FLOTRAC CONNECTING CABLE APCO9

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2013-07-03 for FLOTRAC CONNECTING CABLE APCO9 manufactured by Edwards Lifesciences.

Event Text Entries

[3692102] It was reported that after 1~2 hours of use, the blood pressure value displayed on the nihon kohden bedside monitor attenuated 20~30 mmhg lower than at the start of measurement; however, the details of the value were unable to be obtained. When the event transpired, no error messages were observed, but the customer surmised that the value was not reflective of the patient? S status. There was no report of inappropriate treatment resulting from the suspect value. It was noted that the issue was only observed when the nihon kohden monitor was used with a flotrac connected to a vigileo monitor, and was not observed with a disposable pressure transducer. The flotrac was replaced; however, replacement of the flotrac did not improve the symptom. The customer suspected that a malfunction occurred with either the vigileo monitor or an apco9 cable. Four (4) devices were documented as potentially related to this event, as the serial numbers for the suspect devices could not be positively identified and all likely units were reported.
Patient Sequence No: 1, Text Type: D, B5


[11024910] No evaluation has been performed as the cable is expected to be returned for evaluation and has not yet been received. A follow-up submission will be submitted to communicate the evaluation and investigation results.
Patient Sequence No: 1, Text Type: N, H10


[15874815] This follow-up is submitted to communicate the evaluation results and reference the related mfr. Reports associated with the reported event: vigileo monitor 2015691-2019-20535, vigileo monitor 2015691-2013-20537, and apco9? 2 flotrac connection cable 18 ft (548 cm) 201-5691-20539. The cable was manufactured 01-feb-2007. The device history record was unavailable for review. Examination of the returned cable was unable to replicate the customer? S complaint. The cable was evaluated and passed cirris functional testing without incident. No physical damage was observed during the visual inspection. It is unknown whether procedural processes or a specific circumstance played a role in the reported experience, as no fault could be determined and the evaluation results did not confirm the reported issue with this device or any of the related devices/complaints. The cable will be returned to the customer.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2015691-2013-20541
MDR Report Key3206014
Report Source01,06
Date Received2013-07-03
Date of Report2013-06-06
Date of Event2013-06-05
Date Mfgr Received2013-06-06
Device Manufacturer Date2007-02-01
Date Added to Maude2013-07-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. DAVID VU
Manufacturer Street1 EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal92614
Manufacturer Phone9492502435
Manufacturer G1EDWARDS LIFESCIENCES LLC
Manufacturer Street1 EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal Code92614
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLOTRAC CONNECTING CABLE
Generic NameCONNECTING CABLE
Product CodeISN
Date Received2013-07-03
Model NumberAPCO9
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age6 YR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES
Manufacturer AddressONE EDWARDS WAY IRVINE CA 92614 US 92614


Patients

Patient NumberTreatmentOutcomeDate
10 2013-07-03

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