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

Device Problems Defective Component (2292); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2022

Event Type  malfunction  

Event Description

Baxter blood warmer unable to connect the external heating probe to the circuit due to a defective connection port.Clinical engineering tech contacted baxter for repair.When vendor came to repair they refused to service device because the cables and blood warmer attached to prismaflex were not the same serial numbered devices they had sent us.We have multiple devices that staff swap parts off of when only part of the device fails.We do this so we can give blood back to patient instead of discarding good blood.Baxter not repairing devices due to mismatching serial numbers puts us at risk of not having enough working devices for patient care.We should not have to be having this argument with a medical device supplier when patient care is paramount.Mfr response: they will not repair the device without the matching serial numbered devices attached to it.

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15707608
• MDR Text Key: 302778004
• Report Number: 15707608
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/27/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/27/2022
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Sex: Female