MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AEROAUTOCAT2 INTRA-AORTIC BALLOON PUMP

Catalog Number IAP-0435

Device Problems Battery Problem (2885); Charging Problem (2892)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported per a field service report #(b)(4). Symptom: pump shut off on patient on battery. Cycled power and incident occurred a second time. Ran battery load test gave 20 minute battery alarm after 15 minutes and machine shut off after 28 minutes. Charger voltage 13. 7 volts. Replaced battery as main suspect. Replaced power supply, power switch, and power switch cable as a precaution. Unit checks ok. Fcn level: 1416, software level: 2. 24. Op
=
on patient confirmed.

Manufacturer Narrative

Qn#(b)(4). The battery (p/n 4000-9022-001, l/n 18f16a0006) was returned for evaluation. Visual inspection of battery was performed and no abnor malities were noted. The main power supply (p/n 77-0063-001, s/n (b)(4)) was returned for evaluation. Visual inspection of power supply was performed and found no obvious damage or defects. The power switch (p/n 5100-9009-006) was returned for evaluation. Visual inspection of main power supply was performed and found no obvious damage or defects. The power switch cable (p/n 77-3716-001) was returned for evaluation. Visual inspection of the power switch cable and no abnormalities were found. The battery was installed into a known good autocat2w. The iabp was power-up successfully and all voltages were presented (+5v, +12v, -12v, and 54v). The iabp was switched off and on multiple times and powered- up successfully each time. See other remarks section. Other remarks: the battery was then installed into a known good autocat2w and a battery load test was performed. The iabp was run on battery until the iabp shut down. The battery was left to charge in the pump for over 9 hours; the pump shut off after 48 minutes running on battery (warning alarm: available battery power less than 20 minutes alarm after 28 minutes ran, available battery power less than 10 minutes alarm after 38 minutes ran, and shut off shortly after 48 minutes ran. The battery failed a battery load test. This battery was replaced on march 23, 2016. Per operator's manual "the battery should be maintained at full charge whenever possible. Arrow international recommends that the autocat2 series iabp be kept plugged into a proper ac receptacle whenever possible including time when the unit is in storage or not in use. The power indicator will illuminate when ac power is present. The batteries should not be stored in a discharged state. " the condor power supply was installed into a known good autocat2w and functional testing was performed. The pump startup was normal. A power supply voltage check was performed per autocat2 series service manual (rev 3) and all voltages were within specification. The pump was run on battery (battery load test) until the iabp shut down (>90minutes within spec). A battery load test was performed after letting the pump charge for over 8 hours and the unit ran for over 90 minutes. The condor power supply passed all functional testing. Visual inspection of the condor power supply internal hardware was performed and no component damage or defect was noted. The main power switch was installed into a known good autocat2w and functional testing was performed. The main power switch was found to be normal and the pump powered up and operated as intended. The power switch was then toggled on and off multiples times and the pump powered up successfully each time. The pump was then left to run for 2 hours without any alarms or errors. The power switch cable was tested for continuity using digital multimeter and passed. The power switch was then installed into a known good autocat2w and all connections of power switch cable were properly connected and snugged. The pump powered up and initiated pumping successfully. The pump was then left to run for over 2 hours on ac power and no alarms or errors were occurred. Power switch cable in question passed functional testing. 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 "short battery run time" is confirmed. The battery could not retain a full charge capacity. The pump shut off approximately 48 minutes while running on battery power. Battery life is dependent on usage and maintenance of the battery. The cause of the premature battery failure is undetermined.

Event Description

It was reported per a field service report #(b)(4). Symptom: pump shut off on patient on battery. Cycled power and incident occurred a second time. Findings/action taken: ran battery load test gave 20 minute battery alarm after 15 minutes and machine shut off after 28 minutes. Charger voltage 13. 7 volts. Replaced battery as main suspect. Replaced power supply, power switch, and power switch cable as a precaution. Unit checks ok. Fcn level: 1416, software level: 2. 24. Op
=
on patient. Confirmed.

• Brand Name: AEROAUTOCAT2
• Type of Device: INTRA-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 Key: 6079109
• MDR Text Key: 59227058
• Report Number: 1219856-2016-00239
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Paramedic
• Type of Report: Initial,Followup
• Report Date: 10/07/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: IAP-0435
• Other Device ID Number: 30801902051746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown