MAUDE Adverse Event Report: ARROW INTERNATIONAL ARROW; INTRA-AORTIC BALLOON PUMP

Model Number 7.5/40CC

Device Problems Flushing Problem (1252); Aspiration Issue (2883); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 05/04/2016

Event Type  Injury  

Event Description

Pt.Nr# (b)(4), intra-aortic balloon pump counterpulsation, balloon pump had no arterial waveform, unable to flush, unable to aspirate blood from iabp, iabp pulled.

• Brand Name: ARROW
• Type of Device: INTRA-AORTIC BALLOON PUMP
• Manufacturer (Section D): ARROW INTERNATIONAL
• MDR Report Key: 5700339
• MDR Text Key: 46668267
• Report Number: MW5062658
• Device Sequence Number: 1
• Product Code: DSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/01/2016

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: No Information
• Device Model Number: 7.5/40CC
• Device Catalogue Number: IAB-06840-U
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR
• Patient Weight: 70