MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC TRUWAVE 3CC/ VAMP 60 IN(150CM); TRANSDUCER, PRESSURE, CATHETER TIP

Catalog Number PXVMP160

Device Problem Failure to Calibrate (2440)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2022

Event Type  malfunction  

Event Description

Artline transducer would not zero.Found that the plastic transducer with a pigtail flush broken.Edwards lifesciences pressure monitoring set.Fda safety report id # (b)(4).

• Brand Name: TRUWAVE 3CC/ VAMP 60 IN(150CM)
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; irvine CA 92614
• MDR Report Key: 14168565
• MDR Text Key: 289907889
• Report Number: MW5109213
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/18/2022

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: 07/01/2023
• Device Catalogue Number: PXVMP160
• Device Lot Number: 63826239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Ethnicity: Hispanic