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

Catalog Number IAP-0635

Device Problems Device Alarm System (1012); Circuit Failure (1089); Failure to Pump (1502)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2014

Event Type  malfunction  

Event Description

It was reported per field service report: system - circuit breaker tripped during transport.Reason for service: check out.Findings/action taken: performed functional testing and was unable to duplicate customer's complaint.Unit passed a power supply voltage checkout and battery load test.The circuit breaker and power cord were replaced as a precaution.Unit passed functional checkout with electrical safety test.The pump is back in service.Additional information received on (b)(4) 2014 reported that the biomed stated to the field service representative the problem occurred after the transport was completed.The biomed didn't know if the patient was on the pump at the time of the incident.An update received on (b)(4) 2014 from the sales representative stated that there was no effect to the patient's condition.During transport the internal battery failure alarm occurred and requested to check circuit breaker.The pump was initially able to be run on ac power and they were able to transition the patient from the cardiac cath lab to the ambulance.The pump ran during transport to the other facility.On arrival to the other facility, the iabp would not turn on even when connected to ac power.Iabp taken oos (out of service), spare iabp placed in med 9.

Manufacturer Narrative

(b)(4).

• Brand Name: AEROAUTOCAT 2 WAVE
• Type of Device: INTRA-AORTIC BALLOON PUMP PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: kathryn myers, regulatory assoc. ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4067680
• MDR Text Key: 4738672
• Report Number: 1219856-2014-00158
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/08/2014

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
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0635
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2014
• Initial Date FDA Received: 08/28/2014
• Date Device Manufactured: 09/01/2011
• 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