MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AEROAUTOCAT2; INTRA-AORTIC BALLOON PUMP

Catalog Number IAP-0435

Device Problem Difficult to Interrogate (1331)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a field service report: (b)(4).Symptom: loss of trigger in autopilot mode; could not "re-acquire." findings / action taken: ran for 1 hour in all trigger in ecg and ap.Could not duplicate.Replaced front end board as a precaution.Re-tested - unit checks ok.Performed electrical safety test.Fcn level: 1416.Expedited qa review: yes.Op = on patient.Unconfirmed.

Manufacturer Narrative

(b)(4).No iabp parts or recorder strips were returned for evaluation at the teleflex (b)(4) facility.The pump was checked by the field service agent and no problem was found.The front end board was replaced for a precautionary.The pump passed the functional check and was returned to service.A device history record (dhr) review is not required.No functional issue was found with the pump.Conclusion: the reported complaint of "trigger loss in autopilot mode" is not able to be confirmed.The pump was check by the field service agent and no issue was found.The pump passed the functional check-out.No parts or recorder strips were returned for evaluation.The cause of the reported complaint could not be determined.

Event Description

It was reported via a field service report: (b)(4).Symptom: loss of trigger in autopilot mode - could not "re-acquire." findings / action taken: ran for 1 hour in all trigger in ecg and ap.Could not duplicate.Replaced front end board as a precaution.Re-tested - unit checks ok.Performed electrical safety test.Fcn level: 1416.Expedited qa review: yes.Op = on patient unconfirmed.

• Brand Name: AEROAUTOCAT2
• 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: 6138056
• MDR Text Key: 61249511
• Report Number: 1219856-2016-00267
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0435
• Other Device ID Number: 00801902051745
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1