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

Catalog Number	684267
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for full evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem 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.
Additional 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
• Common Device Name: BLOOD-PRESSURE TRANSDUCER CABLE
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE; 198 yishun ave 7; singapore, 76892 6; SN 768926
• MDR Report Key: 11274003
• Report Number: 8020616-2021-00007
• Device Sequence Number: 17013914
• Product Code: DXN
• UDI-Device Identifier: 00884450330975
• UDI-Public: 884450330975
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: DXN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 684267
• Device Lot Number: 684267
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention