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

Model Number N/A

Device Problems Failure to Infuse (2340); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter's address: (b)(6).The device was not returned; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a prismaflex machine did not deliver calcium chloride to the patient during continuous renal replacement therapy (crrt).The machine did not present an alarm.The reporter stated that five hours after the calcium syringe was changed, it was noted that the full volume (50ml) remained in the syringe.The issue was discovered when the value was not as anticipated during testing (further details not provided).The calcium line was changed from cdk (central dialysis catheter) to cvk (central venous catheter) and the treatment continued without further incident.The prismaflex machine was inspected by local service with no issues found, and is still in use at the clinic.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: product code, 510k number.The device was not received for evaluation.The event history log was analyzed and the analysis showed that no calcium was delivered between the change syringe procedure during treatment.A condition where the calcium syringe pump became inactive unexpectedly has been verified; however, the cause of the condition could not be determined.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: 7438763
• MDR Text Key: 106014306
• Report Number: 9616026-2018-00007
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• 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: 06/11/2018

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 Model Number: N/A
• Device Catalogue Number: 107493
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/17/2018
• Supplement Dates Manufacturer Received: 06/08/2018
• Supplement Dates FDA Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CALCIUM CHLORIDE SYRINGE