MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX TPE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)

Event Date 04/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A patient was treated with therapeutic plasma exchange (tpe), using a prismaflex tpe 2000 set and a prismaflex control unit for the first time.About 15 minutes after treatment start, once the first albumin bag had been infused, the patient reportedly became pale and felt unwell.The patient reportedly presented with a significant blood pressure drop to 70/50 mmhg, and their oxygen saturation was at 90% whereas they had no respiratory history.Treatment was discontinued and the patient received a bolus of 100 ml of isotonic saline solution, which led to an increase of blood pressure to 90/50 mmhg 10 minutes later.The physician suspected a hemolysis without back pain.No additional information is available.

• Brand Name: PRISMAFLEX TPE
• Manufacturer (Section D): GAMBRO INDUSTRIES; 7 avenue lionel terray; meyzieu 69883 ; FR 69883
• Manufacturer (Section G): GAMBRO INDUSTRIES; 7 avenue lionel terray; meyzieu ; FR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6568360
• MDR Text Key: 75209267
• Report Number: 8010182-2017-00030
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P830063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 107144
• Device Lot Number: 17A1806
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 72