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

Model Number	IPN000325
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
There was no patient involvement.It was reported that during product training/demonstration, the alarm of system error 3 went off after pumping started.The user tried to restart the pumping by turning off and on the main power switch; however, the same alarm went off immediately.The alarm went off about 5 times in the end.A technical specialist is scheduled to visit the facility for inspection of the intra-aortic balloon pump (iabp).
Additional Manufacturer Narrative
Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of "system error 3 alarm" is confirmed.A loose connector pin on the output cable of the m-force was noted and caused the alarms.The root cause of the complaint is undetermined.A non-conformance has been initiated to further investigate the issue.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.
Event or Problem Description
There was no patient involvement.It was reported that during product training/demonstration, the alarm of system error 3 went off after pumping started.The user tried to restart the pumping by turning off and on the main power switch; however, the same alarm went off immediately.The alarm went off about 5 times in the end.A technical specialist is scheduled to visit the facility for inspection of the intra-aortic balloon pump (iabp).

• Brand Name: AUTOCAT2 WAVE JAPANESE
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12091787
• Report Number: 3010532612-2021-00170
• Device Sequence Number: 11759434
• Product Code: DSP
• UDI-Device Identifier: 30801902043420
• UDI-Public: 30801902043420
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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
• Operator of Device: Health Professional
• Device Model Number: IPN000325
• Device Catalogue Number: IAP-0500J
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1