MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AUTOCAT 2; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAP-0400

Device Problems Failure to Run on Battery (1466); Complete Loss of Power (4015)

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

Event Date 03/18/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).N/a.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "during the regular equipment inspection, it was found that the iabp had a depleted battery and could not meet the transportation needs of the department without ac power.Subsequently, the built-in battery was replaced.The hospital equipment department reported a medical device adverse event".No patient involvement.

Manufacturer Narrative

(b)(4).The reported complaint of "depleted battery and could not meet the transportation needs" was not able to be confirmed as no iabp part was returned for investigation.As per the event details, the battery was replaced.Additionally, iabp users and servicers must follow the operating instructions manual for recommendations on usage, charging, maintenance and storage of the batteries.If battery maintenance is not performed per the iabp operating instructions manual, the battery may not provide the expected minimum run time of operating power.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported that "during the regular equipment inspection, it was found that the iabp had a depleted battery and could not meet the transportation needs of the department without ac power.Subsequently, the built-in battery was replaced.The hospital equipment department reported a medical device adverse event".No patient involvement.

• Brand Name: AUTOCAT 2
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17930561
• MDR Text Key: 325830835
• Report Number: 3010532612-2023-00581
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902051722
• UDI-Public: 30801902051722
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0400
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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