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

Catalog Number 103401

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that, as soon as the treatment started with a gambro cartridge set, an external blood leakage was observed from a detached blood pump segment line.The volume of the external blood loss was unknown.Treatment was ended without blood restitution.It was reported the patient received an injection of a hematopoietic agent (epo) ¿more than 10000 iu¿.There was no report of patient injury associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: h6 and h10.The actual device was not available; however, photographs and a drawing of the sample were provided for evaluation.Visual inspection of the provided pictures showed that there was an external blood leak; however, it was not possible to identify the exact point where the leak was generated.The reported condition was verified.The drawing showed the location of the reported event was at the joint between pump tube pn and the cartridge port #7.As the actual device was not returned, the cause for 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: 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: 8906288
• MDR Text Key: 182985421
• Report Number: 8030638-2019-00013
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

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: Health Professional
• Device Catalogue Number: 103401
• Device Lot Number: 1000217366
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 08/26/2019
• Supplement Dates FDA Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1