MAUDE Adverse Event Report: TERUMO BCT, INC. SPECTRA OPTIA EXCHANGE SET; SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC

Model Number 190403330

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

Patient Problems Hypoxia (1918); Pain (1994); Chest Tightness/Pressure (2463)

Event Date 05/08/2019

Event Type  Injury  

Event Description

Pt is a sickle-cell disease pt undergoing depletion red blood cell exchange; 12 mins into the depletion phase, the pt experienced a feeling of "water in his ears", chest tightness, cough, pain, and hypoxemia with oxygen saturations in the mid-80s.His symptoms resolved with 40mg iv pepcid and 4l oxygen via nasal cannula.Fda safety report id# (b)(4).

• Brand Name: SPECTRA OPTIA EXCHANGE SET
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC
• Manufacturer (Section D): TERUMO BCT, INC.
• MDR Report Key: 8608017
• MDR Text Key: 145149870
• Report Number: MW5086595
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/09/2019

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 Model Number: 190403330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 75