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

Catalog Number IAP-0700

Device Problem Moisture or Humidity Problem (2986)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).For complaints involving the same patient and event see mdr #3010532612-2019-00403 and (b)(4) , mdr #3010532612-2019-00404 and (b)(4).

Event Description

It was reported by the rn who called the clinical support specialist (css) that the intra-aortic balloon pump (iabp) began getting "drain task incomplete" alarms (5) since the intra-aortic balloon (iab) was inserted.It was noted that the first alarm occurred 12 hours after the therapy was initiated.The rn has emptied the condensation bottle and there was not much in the bottle.There are no signs of condensation in the gas drive tubing.The rn has reported having had at least 2 alarms since the bottle was emptied.Also noted a few possible helium loss 2 alarms.As a result, the css recommended that the console be swapped out and sent to biomed.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation.The reported complaint of iabp drain failure alarm is confirmed based on photos of the pump alarm history submitted with the complaint.Additional information indicates the pump was inspected by the hospitals biomed and no issues were noted.The root cause of the complaint is undetermined.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.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 see mdr #3010532612-2019-00403 and tc #(b)(4), mdr #3010532612-2019-00404 and tc #(b)(4).

Event Description

It was reported by the rn who called the clinical support specialist (css) that the intra-aortic balloon pump (iabp) began getting "drain task incomplete" alarms (5) since the intra-aortic balloon (iab) was inserted.It was noted that the first alarm occurred 12 hours after the therapy was initiated.The rn has emptied the condensation bottle and there was not much in the bottle.There are no signs of condensation in the gas drive tubing.The rn has reported having had at least 2 alarms since the bottle was emptied.Also noted a few possible helium loss 2 alarms.As a result, the css recommended that the console be swapped out and sent to biomed.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: 9306686
• MDR Text Key: 183743537
• Report Number: 3010532612-2019-00402
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902043420
• UDI-Public: 30801902043420
• 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: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• 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: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1