MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE TUBING 72" (180 CM) WITH M/F CONNECTOR; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number 50P172

Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.The hospital discarded the device.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. a device history record review was completed and documented that device met all specifications upon distribution.It is common clinical practice to inspect all products before usage.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.In addition, they are used in critical care units or ors where patients are closely monitored.If the pressure tubing becomes detached during use, it will affect the pressure waveform, which will immediately alert the clinician to begin the troubleshooting process.In this case, there were no patient impact.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 the use of a disposable pressure transducer, the pressure tubing pulled out of the hub.  there was no patient injury reported.  the unit was discarded at the facility.  no patient demographics available.

Manufacturer Narrative

Reference capa-20-00141.

Manufacturer Narrative

The udi number for this complaint is: (b)(4).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.

• Brand Name: PRESSURE TUBING 72" (180 CM) WITH M/F CONNECTOR
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• MDR Report Key: 10242480
• MDR Text Key: 198694624
• Report Number: 2015691-2020-12435
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• PMA/PMN Number: K872596
• 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: 06/18/2020

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: 02/05/2022
• Device Model Number: 50P172
• Device Lot Number: 62915613
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/07/2020
• Supplement Dates Manufacturer Received: 07/23/2020; 06/30/2021
• Supplement Dates FDA Received: 01/12/2021; 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1