MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT 2; INTRA-AORTIC BALLOON PUMP

Catalog Number IAP-0400

Device Problem Gas/Air Leak (2946)

Patient Problems Atherosclerosis (1728); Cardiogenic Shock (2262)

Event Date 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported via a hot line call.The perfusionist called to troubleshoot consistent "possible he loss" alarms.The patient was transferred in from an outside facility.The perfusionist is unsure of how long the alarm has been happening or when the alarms started.In 1:2 the alarm is occurring about every 1-2 minutes, in 1:4 every 5-10 minutes.There is no blood noted in the tubing, the perfusionist is unable to see the insertion angle because the patient is draped.No blood noted up to site.The perfusionist reports the pump is otherwise pumping well, timing is good although augmentation is "not great." the poor augmentation likely due to sv (stroke volume) and a partial kink.The (css) clinical support specialist requested that perfusionist send the css pictures and or strips of the balloon pressure waveform as well as any alarm messages that come up.The css and perfusionist discussed a leak test and the perfusionist agrees this will be difficult due to where they are in the surgical case.Based on the photos sent the bpw (blood pressure waveform) shows some partial obstruction, although the perfusionist and the css agreed this is not significant enough to cause the helium loss alarm in 1:4 at a regular heart rate.The perfusionist feels he has checked all tubing and connections, the css suggested that the perfusionist also check the adapter that was used to connect the competitor's catheter.The css and perfusionist discussed that there could be a small abrasion in the iab so removal would be recommended.The perfusionist is going to follow up after checking the connector as recommended.The perfusionist reported they decided to change the connector and iabp, and are now having no additional alarms.The css reminded the perfusionist to be vigilant in checking the tubing for blood since the abrasion can sometimes clot and cause the alarm to stop.The perfusionist understood.They are going to send the removed pump to biomed to be checked in case there is an internal issue.A second call @ 1452 - the perfusionist reported the patient on second pump with no alarms.The perfusionist had bypassed the alarms and the css had the perfusionist turn the alarms back on, no alarms noted.Another call was place @ 1515 - patient still supported on the pump, no alarms.Additional information @ 0920 est (b)(6) 2016- the perfusionist reported the patient in the unit doing well supported on the pump without alarms.The pump is achieving the goals of therapy and augmentation is somewhat improved.The css spoke to the field service agent who will follow up on the pump status with biomed.

Manufacturer Narrative

(b)(4) no iabp parts or recorder strips were returned to (b)(4) for evaluation.Pictures received.Per the call report, the perfusionist called to troubleshoot the pump having consistent "possible he loss" alarms while on a patient.The css had the rn send photos and they did not indicate significant enough to cause the helium loss alarm.All tubing and connections were checked.The css and perfusionist discussed that there could be a small abrasion in the competitor's iab so removal would be recommended.It was decided to switch out the pump and send it to biomed.No further problems with the second pump.Additional information received from the field service engineer.This is a demand customer and they do their own repair.The call was forwarded to wws for further assistance where they were given a quote for labor and travel for the technician to go onsite to check out the pump.The customer did not agree to the quote at this time.No further service was provided to the pump.Other remarks: a device history record (dhr) review was conducted for the iap lot/serial numbers with no relevant findings.The devices passed all manufacturing specifications prior to release conclusion: the reported complaint of "helium loss alarm" is not confirmed.The pump was sent to the biomed department.The customer did not decide to fix the pump at this time.They are a demand customer and do their own repair.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 hot line call.The perfusionist called to troubleshoot consistent "possible he loss" alarms.The patient was transferred in from an outside facility.The perfusionist is unsure of how long the alarm has been happening or when the alarms started.In 1:2 the alarm is occurring about every 1-2 minutes, in 1:4 every 5-10 minutes.There is no blood noted in the tubing, the perfusionist is unable to see the insertion angle because the patient is draped.No blood noted up to site.The perfusionist reports the pump is otherwise pumping well, timing is good although augmentation is "not great." the poor augmentation likely due to sv (stroke volume) and a partial kink.The (css) clinical support specialist requested that perfusionist send the css pictures and or strips of the balloon pressure waveform as well as any alarm messages that come up.The css and perfusionist discussed a leak test and the perfusionist agrees this will be difficult due to where they are in the surgical case.Based on the photos sent the bpw (blood pressure waveform) shows some partial obstruction, although the perfusionist and the css agreed this is not significant enough to cause the helium loss alarm in 1:4 at a regular heart rate.The perfusionist feels he has checked all tubing and connections, the css suggested that the perfusionist also check the adapter that was used to connect the competitor's catheter.The css and perfusionist discussed that there could be a small abrasion in the iab so removal would be recommended.The perfusionist is going to follow up after checking the connector as recommended.The perfusionist reported they decided to change the connector and iabp, and are now having no additional alarms.The css reminded the perfusionist to be vigilant in checking the tubing for blood since the abrasion can sometimes clot and cause the alarm to stop.The perfusionist understood.They are going to send the removed pump to biomed to be checked in case there is an internal issue.A second call @ 1452 - the perfusionist reported the patient on second pump with no alarms.The perfusionist had bypassed the alarms and the css had the perfusionist turn the alarms back on, no alarms noted.Another call was place @ 1515 - patient still supported on the pump, no alarms.Additional information @ 0920 est (b)(6) 2016- the perfusionist reported the patient in the unit doing well supported on the pump without alarms.The pump is achieving the goals of therapy and augmentation is somewhat improved.The css spoke to the field service agent who will follow up on the pump status with biomed.

• Brand Name: AUTOCAT 2
• 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: 5745049
• MDR Text Key: 48052756
• Report Number: 1219856-2016-00145
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0400
• Other Device ID Number: 30801902051722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2016
• Initial Date FDA Received: 06/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2016
• 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