MAUDE Adverse Event Report: BAXTER CORPORATION TPN PC+ SFTW INSTALL

Model Number 03-3

Device Problems Use of Device Problem (1670); Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Toxicity (2333)

Event Date 06/01/2013

Event Type  Death  

Event Description

This report details an incident involving our mm12/23 compounder.The compounder is an automated pumping system that compounds multiple sterile ingredients into a finished solution, and is designed for the preparation of total parenteral nutrition (tpn).On (b)(6), 2014 a baxter installer was onsite at the customer's facility to install a new exactamix line of compounder.He was told at that time about a patient involved issue that could have involved the baxa/baxter tpn compounding device.The installer was told that in (b)(6) 2013, there were 15 neonates that were poisoned by a heparin product in which 9 patients passed away.The heparin used in this case was a manual add by the customer and therefore, did not involve the baxa/baxter compounding device.However, we are filing a mdr report because, if repeated, the event could require intervention or contribute to a serious patient injury or possible death.If additional information regarding this event becomes available, a follow-up report will be submitted.

Manufacturer Narrative

Evaluation codes: method: no testing methods performed.There was no alleged defect or malfunction of the baxa/baxter device; therefore, there was no need for further device testing.The event was caused by a problem with the heparin used in the tpn solution.The heparin was a manual add ingredient and did not involve the baxa/baxter compounding device.Results: device performed according to specifications.Conclusions: no device failure.Summary: the investigation found that the cause of the event was due to a manually added ingredient.There was no defect or malfunction of the tpn compounder.No further action is required at this time.Should additional information regarding this event become available, a follow-up report will be submitted.

Event Description

The following report involves 15 patients.This mdr is being submitted for the first patient.During the installation of the exacta mix compounder at the customer site in (b)(6) 2014, the installer was made aware of an incident involving 15 neonates, 9 of which did not survive infusion of their tpn.The patient injuries and deaths occurred in (b)(6) 2013.No additional patient information was provided.The tpn was compounded using the tpn pc+ software and an mm12/23 compounder.Through communications between the installer and the hospital representative, the heparin was believed to be ordered as a manual ingredient by the software; therefore, this complaint was initiated against the software.The hospital would not allow access to the compounder or software in order for the installer to perform any troubleshooting or root cause investigation, since they were in the middle of performing their own investigation.After the installation was complete, additional communications confirmed that the issue was due to the incorrect ingredient being manually added to the tpn by the hospital.Heparin containing benzyl alcohol was administered to the neonates.Without access to the software or compounder device involvement cannot be determined.However, the customer admitted to using heparin combined with benzyl alcohol to compound the tpn bags for the neonates.

Manufacturer Narrative

Not returned to manufacturer.

• Brand Name: TPN PC+ SFTW INSTALL
• Type of Device: TPN PC+ SFTW INSTALL
• Manufacturer (Section D): BAXTER CORPORATION; 14445 grasslands dr; englewood CO 80112 706
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; 14445 grasslands drive; englewood CO 80112
• Manufacturer Contact: lou fearing ; 9540 maroon circle; englewood, CO 80112
• MDR Report Key: 4202858
• MDR Text Key: 4960631
• Report Number: 1419106-2014-00014
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: PM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 03-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening