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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP Back to Search Results
Catalog Number IAP-0500
Device Problem Inadequate User Interface (2958)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/16/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via a hotline call. The biomed tech called the clinical support specialist (css) stating that he has a balloon pump that was tipped over while transporting the patient in the hospital. The pump stopped working then. The biomed tech stated that the nursing staff were able to switch it out for a different pump with a small delay getting the other pump. The biomed tech stated that he was told the patient is doing fine. The biomed tech is calling to try to get someone from field service in as soon as possible to repair the broken pump in house. The css told the biomed tech that he is the clinical on call, but that he would forward his information on to field service. The biomed tech thanked the css for the help. The css then forwarded the info on to field service. The patient is stable on the pump. Additional information 07/22/2016: per the field service report (b)(4). Symptom: pump tipped over and stopped working. Findings/action taken: found and replaced defective cpu applied new shielding; replaced rotation latch - and broken screws in display volume. Performed functional checks pass all. Fcn level: 1416, software level: 2. 24.
 
Manufacturer Narrative
(b)(4). The cpu board (p/n 77-1000-002, s/n (b)(4)) was returned for evaluation. Visual inspection of cpu board was performed and a burnt component, u22 (high-speed cmos), was found. The cpu board in question was installed onto the cpu/fe/fos bd test fixture and the functional test was performed. The cpu board in question failed ti ram test. The cpu board was then installed into a known good autocat2w and functional testing was performed. The pump displayed white screen on power-up with constant alarm. 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 complaint of "unit stop working" is confirmed. The pump displayed a white screen on start-up along with a constant alarm. A burnt component u22 (high-speed cmos) was noted during visual inspection and could have potentially caused the white screen. The iabp was tipped over during transporting the patient and that caused the damage on the cpu board.
 
Event Description
It was reported via a hotline call. The biomed tech called the clinical support specialist (css) stating that he has a balloon pump that was tipped over while transporting the patient in the hospital. The pump stopped working then. The biomed tech stated that the nursing staff were able to switch it out for a different pump with a small delay getting the other pump. The biomed tech stated that he was told the patient is doing fine. The biomed tech is calling to try to get someone from field service in as soon as possible to repair the broken pump in house. The css told the biomed tech that he is the clinical on call, but that he would forward his information on to field service. The biomed tech thanked the css for the help. The css then forwarded the info on to field service. The patient is stable on the pump. Additional information 07/22/2016: per the field service report l612065. Symptom: pump tipped over and stopped working. Findings/action taken: found & replaced defective cpu applied new shielding; replaced rotation latch - & broken screws in display volume. Performed functional checks pass all. Fcn level: 1416, software level: 2. 24.
 
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Brand NameAUTOCAT2 WAVE
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 Key5848182
MDR Text Key51231762
Report Number1219856-2016-00182
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 07/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Device Lot Number0001078850
Other Device ID Number30801902051715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2004
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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