MAUDE Adverse Event Report: DATASCOPE CORP. VCARDIO PULMONARY TUBING; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number 701063071

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 01/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned and an evaluation was not possible.If it becomes available a supplemental report with additional information will be provided.(b)(4).

Event Description

The pack had a leaky pressure isolator and the av loop was not wrapped tightly.

• Brand Name: VCARDIO PULMONARY TUBING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): DATASCOPE CORP.; 14 philips parkway; montvale NJ 07645
• MDR Report Key: 5417196
• MDR Text Key: 37723785
• Report Number: 2248146-2016-00009
• 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
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/21/2017
• Device Catalogue Number: 701063071
• Device Lot Number: 3000017856
• Was Device Available for Evaluation?: No
• Device Age: YR
• Date Manufacturer Received: 01/14/2016
• Date Device Manufactured: 10/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1