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

Catalog Number IAP-0700

Device Problems Loose or Intermittent Connection (1371); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: ator support norepinephrine vasopressin epinephrineqn #(b)(4).

Event Description

It was reported by the rn that they have a patient in the operating room (or) that deteriorated and the intra-aortic balloon (iab) was placed.The rn called the clinical support specialist (css) for possible helium loss 2 alarms on the intra-aortic balloon pump (iabp) that began in the or.The css had the staff disconnect the quick connect, clean with alcohol, and reconnect with a twist.No further alarms after 10 minutes.The patient is reported to be critical but supported on the iabp.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

Event Description

It was reported by the rn that they have a patient in the operating room (or) that deteriorated and the intra-aortic balloon (iab) was placed.The rn called the clinical support specialist (css) for possible helium loss 2 alarms on the intra-aortic balloon pump (iabp) that began in the or.The css had the staff disconnect the quick connect, clean with alcohol, and reconnect with a twist.No further alarms after 10 minutes.The patient is reported to be critical but supported on the iabp.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Concomitant medical products: ator support, norepinephrine, vasopressin, and epinephrine.Qn#(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of helium loss alarm is not able to be confirmed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the 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 revised risks.The reported complaint will be monitored for any developing trends.No further action 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: 8887746
• MDR Text Key: 154125420
• Report Number: 3010532612-2019-00264
• 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: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• 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: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)VENTIL; EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)VENTIL; EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)VENTIL