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

Model Number VMP406PX

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

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

Event Date 02/27/2019

Event Type  malfunction  

Manufacturer Narrative

One vamp jr kit was returned for examination.The reported event of "vamp product leaking" was confirmed.Leakage was detected at the bond joint between the pressure tubing to reservoir stopcock.Red dye solution was manually injected into the vamp system to trace the leak path.Leakage was found occurring across the bond area.No visible damage was observed from the pressure tubing and reservoir stopcock.A review of the manufacturing records indicated that the product met specifications upon release.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.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.It is common clinical practice to inspect all products before use.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.In addition, these devices are typically used in intensive care units or operating rooms, where patients are closely monitored.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.Consequently, there is potential for patient injury.In this case, there were no patient complications noted.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.

Event Description

It was reported that during use on a (b)(6) female patient, the vamp jr.System attached to a umbilical artery catheter (uac) was replaced at 5pm.At 5:25pm blood was noticed beginning to back up the uac line.The line was flushed and a clear line was observed.However, a short time later the vamp jr product was leaking blood/fluid.The blood/fluid had backed up past the waste device in the line and was leaking onto the bed.The tubing was switched out and the issue was solved.No patient complications were noted.

Manufacturer Narrative

The investigation of this vamp jr combo kit concluded that a potential root cause could be related to an incorrect solvent bonding execution during the assembly process.Personnel acknowledgement was conducted at the manufacturing site to prevent recurrence of this type of complaint.

Manufacturer Narrative

Corrected data: f10, h6.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: 8445612
• MDR Text Key: 139815911
• Report Number: 2015691-2019-00997
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2019

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: 08/06/2019
• Device Model Number: VMP406PX
• Device Catalogue Number: VMP406PX
• Device Lot Number: 61334777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/22/2019
• Supplement Dates Manufacturer Received: 05/28/2019; 07/23/2020
• Supplement Dates FDA Received: 05/28/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 6 DA