were able to trace the infections to heparin-filled syringes the patients used during home treatment for cancer and other ailments.  Heparin is a blood thinner and the syringes are used to clear out catheters and intravenous lines.  The infections were caused by bacteria found in a single batch of heperin-filled  syringes made in North Carolina, by a company called Sierra Pre-Filled.  The infections were caused by a bacterium called Serratia marcescens (pronounced Sur-AY’-she-uh mar-SUH’-sens).

Taitned Sierra Pre-Filled syringes from that batch were also sent to Colorado, Florida, and Pennsylvania but infections—so far—have turned up only in Illinois and Texas, said Dr. Arjun Srinivasan of the CDC.  The infections can cause fever and chills and can be serious but generally respond well to antibiotics.  The president of Sierra Pre-Filled, Dushyant Patel, said the company is working with both the CDC and the Food and Drug Administration (FDA) on the investigation and has voluntarily recalled the implicated lot. “There’s nothing out there anymore,” according to Patel.

The affected Sierra Pre-Filled syringes where from lot  070926H, Srinivasan said. He said the CDC is working to ensure doctors are alerted about the contamination; doctors and hospitals should be aware that more cases could surface. “Our highest priority is to ensure that all of those cases that occur are identified,” he said. ”Patients who think they used affected syringes should contact their doctors,” Srinivasan said, adding, “We’ll be working to perform genetic fingerprinting on the bacteria to confirm a link between bacteria in the syringes and the case patients.

Heparin is the same drug linked to recent overdoses accidentally given to actor Dennis Quaid’s newborn twins.  In that case, the heparin was made by Deerfield, Illinois-based Baxter Healthcare Corporation.  The twins appeared to be doing well, a lawyer for the Quaids said earlier this month.  Patel said the heparin in his company’s pre-filled syringes comes from a different company.  The overdoses given to the Quaid twins were a result of the babies being dosed with medication from the 10,000 unit vials used for adults and not the 10 unit vials for babies.  Also this year, an alert was issued after three infants died in Indiana after they were mistakenly given adult doses of heparin.  Six other newborns received an overdose and were not among the first to be affected in this sort of mix-up, apparently also happening back in 2001 when two patients were given incorrect dosages of the drug.  Both the 10,000 unit adult vials and the 10 unit baby vials of heparin bear similar packaging which seems to be at the root of under and overdosing errors.

This entry was posted in Defective Medical Devices, Legal News. Bookmark the permalink.

© 2005-2018 Parker Waichman LLP ®. All Rights Reserved.