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

Model Number IPN001112

Device Problem Moisture or Humidity Problem (2986)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint was received via email from medicines and (b)(6).It was reported that the intra-aortic balloon pump (iabp) had an alarm for "drain task incomplete".It was noted that there was no water in the bottle.The iabp was turned on and off for 20 seconds by the perfusionist, but alarm persisted.As a result, the iabp was changed.There was no report of patient complications, serious injury or death.

Event Description

The complaint was received via email from medicines and healthcare products regulatory agency (mhra).It was reported that the intra-aortic balloon pump (iabp) had an alarm for "drain task incomplete".It was noted that there was no water in the bottle.The iabp was turned on and off for 20 seconds by the perfusionist, but alarm persisted.As a result, the iabp was changed.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).No iabp part was returned to teleflex for investigation.The reported complaint of "drain failure alarms" is not able to be confirmed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the iap serial and lot 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 revived risk.This will be monitored for any developing trends.

• 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: 10454632
• MDR Text Key: 204387579
• Report Number: 3010532612-2020-00241
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902084966
• UDI-Public: 30801902084966
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN001112
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1