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

Catalog Number 115263

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

Patient Problem No Patient Involvement (2645)

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection revealed a dark grey medium in the camber of the tubing and in the blood line.There were no visible issues with the adsorba.The reported condition was verified.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.

Event Description

It was reported that an active carbon leakage occurred on one unit of adsorba 150 c during priming.There was no patient involvement associated with the reported event.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, three photographs of the sample were provided for evaluation.Visual inspection of the provided photos showed dark grey medium was visible in the camber of the tubing and in the blood line.The cause of the reported issue 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
• Type of Device: APPARATUS, HEMOPERFUSION, SORBENT
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; hechingen
• MDR Report Key: 8750426
• MDR Text Key: 151764131
• Report Number: 9611369-2019-00089
• Device Sequence Number: 1
• Product Code: FLD
• UDI-Device Identifier: 07332414118167
• UDI-Public: (01)07332414118167
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 07/19/2019

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: Other
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 115263
• Device Lot Number: 7-660
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/06/2019
• Initial Date FDA Received: 07/01/2019
• Supplement Dates Manufacturer Received: 06/25/2019
• Supplement Dates FDA Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1