FDA.reportPublic FDA data

MAUDE MDR 301009

MDR report key
301009
Report number
MW1020186
Event key
0
Event type
3
Date of event
2000-09-20
Date received
2000-10-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KENDALL LIFE TRACE LEG PLATE CABLECABLEKENDALL-LTPKXN*31479549*NN
2KENDALL LIFE TRACE SAFELINE FSE 2100CABLEKENDALL - LTPKXN*31479549*NN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12000-10-173

Event Narratives#

D

Patient 1

CURRENTLY CENTER HAS 8 FETAL MONITORS: HEWLETT PACKARD SERIES 50-3, HEWLETT PACKARD 8040-3 AND COROMETRICS 116-2. ALL OF THE ABOVE MONITORS HAVE THE APPROPRIATE CABLE(S), PLUS THE KENDALL LIFE TRACE LEG PLATE CABLES AND KENDALL LIFE TRACE SAFELINC FSE 2100. A HEWLETT PACKARD SERIES 50 MONITOR WAS IN USE ON A LABORING PT. THIS MONITOR HAD A KENDALL LIFE TRACE SAFELINC LEG PLATE WHOSE CABLE WAS INSERTED INTO THE HEWLETT PACKARD MONITOR. ATTACHED TO THE OPPOSITE END OF THE KENDALL ADAPTOR BOX WAS A KENDALL LIFE TRACE LEG PLATE CABLE. A KENDALL LIFE TRACE SAFELINC FSE 2100 WAS INSERTED INTO THE CABLE WHILE THE OTHER END OF THE FSE WAS IN PLACE ON THE FETAL PRESENTING PART. THE RN CARING FOR THE LABORING PT ALERTED RPTR THAT THEY WERE UNABLE TO OBTAIN A FETAL HEART RATE TO DISPLAY ON THE HEWLETT PACKARD MONITOR. RPTR WENT TO RN TO THE ROOM TO NOTE THAT THE PHYSICIAN OBSTETRICIAN AND AND THREE FAMILY MEMBERS WERE PRESENT. THE CONNECTIONS WERE EXAMINED TO CONFIRM ALL WAS SECURE. THE HEWLETT PACKARD MONITOR CONTINUED TO REFLECT "NOP" ON DISPLAY PANEL. IMMEDIATE DECISION WAS MADE TO OBTAIN ANOTHER MONITOR. A COROMETRICS 116 WAS BROUGHT TO THE ROOM, KENDALL LIFE TRACE LEG PLATE CABLE WAS INSERTED INTO THE MONITOR.THE KENDALL LIFE TRACE SAFELINC FSE 2100 WAS INSERTED INTO THE LEG PLATE CABLE. THE FSE WAS THE SAME ONE IN PLACE WITH BOTH MONITORS. THIS TIME THE FETAL HEART RATE IS DISPLAYING A HEART RATE JUMPING FROM THE 30'S TO THE 200'S IN A VARIATION OF NUMBERS. THE KENDALL LIFE TRACE LEG PLATE CABLE IS REPLACED WITH ANOTHER ONE. RPTR REQUESTED THE PHYSICIAN TO REMOVE THE FSE AND REPLACE IT WITH ANOTHER FSE. THE PROCEDURE WAS COMPLETED AND A FETAL HEART RATE IN THE 110'S IS DISPLAYED AND LATE DECELERATIONS NOTED. THE TRACING CONTINUES FOR 10 MINS AND THEN NO FETAL HEART RATE IS DISPLAYED. AN EXTERNAL US TRANSDUCER IS THEN APPLIED AND SHORTLY THEREAFTER THE DECISION IS MADE TO PROCEED WITH A C/SECTION. BIOMED IS NOTIFIED TO ASSESS INVOLVED MONITORS AND CABLES. RESPONSE IS IMMEDIATE. ELECTRICAL COMPONENT OF THE FETAL MONITOR IS VERIFIED AND CONCERN WAS EXPRESSED ABOUT ACCURATELY ASSESSING KENDALL CABLES WITH THE EQUIPMENT AVAILABLE. KENDALL SALES REP LEFT A VOICE MAIL MESSAGE EXPLAINING THE PROBLEM ENCOUNTERED, THE FRUSTRATION INVOLVED, AND A RESPONSE WAS REQUESTED. RESPONDED PROMPTLY AND THE DECISION WAS MADE FOR REP TO COME TO UNIT. BIOMED DEPT WOULD ALSO BE PRESENT AT THE 0900 MEETING. IT WAS REQUESTED THAT THE REP DETERMINE HOW THE KENDALL CABLES WERE TO BE ANALYZED BY BIOMED FOR PERFORMANCE PROBLEMS. THE KENDALL REP, RPTR, AND A MEMBER OF THE BIOMED DEPT REVIEWS THE PROBLEM ENCOUNTERED. THE RN WAS ALSO PRESENT, AND THEY REVIEWED THE PROCESS FOR APPLICATION OF THE FSE ONTO THE FETAL PRESENTING PART, THE INSERTION OF THE FSE INTO THE CABLE, AND THE APPLICATION OF THE GROUNDING PAD. THE PHYSICIAN ARRIVES AND CONFIRMS THAT ALL CONNECTIONS WERE IN PLACE SECURELY AND DEMONSTRATED. BIOMED PERFORMANCE INFO IS OBTAINED AND FUNCTION OF FSE DISCUSSED. RPTR REQUESTED OF ANOTHER RN WITH A LABORING PT, THE FEASIBILITY OF APPLYING THE KENDALL FSE AND ITS ATTACHMENT, KENDALL LIFE TRACE LEG PLATE CABLE, ON PT. (THE REP WAITS WHILE CONFIRMING THAT ALL FUNCTIONS WELL). THIS TIME ANOTHER HEWLETT PACKARD SERIES 50 MONITOR IS USED, MINUS THE ADAPTOR BOX (IT IS NOT NECESSARY WITH THIS PARTICULAR MACHINE) AND ALL IS CONNECTED APROPRIATELY AND THE FETAL HEART RATE IS DISPLAYED AND ACCURATE. (THE REP LEAVES AND HOSP IS REASSURED ALL IS WORKING WELL.) THE PT, SEVERAL HRS LATER, IS MOVED TO THE C/SECTION ROOM DUE TO DECELERATIONS IN THE FETAL HEART RATE. THE FSE IS LEFT IN PLACE, THE PT IS STILL IN THE BED AND ALL MONITOR CABLES ARE RECONNECTED. NO FETAL HEART RATE WILL DISPLAY. A FETAL HEART RATE DOPPLER IS THEN APPLIED AND A HEART RATE OF 112 IS AUSCULATED. (THE PT IS 9CM AND THE PHYSICIAN, THE SAME ONE, DECIDED TO WAIT ON THE C/SECTION.) THE FSE, ALL OF A SUDDEN, STARTS DISPLAYING THE FETAL HEART RATE ON THE MONITOR AND IS RECORDED AS 80. THE DOPPLER IS AGAIN PLACED AND RECORDS A HEART RATE IN THE 110'S. THE MATERNAL HEART RATE IS CONFIRMED AS 55-60. A DECISION IS MADE TO PROCEED WITH A C/SECTION AS THE RISK OF A HEART RATE, IF ACCURATE, REMAINING IN THE 80'S COULD CAUSE SERIOUS COMPROMISE IN THE NEONATE. THE PHYSICIAN COMMUNICATES THE ABOVE TO RPTR AND THE DECISION IS MADE TO PURSUE THE EQUIPMENT ISSUE FURTHER. RPTR NOTIFIED THE DIR OF MATERIALS MGMT CONCERNING THE PROBLEMS. PROVIDED WITH THE PHONE NUMBERS TO AGILENT (FORMERLY HEWLETT PACKARD). THE REP COULD NOT CONFIRM THE RELIABILITY OF THE KENDALL EQUIPMENT ON AN HP MONITOR. THE DECISION WAS MADE TO PURCHASE ALL NEW FSES, LEG PLATE CABLES, AND ATTACHMENTS FROM AGILENT FOR ALL 6 HEWLETT PACKARD MONITORS. THE DELIVERY OF EQUIPMENT IS TO OCCUR THE WEEK OF 9/25/00. DIR OF MATERIALS MGMT TO ORDER APPROPRIATE CABLES AND FSES FOR THE COROMETRIC 116 MONITOR. RECEIVED SEVERAL MESSAGES FROM KENDALL THEIR CONCLUSION IS AS FOLLOWS: A. THE FIRST INCIDENT WAS A CLINICAL ISSUE - WHICH WAS RESOLVE...

D

Patient 1

ADD'L INFO REC'D FROM MFR 11/30/00: THERE WERE NO RETURNED SAMPLES OF THE POTENTIAL PRODUCTS LISTED IN THE REPORT; THEREFORE, NO FAILURE ANALYSIS OR LAB TESTING COULD BE PERFORMED ON THOSE PARTS. FROM DISTRIBUTION RECORDS TO THIS FACILITY, MFR WAS ABLE TO EXTRAPOLATE LOT NUMBERS FOR THE KENDALL-LTP PRODUCTS THAT MAY HAVE BEEN USED IN THE DESCRIBED EVENTS. ALL DHRS (BATCH RECORDS) FOR THE POTENTIALLY INVOLVED KENDALL-LTP ITEMS WERE REVIEWED WITH NO FINDINGS OF ABNORMALITIES OR NONCONFORMANCES. IT IS UNLIKELY THAT MALFUNCTION OF DEVICES CONTRIBUTED TO THE EVENTS DESCRIBED IN THE MEDICAL DEVICE REPORT FOR THE FOLLOWING REASONS: THERE ARE A VARIETY OF POSSIBLE CONNECTIONS THAT CAN BE MADE FROM THE FSE TO THE MONITOR. ANY ONE OF THOSE POINTS, IF IMPROPERLY CONNECTED, COULD CONTRIBUTE TO THE EVENTS DESCRIBED. MFR'S FOLLOW-UP INVESTIGATION WITH THE FACILITY WAS INCONCLUSIVE AS TO THE SPECIFIC CABLES USED WITH THE FETAL MONITORS. MFR CONTACTED BOTH THE BIOMED GROUP AND THE RISK MGMT GROUP AND NEITHER HAD REPORTS ON THE EVENTS DESCRIBED. THE SEQUENCE OF EVENTS DESCRIBED IN THE MDR REPORT IS UNCLEAR AND CONTAINS AMBIGUITIES. MFR WAS UNABLE TO REACH THE RPTR FOR CLARIFICATION. ACCORDING TO THE SEQUENCE DESCRIBED IN THE REPORT, EACH OF THE SYSTEM COMPONENTS WAS CHANGED DURING THE DESCRIBED EVENTS. IT IS UNLIKELY THERE WERE MULTIPLE DEFECTIVE COMPONENTS IN ALL OF THE COMBINATIONS OF MONITORS, CABLES, FSES, ATTACHMENT PADS AND ADAPTER BOXES. INFO FROM THE SALES REP WHO IN-SERVICED THE ACCOUNT DURING THE INCIDENT INDICATED THAT THE ACCOUNT FELT THAT THEY MAY NOT HAVE BEEN PUSHING THE FSE SAFETY CAP INTO THE LEG PLATE CABLE SUFFICIENTLY. MFR'S INVESTIGATION OF DHR RECORDS AND RETAIN SAMPLES SHOWED NO ANOMALIES THAT WOULD CONTRIBUTE TO THE EVENTS DESCRIBED.