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

Catalog Number 101025

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during dialysis treatment with a gambro cartridge dn prime line, a leak was noted coming from the dialyzer line just below the connection to the dialyzer.It was reported that a transverse break was observed on the line.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information d10 (concomitant medical products), h3 (device evaluated by mfr), h6 and h10.H10: the actual sample was received for evaluation, however, the sample could not be analyzed as it was fully contaminated with blood.The reported condition was not verified.The cause of the condition was not determined.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: 8970270
• MDR Text Key: 182985860
• Report Number: 8030638-2019-00014
• Device Sequence Number: 1
• Product Code: FJK
• 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,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2019,12/17/2020

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 Catalogue Number: 101025
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2019
• Distributor Facility Aware Date: 08/12/2019
• Event Location: Other
• Date Report to Manufacturer: 09/06/2019
• Initial Date Manufacturer Received: 08/12/2019
• Initial Date FDA Received: 09/06/2019
• Supplement Dates Manufacturer Received: 09/25/2019; 12/17/2020
• Supplement Dates FDA Received: 10/08/2019; 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1