Multiple records identified: 4 of 8 records.On january 12, 2015, baxter (b)(4) was notified that on (b)(6) 2014, the head of the pharmacy service at (b)(6) hospital reported 8 patient involved cases exhibiting symptoms of fever.After investigation, the hospital found pyrogen within the patients' total parenteral bags, which were prepared with the exactamix 2400.
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As detailed later in the investigation, the bags were not manufactured by baxter healthcare.On (b)(4) 2014, 34 tpn bags were made using the exactamix compounder by the customer.(b)(6) hospital found pyrogens within the nutrition bags which were prepared on their exactamix 2400 compounder.The patients were already in the hospital at the time of the treatment.Patients exhibited symptoms of shivering and general discomfort.Patient status is unknown at this time.Sample returns were requested from the hospital.There are no samples available from (b)(6) hospital to be returned to the manufacturer for an evaluation.A batch review was conducted for lot number: 1000056 and found no previous complaints or non-conformance history.January 22, 2015, the global product surveillance representative located in (b)(4), emailed baxter (b)(4), requesting samples and additional information.January 29, 2015, it was confirmed that the bags used in this event was determined to be bexen parenteral nutrition bags multi-layer.Bexen medical, who manufactures the bags have been notified of this incident.The bags used in this event are not manufactured by baxter healthcare.In regards to the patient status, patients were treated and discharged from the hospital.February 9, 2015, the doctor from (b)(6) hospital concluded that the hospital cannot confirm why the situation occurred.The doctor, also confirmed that there is no additional information available.Evaluation codes no physical device will be returned for an evaluation.Results: unknown.It is unknown what type of pyrogen(s) the hospital/patients experienced.The results are unknown as it is unknown where the pyrogen could have occurred.Conclusion: unable to confirm the complaint.It is unknown where the pyrogen could have occurred.The bags used in this incident are not manufactured by baxter healthcare.Device not available for return.
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