HEMOSPHERE
Received Apr 3, 2025 · Event occurred Mar 12, 2025
Report 2015691-2025-02557 · MDR key 21764522
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ONE HEMOSPHERE PRESSURE CABLE WAS RETURNED FOR EVALUATION. THE OUTER MOST ELECTRICAL CONTACT OF THE FRONT CONNECTOR IS BENT OR STUCK DOWN. THE PRESSURE CABLE CONNECTED TO AND COMMUNICATED WITH A HEMOSPHERE MONITOR. THE UNIT WAS ZEROED, AND A SYSTEM VERIFICATION TEST WAS RAN THREE TIMES. MEAN ARTERIAL PRESSURE VALUES REMAINED WITHIN PARAMETERS. BENDING AND MOVING THE CABLE WOULD NOT PRODUCE ANY ERRORS. CUSTOMER REPORT OF INACCURATE VALUES WAS UNABLE TO BE CONFIRMED. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING OR DESIGN DEFECT. THEREFORE A ROOT CAUSE COULD NOT BE ESTABLISHED.
Additional Manufacturer Narrative
THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO RELATED NON CONFORMANCES WERE FOUND. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW. ADDITIONAL FDA PRODUCT CODES INCLUDE: DQE CATHETER, OXIMETER, FIBER-OPTIC DQK COMPUTER, DIAGNOSTIC, PROGRAMMABLE MUD OXIMETER, TISSUE SATURATION DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE. DSB PLETHYSMOGRAPH, IMPEDANCE. QMS ADJUNCTIVE OPEN LOOP FLUID THERAPY RECOMMENDER. FLL THERMOMETER, ELECTRONIC, CLINICAL.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE THE HEMOSPHERE CABLE PROVIDED INACCURATE VALUES. THE SYSTOLIC BLOOD PRESSURE WAS READING 15 TO 20 POINTS DIFFERENCE FROM THE HEMOSPHERE TO THE ANESTHESIA MONITOR. ONCE THE SUSPECT CABLE WAS EXCHANGED FOR A NEW ONE THE READINGS DISPLAYED AS EXPECTED. THERE WAS NO TREATMENT ADMINISTERED FOR THE INACCURATE VALUES AND NO ALLEGATION OF IS NO PATIENT INJURY.