MAUDE Adverse Event Report: BAXTER HEALTHCARE - LUND MONITORS PRISMAFLEX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 955052

Device Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); No Consequences Or Impact To Patient (2199); Loss of consciousness (2418); Blood Loss (2597)

Event Date 08/02/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during continuous renal replacement therapy (crrt) using a prismaflex control unit, an external blood leak was observed.It was reported the return blood line was disconnected from the patient¿s catheter which led to a blood leak to the bed (volume of blood unreported).It was reported an alarm was not triggered.There was no report of patient injury or medical intervention associated with the event.No additional information is available.

Manufacturer Narrative

Additional information added to h6.H10: the device was not returned for evaluation.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information added to b1, b2, b5, b7, h1 and h6.B5: it was reported during follow up that the return blood line became disconnected from the patient¿s catheter leading to an unknown amount of blood leaking into the bed.No alarm was allegedly generated.The patient became hypotensive and loss of consciousness resulting in the administration of unspecified ¿blood products¿.At the time of this report, the patient outcome was not reported.H10: the device was received for evaluation.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Corrected information added to b5 and h10.B5: the total blood loss was approximately 681 ml.H10: the event history log review showed that treatment was ended approximately three hours after starting due to the alarm warning: return extremely positive.The alarm warning: return pressure dropping was issued by the control unit and was cleared by the operator.No warning: return disconnection alarm was issued as the alarm criteria was not met.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.No malfunction of the prismaflex control unit could be identified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - LUND MONITORS; lund skane lan
• MDR Report Key: 8931316
• MDR Text Key: 183130429
• Report Number: 9616026-2019-00050
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K110823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955052
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX SET.; SOL.PHOXILIUM.
• Patient Outcome(s): Required Intervention