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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. AUTOCAT 2 INTRA-AORTIC BALLOON PUMP Back to Search Results
Catalog Number IAP-0400
Device Problem Gas 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.
 
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Brand NameAUTOCAT 2
Type of DeviceINTRA-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 Key5745049
MDR Text Key48052756
Report Number1219856-2016-00145
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060309
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received06/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0400
Other Device ID Number30801902051722
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2016
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 Unkown

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