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

Model Number	IPN000325
Medical Device Problem Code	Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "drain error" alarm occurred frequently while in use on a patient.It was possible to continue to use the intra-aortic balloon pump (iabp), however, the user had to reset the alarm each time it occurred.As a result, the pump was replaced with a back-up pump.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.
Additional Manufacturer Narrative
(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iabp drain failure alarm is not able to be confirmed.The root cause of the complaint is undetermined.If a sample is returned later, an investigation of the sample will be performed.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.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 or Problem Description
It was reported that "drain error" alarm occurred frequently while in use on a patient.It was possible to continue to use the intra-aortic balloon pump (iabp), however, the user had to reset the alarm each time it occurred.As a result, the pump was replaced with a back-up pump.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.

• Brand Name: AUTOCAT2 WAVE JAPANESE
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9712437
• Report Number: 3010532612-2020-00023
• Device Sequence Number: 3654427
• 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): 01/24/2020

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: IPN000325
• Device Catalogue Number: IAP-0500J
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1