MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/EMEA; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAP-0700

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon pump (iabp) alarmed for purge failure.The pump was continued to be used with no complications.There was no report of patient injury or consequence.

Event Description

It was reported that the intra-aortic balloon pump (iabp) alarmed for purge failure.The pump was continued to be used with no complications.There was no report of patient injury or consequence.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iabp purge failure alarm is not able to be confirmed.A teleflex field service engineer serviced the pump and could not duplicate the reported complaint.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.

• Brand Name: AC3 OPTIMUS IABP NA/EMEA
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8808356
• MDR Text Key: 151629940
• Report Number: 3010532612-2019-00223
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K162820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1