MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX TPE

Model Number 107144

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Pain (1994); First Use Syndrome (2239)

Event Date 08/17/2016

Event Type  Injury  

Manufacturer Narrative

Event Description

A patient in (b)(6) was undergoing a tpe treatment.Fifteen minutes into treatment and prior to the infusion of albumin, the patient experienced a blood pressure drop, diaphoresis, pallor, oxygen desaturation to 88% followed by severe and intense low back pain.Treatment was discontinued and the blood was returned to the patient.The patient received 300 ml of saline solution, 1g of paracetamol, oxygen @ 2 l/min and inhalation of salbutamol 5 mg.The back pain reportedly lasted for 15 to 20 minutes despite the administration of analgesic drugs.The patient recovered after the event.

• Brand Name: PRISMAFLEX TPE
• Manufacturer (Section D): GAMBRO INDUSTRIES; 7 avenue lionel terray; meyzieu 69883 ; FR 69883
• Manufacturer Contact: thierry palkovics ; 7 avenue lionel terray; meyzieu ; FR ; 472452525
• MDR Report Key: 5967937
• MDR Text Key: 55325580
• Report Number: 8010182-2016-00074
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2019
• Device Model Number: 107144
• Device Lot Number: 16E2007A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2016
• Initial Date FDA Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX (SN UNKNOWN).
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 52