MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX MONITOR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 03/14/2018

Event Type  Injury  

Event Description

Prisma alarmed with a communication error requiring that set be removed from patient and did not allow rn to return any blood to patient.Shortly after the set was removed from the patient, the blood pressure quickly started dropping into 50's requiring an increase in pressors, arterial blood gas, and added labs.

• Brand Name: PRISMAFLEX MONITOR
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO INDUSTRIES; 32650 n. wilson rd.; round lake IL 60073
• MDR Report Key: 7384695
• MDR Text Key: 103938785
• Report Number: 7384695
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2018,03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 79