MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER AND VAMP JR.; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number VMP306PX

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900); Incomplete or Inadequate Connection (4037)

Patient Problem Blood Loss (2597)

Event Date 06/22/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation as it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.The lot number was not provided thus a device history record was not reviewed.A supplemental report will be sent if additional investigation suggests any manufacturing related non conformance.This non-conformance involves a pediatric vamp dpt that had a loose connection from the transducer to the injection port that resulted in minor blood loss.This device is used for monitoring pediatric arterial blood pressure and blood sampling.Since these devices are indicated for pediatric patients whose blood volume is much smaller than an adult, they cannot tolerate blood loss as easily as adults.A leak in the system may cause a dampened waveform to be displayed on the patient monitor, thereby alerting the clinician to start the troubleshooting process.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 a part of the monthly review.

Event Description

It was reported that while using this disposable pressure transducer with vamp on a baby, the connection from the transducer to the injection port got loose and caused 5 ml of blood loss.A blood transfusion was already planned, however due to this incident, the transfusion may have been required sooner.In order to solve the issue, the tubing was resecured in place and there was no need to replace the device.There was no allegation of patient injury.The product was not available for evaluation as it was discarded.Patient demographics are not available.

Manufacturer Narrative

For this possible lot number, the product passed all manufacturing inspections without non-conformance related to the failure reported.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER AND VAMP JR.
• 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
• MDR Report Key: 10344549
• MDR Text Key: 201841398
• Report Number: 2015691-2020-12823
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2021
• Device Model Number: VMP306PX
• Device Catalogue Number: VMP306PX
• Device Lot Number: POSSIBLY 62538090
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1