MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CARDIAC UNKNOWN DUMMY MATERIAL

Catalog Number CARDIAC UNKNOWN

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).After receiving the ufr-mdr from fda, teleflex assembled a team and requested a meeting (b)(6) medical center (b)(6) 2019 at 1pm est.To discuss the reported complaints.At the conclusion of the meeting, it was explained by (b)(6), bidmc clinical engineer, that all issues that were reported to fda on the ufr-mdr were also reported to teleflex in the form of a complaint and that they were satisfied with the response from teleflex and no further action was required from teleflex.

Event Description

This complaint was opened because an mdr/ufr was received by teleflex from fda.The mdr/ufr was submitted to them from beth israel deaconess medical center, which alleged several issues they experienced with iab/iabp devices.No specific dates of the alleged issues, patient involvement information or serial/lot number information was reported.

• Brand Name: CARDIAC UNKNOWN DUMMY MATERIAL
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 9489437
• MDR Text Key: 186292486
• Report Number: 3010532612-2019-00453
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/21/2019

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 Catalogue Number: CARDIAC UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1