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

Catalog Number IAP-0535

Device Problem Pumping Stopped (1503)

Patient Problem Atrial Fibrillation (1729)

Event Date 05/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a field service report: (b)(4).Symptom: the iabp stopped pumping while on patient during transport.Findings/action taken: paramedic nurse explained stop pumping during transport.On ecg trigger and slaved from monitor the patient had (afib) atrial fibrillation arrhythmia.The rn powered off and on to correct issue twice, after second time, pump had no further problems.The fsr replaced (feb) front end board, perform fcn 16 update, software to 2.24.Perform pm.Additional information received on 05/25/2016 per the paramedic rn, there was no harm to the patient.

Manufacturer Narrative

(b)(4).The front end board (feb)(p/n: 77-1010-003, s/n: (b)(4)) was returned for evaluation.Visual inspection of front end board and was performed and no abnormalities were noted.The front end board in question was installed onto the fe/cpu/fos board test fixture and tested.No faults were found with the returned front end board.The front end board passed testing.The front end board in question was then installed into a known good autocat2w and performed functional testing.The fe board passed voltage check, blood pressure (bp) transducer, and static ram memory.Performed (ecg) electro- cardiogram, (ap) arterial pressure signal and trigger checklist and passed.The pump was left to run for six hours without any alarms or errors.The pump with the front end board in question functioned as intended.A device history record (dhr) review is not required.No problem was found with the returned sample.Conclusion: the reported complaint of "unit stop pumping" is not confirmed.The reported problem could not be replicated at the teleflex (b)(4) facility during the functional test.The front end board passed functional testing.The cause of the reported complaint is undetermined.

Event Description

It was reported via (b)(4).Symptom: the iabp stopped pumping while on patient during transport.Findings/action taken: paramedic nurse explained stop pumping during transport.On ecg trigger and slaved from monitor the patient had (afib) atrial fibrillation arrhythmia.The rn powered off and on to correct issue twice, after second time, pump had no further problems.The fsr replaced (feb) front end board, perform fcn 16 update, software to 2.24.Perform pm.Additional information received on 05/25/2016 per the paramedic rn, there was no harm to the patient.

• Brand Name: AEROAUTOCAT 2 WAVE
• Type of Device: INTRA-AORTIC BALLOON PUMP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 5726739
• MDR Text Key: 47494043
• Report Number: 1219856-2016-00126
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0535
• Other Device ID Number: 30801902051739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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