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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE ITALIAN INTRA-AORTIC BALLOON PUMP Back to Search Results
Catalog Number IAP-0500I
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/26/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via an external quality review (eqr) report. Symptom: white monitor, they were able to swap it with another functioning one from another iap until the tech arrival actions: the monitor has been replaced due to problems with the lcd op
=
on patient.
 
Manufacturer Narrative
(b)(4). Additional information received: the pump was not switched off the pump a monitor from another pump was used. There was no interruption in therapy. Patient outcome is unknown. Investigation: the display head assembly was returned for evaluation. Visual inspection of display head cable was performed and noted some water marks on the screen and a missing logo. No other abnormality was noted. The display head assembly was installed onto a known good autocat2w. The display head assembly failed functional testing. The pump displayed blank screen on power-up. Visual inspection of the display head assembly internal hardware was performed. A missing screw after latch was removed and loose connection of the lcd module and keypad assembly were noted. The loose cable was reseated and the display head assembly was then installed onto a known good autocat2w. The system was power up successfully with no issues. The full functional test was performed and passed. The pump was then left to run for over 2 hours and no alarms or errors were occurred. See other remarks section. Other remarks: 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. The risk for display screen failure was reviewed and is acceptable. Conclusion: the reported complaint of "blank display" is confirmed. The reported problem was replicated at teleflex (b)(4) during the functional test. A loose cable connection was found inside the display head assembly and that caused the reported complaint. The reported problem was corrected after reseating the cable. The cause of the loose cable is undetermined.
 
Event Description
It was reported via an external quality review (eqr)report. Symptom: white monitor, they were able to swap it with another functioning one from another iap until the tech arrival actions: the monitor has been replaced due to problems with the lcd. Op
=
on patient.
 
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Brand NameAUTOCAT2 WAVE ITALIAN
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 Key6122650
MDR Text Key60763190
Report Number1219856-2016-00264
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/26/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500I
Other Device ID Number30801902092190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2016
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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