MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX TPE 2000 SET; SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA

Model Number 114093

Device Problem Insufficient Information (3190)

Patient Problems Bradycardia (1751); Dyspnea (1816); Nausea (1970)

Event Date 11/28/2017

Event Type  malfunction  

Event Description

Per report: 25 minutes after initiating albumin plasmapharesis, patient complained of shortness of air and nausea - heart rate: 49, blood pressure:107/54.Doctor at bedside asked if allergic reaction to filter.O2 saturation: 85%.As soon as blood returned, patient symptoms subsided.Heart rate up to 73.Blood pressure: 157/58 and sao2 up to 93%.

• Brand Name: PRISMAFLEX TPE 2000 SET
• Type of Device: SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA
• Manufacturer (Section D): GAMBRO INDUSTRIES; 9540 maroon cir; fl 4; englewood CO 80112
• MDR Report Key: 7078487
• MDR Text Key: 93584373
• Report Number: 7078487
• Device Sequence Number: 1
• Product Code: MDP
• 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: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/01/2020
• Device Model Number: 114093
• Device Catalogue Number: 114093
• Device Lot Number: 17H2201A
• Other Device ID Number: 7676172713044900/10000014002
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/29/2017
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2017
• 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
• Patient Age: 67 YR
• Patient Weight: 94