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

Catalog Number ASKU

Device Problems Disconnection (1171); 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

Additional information: 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.The sample was not returned and the lot number of the device was unknown; therefore, a sample analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

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 an unknown prismaflex set, 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).There was no report of patient injury or medical intervention associated with the event.No additional information is available.

Manufacturer Narrative

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

• Brand Name: NI
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEYZIEU; meyzieu cedex rhone
• MDR Report Key: 8931080
• MDR Text Key: 162745931
• Report Number: 8010182-2019-00173
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2020

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 Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: 08/30/2019; 10/01/2020
• Supplement Dates FDA Received: 09/26/2019; 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX UNIT; SOL.PHOXILIUM
• Patient Outcome(s): Required Intervention