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

Catalog Number IAP-0500

Device Problem Power Problem (3010)

Patient Problem Myocardial Infarction (1969)

Event Date 01/29/2016

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 surgical intensive care unit (sicu) was calling because they just recently received a patient from the cath lab with an intra-aortic balloon pump (iabp) running.When they plugged the pump into the wall outlet, it still showed that it was running on battery.The rn stated that they tried plugging it into several wall outlets with no change.They then changed the pump out for a different pump and this resolved the issue.The rn was calling because they wanted to see about getting a replacement pump.The clinical support specialist (css) first verified that there had been no delays in therapy and the current pump was providing good support for the patient.The css then had the rn verify that the power cord was firmly plugged into the pump itself on the original pump with the serial number reported above ((b)(4)).The css also verified that the green lightbulb did not turn on when plugged in.The css also had the rn check the circuit breaker by the helium tank and she stated that it was on.The css then recommended that they have the pump sent to biomed.It was noted that the length of time prior to the event was 30 minutes and that the outcome of the patient was stable.Additional information received from biomed on 15feb2016 reported that the iabp was checked out and the power supply was exchanged.

Manufacturer Narrative

(b)(4) device evaluation: the power supply was returned for evaluation.Visual inspection of the power supply was performed and found no obvious damage or defects.Visual inspection of the power supply internal hardware was performed and no component damage or defect was noted.The power supply in question was installed into a known good intra-aortic balloon pump (autocat2w) and performed functional testing.The known good autocat2w with the power supply in question installed failed the functional test.The pump failed to power-up with no alarms.Both ac and dc powers were not presented when the main power switch was switched on.The pump was unable to switch to battery due to power supply issue.This is the original power supply and the pump was manufactured in september, 2006.A 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 "power supply malfunction" is confirmed.The reported problem was reproduced during the functional test.The power supply failed the functional test.The pump failed to power-up.The cause of the power supply malfunction is undetermined.

Event Description

It was reported that the rn from the surgical intensive care unit (sicu) was calling because they just recently received a patient from the cath lab with an intra-aortic balloon pump (iabp) running.When they plugged the pump into the wall outlet it still showed that it was running on battery.The rn stated that they tried plugging it into several wall outlets with no change.They then changed the pump out for a different pump and this resolved the issue.The rn was calling because they wanted to see about getting a replacement pump.The clinical support specialist (css) first verified that there had been no delays in therapy and the current pump was providing good support for the patient.The css then had the rn verify that the power cord was firmly plugged into the pump itself on the original pump with the serial number reported above ((b)(4)).The css also verified that the green lightbulb did not turn on when plugged in.The css also had the rn check the circuit breaker by the helium tank and she stated that it was on.The css then recommended that they have the pump sent to biomed.It was noted that the length of time prior to the event was 30 minutes and that the outcome of the patient was stable.Additional information received from biomed on 15feb2016 reported that the iabp was checked out and the power supply was exchanged.

• 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: 5441689
• MDR Text Key: 38360242
• Report Number: 1219856-2016-00033
• 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: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2016
• 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