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

Model Number IPN001112

Device Problem Incomplete or Inadequate Connection (4037)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).For complaints involving the same patient and event date see: mdr #3010532612-2019-00482 and (b)(4).Mdr #3010532612-2019-00483 and (b)(4).

Event Description

It was reported by the cath lab manager that when the intra-aortic balloon (iab) was connected to the intra-aortic balloon pump (iabp), the staff received a purge failure message on start up.A second iab was connected to the pump and the staff kept getting the purge failure message.As a result, the pump was swapped out.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of purge failure alarm is confirmed.Dried condensation and dried blood were noted inside the manifold and valves which potentially created a leak or a block inside the pneumatic system, which can cause purge failure alarms.The root cause of how the condensation buildup and blood enter the pcs assembly 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.This will be monitored for any developing trends.No further action required at this time.Other remarks: for complaints involving the same patient and event date see: mdr #3010532612-2019-00482 and (b)(4).Mdr #3010532612-2019-00483 and (b)(4).

Event Description

It was reported by the cath lab manager that when the intra-aortic balloon (iab) was connected to the intra-aortic balloon pump (iabp), the staff received a purge failure message on start up.A second iab was connected to the pump and the staff kept getting the purge failure message.As a result, the pump was swapped out.There was no report of patient complications, serious injury or death.

• 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: 9582849
• MDR Text Key: 183921580
• Report Number: 3010532612-2019-00479
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902084966
• UDI-Public: 30801902084966
• Combination Product (y/n): N
• 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: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN001112
• Device Catalogue Number: IAP-0500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 02/07/2020
• Supplement Dates FDA Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1