MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX M150; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 109990

Device Problem Disconnection (1171)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762)

Event Date 04/11/2021

Event Type  Injury  

Manufacturer Narrative

The customer reported this event to the fda through medwatch (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during continuous renal replacement therapy (crrt) with a prismaflex m150 set, and prismaflex control unit, a disconnection occurred which led to an external blood loss.The reporter stated they ¿believe¿ an air in blood alarm was generated (no further details).It was reported the tubing was disconnected ¿at the patient connection with the central venous line¿.The estimated blood loss was approximately 500 mls.The extracorporeal blood was not returned as it ¿spilled into the patient¿s bed¿.The reporter stated, ¿the patient may have experienced an air embolism from the open central lines¿.It was reported the patient experienced bradycardia and cardiac arrest.It was reported resuscitation measures were given (cardiopulmonary resuscitation/advanced cardiovascular life support) and aspiration of the central venous line was done ¿in the event of an air embolism¿.It was reported the patient was revived and continued to require vasopressors for blood pressure support.No additional information is available.

Manufacturer Narrative

H10: 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.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX M150
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11876142
• MDR Text Key: 264616072
• Report Number: 8010182-2021-00172
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414090005
• UDI-Public: (01)07332414090005
• Combination Product (y/n): Y
• PMA/PMN Number: K080519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 109990
• Device Lot Number: 20G3104
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 06/22/2021
• Supplement Dates FDA Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX CONTROL UNIT.
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR