MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. MEDEX LOGICAL PRESSURE MONITORING SYSTEM; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number DPS564212CZ

Device Problems Crack (1135); Reflux within Device (1522)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 05/30/2020

Event Type  Death  

Event Description

Information was received indicating that the transducer to a smiths medical medex logical pressure monitoring system was found to have a crack.Due to the tear above the transducer it was reported to have blood reflux followed by air in the system.The customer further noted that this incident resulted in death.There were no further reported information.

Manufacturer Narrative

Additional information received from the customer that there was a crack and probably tear noted off the 3-way stopcock above the transducer.Air was reported to get into the extracorporeal membrane oxygenation (ecmo) system in which the patient was connected.Subsequently, the patient suffered a cardiovascular arrest due to an air embolism leading to resuscitation.No spontaneous return of circulation could be achieved.The dhr was reviewed on the following: lot no.3941469 (700 pcs produced on 2020-02-14) - there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.No scar, ncr and no disposition of nonconforming material/parts were processed within this work order connected with stated issue.Lot no.3945140 (400 pcs produced on 2020-02-21) - there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.No scar, ncr and no disposition of nonconforming material/parts were processed within this work order connected with stated issue.Lot no.3954724 (1900 pcs produced on 2020-03-18) - there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.Ncr no.2361 processed within this work order but not connected with stated issue.The cracks, which were found in 3 separate regions of the system, cannot be confirmed if it was an issue in which happened in the manufacturing and was shipped to sterilization and then to distribution.From the problem description is obvious, that the product was used on the patient.The damage could happened by manual handling after the priming/flushing or no priming / flushing was performed before use.

Manufacturer Narrative

Additional information has been received indicating that the prosecutor advised that "they do not believe smiths medical had done anything wrong." the device is being assessed by the police and "the prosecutor doesn't see any evidence of constructional flaws and that this may change their suggestion that there might have been a missing safety mechanism." it was reported that the unit will remain in police custody until the case is done, it will then be sent to smiths for analysis.

• Brand Name: MEDEX LOGICAL PRESSURE MONITORING SYSTEM
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• MDR Report Key: 10209634
• MDR Text Key: 196901038
• Report Number: 3012307300-2020-06349
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DPS564212CZ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 55 YR