MAUDE Adverse Event Report: DATASCOPE FAIRFIELD BEQ-TOP 5502 CONNECTOR BMU SENSOR 3/8", PLASTICS; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number 701040849

Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2017

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.(b)(4).

Event Description

It was reported that bmu arterial sensor xv3qa-d3eoz-lemz/-jqkp1 in tubing pack 701051791 (beq-top 5502.Lot # 3000047320) transmitting arterial probe communication error on bmu 40 serial (b)(4).The hospital used a different arterial sensor bar code for arterial sensor xv3qa-d3eoz-lemz/-jqkp1 on bmu (b)(4) and then the arterial sensor began to read.The customer stated there was some inconsistencies with the po2 readings in comparison with actual lab measurements.Customer to perform gas exchange analysis to assess functionality of the oxygenator.There was no injury or harm to the patient.

Manufacturer Narrative

Lot # changed from: unknown to: 3000047320.Serial # changed from: unknown to: n/a.Added expiration date.Added manufacture date.Complaint # (b)(4), record # (b)(4).

Event Description

It was reported that bmu arterial sensor xv3qa-d3eoz-lemz/-jqkp1 in tubing pack (b)(4)(beq-top 5502.Lot # 3000047320) transmitting arterial probe communication error on bmu 40 serial # (b)(4) and serial # (b)(4).The hospital used a different arterial sensor bar code for arterial sensor xv3qa-d3eoz-lemz/-jqkp1 on bmu (b)(4) and then the arterial sensor began to read.The customer stated there was some inconsistencies with the po2 readings in comparison with actual lab measurements.Customer to perform gas exchange analysis to assess functionality of the oxygenator.There was no injury or harm to the patient.

Manufacturer Narrative

Correction: date received by manufacturer changed from: 08/02/2017 to:08/02/2018 which should have been captured on the previous emdr follow up submission.Complaint # (b)(4).

Event Description

It was reported that bmu arterial sensor xv3qa-d3eoz-lemz/-jqkp1 in tubing pack 701051791 (beq-top 5502.Lot # 3000047320) transmitting arterial probe communication error on bmu 40 serial # (b)(4) and serial # (b)(4).The hospital used a different arterial sensor bar code for arterial sensor xv3qa-d3eoz-lemz/-jqkp1 on bmu (b)(4) and then the arterial sensor began to read.The customer stated there was some inconsistencies with the po2 readings in comparison with actual lab measurements.Customer to perform gas exchange analysis to assess functionality of the oxygenator.There was no injury or harm to the patient.

• Brand Name: BEQ-TOP 5502 CONNECTOR BMU SENSOR 3/8", PLASTICS
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 6919274
• MDR Text Key: 89704000
• Report Number: 2248146-2017-00441
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K08059223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2019
• Device Catalogue Number: 701040849
• Device Lot Number: 3000047320
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1