MAUDE Adverse Event Report: BAXTER HEALTHCARE - BROOKLYN PARK THERMAX BLOOD WARMER DISPOSABLE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 955516

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.The rupture of the blood warmer bag was associated with a use error when performing the manual blood restitution to the patient.The manual clamp on the return line was not released by the operator before using the crank.Manual blood return instructions are provided in the prismax operator's manual which is provided with every prismax monitor.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported during continuous renal replacement therapy (crrt), using a thermax blood warmer bag, a use error occurred which led to an external blood leak.It was further specified that the event occurred due to an incorrect manual blood restitution procedure.It was reported the healthcare professional did not release the clamp on the return line before using the crank.The amount of external blood loss was estimated to be 50 ml.It was reported the blood was not returned to the patient.It was reported the patient ¿remained stable¿.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: THERMAX BLOOD WARMER DISPOSABLE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - BROOKLYN PARK; minneapolis MN
• Manufacturer (Section G): BAXTER HEALTHCARE - BROOKLYN PARK; 7601 northland drive; n suite 170; minneapolis MN 55428
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9049147
• MDR Text Key: 216645455
• Report Number: 3003504604-2019-00007
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/13/2019

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: 955516
• Device Lot Number: 18K01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 09/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1