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

Catalog Number 2C8750

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that a clearlink system y-type blood/solution set would not flow.This occurred during infusion of packed red blood cells after chemotherapy; the device was being used with an unknown infusion pump.The reporter stated that they had a problem with ¿the 2nd chamber of the blood tubing filling with air and not dripping from the 1st chamber.¿ it was reported that the set had been primed ¿appropriately,¿ including inverting the filter to ensure saturation.It was further reported that the air did not reach the patient.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The reporter stated that the patient's height was (b)(6).The unknown lot number could have been produced in either (b)(4).The addresses for both manufacturing sites are: baxter healthcare (b)(4).The actual device was not received for evaluation; however, a photograph of the device has been received.Upon completion of the investigation, or if any additional relevant information is received, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Evaluation summary: the photographic inspection did not identify any malfunctions or abnormalities.If additional relevant information is obtained, then a follow-up mdr will be submitted.

• Brand Name: ACCESS
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE
• Manufacturer (Section G): BAXTER HEALTHCARE
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3899421
• MDR Text Key: 4428026
• Report Number: 1416980-2014-20516
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C8750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/30/2014
• Initial Date FDA Received: 06/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/22/2014
• Was Device Evaluated by Manufacturer?: No
• 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: UNKNOWN INFUSION PUMP; PACKED RED BLOOD CELLS
• Patient Weight: 44