MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Catalog Number ASKU

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2022

Event Type  malfunction  

Manufacturer Narrative

Lot #: the lot number reported, mpsg860, is not a valid baxter number.Initial reporter facility name : (b)(6) hospital.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during treatment with unknown baxter catheter, a blood leak was observed.During continuous venovenous hemofiltration, blood was observed ¿oozing¿ from the return line (blue lumen).An unspecified volume of blood was observed on the patient¿s pillow and hair.Therapy was stopped.Upon further inspection, the lumen above the clamp was observed ¿split¿.Therapy was discontinued and the catheter was replaced.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: upon further review of the provided photographic samples it was verified this product is not a baxter device.Therefore, baxter does not have reporting rights for this product.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NI
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - HECHINGEN CATHETER; linsenacker 1; hechingen 72379 ; GM 72379
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16734175
• MDR Text Key: 313236069
• Report Number: 3004367028-2023-00003
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1