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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 Gas Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/05/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via an eqr report symptom: pcs has a leakage and possible helium leakage alarm was displayed during therapy the physician switched iap having more than one available, no problem for the patient. Actions: pcs has been replaced according to high standard service.
 
Manufacturer Narrative
(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 a known good autocat2w and performed functional testing. The pump alarmed purge failure (5) immediately 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 mdt-50 leak tester and failed leak testing. Leak was noted to be coming from the drain port. Visual inspection of the pcs assembly internal hardware was performed. Debris and dried blood were found inside the drain valve and manifold block where the drain valve connected to. Notice: the purge failure alarm would occur if system could not pull a negative pressure (drain valve). This is an original pcs assembly, and this 2008 iabp. See other remarks section. Other remarks: 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 "possible helium loss alarm" is confirmed based off the leakage from the drain port during leak testing. The pump alarmed purge failure (5) when pumping was initiated. Debris and dried blood were found inside the drain valve and that caused the reported complaint. The root cause of how the blood entered the drain valve is undetermined.
 
Event Description
It was reported via an eqr report. Symptom: pcs has a leakage and possible helium leakage alarm was displayed during therapy the physician switched iap having more than one available, no problem for the patient. Actions: pcs has been replaced according to high standard service.
 
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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 Key5837983
MDR Text Key50902253
Report Number1219856-2016-00162
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 07/05/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2016
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 Manufacturer07/18/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2016
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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