MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER ADSORBA 150C; APPARATUS, HEMOPERFUSION, SORBENT

Catalog Number 115263

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 12/20/2018

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during priming of an adsorba 150 c unit, a carbon leakage was observed.There was no patient involvement with the reported event.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, a photograph of the sample was provided for evaluation.During visual inspection of the provided photos, black particles in the header cap of the dialyzer were visible on one photo.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ADSORBA 150C
• Type of Device: APPARATUS, HEMOPERFUSION, SORBENT
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; hechingen
• MDR Report Key: 8255173
• MDR Text Key: 133334954
• Report Number: 9611369-2019-00003
• Device Sequence Number: 1
• Product Code: FLD
• UDI-Device Identifier: 07332414118167
• UDI-Public: (01)07332414118167
• Combination Product (y/n): N
• PMA/PMN Number: K873643
• 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: 01/30/2019

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: 05/31/2020
• Device Catalogue Number: 115263
• Device Lot Number: 7-655
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/24/2018
• Initial Date FDA Received: 01/16/2019
• Supplement Dates Manufacturer Received: 01/23/2019
• Supplement Dates FDA Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: POLYFLUX DIALYZER: PRODUCT 112466/LOT 8-4912-H-01