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

Catalog Number 2C8750

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2014

Event Type  malfunction  

Event Description

It was reported that the tubing of a clearlink blood/solution set disconnected from the y-site of the set and was leaking.The reporter stated that this occurred during infusion of blood to the patient at a rate of 125cc/hour with an unknown pump.It was reported that the leaking blood came in contact with the patient; however, there was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is in progress.Upon completion of the investigation, or if any additional relevant information is received, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).This unknown lot could have been produced at either the (b)(4) manufacturing site.The baxter healthcare - (b)(4).The baxter healthcare - (b)(4) address was provided in the initial mdr.Evaluation summary: visual inspection of the returned device found no separations; however, while the sample was being disinfected, the male luer separated from the tubing.Microscopic examination of the tubing end found that there was no visible solvent plow ridge.The remaining solvent bonds were then pull tested with no failures noted.The reported condition was verified.The cause of the separation was unable to be determined.In order to further investigate this condition, a capa was opened.Should additional relevant information become available, a follow up report will be submitted.

• Brand Name: ACCESS
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; parque industrial itabo, zona; haina ; DR
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; parque industrial itabo, zona; haina ; DR
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 4102740
• MDR Text Key: 4839351
• Report Number: 1416980-2014-32313
• 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: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/26/2014

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/01/2014
• Initial Date FDA Received: 09/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2014
• 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: UNKNOWN INFUSION PUMP