MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ADSORBA 300; APPARATUS, HEMOPERFUSION, SORBENT

Catalog Number 115264

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a carbon leak was observed from an adsorba 300c when connected with a polyflux 17l.The event happened before patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information: h3, h6 and h10.The actual device was not available; however, two photographs of the sample were provided for evaluation.Visual inspection of the first provided photo showed the polyflux filter had two black particles in the header area.It was not clearly visible if the particles originated from the adsorba.The reported condition was verified.Visual inspection of the other photograph showed the adsorba filter with the product label.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.As the actual device was not returned, the cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ADSORBA 300
• Type of Device: APPARATUS, HEMOPERFUSION, SORBENT
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11267080
• MDR Text Key: 231329006
• Report Number: 9611369-2021-00014
• Device Sequence Number: 1
• Product Code: FLD
• UDI-Device Identifier: 07332414118174
• UDI-Public: (01)07332414118174
• Combination Product (y/n): Y
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

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: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 115264
• Device Lot Number: 0-505
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: POLYFLUX 17L