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

Model Number IPN000320

Device Problems Detachment of Device or Device Component (2907); Mechanical Jam (2983); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

There was no patient involvement.It was reported that during checking of the intra-aortic balloon pump (iabp), the staff received a system error 3, pump/vent valve failure alarm.The iabp was checked, the pump assembly failure was found.When the iabp was started a loud noise was heard.

Manufacturer Narrative

(b)(4).No parts were returned to teleflex chelmsford for investigation.The reported complaint of system error 3 alarm is not able to be confirmed.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

There was no patient involvement.It was reported that during checking of the intra-aortic balloon pump (iabp), the staff received a system error 3, pump/vent valve failure alarm.The iabp was checked, the pump assembly failure was found.When the iabp was started a loud noise was heard.

Manufacturer Narrative

Qn#: (b)(4).Teleflex received the device for investigation.The reported complaint of "system error 3" is confirmed.The system failed to find the home position, which is likely the cause of the alarm.Corrections have been established for this issue as a result of a non-conformance, and this device was manufactured prior to the release of those corrections.A device history record (dhr) review was conducted for the lot number/serial 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

There was no patient involvement.It was reported that during checking of the intra-aortic balloon pump (iabp), the staff received a system error 3, pump/vent valve failure alarm.The iabp was checked, the pump assembly failure was found.When the iabp was started a loud noise was heard.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10677296
• MDR Text Key: 211296580
• Report Number: 3010532612-2020-00291
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1