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

Catalog Number 2N3342

Device Problem No Flow (2991)

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

Event Date 03/30/2014

Event Type  malfunction  

Event Description

It was reported that a 3 lead extension set experienced no flow.It was reported that the nurse attempted to straighten the line/patient¿s arm and flush the line but was not successful; flow did not occur.There was no patient injury or medical intervention associated with this event.Additional information was requested and is not available.

Manufacturer Narrative

(b)(4).If the sample becomes available for evaluation or any relevant information is obtained that is related to the reported event, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).It was reported that the patient experienced hypoglycemia as a result of this event should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Evaluation summary: baxter received a 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 it 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: 3767138
• MDR Text Key: 4465150
• Report Number: 1416980-2014-13083
• 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: Nurse
• 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: 04/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2N3342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2014
• 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: CLEAR LINK BURETROL SOLUTION SET