MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO ACCESS; FILTER, INFUSION LINE

Catalog Number 2N3342

Device Problems Improper or Incorrect Procedure or Method (2017); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2014

Event Type  malfunction  

Event Description

It was reported that medication was backflowing during use of a non-dehp three lead extension set.The reporter stated that a buretrol set was being used in a setup with a sigma spectrum pump, and was infusing 8ml/hr of saline solution with hyperal total parenteral nutrition.The buretrol set was attached to the device.A smith's syringe pump was connected to an icu medical set, which was connected to the catheter extension set and infusing intralipid at 1.25 ml/hr.Two medications were being given via medline (hydrocortizone and caffeine) with 1l on standby.In an attempt to clear a downstream occlusion alarm on the sigma pump, the setup was reset and the trifuse administration set was changed.The reporter stated that at this point the intralipid backed up.This occurred during infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The reported device was not returned.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).Evaluation: baxter received one used sample of the clearlink buretrol solution set and a non-dehp three lead extension set.The sample was spiked into a 500ml solution bag filled with tpn.Visual inspection showed that the extension set attached to the male luer and was fully primed.There was a pick line with a non-baxter luer activated device attached the extension set.Functional testing was performed by removing the clearlink buretrol set from the solution bag and spiking into an in-house 1000ml solution bag containing distilled water.The setup was then re-primed.An in-house secondary set spiked into an in-house 1000ml solution bag containing distilled water was then attached to the upper and lower y sites with proper head height maintained.The setup was checked for backflow when both y sites were accessed.The returned clearlink buretrol and extension set primed and flowed normally with no back flow noted.The reported condition was not verified and therefore a cause could not be determined.

• Brand Name: ACCESS
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito PR 705
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito PR 705
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3774254
• MDR Text Key: 4444846
• Report Number: 1416980-2014-13520
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2N3342
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/30/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ICU MEDICAL SET; BURETROL SET ((B)(4)); HYPERAL TPN; SALINE SOLUTION ((B)(4)); CAFFEINE; SMITH'S SYRINGE PUMP; HYDROCORTIZONE; MEDLINE; SIGMA SPECTRUM PUMP