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

Model Number IPN001112

Device Problems No Device Output (1435); Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was placed on the intra-aortic balloon pump (iabp) using a fiberoptic catheter and the staff could not get an ap reading to stay on the monitor.The staff was able to get a trigger off of the ecg but neither the fiberoptic or ap was working correctly.Another iabp was brought in and the connections were switched, and everything worked fine.The connections were switched were back to the original pump and the ap or fiber would not work.As a result, the iabp was swapped out.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

Qn#(b)(4).No iabp part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of iabp fos ap signal intermittent is confirmed based on the videos submitted with the complaint.The videos show the iabp intermittently switching between fos and transducer ap signals, and it was noted that no waveform was available on the fos signal, consistent with the reported complaint.A teleflex field service engineer serviced the pump and could not duplicate the reported issue.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 revived risk.This will be monitored for any developing trends.

Event Description

It was reported that the patient was placed on the intra-aortic balloon pump (iabp) using a fiberoptic catheter and the staff could not get an ap reading to stay on the monitor.The staff was able to get a trigger off of the ecg but neither the fiberoptic or ap was working correctly.Another iabp was brought in and the connections were switched, and everything worked fine.The connections were switched were back to the original pump and the ap or fiber would not work.As a result, the iabp 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: 9921021
• MDR Text Key: 186533958
• Report Number: 3010532612-2020-00087
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• 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?: No
• Date Manufacturer Received: 05/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1