MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR CUSTOM DEFINED PRESSURE MONITORING KIT; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number VO0204TSPL02

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation when received.Lot number was not provided, therefore review of the manufacturing records could not be completed.The 510k number is not available as this is a japan custom defined product.

Event Description

It was reported that an incorrect flow rate was observed during use of the disposable pressure transducer in the icu.The kit was connected to 500ml bag of saline and it was pressurized with the pressure bag.However, saline flowed more than the regulated flow rate of 3ml/hour and the saline bag was found to be empty.Backflow of blood was not observed.It was later indicated that the patient was fluid restriction due to the cardiovascular surgery.The kit was in use from dec.4 and the problem was noticed the next morning.The exact time it took for the saline bag to empty is unknown.There is no change in patient condition after the problem and no complications reported.

Manufacturer Narrative

We received one single dpt kit with an iv set and pressure tubing for examination.The reported event of ¿incorrect flow rate¿ was not confirmed.As received into the laboratory, the snap tab was seated where it was supposed to be in the dpt housing.The snap tab functioned properly, and it was able to prime throughout the kit without any problem.It was also able to restrict the fast flush flow properly when the snap tab was not pulled during priming.No leakage was observed from the kit during leak test.All connections were tight and secure.The flow rate testing indicated that it was within specification.The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing.It is not known if some procedural factors may have contributed to the event.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.With pressure tubing sets, it is common for the clinician to check for air or particulates while priming the line for use.Additionally, these products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the possible complications.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: CUSTOM DEFINED PRESSURE MONITORING KIT
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 7136241
• MDR Text Key: 96042790
• Report Number: 2015691-2017-04434
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VO0204TSPL02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 12/25/2017
• Supplement Dates FDA Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1