MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. IABP AUTOCAT 2 WAVE PUMP CONSOLE - ITALIAN; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000324

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other remarks: the field service engineer (fse) serviced the iabp and found the power supply to be faulty.The power supply was replaced.

Event Description

There was no patient involvement.It was reported that the intra-aortic balloon pump (iabp) failed to switch on.As a result, a new iabp was used.

Event Description

There was no patient involvement.It was reported that the intra-aortic balloon pump (iabp) failed to switch on.As a result, a new iabp was used.

Manufacturer Narrative

Qn# (b)(4).No iabp part was returned to teleflex chelmsford for investigation.The reported complaint of "iabp failed to switch on" was confirmed by the teleflex field service engineer.As a result, the power supply was replaced.If the part is received at a later date, an investigation will be performed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the iap serial and 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.Other remarks: the field service engineer (fse) serviced the iabp and found the power supply to be faulty.The power supply was replaced.

Event Description

There was no patient involvement.It was reported that the intra-aortic balloon pump (iabp) failed to switch on.As a result, a new iabp was used.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of "unable to power-up" is confirmed.No voltage outputs were present during testing, which is the result of the reported issue.The root cause of the power supply voltage output failure is undetermined.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 revised risks.This will be monitored for any developing trends.Other remarks: the field service engineer (fse) serviced the iabp and found the power supply to be faulty.The power supply was replaced.

• Brand Name: IABP AUTOCAT 2 WAVE PUMP CONSOLE - ITALIAN
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10750158
• MDR Text Key: 213664288
• Report Number: 3010532612-2020-00315
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902092190
• UDI-Public: 30801902092190
• 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: 10/08/2020

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: IPN000324
• Device Catalogue Number: IAP-0500I
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 11/25/2020; 05/26/2021
• Supplement Dates FDA Received: 12/04/2020; 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1