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

Model Number	IPN000324
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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 or Problem 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.
Additional 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
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10750158
• Report Number: 3010532612-2020-00315
• Device Sequence Number: 19864464
• Product Code: DSP
• UDI-Device Identifier: 30801902092190
• UDI-Public: 30801902092190
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K060309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 11/25/2020; 05/26/2021
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 12/04/2020; 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1