MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE; IABP AUTOCAT 2 WAVE PUMP CONSOLE

Catalog Number IAP-0500

Device Problems Occlusion Within Device (1423); Power Problem (3010)

Patient Problem No Information (3190)

Event Date 05/12/2015

Event Type  malfunction  

Event Description

It was reported via a field service report: (b)(4) symptom.The (iabp) intra-aortic balloon pump was making excessive noise during use on patient, pump was switched with another iap-0500.The biomed also reported loud whistling noise on power down.Findings/action taken: found pump making whistling noise on power down.Found pump makes popping noise during purge and drain cycles.Replaced was the power supply for whistling noise on power down.Found popping noise coming from pcs assembly, replaced pcs assembly.Unit had passed functional testing prior to repair.Unit passed (wws) world wide support functional checkout after repair; replaced power cord that cut in the insulation.Fcn level: 14, software level: 2.23.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Evaluation: the power supply (p/n: 77-0063-001, s/n: (b)(4)) was returned for evaluation.Visual inspection of power supply was performed and no abnormality was noted.The pcs assembly (p/n: 96-3006-001, s/n: (b)(4)) was returned for evaluation.Visual inspection of pcs assembly was performed and found no obvious damage or defects.The power supply was installed into a known good autocat2w and functional testing was performed.The pump was startup as normal.A power supply voltage check was performed and all voltages were within specification.However, a whistle sound for noted at power down.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 power supply passed functional testing.Visual inspection of power supply internal hardware was performed and no abnormality was found.See other remarks section.Other remarks: the pcs assembly in question was installed into known good autocat2w and performed functional testing.The known good autocat2w with the pcs assembly in question installed passed functional test.No alarms were occurred during the functional test.The pcs assembly in question was then installed onto the leak tester and passed leak testing.A popping noise was noted to be coming from relief valve of the pcs assembly during purge and drain cycles.However, this finding did not affect a functionality of the pcs assembly.The pcs assembly passed functional testing.Visual inspection of pcs assembly internal hardware was performed and no abnormality was found.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 complaints of "excessive noise and whistling noise on power down" are confirmed.The reported problems were replicated during functional testing.The whistling noise was noted from the power supply on power down, and also excessive noise was found to be coming from the relief valve of the pcs assembly.However, these findings do not affect functionality of the power supply and pcs assembly.The power supply and pcs assembly both passed functional testing.

Event Description

It was reported via a field service report: (b)(4).Symptom: the (iabp) intra- aortic balloon pump was making excessive noise during use on patient, pump was switched with another iap-0500.The biomed also reported loud whistling noise on power down.Findings / action taken: found pump making whistling noise on power down.Found pump makes popping noise during purge and drain cycles.Replaced was the power supply for whistling noise on power down.Found popping noise coming from pcs assembly, replaced pcs assembly.Unit had passed functional testing prior to repair.Unit passed (wws) world wide support functional checkout after repair.Replaced power cord that cut in the insulation.Fcn level: 14.Software level: 2.23.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: IABP AUTOCAT 2 WAVE PUMP CONSOLE
• 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: 4810733
• MDR Text Key: 5930285
• Report Number: 1219856-2015-00114
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2015
• Initial Date FDA Received: 06/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/09/2015
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: INTRA-AORTIC BALLOON CATHETER