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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 Inflation Problem (1310)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/17/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via a field service report: (b)(4) symptom: pump had "unable to refill" alarms while on patient. The pump was switched out quickly with no patient complications. Findings/action taken: pcs assembly sent to and replaced by hospital biomed. Part being returned on (b)(4) fcn level: (b)(4), software level: 2. 24 op
=
on patient and confirmed by biomed.
 
Manufacturer Narrative
Qn#(b)(4). The pcs assembly (p/n 96-3006-001, s/n (b)(4)) was returned for evaluation. Visual inspection of the pcs assembly was performed and no abnormalities were noted. The pcs assembly in question was installed into known good autocat2w and performed functional testing. The pump alarmed "unable to refill" approximately 20 minutes after pumping was initiated. The known good autocat2w with the pcs assembly in question installed failed the functional test. The pcs assembly was then removed from the pump. The pcs assembly in question was installed onto the leak tester and passed leak testing. All valves were powered with 12 vdc using external power supply and clicking sound was noted; however, the fill valve (v2) was noted to be delay on trigger (clicking sound) approximately one second when power was applied. The external power supply was then switched on/off multiple times and one second delay still occurred. See other remarks section. Other remarks: the suspected fill valve (v2) was removed and replaced with a known good fill valve (v2). The pcs assembly was then reinstalled into a known good autocat2w and the functional test was performed. The pump was ran for over 8 hours and no alarms or errors were occurred. Visual inspection of the pcs assembly internal hardware was performed and dried condensations were noted on and inside the manifold (where drain valve and fill valve connected). Notice: this is an original pcs assembly for this 2009 pump. A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings. The device passed all manufacturing specifications prior to release. Conclusion: the reported complaint of "alarm, unable to refill" is confirmed. The pump alarmed "unable to refill" approximately twenty minutes after pumping was initiated. The fill valve (v2) was noted to be sticky, which potentially caused the alarm. The cause of the sticky valve is undetermined.
 
Event Description
It was reported via a field service report: l611357. Symptom: pump had "unable to refill" alarms while on patient. The pump was switched out quickly with no patient complications. Findings/action taken: pcs assembly sent to and replaced by hospital biomed. Part being returned on wws-ar#01722. Fcn level: 1416, software level: 2. 24. Op
=
on patient and confirmed by biomed.
 
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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 Key5953267
MDR Text Key54826761
Report Number1219856-2016-00199
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 08/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Other Device ID Number30801902051715
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2016
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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