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

Catalog Number IAP-0500

Device Problem No Display/Image (1183)

Patient Problem Myocardial Infarction (1969)

Event Date 03/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device / parts will not be returned for evaluation.

Event Description

It was reported that the rn from the cardiac care unit was calling to ask about calibrating the fiberoptix sensor (fos).They were transferring a patient from another facility for ohs (open heart surgery).The rn was in the back of the ambulance transporting the patient.Per the rn, after insertion, they had to switch to another pump due a screen issue on a previous pump in house.When they transferred to this pump, everything was functioning appropriately; however, the fos arterial pressure (ap) had not been calibrated.The clinical support specialist (css) walked through performing the calibration.The ap waveform would not allow a zero on the transducer, to use for a map (mean arterial pressure) to calibrate to, as there was too much road noise for it to remain stable to zero.The rn switched it back to fos and said the pressures were correlating to the patient's status; she just wanted to be sure if it needed to be done.The css and rn discussed that calibrating had nothing to do with the timing algorithm and as the pressures were accurate, calibrating was not necessary at this point.The css relayed that if the pressures seemed to change and not correlate to the patient's status to call and we would try again.The css received no further calls.It was noted that the intra-aortic balloon used was an iab-05840-lws, s/n (b)(4).

Manufacturer Narrative

Qn#(b)(4).Additional information received per the investigator stated that the pump was check by hospital biomed and a loose connector was found on the display board.A preventative maintenance was completed and passed.Evaluation: no intra-aortic balloon pump parts or recorder strips were returned to (b)(4) facility for evaluation.Device history record review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint of "display screen issue" is unable to be confirmed.The cause of the reported complaint could not be determined.

Event Description

It was reported that the rn from the cardiac care unit was calling to ask about calibrating the fiberoptix sensor (fos).They were transferring a patient from another facility for ohs (open heart surgery).The rn was in the back of the ambulance transporting the patient.Per the rn, after insertion, they had to switch to another pump due a screen issue on a previous pump in house.When they transferred to this pump, everything was functioning appropriately; however, the fos arterial pressure (ap) had not been calibrated.The clinical support specialist (css) walked through performing the calibration.The ap waveform would not allow a zero on the transducer, to use for a map (mean arterial pressure) to calibrate to, as there was too much road noise for it to remain stable to zero.The rn switched it back to fos and said the pressures were correlating to the patient's status; she just wanted to be sure if it needed to be done.The css and rn discussed that calibrating had nothing to do with the timing algorithm and as the pressures were accurate, calibrating was not necessary at this point.The css relayed that if the pressures seemed to change and not correlate to the patient's status to call and we would try again.The css received no further calls.It was noted that the intra-aortic balloon used was an iab-05840-lws, s/n (b)(4).

• Brand Name: AUTOCAT2 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: kathryn myers ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5531325
• MDR Text Key: 41341996
• Report Number: 1219856-2016-00076
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500
• Other Device ID Number: 30801902051715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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