MAUDE Adverse Event Report: DATASCOPE FAIRFIELD BEQ-TOP 5909 1/4 PACK W QPID; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number 701064992

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.(b)(4).

Event Description

It was reported that while priming the circuit the clinician discovered a leak at the stopcock pigtail area.Clinician changed out the stopcock to continue with priming and case.There was no patient involvement.

Manufacturer Narrative

The associated kits and pigtails were not returned and could not be reviewed for any damage.A picture was sent of where the customer claims the leaks occurred on the pigtail.Based on the investigation the most likely root cause of the pigtail leaking can be attributed to a bad glue joint.The complaint has been confirmed.The complaint will be recorded in the database for future reference.Complaint (b)(4); record id 189012.

Event Description

It was reported that while priming the circuit the clinician discovered a leak at the stopcock pigtail area.Clinician changed out the stopcock to continue with priming and case.There was no patient involvement.

Manufacturer Narrative

Additional information added to: analysis of production records, (b)(4.

Event Description

It was reported that while priming the circuit the clinician discovered a leak at the stopcock pigtail area.Clinician changed out the stopcock to continue with priming and case.There was no patient involvement.

• Brand Name: BEQ-TOP 5909 1/4 PACK W QPID
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 8186318
• MDR Text Key: 131341110
• Report Number: 2248146-2018-00746
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K08059223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2019
• Device Catalogue Number: 701064992
• Device Lot Number: 3000053134
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 12/17/2018; 01/10/2019
• Supplement Dates FDA Received: 01/09/2019; 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1