MAUDE Adverse Event Report: DATASCOPE FAIRFIELD BO-TOP 15200 OR PACK HMO & RF; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number 701050647

Device Problem Improper Device Output (2953)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).It was indicated that the device is not available to be returned to maquet, a technical evaluation cannot be performed.All events are tracked and trended to determine whether or not any trends develop.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.

Event Description

The hospital reported during pack set-up customer, discovered the orientation of the vrv in the green line was reversed.

Manufacturer Narrative

(b)(4): when the kit was set up by the hospital, it was noticed that the vrv valve was assembled in reverse on line three.Vrv valve cell was reassembled to the kit correctly and the kit was use without any issues.This event is considered to be an isolated incident.Based on the investigation the root cause of the reversed vrv valve, cannot be attributed to any specific cause.Retraining was performed to notify operators of the issue.The kit was not returned for evaluation, but a picture was sent.(b)(4).

• Brand Name: BO-TOP 15200 OR PACK HMO & RF
• 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: 5263601
• MDR Text Key: 32873841
• Report Number: 2248146-2015-01044
• 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,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/27/2017
• Device Catalogue Number: 701050647
• Device Lot Number: 3000010144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 12/07/2015
• Date Device Manufactured: 05/27/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1