Highlighted Reports
MedSun: Newsletter #67, December 2011

This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period September 1 through September 30, 2011. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.

CARDIOVASCULAR

Device:
Type: Catheter, Ablation, Rf, Cardiac
Manufacturer: St. Jude Medical
Brand: Safire Blu
Model#: A402871
Lot #: 3383732
Other #: 1304-CPS-7-25-MC-BD; FG-100020943

Problem:
The 7 FR Safire Blu Ablation Catheter would not flush after being inserted into the venous sheath into the body. The catheter was removed and another catheter from another company was used. The patient's outcome was successful with the use of another catheter.
======================
Manufacturer response for Safire Blu Ablation Catheter, 7 FR, 2.3 mm MC-BD, Safire BLU (per site reporter)
======================
A replacement catheter was given to use and the representative from St. Jude will follow up with the evaluation of the defective catheter.


Device:
Type: Catheter, Electrode Recording
Manufacturer: Boston Scientific
Brand: Polaris X
Model#: M004 7003D0
Lot #: 14476871

Problem:
The EP physician was using the Boston Scientific Polaris X catheter and stated he was unable to deflect or steer the catheter. This occurred after being in the patient. Many times the physician will check the deflection of the tips of the catheters before using them but it is undetermined if that was done with this catheter. The physician requested to use another catheter. The case was incomplete. We were unable get to the PVC's to ablate them.
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Manufacturer response for Polaris X, standard curve decapolar catheter. 2.5/5/2.5mm x 6F (200mm), Polaris X (per site reporter)
======================
A new replacement will be sent to our facility. He will follow up with his company to evaluate the catheter.


Device:
Type: Catheter, Intravascular, Diagnostic
Manufacturer: Cordis Corporation
Brand: Williams Right Posterior Catheter
Model#: MODC18498

Problem:
During a cardiac cath procedure, the patient developed bilateral arm pain. Upon review of the films, a foreign body was noted in the right coronary artery (RCA). After pictures and the diagnostic catheter was reviewed by procedure physician and the intervention MD, it was determined to be the tip of a 4Fr Williams right posterior (WRP) catheter. An intervention to remove the catheter tip was performed. The foreign body was no longer observed and the patient denied any further pain.


Device:
Type: Catheter, Percutaneous
Manufacturer: Arrow International, Inc.
Brand: Multi-lumen Central Venous Catheter With Blue Flextip
Model#: ML-00703
Lot #: RF1060005

Problem:
An emergent trauma patient was admitted via the Emergency department, where an Arrow PSI (percutaneous sheath introducer from kit ASK-09903-MGH2) introducer was placed for access. No catheter was inserted via the access device at the time of placement. The patient was emergently transferred to the OR for surgery. The anesthesia providers elected to place a triple lumen catheter (Multi-lumen central venous catheter, REF ML-00703) via the in-situ introducer to augment IV access for the surgical procedure. The catheter inserted via this access device was intended to be used with the Arrow MAC two-lumen central venous access device from kit ASK-11142-MGH3. The device that should have been inserted into the in-situ introducer was Multi-lumen central venous catheter (REF SS-14703). The error was not immediately apparent to the anesthesia team because both types of catheter fit both types of access device and lock interchangeably. This could potentially have been a problem with drug delivery or location of the catheter in the patient due to the size. These devices are stored in separate bins, but it would be helpful if the manufacturer changed the packaging and included bolder packaging to make the difference easier to detect. The patient was not compromised in any way. We also have photos to share and have educated staff due to the similar packaging.

See device images:
Image shows the Multi-lumen Central Venous Catheter with Blue Flextip next to the package information

Image shows the two packages side by side.  The packaging on the left has 2 purple portions, whereas the packaging on the right has no purple demarcations

Image shows two Multi-lumen Central Venous Catheters side by side.  The first device has the PSI demarcation, whereas the second has the MAC demarcation.  These demarcations indicate the difference between the two Central Venous Catheters


Device:
Type: Catheter, Percutaneous
Manufacturer: Abbott Vascular
Brand: Viking
Lot #: 1051191
Cat #: 1001896-06

Problem:
It was noticed that the catheter was kinked before removal from the package. Please note that this report could not be filled out fully, as the tech did not give complete information. The package on this device was not kept and this device was not used on the patient. A new catheter was used and worked.


Device 1:
Type: Catheter, Percutaneous
Manufacturer: Arrow International
Brand: Radial Artery Catheterization Set
Model#: RA-04020
Lot #: CF1070769

Device 2:
Type: Catheter, Percutaneous
Manufacturer: Arrow International
Brand: Radial Artery Catheterization Set
Model#: RA-04020
Lot #: CF1070769

Device 3:
Type: Catheter, Percutaneous
Manufacturer: Arrow International
Brand: Radial Artery Catheterization Set
Model#: RA-04020
Lot #: CF1070769

Problem:
This report is to document that there have been multiple arterial line catheters with wire malfunctions that resulted in kinking and the inability to thread wire, advance catheter and to retract the wire. One wire we saved has a chamber kink and two saved wires have external kinks. It appears the devices are from the same lot. There was no adverse outcome to the patient as a result of these device malfunctions.

Device:
Type: Catheter, Percutaneous
Manufacturer: Arrow
Brand: Multi-lumen Central Venous Catheterization Kit With Blue Flextip® Arrowguard Blue® Catheter
Lot #: RF1069249
Cat #: AK-25703-A

Problem:
Upon establishment of central line placement, the physician was removing the guidewire from the right femoral vein. The guide wire was withdrawing and unraveled/uncoiled; it was no longer intact.


Device:
Type: Catheter, Ptca, Scoring
Manufacturer: Angiocore, Inc.
Brand: Angiosculpt Ex
Lot #: F11050032
Cat #: 2034-2010

Problem:
Device was difficult to remove from vessel after intervention, then stuck in guide catheter, and distal portion of balloon and wire broke off within the guide catheter.


Device:
Type: Console, Cryoablation
Manufacturer: Medtronic, Inc.
Brand: 104a2 Gen Iv Cryoconsole
Model#: 16000

Problem:
The Medtronic Cryo machine (N-547 Console 104A2 GEN IV CryoConsole US CAN) malfunctioned in the mapping mode. The alert was concerning. This is not the first time we have had alerts with the mapping functionality. Ablation Mode is functioning well. There have been several different alerts during several different cases. The company has taken all the catheters that we used with malfunction alerts. They are going to QA the Freezor Catheters & umbilical injection cables. We are not sure if it is a catheter or console issue. Alerts occur with different catheters and always in mapping function. The problem remains intermittent. It worked well in mapping mode the next week and then failed the following week. With this event, they were able to complete the case and there was no harm done to the patient.
======================
Manufacturer response for Medtronic Cryo machine (N-547 CONSOLE 104A2 GEN IV CRYOCONSOLE US CAN, CONSOLE 104A2 GEN IV CRYOCONSOLE US CAN (per site reporter)
======================
Inspection following 50012 errors during case. Disposables (coaxial umbilical and catheter) have been sent back to Medtronic for quality inspection. Tested console with numerous Freezor test catheters and coaxial umbilical cables. Used mapping in each test and went from mapping to ablation. No errors were reproduced in the same room the console is normally operated in. Vacuum system operated normally and test cases were completed without issue. Tested power supply voltages, temperature calibration, sub-cooler temperature, and all other values of console. No calibrations were required, all readings were within specifications. Replaced (2) auto connection boxes rev 04 with new auto connection boxes, rev 05. Replaced ECG leads with new cables. Returned console to service.


Device:
Type: Electrode, Electrocardiograph
Manufacturer: MedLine Industries, Inc.
Brand: Neonatal 1. 5Mm Radiotranslucent
Model#: MDS61115R
Lot #: 110517

Lollipop Icon

Problem:
The toddler handed her mom a piece of the prewired cardiac monitoring lead. The electrode end was still on the skin. The piece that came off is a 3 cm x 5 mm hard plastic piece (DIN connector) which became disconnected from the wire. This is the end that goes into the monitor. It would take a lot of force to pull this out. It looks like the wire slid out from this plastic piece at the end. The small piece can be a choking hazard. Toddler's pull at equipment, but this type of event where the lead disconnects from the lead should not be able to occur so easily. It was replicated by the nurses. Our Materials Management told me that they had problems in the past with the leads from this company.


Device:
Type: Endovascular Graft, Aortic Aneurysm
Manufacturer: W L GORE & Associates, Inc.
Brand: Excluder Contralateral Limb
Lot #: 9063472
Cat #: PXC141200

Problem:
The patient was admitted for repair of an aortic stent graft originally performed 11 years ago that had developed a type 3 endoleak. This was due to separation between the left iliac arm of the stent from the main aortic portion of the stent. This repair was performed percutaneously using a Gore Excluder Abdominal Aortic Aneurysm (AAA) Endoprosthesis in Interventional Radiology. Upon completion of the procedure, X-ray angiography indicated the graft was in good placement. However, follow up CT scans were performed to assess the status of the repair and the radiology report indicated there was a 7 cm radiopaque linear density within the abdominal aortic lumen with the tip near the proximal aspect of the graft extending cranially into the thoracic aorta. Pressure is applied on the introducer of the device at the tip where it deploys. The wire broke from the main part of the introducer and the 7cm white distal tip was seen on CT and remains in the patient. This was not able to be seen on fluoroscopy, but only afterward on the CT scan. The surgeon then notified Risk Management.

The surgeon's dictated report indicated that he changed the delivery catheter with another - he felt that the tip of the 12 French sheath was damaged from trying to push it up with force. *It is a single piece stent set. The doctor feels the patient will be stable and will not remove it since it is an endovascular device. There was no adverse outcome to the patient.
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Manufacturer response for Thoracic Endograft, Gore Excluder - Contralateral Limb (per site reporter)
======================
They could not identify the device in the radiographs.

See device image:

Image shows the tip of the Stent Graft next to its delivery catheter.  These two devices are on a white piece of paper with the text ‘Tip of Stent Graft’ with a white arrow pointing to draw attention to the tip portion of the problematic device


Device:
Type: Introducer, Catheter
Manufacturer: Arstasis, Inc.
Brand: Axera Access System
Cat #: AXE60

Problem:
Arstasis device footplate would not fold down resulting in removal of the device. Patient had femoral artery oozing and bleeding after access was obtained, after gaining access with placement of sheath there continued oozing around the sheath. Post procedure exam and cineangiography did not show extravastion of dye or dissection. There was no adverse outcome to the patient.
======================
Manufacturer response for Arstasis closure device, Arstasis (per site reporter)
======================
Has not responded the cardiac cath lab (CCL) let the rep take the product


Device:
Type: Lead, Left Ventricular
Manufacturer: Medtronic, Inc.
Brand: Attain Starfix
Model#: 4195-88 cm
Other #: UPN # 00885074511955

Problem:
The patient was in the process of getting a Bi-ventricular ICD implant. The Attain Starfix left ventricular (LV) lead became caught on itself in the coronary sinus and appeared on X-ray to be knotted. The physician was unable to get lead untangled in the coronary sinus or right atrium so the lead and Hockey Stick guide were pulled back into and through the left subclavian 9 French Sheath without harm or injury to the patient.


Device 1:
Type: Radial Artery Catheterization Set
Manufacturer: Teleflex Medical
Brand: Arrow International
Lot #: CF1057860
Cat #: RA-04020

Device 2:
Type: Radial Artery Catheterization Set
Manufacturer: Teleflex Medical
Brand: Arrow International
Lot #: CF1057860
Cat #: RA-04020

Device 3:
Type: Radial Artery Catheterization Set
Manufacturer: Teleflex Medical
Brand: Arrow International
Lot #: CF1057860
Cat #: RA-04020

Problem:
Four radial artery catheter sets were opened in preparation for inserting a radial catheter. Three of the catheters were found to have a defect close to the shoulder on the distal end of the device. All three sets were from the same lot. These three catheters were not used for fear that the defect might cause injury to the vessel or that slivers of the catheter plastic might be left behind in the vessel. Photos of two of the catheters are available if they would be of benefit.
======================
Manufacturer response for Radial Artery Catheterization Set, Arrow International (per site reporter)
======================
The manufacturer hasn't had time to investigate.


GENERAL & PLASTIC SURGERY

Device:
Type: Antimicrobial Dressing, Picc
Manufacturer: Ethicon
Brand: Ethicon Biopatch

Problem:
While nurse was removing dressing from PICC line, the "blue" layer of the Biopatch pulled off and was wrapped around PICC line. The PICC line was pulled out approximately one inch while trying to remove blue layer.


Device 1:
Type: Blade, Sagital
Manufacturer: Stryker Orthopedics
Brand: System 6
Model#: 6125-127-090

Device 2:
Type: Blade, Sagital
Manufacturer: Stryker Orthopedics
Brand: System 6
Model#: 6125-127-090

Problem:
Two disposable saw blades shattered while making femoral cuts. The first broke into several pieces and all pieces were accounted for. A second saw blade was obtained and used also broke into two pieces. All pieces found and accounted for. Third saw blade used without incident. We are unable to confirm the lot numbers of these devices. There was no harm to the patient.


Device 1:
Type: Electrosurgical, Cutting &Coagulation &Accessories
Manufacturer: STRYKER ENDOSCOPY
Brand: Serfas Energy 90 S
Model#: 90 S
Lot #: 11195AE2
Cat #: 279 351 100

Device 2:
Type: Electrosurgical, Cutting &Coagulation &Accessories
Manufacturer: STRYKER ENDOSCOPY
Brand: Serfas Energy 90 S
Model#: 90 S
Lot #: 11195AE2
Cat #: 279 351 100

Problem:
Flaking noted with two Stryker Serfas Energy 90-S 3.5 mm wands during use: Wand 1) the black plastic flaked off the shaft. Wand 2) white tip chipped off. All wands with Lot number 11195AE2 were removed from the shelves, and no further ones will be ordered with this lot number.


Device:
Type: Electrosurgical, Cutting &Coagulation &Accessories
Manufacturer: Karl Storz Endoscopy
Brand: High Frequency Bipolar Cable
Lot #: 711096
Cat #: 26176 LD

Problem:
The pt was taken to the OR, draped and anesthetized. The physician had made the necessary laparoscopic incisions and was preparing to cauterize when the cautery system was not functional. The staff began to troubleshoot by exchanging cautery pens, high frequency bipolar cables and the power supply units; nothing worked. After 45min-1 hour, the physician made the decision to abort the procedure. Biomedical and engineering were called to ensure all equipment and power to the surgical suite was appropriate. During this time, the staff realized all of the high frequency bipolar cables were manufactured by the same company with the same lot number. (Biomed confirmed the power supply units were functioning appropriately and engineering confirmed the power supply to the OR suite had not been interrupted).


GENERAL HOSPITAL

Device:
Type: Aesculap Extra Long Container With Lid And Filter Paper
Manufacturer: Aesculap, Inc.
Brand: Aesculap Extra Long Hard Container System
Model#: Extra long hard container JN445, Lid JK 489 and filter paper US 751
Cat #: extra long container JN445

Problem:
During GYN surgery it was discovered that the pelvicscopy kit we thought was gas sterilized had only been cleaned and decontaminated. The hard Aesculap Instrument Container we labeled as Pelvicscopy Instrument Set had three external labels for this Aesculap Instrument Container.

Our concern and reason for filing this MedSun report is our belief that there is a design failure as to these external indicators do not properly demonstrate clear view of indicator status. The external indicators are small in size and color is dark but should be more distinct color to note steam sterilization has occurred.

As technology evolves, there are multiple varieties of indicators to allow the end user visualization if all parameters for sterilization have been met. In the past there was one indicator. The indicator color change was from white to black or a light color to a darker color. Current technology has many different color changes and sometimes the opposite of past technology. New color changes allows for subjectivity to color change. Some of the new indicators are small and difficult to visualize. Filter paper is difficult to visualize and needs to be larger in size. Staff are confused because some filter papers change colors and others do not. It is difficult for OR staff to remember all the different forms of sterilization and indicators. Color changes does not allow for staff with color blindness.

As a result, the Sterile Processing Department technician will verify/scan the external indicators of all instruments and kits prior to leaving the central supply area before transport to the OR. Also, staff awareness has been raised through education and posting of colored laminated cards in each OR room displaying the different methods of sterilization with their indicators, locks, tape, and filter paper.

NO STANDARDIZATION IN THE INDUSTRY FOR STERILIZATION COMPLIANCE


Device:
Type: Bed Mattresses
Manufacturer: Hill-Rom, Inc

Problem:
A patient was admitted to a bed. The mattress cover was noted to have "deteriorated" and subsequently allowed fluids stored in the mattress foam to seep upwards through the cover up through the sheets. Upon examination, there were breaks in the mattress liner appearing that fluid had accumulated into the foam and when the patient's weight compressed the foam, fluids seeped back through the non-intact cover staining the sheets with a fluid substance that was red-tinged.


Device:
Type: Catheter Stabilization Device
Manufacturer: Bard Medical
Brand: Statlock Picc Plus Foam
Cat #: VPPCSP

Problem:
Six StatLock devices from five patients were found to have the hard plastic "clip" portion separated from the adhesive foam portion of the device.

In two of the events, the StatLock device was included in a PICC tray received from the PICC manufacturer. In the four other events, the devices were opened separately, but the packaging was not saved. No lot numbers were documented as they are disposable devices.
In one of the events, the loss of stabilization of the PICC line resulted in the patient needing another central venous catheter placed quickly by the physician, as the patient was on inotropes and other vasoactive medications. In that instance, it was determined that the StatLock device may not have been the appropriate securement device because of the patient's small size (2.9 kg).

In all instances, it appears that the way the hard plastic clip device was joined to the foam adhesive portion failed.
======================
Manufacturer response for Catheter Stabilization Device, StatLock PICC Plus Foam (per site reporter)
======================
No response yet.


Device:
Type: Catheter, Picc
Manufacturer: Bard Access Systems, Inc.
Brand: 4Fr Dual Lumen Picc
Cat #: REVE0051
Other #: concern with other lot numbers of REU10556, REUF1089

Problem:
Between the spring of this year and late summer ten PICC lines on ten different patients had to be replaced because they have had a hole and/or were broken. These repeated holes or breaks have our IV specialist concerned of product defect.


Device:
Type: Catheter, Picc
Manufacturer: Navilyst Medical
Brand: Xcela Pasv 3f 55cm Intermediate Mst -45 Lido Kit
Model#: Product Number H965457050
Lot #: 4105215
Cat #: Order Number 45-705

Problem:
Conducting a trial of the Navilyst PowerPicc line. On three occasions, when inserting the line, the RN's noted that the catheter length markings were rubbing off of the catheter. Length markings are integral to confirming the placement of the line.
======================
Manufacturer response for Power PICC line, XCELA PASV 3F 55CM INTERMEDIATE MST - 45 LIDO KIT (per site reporter)
======================
Requested products be sent to them. Indicated that they had not heard of this happening before. "Navilyst Medical's catheter assembly process includes verification that all printing is complete and legible, as well as testing for ink adhesion. A review of the Device History Records was performed for the reported packaging lot for any deviations related to the reported defect of the complaint. The review confirms that the lot met all material, assembly and performance specifications."


Device 1:
Type: Catheter, Picc
Manufacturer: Navilyst Medical
Brand: Xcela Pasv 3f 55cm Intermediate Mst -45 Lido Kit
Model#: H965457050
Lot #: 4105214
Cat #: 45-705

Device 2:
Type: Catheter, Picc
Manufacturer: Navilyst Medical
Brand: Xcela Pasv 3f 55cm Intermediate Mst -45 Lido Kit
Model#: H965457050
Lot #: 4128439
Cat #: 45-705

Problem:
RN was placing a PowerPICC line, and attempts to advance the wire stylet were met with resistance. The wire began to kink. The RN made an attempt to retract the wire stylet. It bunched up and was unable to be removed. The whole catheter with stylet had to be removed and another kit obtained for placement of the line. In one of these cases, the RN also reported that the black numbers and measurement marks on the catheter rubbed off during handling.
======================
Manufacturer response for Power PICC line, XCELA PASV 3F 55CM INTERMEDIATE MST - 45 LIDO KIT (per site reporter)
======================
Manufacturer has not yet had the opportunity to evaluate the product for the wire stylet issue.
======================
Manufacturer response for POWER PICC Line, XCELA PASV 3F 55CM INTERMEDIATE MST - 45 LIDO KIT (per site reporter)
======================
Manufacturer has not yet had the opportunity to evaluate the problem with the wire stylet kinking.


Device:
Type: Catheter, Picc
Manufacturer: Vygon
Brand: Premicath 1fr /28g X20 Cm
Lot #: 240311GD
Cat #: 1261.208

Problem:
Nurse was preparing a Premicath 1Fr 28 gauge central venous catheter for insertion and noted that the line was leaking. The leak was observed between the 9 and 10 cm markings on the catheter.

As this product was not actually used (due to the leak), no patient information was provided.
======================
Manufacturer response for Neonatal PICC Line, Premicath 1Fr / 28G x 20 cm (per site reporter)
======================
Awaiting results of product testing.


Device:
Type: Lights, Phototherapy
Manufacturer: Natus Medical Incorporated
Brand: Bili Light

Lollipop Icon

Problem:
Nurse cut her lower thumb area on fiberglass cover of phototherapy light while moving it over infant's bed. To prevent future injuries the nurse wrote "manufacturer should cover edges of fiberglass so sharp edges are not exposed".


Device:
Type: Mediport
Manufacturer: Bard Access Systems
Lot #: 3789
Cat #: 3789

Problem:
Bard Mediport catheter was placed at different facility. One or two weeks later, when the patient went to receive their chemo through this port, the patient experienced pain and discomfort. The patient was then taken to radiology. The x-ray revealed that the catheter had broken away from the port. The patient then made an appointment to be seen here to have a catheter removed. It was discovered upon removal that the catheter had broken away from the port. It certainly appears that this was not a clean-cut and had nothing to do with how it was implanted, but actual breakdown of the material around the port.

Device:
Type: Port, Catheter, Implanted
Manufacturer: AngioDynamics
Brand: Smartport Ct
Model#: CT80STPD
Lot #: 504373
Cat #: CT80STPD

Problem:
Patient brought to the operating room to have a fractured SmartPort removed and replaced.
======================
Manufacturer response for SmartPort CT-Injectable Port, Smart Port CT (per site reporter)
======================
Manufacturer provided RGA# for product return evaluation.


Device 1:
Type: Port, Implanted, Catheter
Manufacturer: Covidien
Brand: Autosuture Chemosite
Model#: 9 French
Lot #: N1B0746L
Cat #: 120045

Device 2:
Type: Port, Implanted, Catheter
Manufacturer: Covidien
Brand: Autosuture Chemosite
Model#: 9 French
Lot #: N1B0746L
Cat #: 120045

Device 3:
Type: Port, Implanted, Catheter
Manufacturer: Covidien
Brand: Autosuture Chemosite
Model#: 9 French
Lot #: N0MO641L
Cat #: 120045

Device 4:
Type: Port, Implanted, Catheter
Manufacturer: Covidien
Brand: Autosuture Chemosite
Model#: 9 French
Lot #: N0MO641L
Cat #: 120045

Problem:
Patient #1 had a Chemosite port implanted at the hospital for chemotherapy treatment. The patient did not show signs of bruising or complain of pain. However, a follow up x-ray showed that the catheter had broken. The catheter and port were removed at another facility.
The port and remaining piece of catheter were removed and retained by the hospital for evaluation. The catheter appears to have sheared about 2-5/8" from the port. The edge of the cut was straight and it does not appear like the catheter had burst.

It was noted that another catheter from the same lot# had recently been removed because it had cracked. Hospital records showed that 2 additional catheters from different lots had also been removed recently due to leaking or breakage.

Patient #2 had the same type of Chemosite port implanted in the spring of this year. After about a month, the catheter began leaking and the port was removed. Another port was implanted on the same patient. This port also began leaking and was removed.

Patient #3 also had the same type of port implanted. This port was removed five months later because the catheter had broken and a piece had embolized.

In addition, a fourth incident was noted from a few years ago. Patient#4 had the same type of port implanted. Subsequently, the catheter broke and the port and remaining catheter had to be removed. This port had been retained by the hospital. The catheter had broken approximately 3-1/2" from the port. The edges of the break are frayed and stretched.

There have been a total of four recent Chemosite 9 French catheters breaking after implantation, with two from the same lot. An additional incident was noted from a few years ago.


Device:
Type: Warmer, Infant Radiant
Manufacturer: Draeger Medical
Model#: RW22-1

Lollipop Icon

Problem:
Caster broke while moving the device from storage spot to patient room. Examination of the wheel indicated that the stud supporting the caster was made of "pot" metal and did not appear to be of sufficient strength to be used on equipment that could be transporting critically ill neonates.
======================
Health Professional's Impression
======================
Broken wheel rendered the device unsafe for pt. use
======================
Manufacturer response for Infant resuscitation/warming device, (brand not provided) (per site reporter)
======================
All 4 casters changed as a precautionary practice


NEUROLOGY

Device:
Type: Cap, Cooling
Manufacturer: Natus Medical Incorporated
Brand: Cool-cap
Model#: COOL-CAP

Lollipop Icon

Problem:
An electrical burning odor was noted at 0500. Staff swapped out open warmer, at approximately 1320 the electrical burning odor was once again noted at the bedspot. Clinical Engineering was called and about ten minutes later a popping noise (three quick pops) was heard and the screen on the cool cap machine went blank and the machine stopped functioning. The infant was immediately taken off the cool cap and moved to another bedspot. To maintain therapy the infant was transported to another facility that could offer cooling therapy.
======================
Manufacturer response for Hypothermia Units, Infant, Head, Cool-Cap (per site reporter)
======================
Manufacturer provided RGA# for device return evaluation and repair.


Device:
Type: Shunt, Central Nervous System
Manufacturer: Medtronic, Inc.
Brand: Strata Ii Programmable Vp Shunt

Problem:
Pt admitted to hospital. During hospital stay, a brain MRI was warranted and completed. Pt's programmable VP shunt settings were not checked while pt remained in inpatient status. Approximately 3 weeks later, pt developed increased headache and went to neurosurgeon's office for evaluation. At clinic, pt's VP shunt settings were checked and noted to not be at correct settings. Settings were corrected at this time. Pt did not suffer any permanent injury and did not develop any other medical conditions related to this, but there is a potential for harm for pt's who do not get their programmable VP shunt settings checked after MRI procedures done.


OBSTETRICS/GYNECOLOGY

Device:
Type: Clamp, Circumcision
Manufacturer: Covidien
Brand: Devon
Model#: 56421

Lollipop Icon

Problem:
Physician did a circumcision that required pressure and use of Avitene. She felt that the clamp was defective due to oozing at circumcision site. Clamp brought down to sterile processing for evaluation. Sterile processing manager confirmed that the circumcision clamp was the correct size, but the set will be taken out of circulation because he saw that it was old and worn.


PHYSICAL MEDICINE

Device:
Type: Warmer, Infant
Manufacturer: Cardinal Health
Brand: Cardinal Heel Warmer
Lot #: (01)00630140017394
Cat #: 11460-010T

Lollipop Icon

Problem:
RN was squeezing the Cardinal Infant Heel Warmer to activate the warming chemicals and it burst, spewing the contents all over her and another nurse. RN got it on her skin and said it burned for a few minutes but did not leave any lasting marks. The defect on the heel warmer package was that it split from the top. Although no other incidents have occurred to date, there is a concern about possible defective packaging.


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Lollipop Icon
Special Note: The lollipop icon distinguishes highlighted reports that describe medical device events involving neonatal or pediatric patients, or those events involving a medical device that is indicated for use in neonatal and pediatric patient populations. FDA defines pediatric patients as less than 21 years of age.


MedSun Newsletters are available at www.fda.gov/cdrh/medsun