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

Catalog Number IAP-0400

Device Problem Battery Problem: Low Impedance (2973)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon pump (iabp) repeatedly showed signs of self-screen extinguishing, shutdown and restart during iabp implantation.As a result, the staff consulted iabp engineer by telephone and then make a series of adjustments under the guidance of the engineer (turn off iabp battery and select external power supply directly).There was no report of patient complications, serious injury or death.The pump has since been maintained and it was found that the battery module has problem.As a result, the battery was replaced and the pump works normally.

Manufacturer Narrative

Qn#: (b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iabp "repeatedly showed signs of self-screen extinguishing, shutdown, and restart" is not able to be confirmed.The battery was replaced, and the issue was resolved.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Note: 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.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that the intra-aortic balloon pump (iabp) repeatedly showed signs of self-screen extinguishing, shutdown and restart during iabp implantation.As a result, the staff consulted iabp engineer by telephone and then make a series of adjustments under the guidance of the engineer (turn off iabp battery and select external power supply directly).There was no report of patient complications, serious injury or death.The pump has since been maintained and it was found that the battery module has problem.As a result, the battery was replaced and the pump works normally.

• Brand Name: AUTOCAT 2
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9532910
• MDR Text Key: 183176831
• Report Number: 3010532612-2019-00467
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902051722
• UDI-Public: 30801902051722
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VASOACTIVE DRUGS; VASOACTIVE DRUGS
• Patient Age: 57 YR