• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HIDEMAN LUMEN

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HIDEMAN LUMEN Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Abdominal Pain (1685); Diarrhea (1811); Fever (1858); Complaint, Ill-Defined (2331); Malaise (2359); Reaction (2414)
Event Date 04/15/2016
Event Type  Injury  
Event Description

A (b)(6) female with a history of relapsed/relapsed aml (flt3/itd positive, npm1 positive, initially diagnosed (b)(6) 2008) c/b cns disease, s/p mini-haplo bmt (2009), s/p hidac ((b)(6) 2015) and dli ((b)(6) 2015), s/p re-induction with acivp16 ((b)(6) 2015), crenolanib, s/p clag (b)(6) 2016), currently on asp2215 (b)(6) 2016). During her admission from (b)(6) 2016 for clag, she developed neutropenic fever and was started on vanc/zosyn. No source of infection was found, and she was discharged to ipop to continue daily ertapenem as she was still neutropenic. She was admitted again from (b)(6) 2016 after developing another neutropenic fever to 104f with associated abdominal pain and diarrhea. Central cultures from both hickman lumens as well as peripheral blood cultures grew cons sensitive to vancomycin. She was started on vancomycin and ertapenem was changed to zosyn. Her hickman was not removed due to "atresia of large vein and extreme difficulty in establishing central venus access in the past". She defervesced and her diarrhea improved. Subsequent blood cultures on (b)(6) were no growth. The zosyn was narrowed to ertapenem and she was discharged to ipop to continue iv ertapenem and vancomycin for at least 6 weeks. In ipop, posaconazole was changed to micafungin for antifungal prophylaxis given uptrending lfts. Routine central blood cultures were obtained on (b)(6) 2016 in ipop and later returned positive for vre (sensitive to linezolid). Her vancomycin was changed to linezolid on (b)(6) 2016. She has remained on ertapenem and micafungin as well. Subsequent central cultures on (b)(6) grew cons (sensitive to vancomycin and linezolid). No peripheral cultures were sent. Central cultures on (b)(6) were no growth. She has not had any further vre in her cultures. Repeat blood cultures on (b)(6) grew cons again. She has had ongoing diarrhea and malaise over this time period. Given the recurrent positive blood cultures, she is being admitted for line removal and iv antibiotics. Of note,tte obtained on (b)(6) 2016 was notable for ef 35-40%, decreased from 55% on (b)(6) 2016 and 65% on (b)(6) 2016, as well as diastolic dysfunction.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHIDEMAN LUMEN
Type of DeviceHIDEMAN LUMEN
MDR Report Key5593456
MDR Text Key43524614
Report NumberMW5061818
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation NURSE
Type of Report Initial
Report Date 04/18/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/18/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/18/2016 Patient Sequence Number: 1
-
-