ABVISER INTRA-ABDOMINAL PRESSURE (IAP) MONITORING SYSTEM

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: SALINE SOLUTION 0.9% WAS THE TYPE OF INFUSION FLUID THAT WAS USED BY THE CLINICIAN TO OPERATE THE DEVICE. IT WAS 4 HOURS IN BETWEEN SHIFT WHEN THE DEVICE WAS KNOWN TO BE OPERATING PROPERLY AND WHEN THE NURSE FOUND THE AUTOVALVE NOT FUNCTIONING PROPERLY. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: SIX MONTHS OF HISTORICAL BATCH RECORDS WHICH WERE MANUFACTURED FROM THE BEGINNING OF APRIL 2015 TO THE END OF SEPTEMBER, 2015, WERE REVIEWED AND ALL SHOWED THAT ALL SAMPLES SUBJECTED TO THE OPERATIONAL TIMING TEST FOR THE AUTOVALVE MET THE SPECIFICATION FOR OPERATIONAL TIMING OF 90 SECONDS (-30 SECONDS TO + 90 SECONDS). WITH THE AUTOVALVE DISCARDED BY THE END USER, IT WAS NOT AVAILABLE FOR PHYSICAL ANALYSIS TO DETERMINE THE POTENTIAL ROOT CAUSE. FROM THE EXAMINATION OF THE PHOTO, HISTORY AND COMPLAINT DESCRIPTION, THE POTENTIAL REASON WAS THAT THE AUTOVALVE MAY HAVE BEEN OCCLUDED. NO PREVIOUS INVESTIGATIONS ARE AVAILABLE. AFTER REVIEW OF THE RETURNED AND DETAILED SIX MONTH BATCH REVIEW, NO DISCREPANCIES WERE FOUND. 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. 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

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. EXPIRATION DATE: 09/2016. (B)(4).

Description of Event or Problem

IT WAS REPORTED THE PATIENT WAS ADMITTED WITH A DIAGNOSIS OF ACUTE PANCREATITIS, BILATERAL PLEURAL EFFUSION, ACUTE KIDNEY FAILURE WITH INTRA-ABDOMINAL HYPERTENSION SYMPTOMS. THE CLINICIANS BEGAN MONITORING THE PATIENT'S INTRA-ABDOMINAL PRESSURE VIA AN ABVISER AUTOVALVE IAP MONITORING DEVICE. THE HEALTHCARE PROFESSIONALS CONTINUED WITH THE CLINICAL MANAGEMENT AND PERFORMED A THORACOCENTESIS TO IMPROVE THE PATIENT'S RESPIRATORY PATTERN. FOR THREE DAYS, THE ABVISER WAS FUNCTIONING CORRECTLY, AND HIGH VALUES OF IAP WERE OBSERVED. ON THE FINAL DAY OF USE, THE PATIENT DID NOT ELIMINATE (URINE) "DURING THE SHIFT" AND EXPRESSED SEVERE ABDOMINAL PAIN. IN ADDITION, THERE APPEARED TO BE "A LOT OF SEDIMENT WITHIN THE URINE COLLECTION SYSTEM." THE SYSTEM WAS DISCONNECTED AND THE PATIENT ELIMINATED 1300CC OF URINE. THE ABVISER WAS REMOVED AND REPLACED. WHEN THE AUTOVALVE OF THE OLD ABVISER WAS INSPECTED BY THE FACILITY, THE MEMBRANE WAS REPORTED "INFLATED" AND WAS "BLOCKING THE SYSTEM'S VENT." NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).