MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000320

Device Problem No Audible Alarm (1019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is also linked to mdr no.3010532612-2020-00041 and teleflex confirmation (b)(4).

Event Description

It was reported by field service engineer (fse) that during use on a patient, the intra-aortic balloon pump (iabp) lost signal, pump stopped but no alarm.As a result, the pump was swapped out with no harm to patient.The fse could not confirm the symptom.The fse ran trigger loss both arterial pressure (ap) and electrocardiogram (ecg), the pump always alarmed.Fse checked all alarms and performed functional checks everything passed.

Event Description

It was reported by field service engineer (fse) that during use on a patient, the intra-aortic balloon pump (iabp) lost signal, pump stopped but no alarm.As a result, the pump was swapped out with no harm to patient.The fse could not confirm the symptom.The fse ran trigger loss both arterial pressure (ap) and electrocardiogram (ecg), the pump always alarmed.Fse checked all alarms and performed functional checks everything passed.

Manufacturer Narrative

Qn#(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of the pump stops pumping after trigger loss without any alarms is not able to be confirmed.The field service engineer checked the pump and no problem was found with the pump.The pump passed functional checkout.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 revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.Other remarks: this complaint is also linked to mdr no.3010532612-2020-00041 and teleflex confirmation no.(b)(4).

• Brand Name: AUTOCAT2 WAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9722581
• MDR Text Key: 183164824
• Report Number: 3010532612-2020-00046
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902051715
• UDI-Public: 30801902051715
• Combination Product (y/n): N
• PMA/PMN Number: K060309
• 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: 01/31/2020

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 Operator: Health Professional
• Device Model Number: IPN000320
• Device Catalogue Number: IAP-0500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 02/18/2020
• Supplement Dates Manufacturer Received: 03/19/2020
• Supplement Dates FDA Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1