MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-11-18 for IMPELLA CP 0048-0003 manufactured by Abiomed, Inc.
[60423764]
The investigation of product, returned by the hospital, included running the pump through internal hemolysis testing in porcine blood twice over four days. Serial plasma free hemoglobin labs were drawn during these three hour tests. The lab results all were below the value which is used to determine hemolysis on the first day of testing. When the hemolysis testing was repeated days later, the results were positive for hemolysis. In addition to the results being of a value that confirmed hemolysis, a defect was seen at the outflow cage that could have contributed to or caused the hemolysis. The defect could protrude and cause obstructed flow. The delaminated area from the sleeve bearing was raised into the outflow cage window. Of note, no plasma free hemoglobin labs were drawn at the hospital. Hemolysis was only documented via a standard cbc and urinalysis, as well as an observation of the urine changing in color and output. In addition to the porcine blood testing, the data logs were analyzed for signs of hemolysis. The logs show the device provided good flow throughout the support. The logs did show suction alarms, however each of these alarms rectified quickly, and can be accounted to the patient's pressure lowering in response to inotropic support. The use of the impella was the most likely cause of the hemolysis. However, the physician stated to the representative that the patient condition could contribute to the hemolysis. As stated in the event description, the patient had multiple contributing cardiac and renal conditions. No corrective action is recommended. The outflow cage defect that prompted the patient to experience hemolysis, with the delamination failure, is of low risk and rare. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[60423765]
Complainant reported that on (b)(6) 2016 the hospital staff was treating a (b)(6) admitted with cardiomyopathy, hypertension, and acute renal failure who now presented with elevated labs, edema, and shortness of breath. Patient was treated with lasix and an intraaortic balloon pump. As there was a need for escalated care due to symptoms worsening, the iabp was removed and an impella cp was placed at the same groin access site. Support was seen be successful with good flows and the patient having an easier time breathing. On the next day of support, after a restless night, there was an observed change in the urine output color. A urinalysis was performed and labs pointed to hemolysis. To troubleshoot this issue the catheter position was checked under echo and repositioned. Later in the evening of (b)(6), the staff did remark that the patient was being ruled out for an ileus due to abdominal pain and distension. The patient's condition was monitored and care was again escalated with an increase in inotropes on the following day, (b)(6). Also, the physician decided to give the patient three units of blood replacement products for the hemolysis. The physician did note that the patient's condition could contribute to the hemolysis, along with the use of impella support. The decision was made to wean the patient off of impella support and explant the device. Due to the patient being made a dnr and not being a candidate for a vad device, there is only care and comfort being provided. The patient is being monitored and supported with multiple cardiac medications, including dopamine, levophed, dobutamine, and milrinone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2016-00024 |
| MDR Report Key | 6114602 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-11-18 |
| Date of Report | 2016-08-04 |
| Date of Event | 2016-08-04 |
| Date Facility Aware | 2016-08-04 |
| Report Date | 2016-08-04 |
| Date Reported to Mfgr | 2016-08-04 |
| Date Mfgr Received | 2016-08-04 |
| Device Manufacturer Date | 2016-05-04 |
| Date Added to Maude | 2016-11-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. WILLIAM BOLT |
| Manufacturer Street | ABIOMED INC. 22 CHERRY HILL DRIVE |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal | 01923 |
| Manufacturer Phone | 9786461451 |
| Manufacturer G1 | ABIOMED, INC |
| Manufacturer Street | 22 CHERRY HILL DRIVE |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01923 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA CP |
| Generic Name | TEMPORARY CARDIAC SUPPORT BLOOD PUMP |
| Product Code | PBL |
| Date Received | 2016-11-18 |
| Returned To Mfg | 2016-08-11 |
| Model Number | IMPELLA CP |
| Catalog Number | 0048-0003 |
| Lot Number | 1233151 |
| Device Expiration Date | 2018-02-28 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 90 DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED, INC |
| Manufacturer Address | 22 CHERRY HILL DRIVE DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-18 |