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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/EMEA SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/EMEA SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0700
Device Problems Device Alarm System (1012); Loss of Power (1475); Material Twisted/Bent (2981)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2018
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) has given 5 minute alarm then shuts off. The battery was replaced. The field service engineer was called to service the pump, during service it was noted that kinked tubing caused 7vdc on the balloon pressure waveform (bpw). As a result, the field service engineer replaced the pneumatic control system (pcs). There was no report of patient consequence.
 
Manufacturer Narrative
(b)(4). Teleflex received the device for investigation. The reported complaint of alarm: system error 1 is confirmed. The pressure sensor on the pcs assembly was noted to be out of range, resulting in the system error 1 alarm. The root cause of how the pressure sensor became out of range is undetermined. A potential cause is a faulty pressure transducer. The pcs assembly was replaced by the fse and the pump was returned to service. 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. Teleflex assessed the risk for the reported complaint. There are no new or revised risks. This will be monitored for any developing trends. No further action required at this time.
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) has given 5 minute alarm then shuts off. The battery was replaced. The field service engineer was called to service the pump, during service it was noted that kinked tubing caused 7vdc on the balloon pressure waveform (bpw). As a result, the field service engineer replaced the pneumatic control system (pcs). There was no report of patient consequence.
 
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Brand NameAC3 OPTIMUS IABP NA/EMEA
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8196528
MDR Text Key131490420
Report Number3010532612-2018-00402
Device Sequence Number1
Product Code DSP
UDI-Device Identifier00801902084965
UDI-Public00801902084965
Combination Product (y/n)N
PMA/PMN Number
K162820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0700
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2019
Is This a Reprocessed and Reused Single-Use Device?

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