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

Catalog Number 101025

Device Problems Disconnection (1171); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that while using a gambro cartridge dn prime line, during the return of extracorporeal blood at completion of treatment, the arterial blood line became disconnected from the arterial injection port, resulting in "very minimal" blood loss.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the actual sample and some pictures were received for evaluation.The reported condition was verified.The arterial patient line was detached from the arterial injection port.The cause was attributable to the manufacturing process when the operator does not follow the wetting technique according to work instruction.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Specific actions have been initiated at the manufacturing site in order to improve the manufacturing process of the lines, avoiding this type of issue reoccurring.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction: removal of information in section f related to importer - the initial report inadvertently included the importer report number.This mdr should have been submitted only with the mfr.Number (and not as importer).

• Brand Name: CARTRIDGE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): BAXTER HEALTHCARE - TIJUANA BAJA; tijuana baja california
• MDR Report Key: 9194442
• MDR Text Key: 182986134
• Report Number: 8030638-2019-00015
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 07332414007836
• UDI-Public: (01)07332414007836(10)1000218866(17)220215
• Combination Product (y/n): N
• 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,Followup
• Report Date: 10/15/2019,12/18/2020

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: 02/15/2022
• Device Catalogue Number: 101025
• Device Lot Number: 1000218866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2019
• Distributor Facility Aware Date: 09/20/2019
• Event Location: Other
• Date Report to Manufacturer: 10/15/2019
• Initial Date Manufacturer Received: 09/20/2019
• Initial Date FDA Received: 10/15/2019
• Supplement Dates Manufacturer Received: 10/23/2019; 12/17/2020
• Supplement Dates FDA Received: 11/11/2019; 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1