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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP Back to Search Results
Catalog Number IAP-0500
Device Problem Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/18/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Sample not returned.
 
Event Description
It was reported via a hotline call from the registered nurse (rn) in the cardiac icu regarding the volume is reading 35cc on a 40cc intra-aortic balloon (iab) and she cannot change it as it is showing 100%. The rn stated she had discussed this issue with sales rep earlier and reviewed occlusive (balloon pressure waveform (bpw) plateau and augmentation were within 25 pts at 35cc fill volume and that the sales rep. Suggested the register nurse call the hotline to troubleshoot the 100% reading at 35cc. The (css) clinical support specialist had the register nurse turn the pump off (red off button), disconnect the helium driveline, reconnect and then check the balloon volume and it now read 40cc 100%. The css then had the rn turn the pump back on. Iabp therapy was held for less than 20 seconds. The rn then measured the bpw plateau and augmentation and the plateau was 35 above augmentation. The css asked if the pressures on the iab were correlating to the patient's status and she said not at all. The css asked if it was a fiberoptix iab, which the rn confirmed it was (b)(4). The register nurse relayed that it had not been zeroed prior to insertion (icon is blue - fiberoptix iab not zero'd prior to insertion). The css then had the rn do a map calibration and once that was complete, the pressures on the iab were accurate for the patient status and the bpw plateau and augmentation were then only a few points apart. The register nurse had stated that the md had wanted to pump at 35 cc stating "that the pump will adjust automatically. " the css explained that the delivery volume is changed by manual changes only and the pump will not make changes itself. The css suggested that the register nurse discuss with the md and determine if he wants to pump at 40cc or 35cc knowing now that the pressures are accurate to use to troubleshoot. The css did ask that the pump be sent to biomed for testing to ensure no issues once removed from the patient and that the iab be held for return after removal. The css gave the register nurse her direct cell number should she have any further issues or if the md had any questions for the css. The register nurse verbalized understanding of all and has no further questions at this time. Length of time prior to the event: greater than 24 hours. The patient is stable.
 
Manufacturer Narrative
(b)(4). No parts or recorder strips were returned to the teleflex (b)(4) facility for evaluation. Per the hotline call, the rn called to troubleshoot the volume was reading 35cc on a 40cc iab that she could not change as it was showing 100%. The css first had the rn disconnect and reconnect the helium driveline after the pump was shut down. This resolved the balloon volume and it then read 40cc 100%. The css also assisted the rn with the pressures with the fiberoptix iab. The css had the rn do a map calibration. The pressures on the iab were then accurate for the patient status. The css explained also that the delivery volume needs to be changed manually and the pump will not make changes itself. The support service database was checked and there has been no service provided to the pump and no parts replaced. A device history record (dhr) review was conducted for the iap serial number and lot number with no relevant findings. The device passed all manufacturing specifications prior to release. See other remarks section. Other remarks: conclusion: the reported complaint of the volume was reading 35cc on a 40cc iab was confirmed based on the information provided to the css. The css assisted the rn with the volume and pressure difficulties. The decrease in the volume reading 35cc on a 40 cc iab or a drop in the current may be due to oil/dirt on the resistor pins. Once the pump was shut off and the helium driveline was disconnected and then reconnected the volume read correctly solving the issue. The issue with the pressures was resolved with a map calibration. The pressures on the iab were then accurate. This was a successful clinical call. No further action required.
 
Event Description
It was reported via a hotline call from the registered nurse (rn) in the cardiac icu regarding the volume is reading 35cc on a 40cc intra-aortic balloon (iab) and she cannot change it as it is showing 100%. The rn stated she had discussed this issue with sales rep earlier and reviewed occlusive (balloon pressure waveform (bpw) plateau and augmentation were within 25 pts at 35cc fill volume and that the sales rep. Suggested the rn call the hotline to troubleshoot the 100% reading at 35cc. The (css) clinical support specialist had the rn turn the pump off (red off button), disconnect the helium driveline, reconnect and then check the balloon volume and it now read 40cc 100%. The css then had the rn turn the pump back on. Iabp therapy was held for less than 20 seconds. The rn then measured the bpw plateau and augmentation and the plateau was 35 above augmentation. The css asked if the pressures on the iab were correlating to the patient's status and she said not at all. The css asked if it was a fiberoptix iab, which the rn confirmed it was (iab-05840-lws). The rn relayed that it had not been zeroed prior to insertion (icon is blue - fiberoptix iab not zero'd prior to insertion). The css then had the rn do a map calibration and once that was complete, the pressures on the iab were accurate for the patient status and the bpw plateau and augmentation were then only a few points apart. The rn had stated that the md had wanted to pump at 35 cc stating "that the pump will adjust automatically. " the css explained that the delivery volume is changed by manual changes only and the pump will not make changes itself. The css suggested that the rn discuss with the md and determine if he wants to pump at 40cc or 35cc knowing now that the pressures are accurate to use to troubleshoot. The css did ask that the pump be sent to biomed for testing to ensure no issues once removed from the patient and that the iab be held for return after removal. The css gave the rn her direct cell number should she have any further issues or if the md had any questions for the css. The rn verbalized understanding of all and has no further questions at this time. Length of time prior to the event: <24 hours. The patient is stable.
 
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Brand NameAUTOCAT2 WAVE
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 Key5847482
MDR Text Key51378872
Report Number1219856-2016-00181
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Device Lot Number0001082326
Other Device ID Number30801902051715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2005
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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