MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WORKMATE CLARIS EP-4 CARDIAC STIMULATOR; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number H403023

Device Problem Environmental Compatibility Problem (2929)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

Event Description

Related manufacturer reference: 2184149-2020-00056, 2184149-2020-00057.During a procedure, a saline bag ruptured causing water damage to devices.The procedure was cancelled.The claris ep4 stimulator had evidence of saline fluid damage and had fluid inside the unit.The signals were intermittent and could not be repaired.The db9 serial to fiber media converter and the catheter input module 1¿cm1 pin box both had water damage.There was no harm to the patient or the staff.

Manufacturer Narrative

The root cause of the investigation is inconclusive since the device was not returned for analysis.Based on communication with the user the root cause of the event may be traced to liquid intrusion from a ruptured saline bag.

• Brand Name: WORKMATE CLARIS EP-4 CARDIAC STIMULATOR
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 10080860
• MDR Text Key: 191763070
• Report Number: 2184149-2020-00055
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734030236
• UDI-Public: 05414734030236
• Combination Product (y/n): N
• PMA/PMN Number: K092913
• 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: 06/23/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: H403023
• Device Catalogue Number: H403023
• Device Lot Number: 5293033
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 05/21/2020
• Supplement Dates Manufacturer Received: 04/28/2020
• Supplement Dates FDA Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDIA CONV, DB9 TO FIBER SC.; WORKMATE¿ CLARIS¿ SYSTEM CATHETER INTERFACE.; MEDIA CONV, DB9 TO FIBER SC; WORKMATE¿ CLARIS¿ SYSTEM CATHETER INTERFACE MODULE
• Patient Outcome(s): Other