MAUDE Adverse Event Report: MALLINCKRODT PHARMACEUTICALS THERAKOS ECP; EXTRACORPOREAL PHOTOPHERESIS

Device Problem Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Stacking Breaths (1593)

Event Date 06/19/2018

Event Type  Injury  

Event Description

Patient receiving extracorporeal photopheresis (ecp) for gvhd after bmt.Had increasing sob and was found to have bilateral pes by v/q scan.Per the fda's letter to healthcare providers, i am reporting this.There is nothing specific to make us think that the ecp led to the pe, we are reporting since asked by the fda.

• Brand Name: THERAKOS ECP
• Type of Device: EXTRACORPOREAL PHOTOPHERESIS
• Manufacturer (Section D): MALLINCKRODT PHARMACEUTICALS
• MDR Report Key: 7645574
• MDR Text Key: 112842825
• Report Number: MW5078116
• Device Sequence Number: 1
• Product Code: LNR
• 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: 06/25/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2018
• 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: 34 YR
• Patient Weight: 85