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


  • 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

Device Problems Use of Device Problem (1670); Obstruction of Flow (2423); Detachment of Device or Device Component (2907)
Patient Problems Bacterial Infection (1735); Bacterial Infection (1735); Death (1802); Death (1802); Laceration(s) of Esophagus (2398); Laceration(s) of Esophagus (2398); Iatrogenic Source (2498); Iatrogenic Source (2498)
Event Date 01/07/2016
Event Type  Death  
Event Description
The reporter states that (b)(6) 2016, that there was an emergency pure transfer of her mother to another facility from the current facility that she was at. The reporter states that her mother's medical condition was not properly disclosed to her despite having power of attorney privileges. She states that due to the improper use of the feeding tube. The device clogged up and also had bacteria that was pulling up on the tube. She further states that a nurse at the facility, placed water in the feeding tube, improperly. The reporter states that there was an issue with the lung bypass machine, in which part of detached and caused a laceration in the pt's esophagus leading to a localized bacterial infection. The reporter also states that the collar for the trach tube collar kept becoming detached from the area where it needed to stay attached. She goes on to state that the kangaroo pump that the pump was not delivering the water flushes as designated. The reporter states that a lot of the events suffered by her mother were latrogenic in nature.
Event Description
Add'l info received on phone by reporter on 07/23/2018 for mw5078471. Reporter stated that on (b)(6) 2016, her mother was placed on the bypass machine for 24 hrs without food, water or rest and no monitoring was in place for her mother's blood gases. Reporter stated that pt went on for three straight days with indefinite "no monitoring". The pt chewed a piece of plastic from the mouthpiece, and the pressure from the bypass forced the piece of plastic down to her throat and she ended up with a (b)(6) infection. Reporter stated that pt could have ended up with the piece of plastic in her lungs or stomach. There was bleeding in her mouth and streaks of blood on her right cheek definitive of an injury. The nurse was unable to find the piece of plastic. (b)(6) introduced antibiotics for 7-20 days for pneumonia. There were sores infected with (b)(6) on her right gluteal that never healed. Reporter mentioned that hospital was aware pt had sepsis from her picc line as early as (b)(6) 2018, but no one brought ths to her attention. (b)(6) has multiple pumps that malfunctioned and unable to deliver flushes. It took 3 pumps to find the one that worked. Pt was given a very small feeding tube which was easy to get clogged related to less water flushes. Pt was sent to (b)(6) and got less water flushes. A nurse placed a tie on the tube and attached this to the abdomen which caused to tube to clog, causes malnutrition and dehydration for pt. The tie was twisted and pt's supplements could not flow through the tube. Personnel at the hospital declogged the tube with (b)(6). Reporter stated that these was "adverse treatment. " reporter stated that early 2016, a new policy was put in place at (b)(6) that stopped the use of foley catheter to get urine samples, and commenced with use of the closed system (straight catheter). Reporter stated that the closed system does not allow sediments and pus to be drained out. This made her mother present with "corn flakes size" sediments sitting in her for 5 months. She was taken to (b)(6) where foley catheter was used and copious amounts of sediments and pus were drained out of her bladder. Pt was admitted to the hospital on the following dates: (b)(6) 2016, and all along uti had been building up, causing her to have sepsis. On (b)(6) 2018, pt's blood thinner was discontinued abruptly by dr and no (such as baby aspirin) was used. Pt had a stroke and died on (b)(6) 2016.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

MDR Report Key7702161
MDR Text Key114543430
Report NumberMW5078471
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial,Followup
Report Date 07/23/2018
5 Devices were Involved in the Event: 1   2   3   4   5  
2 Patients were Involved in the Event: 1   2  
Date FDA Received07/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/18/2018 Patient Sequence Number: 0