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

Catalog Number IAP-0500

Device Problem Pumping Stopped (1503)

Patient Problems Myocardial Infarction (1969); No Consequences Or Impact To Patient (2199)

Event Date 07/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No sample for return.

Event Description

It was reported via a hotline call received at 0440 est.The registered nurse (rn) called because the "blue waveform on the monitor is a flat line." the clinical support specialist (css) explained to the rn that this meant the pump was not pumping.The css asked if there had been any alarms.The rn stated there had been one helium loss alarm and there were no kinks in the tubing.The css asked the rn if there was any blood in the helium line and the rn relayed there is not.The css then asked how long it had been since the pump alarmed and stopped pumping and the rn relayed about 10 minutes.The css told the rn to start the pump back up which it did without issue.The css then discussed that due to the class 1 alarm, the pump goes to the off position automatically and stops pumping.The pump alarm was reset by one of the rn's taking care of the patient however; the pump was not started back up by the rn's.The css further discussed that it is the staff's responsibility to restart pumping after assessing the patient/lines etc.The rn verbalized understanding of all.The patient was being repositioned/moving legs at the time of the alarm.The rn has no further questions and received no further calls.

Manufacturer Narrative

Qn#(b)(4).No intra-aortic balloon pump (iabp) parts or recorder strips were returned to teleflex (b)(4) for evaluation.Per the call report, the registered nurse (rn) called the hotline because the "blue waveform on the monitor was a flat line." this most likely was caused by the helium loss alarm which is a class 1 alarm.A class 1 alarm will cause the pump to stop pumping (pump off), deflate iab, open vent valve, audio alarm, alarm message, freeze w/form - prints out on strip.The clinical support specialist (css) discussed with the rn that it is the staff's responsibility to restart pumping.The pump will not start back up by itself.Once the pump was started back up, there were no further issues with the pump.The specific serial number was not reported, but a device history record (dhr) review was conducted for all the lot numbers/serial numbers at this account with no relevant findings.All devices passed all manufacturing specifications prior to release.See other remarks section.Other remarks: conclusion: the reported complaint of "helium loss alarms" is confirmed with the information provided to the css.The helium loss caused the pump to stop pumping.The pump was reset by the rn and the pump started pumping.There were no further issues.No iabp parts or recorder strips were returned to teleflex (b)(4) for evaluation.The cause of the reported complaint is undetermined.

Event Description

It was reported via a hotline call received at 0440 est.The registered nurse (rn) called because the "blue waveform on the monitor is a flat line." the clinical support specialist (css) explained to the rn that this meant the pump was not pumping.The css asked if there had been any alarms.The rn stated there had been one helium loss alarm and there were no kinks in the tubing.The css asked the rn if there was any blood in the helium line and the rn relayed there is not.The css then asked how long it had been since the pump alarmed and stopped pumping and the rn relayed about 10 minutes.The css told the rn to start the pump back up which it did without issue.The css then discussed that due to the class 1 alarm, the pump goes to the off position automatically and stops pumping.The pump alarm was reset by one of the rn's taking care of the patient however; the pump was not started back up by the rn's.The css further discussed that it is the staff's responsibility to restart pumping after assessing the patient/lines etc.The rn verbalized understanding of all.The patient was being repositioned/moving legs at the time of the alarm.The rn has no further questions and received no further calls.

• 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: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 5882539
• MDR Text Key: 52320777
• Report Number: 1219856-2016-00178
• 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: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2016
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2016
• 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