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

Catalog Number IAP-0500

Device Problem Communication or Transmission Problem (2896)

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

Event Date 09/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the staff found the fiberoptic not connected.When the staff connected the fiberoptic, it was working but the intra-aortic balloon pump (iabp) began giving them an ap out of range alarm.It was noted that the status code was tl, the waveform was good, and the pressure readings were appropriate.After two hours, they continued to have the ap out of range alarms.As a result, the staff switched to a different iabp and the first iabp was sent to biomed.There was no report of patient complication, serious injury or death.

Manufacturer Narrative

Qn# (b)(4).No iabp part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of fos ap out of range alarm is not able to be confirmed.According to the field service database, no service has been performed on this pump as of 27oct2021.If additional information is received at a later date, the notification will be reopened and a full investigation will be completed.The root cause of the complaint 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.

Event Description

It was reported that the staff found the fiberoptic not connected.When the staff connected the fiberoptic, it was working but the intra-aortic balloon pump (iabp) began giving them an ap out of range alarm.It was noted that the status code was tl, the waveform was good, and the pressure readings were appropriate.After two hours, they continued to have the ap out of range alarms.As a result, the staff switched to a different iabp and the first iabp was sent to biomed.There was no report of patient complication, serious injury or death.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12586420
• MDR Text Key: 275052337
• Report Number: 3010532612-2021-00295
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902051714
• UDI-Public: 00801902051714
• 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: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1