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

Catalog Number IAP-0500

Device Problem Unable to Obtain Readings (1516)

Patient Problems Myocardial Infarction (1969); Cardiogenic Shock (2262)

Event Date 02/07/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported by the cardiac care unit (ccu) nurse that they had an intra-aortic balloon (serial #(b)(4)).They zeroed the central lumen pressure and then they had no waveform on screen.There had been a good waveform prior to zeroing the central lumen.The pump was on transducer and she had numbers, but no waveform.The scale for arterial pressure (ap) is 50 to 0.The clinical support specialist (css) had her shake the transducer set up with no disturbance noticed on screen.The central lumen was flushed with no change.The ap scale was on auto and not manual.All the connections from the central lumen to the intra-aortic balloon pump (iabp) were checked and appropriate.The css had the nurse power the iabp off and then on.The ap was now present and she started pumping.The waveform was good and the pressure readings were appropriate.The patient was stable on the iabp.They may transfer the patient for consideration for a ventricular assist device (vad).

Manufacturer Narrative

(b)(4) additional information received from the field service engineer stated that the pump was not checked out by teleflex.The pump was now working and no further action was taken by the hospital.The pump is not under warranty and they have no agreement with teleflex.Evaluation: no parts or recorder strips were returned to teleflex (b)(4) for evaluation.A device history record review was conducted for the iap serial number and lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint of "ap waveform missing" is confirmed based on the information provided to the css.The css troubleshot with the rn and the pump was powered down and powered back on again.This resolved the issue.The cause of the reported complaint could not be determined.

Event Description

It was reported by the cardiac care unit (ccu) nurse that they had an intra-aortic balloon (serial (b)(4)).They zeroed the central lumen pressure and then they had no waveform on screen.There had been a good waveform prior to zeroing the central lumen.The pump was on transducer and she had numbers, but no waveform.The scale for arterial pressure (ap) is 50 to 0.The clinical support specialist (css) had her shake the transducer set up with no disturbance noticed on screen.The central lumen was flushed with no change.The ap scale was on auto and not manual.All the connections from the central lumen to the intra-aortic balloon pump (iabp) were checked and appropriate.The css had the nurse power the iabp off and then on.The ap was now present and she started pumping.The waveform was good and the pressure readings were appropriate.The patient was stable on the iabp.They may transfer the patient for consideration for a ventricular assist device (vad).

• 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: 5452033
• MDR Text Key: 38722362
• Report Number: 1219856-2016-00047
• 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: 02/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• 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: 04/07/2016
• 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