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

Model Number IPN001096

Device Problems Defective Device (2588); Pressure Problem (3012)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

There was no patient involvement.It was reported that a high baseline was detected during preventative maintenance (pm) of the intra-aortic balloon pump (iabp).

Manufacturer Narrative

(b)(4).No iap part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of "high baseline alarm" was confirmed by the field service engineer.As a result, the pump assembly was replaced.If the product is returned at a later date, a full investigation of the sample 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 revived risk.This will be monitored for any developing trends.

Event Description

There was no patient involvement.It was reported that a high baseline was detected during preventative maintenance (pm) of the intra-aortic balloon pump (iabp).

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of "high baseline alarm" is confirmed.The pump alarmed high baseline during the complaint investigation.An excessive noise was noted from the pump assembly consistent with a motor/lead screw malfunction.The root cause of this 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

There was no patient involvement.It was reported that a high baseline was detected during preventative maintenance (pm) of the intra-aortic balloon pump (iabp).

• Brand Name: AUTOCAT2 WAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: kaylia pen ; 16 elizabeth drive; chelmsford, MA 01824
• MDR Report Key: 11308238
• MDR Text Key: 231318125
• Report Number: 3010532612-2021-00038
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902051714
• UDI-Public: 00801902051714
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2021

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: IPN001096
• Device Catalogue Number: IAP-0500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 03/16/2021; 01/21/2022
• Supplement Dates FDA Received: 03/17/2021; 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1