Model Number 550AHCT |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/28/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Per the manufacturer's subsidiary, the temperature value was the measured value that varied.After a while the value normalized so the device was continued to be used, and the measured values were compared to the lab data for accuracy.The variation had occurred multiple times since last summer.
|
|
Event Description
|
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the blood parameter monitor (bpm) measured values were varying.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per the clinical review: on (b)(6) 2022, the team experienced a problem with the bpm during cpb whereby the temperature measure value had variation.There was no blood loss, no delay, and no change out and the procedure was completed successfully.
|
|
Manufacturer Narrative
|
During laboratory evaluation the product surveillance technician (pst) connected the blood parameter monitor (bpm) to lab use only (luo) testing equipment and was compared against multimeter readings.At 15.0 degrees celsius (c) on the multimeter, the monitor read 14.5 c.At 34.4 c, the monitor read 36.9 c, a difference of 2.5 c.At the higher temperature, a luo bpm was also used as a comparison.The multimeter read 34.2 c and the luo bpm read 33.9 c, a difference of only 0.3 c.It was determined that the bpm was less accurate than the luo bpm.
|
|
Manufacturer Narrative
|
Updated block: h6.The reported complaint was confirmed as there appeared to be a slight variation in the temperature reading, but the unit passed all applicable testing and operated to the manufacturer's specifications.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
|
|
Manufacturer Narrative
|
The service repair technician (srt) could not duplicate the reported complaint.The blood parameter monitor (bpm) powered on and passed self-testing.The arterial bpm passed service mode and intensity testing.The hematocrit saturation (hsat) passed service mode testing.The erasable electronically programmable read only memory (eeprom) contained zero critical errors.The unit operated to the manufacturer's specifications.
|
|
Search Alerts/Recalls
|