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

Model Number	IPN000329
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the intra-aortic balloon pump (iabp) was in use and the staff experienced a white screen and powered down during patient care.This continued to happen on both battery and plugged in.The iabp did make an audible alarm but no warnings came across the screen.As a result, the iabp was swapped out at the hospital.There was no report of patient complications, serious injury or death.
Additional Manufacturer Narrative
(b)(4).No part has returned to teleflex chelmsford for investigation.The reported complaint of the pump would not power on was confirmed by the field service agent.A field service agent (fsa) serviced the pump and confirmed the battery was defective.The battery was replaced, and the issue was resolved.The pump passed functional checkout.If the part is received at a later date, an investigation will be performed.The root cause of the complaint is undetermined.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.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 or Problem Description
It was reported the intra-aortic balloon pump (iabp) was in use and the staff experienced a white screen and powered down during patient care.This continued to happen on both battery and plugged in.The iabp did make an audible alarm but no warnings came across the screen.As a result, the iabp was swapped out at the hospital.There was no report of patient complications, serious injury or death.
Event or Problem Description
It was reported the intra-aortic balloon pump (iabp) was in use and the staff experienced a white screen and powered down during patient care.This continued to happen on both battery and plugged in.The iabp did make an audible alarm but no warnings came across the screen.As a result, the iabp was swapped out at the hospital.There was no report of patient complications, serious injury or death.
Additional Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of "short battery runtime" is confirmed.The pump shut off approximately 28 minutes when operating on battery power after a full charge during.The battery failed battery load test.A definitive root cause could not be determined but a potential cause of the short battery life is a result of maintaining of the battery.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.

• Brand Name: AEROAUTOCAT 2 WAVE
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10275565
• Report Number: 3010532612-2020-00185
• Device Sequence Number: 2398798
• Product Code: DSP
• UDI-Device Identifier: 30801902051739
• UDI-Public: 30801902051739
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K060309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2020

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
• Operator of Device: Health Professional
• Device Model Number: IPN000329
• Device Catalogue Number: IAP-0535
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 08/19/2020; 01/05/2021
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 08/20/2020; 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1