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

Catalog Number 113081

Device Problem Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

Alternate telephone number: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during continuous veno-venous hemodiafiltration (cvvhdf), using a prismaflex control unit, multiple alarms were generated which resulted in pediatric patient treatment termination without blood restitution.It was reported the effluent pressure sensor housing was cleaned, then a filter clotted alarm followed by a filter is clotting alarm were generated.Then a transmembrane pressure (tmp) too high alarm occurred.The reporter decreased the blood flow rate from 90 to 40.Subsequently a filter extremely positive alarm was generated.The reporter attempted to return the blood.The reporter aspirated/flushed the return side of the catheter before starting the blood return.The filter extremely positive and return extremely positive alarms occurred.The patient was disconnected and treatment was discontinued without blood restitution of extracorporeal circuit.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: h6 and h10.The device was not received for evaluation; therefore, a device analysis could not be completed.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.

• 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: 8664662
• MDR Text Key: 146938212
• Report Number: 9616026-2019-00032
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/03/2019,07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 113081
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2019
• Distributor Facility Aware Date: 05/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2019
• Date Manufacturer Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.