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 Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2018

Event Type  malfunction  

Manufacturer Narrative

One single dpt - vamp jr.Kit was returned for examination.The reported event of "distal portion simply snapped off" was confirmed.The pressure tubing was found broken from the bond joint that connects with the vamp jr.Reservoir.The cross surfaces of the broken tubing appeared uneven.No other damage was observed from the kit.An investigation has been initiated to determine the root cause and implement any necessary corrective actions.A review of the manufacturing records indicated that the product met specifications upon release.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.Tubing breakage will most likely occur during handling and manipulation of the product and will result in an obvious leak prior to connecting to the patient or during tightening of connections during use.Therefore, the break in the system will be immediately detected.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, the break was found before use and there was no patient involvement.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.(b)(4).

Event Description

It was reported that the vamp jr arterial line tubing broke when being set up prior to placement on a (b)(6) infant.While priming the vamp jr with 0.9%ns, a segment of the vamp jr disconnected with the rn's normal handling of the product.There was no tension placed; rather, when the product was in hand, the distal portion snapped off.This product was not connected to the patient during priming.A new set was primed and then placed on the infant with no injuries reported.

Manufacturer Narrative

The investigation of this pressure monitoring kit with vamp jr concluded that a potential root cause of broken pressure tubing 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 (b)(4).

• 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: 7774798
• MDR Text Key: 117014596
• Report Number: 2015691-2018-03329
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2018

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: 05/08/2019
• Device Model Number: VMP306PX
• Device Catalogue Number: VMP306PX
• Device Lot Number: 61161578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Initial Date Manufacturer Received: 07/20/2018
• Initial Date FDA Received: 08/10/2018
• Supplement Dates Manufacturer Received: 10/10/2018; 07/23/2020
• Supplement Dates FDA Received: 10/16/2018; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 26 WK