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

Catalog Number 115269

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during treatment with a prismaflex machine, the device had a missing blood pump crank.It was reported that blood was not returned to the patient a total of three times.The amount of blood loss was not reported.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: h3, h6 and h10.The monitor was evaluated on site by a qualified technician.Visual inspection found a missing crank on the device.The reported condition of missing crank was verified.To resolve the issue, the qualified technician replaced the missing blood pump crank.The cause of the condition could not be determined.The qualified technician performed prime, priming test and a 30 minute simulated treatment with no issues noted.The reported condition of blood loss was not verified.The cause of the condition could not be determined.A device history review revealed no issues that could have caused or contributed to the reported issue.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 CORPORATION; deerfield IL
• MDR Report Key: 11315064
• MDR Text Key: 247749379
• Report Number: 9616026-2021-00007
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414117702
• UDI-Public: (01)07332414117702(21)
• Combination Product (y/n): Y
• PMA/PMN Number: K131516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

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: 115269
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 03/17/2021
• Supplement Dates FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1