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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 No Display/Image (1183)
Patient Problems No Consequences Or Impact To Patient (2199); Cardiogenic Shock (2262)
Event Date 09/26/2016
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: ventilated. The qn#(b)(4).
 
Event Description
It was reported via a hot line call. The biomed called to discuss the repair of the pump that had the ecg problem over the weekend. There is no pump currently on the patient. This pump was exchanged and brought down to biomed for inspection / repair. The clinical support specialist (css) told the biomed that she would have the field service agent give him a call back. Additional information on 09/27/16: the registered nurse (rn) from the intensive care unit (icu) was calling because they were having issues with triggering. When the clinical support specialist spoke to the rn she found that the patient had the iab place on (b)(6) 2016. The rn stated that the pump was in pattern trigger and now is in arterial pressure (ap) trigger, they have changed leads, lead placement and ecg cable. The pump still remains in ap trigger. The css asked the rn what the ecg looked like on the screen. They see pacer spikes, but very low voltage qrs. The css asked the rn to send her a picture of the screen. The qrs complex is too small to meet criteria for trigger. The css asked the rn to read me the ecg scoring. All of the numbers are 15. The css explained that the pump has gone to ap trigger because the qrs complex is too small to be recognized. The css asked the rn if the complex has always been like this. The rn said that it had been better, but the patient had become restless and thrashing and then the ecg changed. Since they had changed the leads, lead placement and ecg cable on this pump, the css asked the rn to get a second pump and connect the ecg cable to the second pump. The second pump sn is: (b)(4). They have a good ecg complex on the second pump. The css then had the rn change everything over to the second pump. The second pump is using the ecg for trigger and pumping appropriately in 1:1 in auto-pilot. The rn had no other issues and thanked the css for her assistance. The css told the rn to make sure the first pump went to biomed to be checked. Iab-06830-u s/n (b)(4) is the iab used for this patient. Additional information on 10/03/2016: field service report (b)(4). Symptom: report of lost ecg signal, no harm to patient. Findings / action taken: the biomed was looking to get service history on pump. He could not reproduce problem in biomed. Wants to replace ecg cable - gave all part #'s complete set, trunk, & leads. Pump had no reported ecg problems or repairs.
 
Manufacturer Narrative
Ventilated. The qn#(b)(4). No parts or recorder strips were returned to teleflex (b)(4) facility for evaluation. The pump was checked out by the field service engineer. There were no problems found with the pump related to the ecg. The reported complaint could not be reproduced. The hospital biomed wanted to replace the ecg cable and was given the part numbers for a complete set, trunk and leads. No further action needed. A photo of the display screen was reviewed and indicated that the qrs was tall enough and it is unknown at what time in the event it was taken. A device history record (dhr) 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 "ecg problems" is confirmed based on the information provided to the css. The pump was switched out and sent to the biomed. The pump was checked by the field service engineer and the reported complaint of ecg problems could not be reproduced. The pump functioned as designed. No parts or recorder strips were returned to teleflex (b)(4) for evaluation. The cause of reported complaint is undetermined.
 
Event Description
It was reported via a hot line call. The biomed called to discuss the repair of the pump that had the ecg problem over the weekend. There is no pump currently on the patient. This pump was exchanged and brought down to biomed for inspection / repair. The clinical support specialist (css) told the biomed that she would have the field service agent give him a call back. Additional information on 09/27/16: the registered nurse (rn) from the intensive care unit (icu) was calling because they were having issues with triggering. When the clinical support specialist spoke to the rn she found that the patient had the iab place on (b)(6) 2016. The rn stated that the pump was in pattern trigger and now is in arterial pressure (ap) trigger, they have changed leads, lead placement and ecg cable. The pump still remains in ap trigger. The css asked the rn what the ecg looked like on the screen. They see pacer spikes, but very low voltage qrs. The css asked the rn to send her a picture of the screen. The qrs complex is too small to meet criteria for trigger. The css asked the rn to read me the ecg scoring. All of the numbers are 15. The css explained that the pump has gone to ap trigger because the qrs complex is too small to be recognized. The css asked the rn if the complex has always been like this. The rn said that it had been better, but the patient had become restless and thrashing and then the ecg changed. Since they had changed the leads, lead placement and ecg cable on this pump, the css asked the rn to get a second pump and connect the ecg cable to the second pump. The second pump sn is: (b)(4). They have a good ecg complex on the second pump. The css then had the rn change everything over to the second pump. The second pump is using the ecg for trigger and pumping appropriately in 1:1 in auto-pilot. The rn had no other issues and thanked the css for her assistance. The css told the rn to make sure the first pump went to biomed to be checked. Iab-06830-u s/n (b)(4) is the iab used for this patient. Additional information on 10/03/2016: field service report l611511. Symptom: report of lost ecg signal, no harm to patient. Findings / action taken: the biomed was looking to get service history on pump. He could not reproduce problem in biomed. Wants to replace ecg cable - gave all part #'s complete set, trunk, & leads. Pump had no reported ecg problems or repairs.
 
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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 Key6052818
MDR Text Key58358231
Report Number1219856-2016-00224
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 09/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2016
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 Received11/22/2016
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

Patient Treatment Data
Date Received: 10/24/2016 Patient Sequence Number: 1
Treatment
TRANS-VENOUS PACEMAKER, 100% V-PACED, SEDATED AND
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