MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO ACCESS; SET, BLOOD TRANSFUSION

Catalog Number 2C8750

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned; therefore, an evaluation could not be conducted.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).(b)(6).Should the sample and/or additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a clearlink system y-type blood/solution set allowed solution to flow simultaneously through the primary and secondary lines.The reporter stated that platelets were to be delivered through the secondary line followed by saline delivery through the primary line.The primary line was correctly primed and its clamp was closed.15 minutes into patient infusion, a nurse noticed that the platelets were infusing at too slow of a rate.30 minutes into the infusion, the platelets still had not fully infused while the saline had.This event resulted in the administration of platelets being delayed, with platelet infusion taking approximately twice the expected time.A peripheral ppc draw with morning lab results was planned based on the expected platelet infusion time.There was no patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: ACCESS
• Type of Device: SET, BLOOD TRANSFUSION
• 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: 3546951
• MDR Text Key: 11688174
• Report Number: 1416980-2014-00047
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993120
• 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
• Report Date: 12/09/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C8750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2014
• 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