TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Description of Event or Problem

AS REPORTED, IN SEVERAL OCCASIONS IN THE PAST, WHEN TACKING BLOOD SAMPLE OF DISPOSABLE PRESSURE TRANSDUCER WITH VAMP WITH A LUER SLIP SYRINGE, VACUTAINER AND GAS SYRINGES DID NOT STAY IN SITU WELL AND THE LASS VALVE GOT STUCK, CAUSING BLOOD CLOT FORMATION AND MINIMAL BLOOD SPLASH WHEN IT SLIPPED OUT OF THE PORT. NO AIR ENTERED INTO THE PATIENT. SOME OCCASIONS STAFF HAVE BEEN SPLASHED IN THEIR FACE/EYES AND HAD TO GO TO ED TO HAVE BLOODS TAKEN AND OH APPOINTMENT. THE TEST RESULTS WERE OK. IN ADDITION, WHEN RETURNING THE BLOOD FROM THE VAMP RESERVOIR TO THE PATIENT, THERE WAS MINIMAL BLOOD LEAKAGE AT THE SAMPLE PORT. SALES REPRESENTATIVE RECOMMENDED TO USE LUER LOCK SYRINGES TO ENSURE A SECURE CONNECTION TO THE PORT. THERE WAS NO ALLEGATION OF PATIENT INJURY.

Additional Manufacturer Narrative

BASED ON FURTHER INFORMATION PROVIDED, UPDATED SECTION B5: NO AIR ENTERED INTO THE PATIENT. THE PERSONNEL TEST RESULTS WERE OK; REMOVED FROM SECTION H6 (DEVICE CODE) 4062 - AIR/GAS IN DEVICE ADDED INFORMATION TO SECTION H6 (TYPE OF INVESTIGATION). UPDATED SECTION H6 (COMPONENT CODE), H6 (INVESTIGATION FINDINGS) AND H6 (INVESTIGATIONS CONCLUSIONS). NO PRODUCT WAS RETURNED FOR EVALUATION; IT WAS DISCARDED AT THE HOSPITAL. WITHOUT THE RETURN OF THE PRODUCT, IT IS NOT POSSIBLE TO DETERMINE IF DAMAGES OR DEFECTS EXISTED ON THE PRODUCT, NOR COULD A ROOT CAUSE OR POTENTIAL CONTRIBUTING FACTORS BE IDENTIFIED. THE LOT NUMBER FOR THIS DEVICE WAS NOT SUPPLIED; THEREFORE, FURTHER REVIEW OF THE RELATED MANUFACTURING RECORDS COULD NOT BE PERFORMED.

Description of Event or Problem

AS REPORTED, IN SEVERAL OCCASIONS, WHEN TACKING BLOOD SAMPLE OF THIS DISPOSABLE PRESSURE TRANSDUCER WITH VAMP WITH A LUER SLIP SYRINGE, VACUTAINER AND GAS SYRINGES DID NOT STAY IN SITU WELL AND THE LASS VALVE GOT STUCK, CAUSING BLOOD CLOT FORMATION, AIR IN THE LINE AND MINIMAL BLOOD SPLASH WHEN IT SLIPPED OUT OF THE PORT. AT LEAST IN TWO OCCASIONS, STAFF HAVE BEEN SPLASHED IN THEIR FACE/EYES AND HAD TO GO TO ED TO HAVE BLOODS TAKEN AND OH APPOINTMENT. IN ADDITION, WHEN RETURNING THE BLOOD FROM THE VAMP RESERVOIR TO THE PATIENT, THERE WAS MINIMAL BLOOD LEAKAGE AT THE SAMPLE PORT. SALES REPRESENTATIVE RECOMMENDED TO USE LUER LOCK SYRINGES TO ENSURE A SECURE CONNECTION TO THE PORT. THERE WAS NO ALLEGATION OF PATIENT INJURY.

Additional Manufacturer Narrative

THE DEVICE IS NOT AVAILABLE FOR EVALUATION SINCE IT WAS DISCARDED, AN ENGINEERING INVESTIGATION WILL BE PERFORMED IN ORDER TO CONSIDER ANY POTENTIAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT. 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 PART OF THIS MONTHLY REVIEW.