MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 101025

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that upon connecting the patient to a gambro cartridge set, the arterial patient line disconnected from the arterial injection port.Only saline was in the lines at the time of the event.A new set was used to continue with treatment.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: h10: the actual device was not available; however, three photographs of the sample were provided for evaluation.The visual inspection revealed the arterial patient line was detached from the arterial injection port.The reported condition was verified.Pictures are not clear enough to determinate if solvent was applied to the line.The cause could be associated to an operational deviation in which the operator omitted to apply enough solvent during the assembly of the involved component.A nonconformance has been opened to address this issue.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: CARTRIDGE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10387511
• MDR Text Key: 202986975
• Report Number: 8030638-2020-00011
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 07332414007836
• UDI-Public: (01)07332414007836
• Combination Product (y/n): Y
• PMA/PMN Number: K070414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2022
• Device Catalogue Number: 101025
• Device Lot Number: 1000240326
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/15/2020
• Event Location: Hospital
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1