FDA Adverse Event Injury Summary report: N

HLM TUBING SET W/SOFTLINE COATING

MDR report key: 4820651 · Received June 3, 2015

Report

Report Number: 8010762-2015-00699
Event Type: Injury
Date Received: June 3, 2015
Date of Event: April 15, 2015
Report Date: March 16, 2016
Manufacturer: MAQUET CARDIOPULMONARY AG
Product Code: DTZ
PMA / PMN Number: K101153
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT AND AN INTERNAL PROCESS (NC 15-02-206) WAS INITIATED TO DETERMINE THE MOST PROBABLE ROOT CAUSE AND TO IMPLEMENT THE APPROPRIATE CORRECTIVE ACTION. THE PROCESS IS IN THE ROOT CAUSE DEFINITION AND INVESTIGATION PHASE. THE CORRECTIVE ACTION PHASE WILL IMMEDIATELY FOLLOW THE ROOT CAUSE INVESTIGATION. MAQUET CARDIOPULMONARY (B)(4) WILL CONTINUE TO MONITOR INCOMING REPORTS FOR ANY TRENDS AND TO DETERMINE IF FURTHER ACTION IS NECESSARY. ADD'L INFO: THE PRODUCT MENTIONED UNDER SECTION D IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-ID WHICH IS REGISTERED UNDER 510 (K) K101153.

Additional Manufacturer Narrative · 1

MAQUET CARDIOPULMONARY (B)(4) IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT. THESE SIMILAR PRODUCTS, SHOWING A SIMILAR MALFUNCTION, HAVE BEEN TESTED AND DURING A TIGHTNESS TEST, A LEAKAGE FROM THE DE-AIRING PORT COULD BE CONFIRMED. THE MANUFACTURER DETERMINED SO FAR THAT THE DE-AIRING MEMBRANE BECOMES PERMEABLE FOR FLUIDS (PRIMING SOLUTION/ BLOOD). THE INVESTIGATED CUSTOMER COMPLAINTS SHOWED NONCONFORMING AREAS IN THE MEMBRANE BODY AS WELL AS WEAK BONDING BETWEEN THE MEMBRANE AND OXYGENATOR AS MOST PROBABLE CAUSE. DETERMINING THE ROOT CAUSE IS STILL UNDER INVESTIGATION. THEREFORE MAQUET CARDIOPULMONARY (B)(4) HAS INITIATED A CAPA PROCESS ((B)(4)) TO ADDRESS THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTION. INVESTIGATION IS STILL PENDING. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED IS A VKMO SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-I WHICH IS REGISTERED UNDER 510(K): K082117.

Additional Manufacturer Narrative · 1

RESULT OF THE ROOT CAUSE ANALYSIS: MEANWHILE THE ROOT CAUSE WAS IDENTIFIED. INVESTIGATIONS COULD PROVE THAT THE INTRODUCTION OF THE NEW GLUE FOR ADULT AND SMALL ADULT OXYGENATORS AT THE BEGINNING OF 2013 - IS NOT RESPONSIBLE FOR THE INCREASED LEAKAGE OF DE-AIRING CONNECTORS. THE ROOT CAUSE COMPRISES THE FOLLOWING THREE SUB ITEMS: -THE LAMINATED PTFE MEMBRANE SHOWS QUALITATIVE DIFFERENCES WITHIN THE LOT DUE TO THE SIZE OF THE PRODUCTION LOT (MINIMUM 1850 FEET X 11.25 INCH) AND THE PACKAGING OF THE ROLLS. -THE FUNCTIONAL PTFE MEMBRANE IS VERY SENSITIVE TO MECHANICAL STRESS. THEREFORE THE HITHERTO EXISTING INSTRUCTIONS IN BOP (BASIC OPERATION PROCEDURE) 714 FOR PUNCHING AND BOP 715 FOR WELDING THE DE-AIRING MEMBRANE WILL BE ADJUSTED. -THE SOFTLINE COATING AND THE PRESSURE TEST OF OXYGENATORS TAKES PLACE SIMULTANEOUSLY AT 1.1 BAR. THE HYDROPHOBIC CHARACTER OF THE MEMBRANE IS CHANGED BY DINT OF THE HYDROPHILIC SOFTLINE COATING SOLUTION, WHICH ENTERS INTO THE PTFE MEMBRANE

Additional Manufacturer Narrative · 1

CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN ESTABLISHED BASED ON THE ROOT CAUSE ANALYSIS: -DEVELOPMENT AND IMPLEMENTATION OF AN OPTICAL INSPECTION OF THE RAW MATERIAL (MEMBRANE). -DEVELOPMENT AND IMPLEMENTATION OF A NEW PUNCHING PROCESS. -IMPROVEMENT OF THE PACKAGING OF THE MEMBRANE ROLLS AT THE SUPPLIER. -PREVENTION OF PRESSURES ABOVE THE TOLERANCE IN PRESSURE TEST UNITS (REVISION/ENHANCEMENT OF BASIC OPERATING PROCEDURES). FULL FURTHER INVESTIGATION AND ALL OTHER ACTIONS AND THE EFFECTIVENESS THEREOF WILL BE CARRIED OUT AS PART OF THE CAPA INVESTIGATION. THE CORRECTIVE AND PREVENTIVE ACTIONS ABOVE BASED ON THE RCA HAVE A PROJECTED TIMEFRAME FOR COMPLETION BY JULY 2017. THIS IS THE FINAL REPORT.

Additional Manufacturer Narrative · 1

MAQUET CARDIOPULMONARY (B)(4) IS AWARE OF SIMILAR COMPLAINTS SHOWING A SIMILAR MALFUNCTION. THESE PRODUCTS HAVE BEEN TESTED AND DURING TIGHTNESS TEST, A LEAKAGE FROM THE DE-AIRING PORT COULD BE CONFIRMED. THEREFORE MAQUET CARDIOPULMONARY (B)(4) HAS INITIATED A CAPA PROCESS TO ADDRESS THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTION. EVERY OXYGENATOR - PRODUCED BY MAQUET (B)(4) - POSSESSES A DE-AIRING PORT LOCATED AT THE BLOOD INLET SIDE OF THE DEVICE. FOR THIS PURPOSE A HYDROPHOBIC PFTE (POLY-TETRA-FLUORO-ETHYLENE) MEMBRANE, WHICH IS LAMINATED ON A POLYESTER FLEECE, IS WELDED ONTO A DE-AIRING CONNECTOR. THIS COMBINATION IS FIXED AT THE OXYGENATOR BY GLUING. DUE TO LEAKAGE OF LIQUIDS THROUGH THE DE AIRING MEMBRANE, BOTH THE NUMBER OF CUSTOMER COMPLAINTS AND THE OXYGENATOR PRODUCTION FAILURE RATE, INCREASED CONSIDERABLY DURING THE LAST YEARS, PARTICULARLY SINCE 2013. THE OVERALL DUE DATE FOR THE ROOT CAUSE ANALYSIS IS 2016-03-30. UP TO DATE INVESTIGATION ACTIONS CONTINUE, HOWEVER SOME FINDINGS ARE ALREADY AVAILABLE. EXPERIMENTS COULD DEMONSTRATE THAT ROUGH HANDLING DURING WELDING AS WELL AS BAD STORAGE OF THE DE-AIRING CONNECTORS CAN RESULT IN LEAKAGE. THE FIRST MEASURE AGAINST LEAKAGE IS ALREADY TAKEN BY MANUFACTURING STACKABLE STORAGE BOXES WITH CAVITIES FOR 150 DE-AIRING CONNECTORS IN EACH CASE. (B)(4).