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

Model Number IPN000320

Device Problem Charging Problem (2892)

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

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported that the "intra-aortic balloon pump (iabp) machine is not responding to external power supply, battery is not getting charged.Suspecting power supply failure." it is currently unknown if there was any patient involvement.There was no report of patient complication, serious injury, or death.

Event Description

It was reported that the "intra-aortic balloon pump (iabp) machine is not responding to external power supply, battery is not getting charged.Suspecting power supply failure." it is currently unknown if there was any patient involvement.There was no report of patient complication, serious injury, or death.

Manufacturer Narrative

Qn#(b)(4).The product was not returned for investigation.The reported complaint of "unit failed to power-on" is confirmed.The pump displayed blank screen with no voltage outputs during testing.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 risk.This will be monitored for any developing trends.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12338884
• MDR Text Key: 267150309
• Report Number: 3010532612-2021-00230
• 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
• Report Date: 07/29/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 09/17/2021
• Supplement Dates FDA Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1