FDA Adverse Event
Death
Summary report: N
HUDSON VOLDYNE VOLUMETRIC DEVICE
MDR report key: 11811898
·
Received May 11, 2021
Report
- Report Number
- MW5101288
- Event Type
- Death
- Date Received
- May 11, 2021
- Date of Event
- August 20, 2017
- Report Date
- May 8, 2021
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BWF
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- NO INFORMATION
Narratives
Description of Event or Problem · 1
AN (B)(6) YEAR OLD CONGESTIVE HEART FAILURE /ACUTE KIDNEY INJURY, DIZZINESS, LIGHTHEADED PATIENT COUGHING UP PHLEGM WITH COARSE CRACKLES ON OXYGEN THERAPY, NON-AMBULATORY/WEAK PATIENT WAS REQUIRED TO USE A HUDSON VOLDYNE VOLUMETRIC DEVICE CAUSING PATIENT TO NOT PROCESS IV FLUIDS PROPERLY IS GIVEN MORPHINE LEADING TO CARDIAC ARREST AND INTUBATED DUE TO SEVERE ANOXIA, POSSIBLE PULMONARY EMBOLISM, SEVERE SEPSIS. HUDSON VOLDYNE VOLUMETRIC DEVICE WOULD PROVIDE PATIENT SAFETY BY PLACING A WARNING LABEL FOR PATIENTS OVER THE AGE APPROPRIATE GUIDELINES OF 80 ON THEIR DEVICE PAMPHLET. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 705987 | HUDSON VOLDYNE VOLUMETRIC DEVICE | SPIROMETER, THERAPEUTIC (INCENTIVE) | BWF | TELEFLEX MEDICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Death| L |