MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING SET; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number T001650A

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2016

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However the complaint could not be confirmed without the completion of the product evaluation.A supplemental report will be forthcoming with the evaluation results.

Event Description

It was reported that the dpt (disposable pressure transducer) tubing detached from the reservoir.There was no allegation of patient injury.Device was available for evaluation.

Manufacturer Narrative

We received one bifurcated iv set for examination.As received the iv tubing was detached from the bond joint with the drip chamber.No apparent indication of bonding material was observed on either the iv tubing or drip chamber bond areas.The instructions indicate to bond the iv tubing and drip chamber with bonding solvent (mixture of cyclohexanone and mek).No other damage or defect was observed from the returned iv set.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.A review of the manufacturing records indicated that the product met specifications upon release.

• Brand Name: PRESSURE MONITORING SET
• 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: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 5634685
• MDR Text Key: 45309853
• Report Number: 2015691-2016-01491
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K142749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2016

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 Expiration Date: 10/02/2017
• Device Model Number: T001650A
• Device Lot Number: 60174243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2016
• Initial Date FDA Received: 05/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2015
• 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