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

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2021

Event Type  malfunction  

Event Description

Preventative maintenance (pm) is due on our baxter prismax crrt machines due to lack of available supplies to complete the activity.Machine preventative maintenance (pm) due dates varied by machine but were all due in winter.The kit to perform pm was obtained from baxter however there is also a syringe required to calibrate the heparin administration device.Pm cannot be completed until calibration syringe is obtained.Biomed has contacted baxter on multiple occasions to order the syringe.When the order was not fulfilled, biomed reached out to the syringe manufacturer to see if it could be ordered from them.They are unable to provide the syringe directly to the customer.Clinical staff contacted baxter educator, sales manager, and sales rep for our facility.None of them were able to assist with obtaining the syringe.Our baxter technician visited to work on a warranty covered item but he was unable to supply us with a syringe either.Baxter was asked to provide the pm service since their technicians have the calibration syringe.The cost was approximately(b)(6) per machine for them to do the service.It would not be covered as part of the warranty and would not be compensated due to lack of supply availability.

• Brand Name: PRISMAXPRISMAX SYSTEM
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; 1 baxter pkwy; deerfield IL 60015
• MDR Report Key: 14458005
• MDR Text Key: 295251453
• Report Number: 14458005
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/10/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1