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

Model Number IPN001112

Device Problem Failure to Calibrate (2440)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other remarks: this report would not be likely to cause or contribute to a death or serious injury, and if it were to reoccur, it would be unlikely to cause or contribute to a death or serious injury.A fiber optic sensor (fos) not connecting cannot in itself cause or contribute to a patient death or serious injury.The fos is a portion of the catheter that monitors the patient's arterial pressure.When the fiber optic pressure signal is not available, the intra-aortic balloon (iab) is still able to be used since an arterial pressure signal is available through the central lumen.Iab therapy continues to the patient uninterrupted.

Event Description

It was reported that the staff got a cal key corrupt or missing error message when they were getting ready to insert a fiberoptic intra-aortic balloon (iab).The staff got the error message again after they disconnected and reconnected the fiberoptic connections on the intra-aortic balloon pump (iabp) that they were using.The staff got another iabp, made the fiberoptic connections and there was no error message and the iab was inserted into the patient and everything functioned appropriately.There was no report of patient complications, serious injury or death.

Event Description

It was reported that the staff got a cal key corrupt or missing error message when they were getting ready to insert a fiberoptic intra-aortic balloon (iab).The staff got the error message again after they disconnected and reconnected the fiberoptic connections on the intra-aortic balloon pump (iabp) that they were using.The staff got another iabp, made the fiberoptic connections and there was no error message and the iab was inserted into the patient and everything functioned appropriately.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Other remarks: this report would not be likely to cause or contribute to a death or serious injury, and if it were to reoccur, it would be unlikely to cause or contribute to a death or serious injury.A fiber optic sensor (fos) not connecting cannot in itself cause or contribute to a patient death or serious injury.The fos is a portion of the catheter that monitors the patient's arterial pressure.When the fiber optic pressure signal is not available, the intra-aortic balloon (iab) is still able to be used since an arterial pressure signal is available through the central lumen.Iab therapy continues to the patient uninterrupted.Corrected data: it was discovered that the defect reported by the customer is not a reportable event, thus the initial mdr sent on 03 mar 2021 should be retracted.

• 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: 11588907
• MDR Text Key: 242929870
• Report Number: 3010532612-2021-00068
• 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: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• 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?: No
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1