MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION AUTOMATED COMPOUNDING DEVICE INLET. NON-VENTED HIGH VOLUME INLET FOR BAGS OR VEN; NON VENTED HIGH VOLUME INLET (173)

Model Number 174

Device Problem Insufficient Information (3190)

Patient Problem Fever (1858)

Event Date 11/19/2014

Event Type  No Answer Provided  

Event Description

Multiple records identified: 5 of 8 records.On (b)(6) 2015, baxter (b)(4), was notified that on (b)(6) 2014, the head of the pharmacy service at (b)(6) reported of 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.

Manufacturer Narrative

As detailed later in the investigation, the bags were not manufactured by baxter healthcare.On november 19, 2014, 34 tpn bags were made using the exactamix compounder by the customer.(b)(6) 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) to be returned to the manufacturer for an evaluation.A batch review was conducted for lot number: 801537 and found no previous complaints or non-conformance history.January 22, 2015, the global product surveillance representative located in englewood, colorado, emailed baxter europe, 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.(b)(6) 2015, the doctor from h(b)(6) concluded that that the hospital cannot confirm why the situation occurred.The doctor, also confirmed that there is no additional information available.Evaluation codes method: (code unspecified).No physical device will be returned for an evaluation.Results: unknown (unk).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 evaluation.

• Brand Name: AUTOMATED COMPOUNDING DEVICE INLET. NON-VENTED HIGH VOLUME INLET FOR BAGS OR VEN
• Type of Device: NON VENTED HIGH VOLUME INLET (173)
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 14445 grasslands drive; englewood CO 80112
• Manufacturer Contact: phone vang ; 9540 s maroon circle; # 400; englewood, CO 80112 ; 3037846639
• MDR Report Key: 4508987
• MDR Text Key: 22069426
• Report Number: 1419106-2015-00007
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K002705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 174
• Device Catalogue Number: H93174
• Device Lot Number: 801537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/20/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other