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); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that while the patient was connected to a gambro cartridge dn prime line, the ¿tubing disconnected slightly at the medication port and leaked blood around it¿.The amount of external blood loss was not reported.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The actual sample was received for evaluation, however, the sample could not be analyzed as it was fully contaminated with blood.Eight retained samples were evaluated.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A manual pull was applied to the join between the tubes of the arterial inclined access site and venous inclined access site, which revealed the tubes were connected into of the inclined access sites correctly.It was observed that there was solvent presence in all samples inspected.No abnormalities were identified that could have contributed to the reported condition.The reported condition was not verified.The cause of the condition was not determined.This issue is being further investigated.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.

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: 8893707
• MDR Text Key: 182985374
• Report Number: 8030638-2019-00012
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 07332414007836
• UDI-Public: (01)07332414007836
• 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: 08/14/2019,12/17/2020

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 Expiration Date: 04/15/2022
• Device Catalogue Number: 101025
• Device Lot Number: 1000223073
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/14/2019
• Distributor Facility Aware Date: 07/23/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2019
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 08/20/2019; 12/17/2020
• Supplement Dates FDA Received: 09/16/2019; 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1