ABVISER - INTRA ABDOMINAL PRESSURE MONITOR DEVICE

Additional Manufacturer Narrative

A USED AUTOVALVE PRODUCT SAMPLE WAS RETURNED FOR PHYSICAL ANALYSIS TO DETERMINE THE POTENTIAL ROOT CAUSE. THE UNIT WAS OPENED, AND PROPER ASSEMBLY AND COMPONENTS WERE VERIFIED. THE FILTER WAS CLEANED AND A PARTICLE WAS FOUND LODGED IN THE 0.0015" DIAMETER LASER DRILLED TIMING HOLE, WHICH HAD PREVENTED IT FROM DRAINING. PRODUCT MONITORING REVIEWS WILL CONTINUE TO MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. NO FURTHER ACTIONS ARE REQUIRED, AND THE COMPLAINT WILL BE CLOSED. NO ADDITIONAL PATIENT/ EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

Additional Manufacturer Narrative

EXP DATE 05/2017. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE AUTO-VALVE IN THE ABVISER INTRA-ABDOMINAL PRESSURE MONITOR WOULD NOT DEFLATE AFTER 60 HOURS OF USE. THE DEVICE WAS REMOVED AND REPLACED, NO PATIENT HARM RESULTED DUE TO THE REPORTED COMPLAINT.

Additional Manufacturer Narrative

NO PREVIOUS INVESTIGATIONS ARE AVAILABLE. A DETAILED, SIX (6) MONTH BATCH RECORD REVIEW FOR THE ASSOCIATED LOT WAS CONDUCTED AND REVEALED THAT ALL SAMPLES SUBJECTED TO THE OPERATIONAL TIMING TEST MET SPECIFICATIONS. HOWEVER, A ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE AUTO-VALVE IN QUESTION WAS NOT AVAILABLE FOR PHYSICAL ANALYSIS. NO DISCREPANCIES (INCLUDING NON-CONFORMANCES/DEVIATIONS) WERE FOUND AND THERE IS NOT ENOUGH INFORMATION TO CONCLUDE THE PRODUCT DID NOT MEET SPECIFICATION AND PERFORM AS INTENDED. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. A PRODUCT SAMPLE WAS RECEIVED HOWEVER, ONLY THE DIAPHRAGM TRANSDUCER SECTION OF THE ABVISER WAS INCLUDED. THE RETURN SAMPLE HAS BEEN FORWARDED TO THE APPROPRIATE PARTY FOR EVALUATION. MFG DATE: DEVICE MANUFACTURE DATE CORRECTED. THE FOLLOWING CODES WERE REPORTED IN ERROR ON THE INITIAL MFR#: 1049092-2016-00071 , REPORTED TO THE FDA ON FEBRUARY 29, 2016: RESULTS CODE, CONCLUSION CODE. THE FOLLOWING CODES WERE OMITTED FROM THE INITIAL MFR#: 1049092-2016-00071, REPORTED TO THE FDA ON FEBRUARY 29, 2016 AND ARE BEING CORRECTED ON THIS REPORT: METHOD CODE, CONCLUSION CODE. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).