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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 Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the pump alarmed "high baseline" or "system error 3 (2, 4, and 5)" in using. The engineer inspected the pump and did a simulation operation. The alarm still showed high baseline and system error 3. Engineer suspected stepped monitor malfunction so he replaced stepped monitor. The pump ran well and stepped monitor ((b)(4)) malfunction confirmed. Customer purchased this device in (b)(6) 2015, so the warranty is still in effect. Additional information was received 08/09/2016: the pump was on a patient at the time of the event. The md replaced the pump with another pump to support the patient. The event did not cause damage to the patient; however, customer didn't give patient data.
 
Manufacturer Narrative
(b)(4). The pump assembly (p/n: 77-3200-001w, s/n: (b)(4)) was returned without its original pcs assembly. Visual inspection of pump assembly was performed and no abnormalities were noted. The pump assembly in question was installed into a known good autocat2w and performed functional testing. Excessive noise was noted from the pump assembly. The pump alarmed high baseline approximately 25 minutes after pumping was initiated. A visual inspection of the pump assembly internal hardware was performed and no abnormalities were noted. A device history record (dhr) review was conducted for the iabp serial/ lot number with no relevant findings. The device passed all manufacturing specifications prior to release. Conclusion: the reported problem of "alarm, high baseline and system error 3" is confirmed. The pump alarmed high baseline approximately 25 minutes after initiating pumping. The excessive noise was potentially caused by the stepping motor or leadscrew assembly; however, the cause of pump assembly malfunction is undetermined. Engineering was notified, this type of issue will be monitored for any developing trend.
 
Event Description
It was reported that the pump alarmed "high baseline" or "system error 3(2, 4, and 5)" in using. The engineer inspected the pump and did a simulation operation. The alarm still showed high bassline and system error 3. Engineer suspected stepped monitor malfunction so he replaced stepped monitor. The pump ran well and stepped monitor (b)(4)) malfunction confirmed. Customer purchased this device in (b)(6) 2015, so the warranty is still in effect. Additional information was received (b)(6) 2016: the pump was on a patient at the time of the event. The md replaced the pump with another pump to support the patient. The event did not cause damage to the patient; however customer didn't give patient data.
 
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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 Key5883824
MDR Text Key52388875
Report Number1219856-2016-00183
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/03/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2016
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? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2016
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 Unkown

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