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

Catalog Number IAP-0700

Device Problem No Audible Alarm (1019)

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

Event Date 12/11/2023

Event Type  malfunction  

Event Description

The report states "[user] called the hotline to troubleshoot a 'squared off bpw with not much of a seat'.She stated it was hard to describe and wanted to facetime call.Facetime call noted very small bpw with plateau pressure at 68 and baseline noted below zero.There have been no alarms on the pump and no alarms currently present.5830 lws iab connected volume verified at 30cc 100%.Alarm history shows only deflation timing may be late at 0527, 10dec 0424 trigger loss 2351 deflation timing, and 09dec 1948 possible he loss 3and 1136 system error 1- the pump has been in autopilot mode, fos ap waveform source.Augmentation not noted, no ap waveform but aug pressure displaying 115 (roughly the same as the patient).[user] stated they had just noted this on the waveform and it had not previously been this way.There is no blood noted in the tubing the patient is stable.Time noted on pump verified as correct".The issue was resolved as a "pump manual purge performed, waveform now noted normal, bpp now normal, augmentation 132".No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).

Manufacturer Narrative

Qn# (b)(4).The reported complaint of "squared off bpw, no alarms, no augmentation" was confirmed based on customer supplied pictures.However, complaint verification testing could not be performed as no iabp part was returned for investigation.According to the additional information received, the pump was checked by the hospital's biomed, and the reported issue could not be duplicated.The pump was returned to service.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the balloon baseline too low.The root cause of the complaint was undetermined.No further action required at this time.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

Event Description

The report states "[user] called the hotline to troubleshoot a 'squared off bpw with not much of a seat'.She stated it was hard to describe and wanted to facetime call.Facetime call noted very small bpw with plateau pressure at 68 and baseline noted below zero.There have been no alarms on the pump and no alarms currently present.5830 lws iab connected volume verified at 30cc 100%.Alarm history shows only deflation timing may be late at 0527, (b)(6) 0424 trigger loss 2351 deflation timing, and (b)(6) 1948 possible he loss 3 and 1136 system error 1- the pump has been in autopilot mode, fos ap waveform source.Augmentation not noted, no ap waveform but aug pressure displaying 115 (roughly the same as the patient).[user] stated they had just noted this on the waveform and it had not previously been this way.There is no blood noted in the tubing the patient is stable.Time noted on pump verified as correct".The issue was resolved as a "pump manual purge performed, waveform now noted normal, bpp now normal, augmentation 132".No patient harm or injury.The patient status is reported as "fine".

• 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: 18426679
• MDR Text Key: 331914475
• Report Number: 3010532612-2024-00006
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Female