ULITPOR® 100 BREATHING SYSTEM FILTER

Report

Report Number: 9680602-2010-00008
Event Type: Death
Date Received: December 6, 2010
Date of Event: June 1, 2010
Report Date: July 30, 2010
Manufacturer: PALL NEWQUAY
Product Code: CAH
PMA / PMN Number: K791307
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REVISE MODEL # TO BB100A, ULTIPOR 100 BREATHING SYSTEM FILTER, AND FILTER, BACTERIAL, BREATHING CIRCUIT.

Additional Manufacturer Narrative · 1

IT WAS NOT POSSIBLE TO CONDUCT LABORATORY TESTING OF THE DEVICE LISTING IN THE USER MED WATCH REPORT BECAUSE THE USER EITHER DID NOT RETAIN THE DEVICE OR WAS UNWILLING TO PROVIDE THE DEVICE FOR LABORATORY EVALUATION. A FAILURE ANALYSIS WAS NOT POSSIBLE BECAUSE THE REPORTER DID NOT KNOW THE MANUFACTURING LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT. ALSO, BECAUSE THE REPORTER FAILED TO PROVIDE ANY INFORMATION CONCERNING THE PATIENT OR CONCERNING USE OF THE DEVICE, BEYOND THE EXTREMELY LIMITED DESCRIPTION IN THE USER'S MEDWATCH REPORT, DESPITE NUMEROUS ATTEMPTS BY THE MANUFACTURER TO OBTAIN SUCH INFORMATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE BECAUSE THE REPORTER DID NOT PROVIDE THE LOT NUMBER OR MODEL OF DEVICE THAT WAS IN USE. THE REPORTER PROVIDED NO INFORMATION IN THE (B)(4) FIELDS AS FOLLOWS: (B)(6). THE BOX "DEATH" WAS TICKED, BUT THE FIELD FOR DATE WAS POPULATED: "DATE UNKNOWN". SINCE THE DATE OF THE EVENT WAS LISTED AS (B)(6) 2010 YET THE DATE OF THE (B)(4) WAS LISTED AS (B)(6) 2010, IT IS INEXPLICABLE THAT THE DATE OF DEATH WOULD BE UNKNOWN; IF INDEED THE REPORTED DEVICE MALFUNCTION WAS RELATED TO THE ADVERSE OUTCOME. PATIENTS, IN GENERAL, SUPPORTED BY MECHANICAL VENTILATION REQUIRE CLOSE CLINICAL MONITORING. IN ADDITION, THE DEVICE LABELING'S PRECAUTION STATEMENT PROVIDES INFORMATION ON CONSIDERATIONS NEEDED IN CERTAIN THERAPY MODES. IN PARTICULAR, THE PRECAUTIONS STATE: "ALTHOUGH RARE, PROGRESSIVE INCREASE IN RESISTANCE TO AIRFLOW MAY OCCUR DURING LIQUID DRUG NEBULIZATION. THEREFORE, VIGILANCE SHOULD BE MAINTAINED." AND "VENTILATOR ALARMS SHOULD BE IN USE AT ALL TIMES." WHEN SUCH PRECAUTIONS ARE OBSERVED, IT IS NOT EXPECTED THAT THE MANAGEMENT OF A PATIENT IN THE CASE OF A DEVICE MALFUNCTION WOULD DETERIORATE TO SIGNIFICANT BAROTRAUMA AND THE REPORTED PNEUMOTHORAX. SUMMARY: THE USER REPORT COULD NEITHER BE CONFIRMED NOR COMPLETELY DISCOUNTED. IT IS POSSIBLE THAT AN INCREASE IN FLOW RESISTANCE MAY HAVE OCCURRED; THE CAUSE IS INDETERMINATE. PROPER PATIENT MANAGEMENT IS NOT EXPECTED TO RESULT IN PNEUMOTHORAX IN SUCH AN EVENT WHEN THE INSTRUCTIONS FOR USE INCLUDING PRECAUTIONS ARE OBSERVED, THE USER'S DESCRIPTION OF THE EVENT STATED THAT ONCE THE DEVICE WAS REMOVED, THE PATIENT WAS OXYGENATED. THAT STATUS PRECLUDES THE POSSIBILITY THAT PATIENT'S DEATH WAS CAUSED BY THIS EVENT; THE DATE OF DEATH WAS LISTED AS "UNKNOWN". UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

Additional Manufacturer Narrative · 1

IT WAS NOT POSSIBLE TO CONDUCT LABORATORY TESTING OF THE DEVICE LISTING IN THE USER MW REPORT BECAUSE THE USER EITHER DID NOT RETAIN THE DEVICE OR WAS UNWILLING TO PROVIDE THE DEVICE FOR LABORATORY EVALUATION. A FAILURE ANALYSIS WAS NOT POSSIBLE BECAUSE THE REPORTER DID NOT KNOW THE MANUFACTURING LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT. ALSO, BECAUSE THE REPORTER FAILED TO PROVIDE ANY INFORMATION CONCERNING THE PATIENT OR CONCERNING USE OF THE DEVICE, BEYOND THE EXTREMELY LIMITED DESCRIPTION IN THE USER MEDWATCH REPORT, DESPITE NUMEROUS ATTEMPTS BY THE MANUFACTURER TO OBTAIN SUCH INFORMATION A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE BECAUSE THE REPORTER DID NOT PROVIDE THE LOT NUMBER OR MODEL OF DEVICE THAT WAS IN USE. (B)(4). SINCE THE DATE OF THE EVENT WAS LISTED AS (B)(6) 2010 YET THE DATE OF THE MW REPORT WAS LISTED AS (B)(6) 2010, IT IS INEXPLICABLE THAT THE DATE OF DEATH WOULD BE UNKNOWN; IF INDEED THE REPORTED DEVICE MALFUNCTION WAS RELATED TO THE ADVERSE OUTCOME. PATIENTS, IN GENERAL, SUPPORTED BY MECHANICAL VENTILATION REQUIRE CLOSE CLINICAL MONITORING. IN ADDITION, THE DEVICE LABELING'S PRECAUTION STATEMENT PROVIDES INFORMATION ON CONSIDERATIONS NEEDED IN CERTAIN THERAPY MODES. IN PARTICULAR, THE PRECAUTIONS STATE: "ALTHOUGH RARE, PROGRESSIVE INCREASE IN RESISTANCE TO AIRFLOW MAY OCCUR DURING LIQUID DRUG NEBULIZATION. THEREFORE, VIGILANCE SHOULD BE MAINTAINED." AND "VENTILATOR ALARMS SHOULD BE IN USE AT ALL TIMES." WHEN SUCH PRECAUTIONS ARE OBSERVED, IT IS NOT EXPECTED THAT THE MANAGEMENT OF A PATIENT IN THE CASE OF A DEVICE MALFUNCTION WOULD DETERIORATE TO SIGNIFICANT BAROTRAUMA AND THE REPORTED PNEUMOTHORAX. SUMMARY: THE USER REPORT COULD NEITHER BE CONFIRMED NOR COMPLETELY DISCOUNTED. IT IS POSSIBLE THAT AN INCREASE IN FLOW RESISTANCE MAY HAVE OCCURRED; THE CAUSE IS INDETERMINATE. PROPER PATIENT MANAGEMENT IS NOT EXPECTED TO RESULT IN PNEUMOTHORAX IN SUCH AN EVENT WHEN THE INSTRUCTIONS FOR USE INCLUDING PRECAUTIONS ARE OBSERVED. THE USER'S DESCRIPTION OF THE EVENT STATED THAT ONCE THE DEVICE WAS REMOVED, THE PATIENT WAS OXYGENATED. THAT STATUS PRECLUDES THE POSSIBILITY THAT PATIENT'S DEATH WAS CAUSED BY THIS EVENT; THE USER'S TICKING OF THE FORM 3500A "DEATH" APPEARS ERRONEOUS, PARTICULARLY SINCE THE DATE OF DEATH WAS LISTED AS "UNKNOWN". UNLESS SUBSTANTIALLY SIGNIFICANT INFORMATION BECOMES AVAILABLE, THIS CONSTITUTES A FINAL REPORT.

Description of Event or Problem · 1

TENSION PNEUMOTHORAX CAUSING CARDIOPULMONARY ARREST. FILTER MAY HAVE BEEN DEFECTIVE, AS IT WAS VERY DIFFICULT TO BAG AND VENTILATE PATIENT DURING CODE. ONCE FILTER WAS REMOVED, NO MORE RESISTANCE WAS MET AND PATIENT WAS OXYGENATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ULITPOR® 100 BREATHING SYSTEM FILTER	FILTER, BACTERIA, BREATHING CIRCUIT	CAH	PALL NEWQUAY	BB100A	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR		Death