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

Catalog Number IAP-0700

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 04/10/2024

Event Type  malfunction  

Event Description

It was reported "pump had interference on ap waveform".No patient harm or injury reported.Additionally, it was reported that the pump was not switched out.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn# (b)(4).The reported complaint of "interference on ap waveform" could not be confirmed upon investigation of the returned sample.The customer returned an ac3 i/o board, a front-end board, and a cpm board for investigation.The returned parts passed visual and functional test specifications during the complaint investigation.Based on a review of the device history record (dhr), the product met specification upon release.No problem was found with the returned device.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported "pump had interference on ap waveform".No patient harm or injury reported.Additionally, it was reported that the pump was not switched out.

• Brand Name: AC3 OPTIMUS IABP NA/EMEA
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19168774
• MDR Text Key: 340964943
• Report Number: 3010532612-2024-00343
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902084966
• UDI-Public: 30801902084966
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: NONE REPORTED