MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE TRANSDUCER INTERFACE CABLE.DTX. NON STERILE; BLOOD-PRESSURE TRANSDUCER CABLE

Catalog Number 684267

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/23/2021

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for full evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during post-op monitoring of a heart surgery patient, the clinical staff believed that the patient developed hypertension due to pressure changes demonstrating r-r variability.The patient was medically treated for hypertension [catapresan iv] with no additional consequences to report.The account alleges that the inaccurate pressure changes may be related to a faulty transducer interface cable.The cable has been tested at another site and the fault was reproducible.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: TRANSDUCER INTERFACE CABLE.DTX. NON STERILE
• Type of Device: BLOOD-PRESSURE TRANSDUCER CABLE
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE; 198 yishun ave 7; singapore, 76892 6; SN 768926
• MDR Report Key: 11274003
• MDR Text Key: 230134502
• Report Number: 8020616-2021-00007
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00884450330975
• UDI-Public: 884450330975
• Combination Product (y/n): N
• PMA/PMN Number: DXN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 684267
• Device Lot Number: 684267
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention