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

Catalog Number ASKU

Device Problems Crack (1135); Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 12/10/2022

Event Type  malfunction  

Event Description

It was reported that during treatment with unknown baxter catheter, a blood leak was observed.During continuous venovenous hemofiltration, the patient's catheter become dislodged and the patient's bed had an unknown volume of blood on it.Pressure was applied with gauze and the return line was disconnected from the catheter housing.Upon closer inspection of line, the blue housing was noted to have a crack in the return line of the housing.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

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.

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: 16733176
• MDR Text Key: 313235876
• Report Number: 3004367028-2023-00002
• 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

• 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
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 05/11/2023
• 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